NO ( DrugBank: - )

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9 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
6	パーキンソン病	1204
46	悪性関節リウマチ	2861
58	肥大型心筋症	63
62	発作性夜間ヘモグロビン尿症	292
86	肺動脈性肺高血圧症	706
97	潰瘍性大腸炎	1685
222	一次性ネフローゼ症候群	121
299	嚢胞性線維症	1091
321	非ケトーシス型高グリシン血症	1

6. パーキンソン病

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臨床試験数 : 2,307 /  薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05669170 (ClinicalTrials.gov)	January 2024	16/12/2022	Methylphenidate for Apathy in Veterans With Parkinson's Disease	Evaluating Safety and Potential Benefit of Methylphenidate as a Symptomatic Treatment for Apathy in Veterans With Parkinson's Disease.	Parkinson Disease;Apathy	Behavioral: Psychosocial intervention;Drug: Methylphenidate	Ralph H. Johnson VA Medical Center	NULL	Not yet recruiting	40 Years	N/A	All	60	Phase 2	NULL
2	NCT05721911 (ClinicalTrials.gov)	June 2023	30/1/2023	Implementing a National Biobank of PD With WGS and Functional Assessment of Polygenic Inheritance by iPSC Technology	Implementing a National Biobank of Genetic, Sporadic and Prodromic Parkinson's Disease With Whole Genome Analysis and Functional Assessment of Polygenic Inheritance by iPSC Technology	Parkinson Disease;REM Sleep Behavior Disorder	Genetic: whole genome sequencing	Neuromed IRCCS	NULL	Not yet recruiting	18 Years	N/A	All	230		Italy
3	NCT05709301 (ClinicalTrials.gov)	April 1, 2023	11/1/2023	Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease	Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease	Parkinson Disease;Mild Cognitive Impairment	Drug: Donepezil Hydrochloride;Drug: Placebo	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	NULL	Not yet recruiting	50 Years	80 Years	All	120	Phase 2	NULL
4	NCT05634876 (ClinicalTrials.gov)	April 2023	23/11/2022	UB-312 in Patients With Synucleinopathies	A Phase 1b Clinical Trial of UB-312 in Patients With Synucleinopathies	Multiple System Atrophy;Parkinson Disease	Biological: UB-312 Injection;Biological: Placebo Injection	NYU Langone Health	NULL	Not yet recruiting	40 Years	75 Years	All	8	Phase 1/Phase 2	United States
5	NCT05636852 (ClinicalTrials.gov)	March 31, 2023	1/11/2022	Altropane Dose for Imaging Patients With Suspected Parkinson's Disease	An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging	Parkinson Disease;Movement Disorders	Drug: Altropane (123I) Injection	GE Healthcare	Labcorp Drug Development Inc	Not yet recruiting	18 Years	N/A	All	30	Phase 2	NULL
6	NCT05094011 (ClinicalTrials.gov)	March 1, 2023	20/7/2021	Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease	A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease	Idiopathic Parkinson's Disease	Biological: Aadipose-Derived Mesenchymal Stem Cells	Taiwan Mitochondrion Applied Technology Co., Ltd.	NULL	Not yet recruiting	45 Years	70 Years	All	9	Phase 1	NULL
7	NCT05611372 (ClinicalTrials.gov)	January 1, 2023	6/11/2022	Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease	Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease	REM Sleep Behavior Disorder;Parkinson Disease;Synucleinopathies	Drug: Rasagiline	Second Affiliated Hospital, School of Medicine, Zhejiang University	Beijing Tiantan Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Jiangsu Province Nanjing Brain Hospital;The First Affiliated Hospital of Anhui Medical University;Huashan Hospital;Second Affiliated Hospital of Soochow University;Guizhou Medical University;The First Affiliated Hospital of Guangzhou Medical University;West China Hospital;Sir Run Run Shaw Hospital;The Affiliated Hospital of Hangzhou Normal University;The First Affiliated Hospital of Dalian Medical University;Qilu Hospital of Shandong University;Fujian Medical University Union Hospital	Not yet recruiting	30 Years	75 Years	All	732	Phase 2/Phase 3	NULL
8	NCT05469997 (ClinicalTrials.gov)	January 2023	15/6/2022	Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome	Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome	Parkinson Disease	Behavioral: Mediterranean-Ketogenic Diet;Dietary Supplement: Mediterranean diet supplemented with medium-chain triglyceride oil	University of British Columbia	Weston Family Foundation	Not yet recruiting	45 Years	85 Years	All	50	N/A	NULL
9	NCT05435755 (ClinicalTrials.gov)	December 2, 2022	15/3/2022	Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease.	The Precise Transplantation of Human Amniotic Epithelial Stem Cells Into the Ventricle Through Surgical Robot in the Treatment of Parkinson's Disease.	Parkinson's Disease	Biological: hAESCs treatment;Biological: placebo (saline)	Shanghai East Hospital	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Not yet recruiting	30 Years	70 Years	All	12	Early Phase 1	China
10	NCT05197439 (ClinicalTrials.gov)	December 1, 2022	5/1/2022	Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease	Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial	Dexmedetomidine;Postoperative Delirium;Deep Brain Stimulation	Drug: Dexmedetomidine;Drug: 0.9% saline	Beijing Tiantan Hospital	NULL	Not yet recruiting	60 Years	N/A	All	192	N/A	China
11	NCT05635409 (ClinicalTrials.gov)	November 30, 2022	15/11/2021	A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease	STEM-PD Trial: A Multicentre, Single Arm, First in Human, Dose-escalation Trial, Investigating the Safety and Tolerability of Intraputamenal Transplantation of Human Embryonic Stem Cell Derived Dopaminergic Cells for Parkinson's Disease (STEM-PD Product)	Parkinson Disease	Biological: STEM-PD	Region Skane	Lund University;Cambridge University Hospitals NHS Foundation Trust;University of Cambridge	Recruiting	50 Years	75 Years	All	8	Phase 1	Sweden;United Kingdom
12	NCT05589766 (ClinicalTrials.gov)	November 28, 2022	13/10/2022	N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease	N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease	Parkinson Disease	Dietary Supplement: Nicotinamide Riboside;Other: Placebo	Haukeland University Hospital	NULL	Recruiting	40 Months	100 Years	All	80	N/A	Norway
13	NCT05568498 (ClinicalTrials.gov)	October 30, 2022	15/6/2022	Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease	Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease	Parkinson Disease;Depression	Dietary Supplement: Probiotic;Dietary Supplement: Placebo	University of British Columbia	NULL	Not yet recruiting	40 Years	80 Years	All	60	Phase 2	NULL
14	NCT05581823 (ClinicalTrials.gov)	October 19, 2022	12/10/2022	Study to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Inducer Carbamazepine on Tavapadon Pharmacokinetics in Healthy Adult Participants	A Phase 1, Open-label, Fixed-sequence, Crossover Trial to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Induction by Carbamazepine on the Steady-state Pharmacokinetics of Tavapadon in Healthy Adult Participants	Parkinson Disease	Drug: Tavapadon;Drug: Carbamazepine	Cerevel Therapeutics, LLC	NULL	Active, not recruiting	18 Years	55 Years	All	16	Phase 1	United States
15	NCT05550714 (ClinicalTrials.gov)	October 15, 2022	20/9/2022	Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease	Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION):A Randomized Controlled, Non-Inferiority Study	PD - Parkinson's Disease;Dexmedetomidine;Desflurane;Deep Brain Stimulation	Drug: general anesthesia;Drug: Conscious sedation	Beijing Tiantan Hospital	NULL	Recruiting	50 Years	80 Years	All	188	N/A	China
16	NCT04810104 (ClinicalTrials.gov)	October 2022	15/3/2021	Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug	Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug	Parkinson Disease;Mild Cognitive Impairment	Drug: AZD0328;Drug: Placebo	King's College London	Helse Stavanger HF;Michael J. Fox Foundation for Parkinson's Research;Parkinsons Org UK;AstraZeneca;Masaryk University;Norges Parkinsonforbund, Norway;University of Exeter;Stichting Lygature;Innovative Medicines Initiative	Withdrawn	50 Years	80 Years	All	0	Phase 2	Norway
17	NCT05370079 (ClinicalTrials.gov)	September 16, 2022	6/5/2022	Control Cohort CTRL COH	Control Cohort CTRL COH	Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis	Biological: Collection of biological sample (blood and/or CSF)	Hospices Civils de Lyon	NULL	Not yet recruiting	18 Years	N/A	All	350	N/A	France
18	NCT05523570 (ClinicalTrials.gov)	August 22, 2022	24/8/2022	A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension	Phase 1, Non-randomized, Single Ascending Doses (SAD) Study Following Single Injection in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HNC364 Injectable Suspension	Parkinson's Disease	Drug: HNC364	Guangzhou Henovcom Bioscience Co. Ltd.	NULL	Recruiting	18 Years	45 Years	All	18	Phase 1	United States
19	JPRN-jRCTs041220054	15/08/2022	15/08/2022	The effects of prebiotics on Parkinson's disease patients with wearing-off	The effects of prebiotics on wearing-off and intestinal environment in patients with Parkinson's disease	Parkinson's disease patients with wearing-off over 20 years old	administration of kestose and inulin Dose / Usage) Kestose: 6 g (3 g in the morning, 3 g in the evening) / 2 times a day, orally Inulin: 6g (3g in the morning, 3g in the evening) / 2 times a day, orally Administration period) 8 weeks	Hirooka Yoshiki	Watanabe Hirohisa	Recruiting	>= 20age old	Not applicable	Both	20	Phase 1-2	Japan
20	NCT04147949 (ClinicalTrials.gov)	August 2022	27/10/2019	AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia	Randomized, Double-Blind, Placebo-Controlled, Crossover, Proof-of-Concept Phase 2 Study to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia	Parkinson Disease;Dyskinesia, Medication-Induced;L-Dopa Causing Adverse Effects in Therapeutic Use	Drug: AV-101;Drug: Placebo	VistaGen Therapeutics, Inc.	NULL	Not yet recruiting	30 Years	80 Years	All	20	Phase 2	NULL
21	JPRN-UMIN000047341	2022/07/01	31/03/2022	Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease.	Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease. - Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease.	Parkinson's disease	The dance exercise group will have one online lesson per week with a coach, 60 minutes (see Appendix for details) and 30 minutes of video dance (movement review and lesson) as a home trainer to perform the exercises. The active control group was instructed to perform stretching, flexibility, and relaxation exercises (excluding strength, balance, aerobic, and functional training) three times a week for 30 minutes per session. These exercises were selected from several physical therapy programs created for persons with Parkinson's disease.	Department of Neurology, Fukuoka university	NULL	Pending	30years-old	75years-old	Male and Female	60	Not selected	Japan
22	NCT05355064 (ClinicalTrials.gov)	May 2022	18/12/2021	Efficacy of Oral Administration of Trehalose in Patients With Parkinson Disease	Efficacy of Oral Administration of Trehalose in Patients With Parkinson Disease in Both Idiopathic and Induced by LRRK2 Mutation	Parkinson Disease	Drug: Trehalose	Neuromed IRCCS	NULL	Not yet recruiting	18 Years	80 Years	All	20	Phase 4	NULL
23	JPRN-jRCTs052220012	01/04/2022	22/04/2022	A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device in patients withParkinson's disease.	A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device for gait instability in patients with Parkinson's disease. a randomized controlled trial	Parkinson's disease Parkinson's disease	The normal rehabilitation group and the HAL grou p are assigned 1: 1 and the normal rehabilitation g roup is subjected to normal walking training, and t he HAL group is subjected to walking training by H AL.	Kohara Nobuo	NULL	Recruiting	>= 20age old	Not applicable	Both	30	N/A	Japan
24	ChiCTR2100048680	2022-04-01	2021-07-12	The clinical study on the sedative efficacy and wakefulness of dexmedetomidine in Parkinson's disease patients	The clinical study on the sedative efficacy and wakefulness of dexmedetomidine in Parkinson's disease patients	Parkinson's disease	Experimental group:An infusion of dexmedetomidine;Control group:None;	The First Affiliated Hospital of University of Science and Technology of China (Southern District Phase 2)	NULL	Recruiting	45	65	Both	Experimental group:30;Control group:30;		China
25	NCT05266417 (ClinicalTrials.gov)	February 7, 2022	23/2/2022	Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease	A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD)	Parkinson Disease	Drug: INS-GSH;Drug: Matched Placebos	Gateway Institute for Brain Research	NULL	Recruiting	30 Years	85 Years	All	56	Phase 2	United States
26	EUCTR2021-005024-37-NL (EUCTR)	24/01/2022	19/01/2022	Evaluation of a novel PET tracer [18F]MC225 to measure the function of P-glycoprotein, a transporter at the blood brain barrier, in neurodegenerative disease	Evaluation of [18F]MC225 to measure P-glycoprotein function in neurodegenerative disease	- Alzheimer's disease - Mild Cognitive Impairment - Parkinson's disease;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Product Name: [18F]MC225 INN or Proposed INN: [18F]MC225 Other descriptive name: [18F]MC225	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Netherlands
27	NCT04831281 (ClinicalTrials.gov)	January 20, 2022	1/4/2021	ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)	A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies	Parkinson Disease Dementia;Dementia With Lewy Bodies	Drug: ATH-1017;Drug: Placebo	Athira Pharma	NULL	Active, not recruiting	40 Years	85 Years	All	28	Phase 2	United States
28	NCT05094050 (ClinicalTrials.gov)	January 18, 2022	20/10/2021	Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease	Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients	Parkinson's Disease	Drug: ABBV-951	AbbVie	NULL	Active, not recruiting	30 Years	N/A	All	16	Phase 1	United States
29	NCT05152394 (ClinicalTrials.gov)	January 2022	29/11/2021	Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Parkinson's Disease	Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Parkinson's Disease	Parkinson Disease	Biological: AlloRx	The Foundation for Orthopaedics and Regenerative Medicine	NULL	Not yet recruiting	N/A	N/A	All	20	Phase 1	Antigua and Barbuda
30	NCT04265209 (ClinicalTrials.gov)	December 1, 2021	6/2/2020	[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor	Non-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor.	Parkinson Disease;Essential Tremor	Drug: SPECT;Drug: PET	Zionexa	NULL	Recruiting	35 Years	80 Years	All	112	Phase 3	France
31	NCT03446807 (ClinicalTrials.gov)	December 2021	20/2/2018	Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism	Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism	Parkinson Disease;Multiple System Atrophy;Progressive Supranuclear Palsy	Drug: Droxidopa;Drug: Placebo Oral Tablet	Loma Linda University	H. Lundbeck A/S	Not yet recruiting	50 Years	N/A	All	32	Phase 2	United States
32	NCT04990284 (ClinicalTrials.gov)	November 29, 2021	27/7/2021	eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.	A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease.	Parkinson Disease	Drug: Opicapone;Drug: L-DOPA/DDCI	Bial - Portela C S.A.	NULL	Recruiting	30 Years	N/A	All	100	Phase 4	Germany;Italy;Portugal;Spain;United Kingdom
33	NCT04944017 (ClinicalTrials.gov)	November 23, 2021	22/6/2021	Ketamine for the Treatment of Depression in Parkinson's Disease	Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD)	Parkinson's Disease;Depression	Drug: Ketamine Infusion;Other: Placebo - Saline Infusion	Yale University	Fox (Michael J.) Foundation for Parkinson's Research	Recruiting	40 Years	80 Years	All	56	Phase 2	United States
34	NCT05164783 (ClinicalTrials.gov)	November 23, 2021	28/10/2021	Multicenter Implementation of E-monitoring in Parkinson's Disease	Multicenter Implementation of E-monitoring in Parkinson's Disease	Parkinson Disease	Combination Product: Sanacoach Parkinson (SCP)	Zuyderland Medisch Centrum	AbbVie	Recruiting	30 Years	N/A	All	450	N/A	Netherlands
35	NCT05173701 (ClinicalTrials.gov)	November 22, 2021	8/11/2021	Effects of Probiotics on Peripheral Immunity in Parkinson's Disease	Effects of Probiotics on Peripheral Immunity in Parkinson's Disease	Parkinson's Disease	Dietary Supplement: Probiotics;Dietary Supplement: Placebo	Franca Marino	Università degli Studi del Piemonte Orientale Amedeo Avogadro;Università degli Studi dell'Insubria	Enrolling by invitation	N/A	N/A	All	88	N/A	Italy
36	NCT04871464 (ClinicalTrials.gov)	November 11, 2021	29/4/2021	Role and Mechanism of Probiotics in Improving Motor Symptoms in Mild to Moderate Parkinson's Disease	Role and Mechanism of Bifidobacterium Triple Viable Capsules in Improving Motor Symptoms in Patients With Mild to Moderate Parkinson's Disease: a Multicenter Randomized Clinical Study	Parkinson Disease;Parkinsonian Disorders;Basal Ganglia Diseases;Brain Diseases;Movement Disorders;Neurodegenerative Diseases;Central Nervous System Diseases;Nervous System Diseases	Drug: Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules;Other: Placebo	Beijing Friendship Hospital	NULL	Recruiting	40 Years	85 Years	All	240	Phase 4	China
37	NCT05297201 (ClinicalTrials.gov)	November 2, 2021	17/2/2022	Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients With Levodopa Induced Dyskinesia	Phase II, Double Blind, Randomized, Placebo Controlled, Parallel Group, Trial to Explore the Potential Anti-dyskinetic Properties of CPL500036 (PDE10A Inhibitor) in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesia	Parkinson Disease;Dyskinesia, Medication-Induced	Drug: CPL500036 - low dose;Drug: CPL500036 - high dose;Drug: Placebo	Celon Pharma SA	National Center for Research and Development, Poland	Recruiting	50 Years	80 Years	All	108	Phase 2	Poland
38	NCT05056194 (ClinicalTrials.gov)	November 1, 2021	17/9/2021	Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study	A Double-blind, Randomized, Placebo-controlled, Parallel, Study to Assess the Efficacy and Safety of XW10172 MR for the Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease	Parkinson Disease;Excessive Daytime Somnolence	Drug: Valiloxybate;Other: Placebo	XWPharma	NULL	Not yet recruiting	40 Years	75 Years	All	70	Phase 2	NULL
39	NCT04983290 (ClinicalTrials.gov)	November 1, 2021	9/6/2021	Outcomes to the Nutritional Need of Patients With Parkinson's Disease	Clinical Trial to Assess the Effectiveness of the Food Plan Consisting of Products With Modified Consistency Called (Weancare-Domus) in Changing the Quality of Life in Patients With Parkinson's Disease	Deglutition Disorders;Parkinson Disease;Nursing;Quality of Life	Dietary Supplement: weancare-domus	Milko Zanini	Azienda Sanitaria Locale 3 Genovese	Not yet recruiting	18 Years	N/A	All	140	N/A	Italy
40	NCT05128175 (ClinicalTrials.gov)	October 29, 2021	27/10/2021	Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions	An Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed Conditions	Parkinson Disease	Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets	Shanghai WD Pharmaceutical Co., Ltd.	NULL	Recruiting	18 Years	45 Years	All	15	Phase 1	India
41	NCT05084365 (ClinicalTrials.gov)	October 10, 2021	7/10/2021	A 6-month Study to Evaluate Sulforaphane Effects in PD Patients	A 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD Patients	Parkinson Disease	Drug: Sulforaphane;Drug: Placebo	Central South University	NULL	Not yet recruiting	40 Years	75 Years	All	100	Phase 2	NULL
42	NCT05106504 (ClinicalTrials.gov)	September 2, 2021	16/10/2021	Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease	Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease	Bladder, Overactive;Parkinson Disease	Drug: Medical Cannabis	Sheba Medical Center	NULL	Recruiting	18 Years	80 Years	All	100		Israel
43	ChiCTR2200059544	2021-09-01	2022-05-04	Nomogram for Prediction of Postoperative Delirium after Deep Brain Stimulation of Subthalamic Nucleus in Parkinson's Disease under General Anesthesia	Nomogram for Prediction of Postoperative Delirium after Deep Brain Stimulation of Subthalamic Nucleus in Parkinson's Disease under General Anesthesia	Parkinson's disease	Gold Standard:Clinical outcome;Index test:The clinical prediction model of delirium after deep brain stimulation of the subthalamic nucleus in Parkinson's disease under general anesthesia.;	First Affiliated Hospital of Sun Yat-sen University	NULL	Completed	18	80	Both	Target condition:240;Difficult condition:0		China
44	ChiCTR2100050538	2021-09-01	2021-08-28	Clinical study of Ganoderma lucidum extract in the treatment of motor and non motor symptoms in patients with early PD	Clinical study of Ganoderma lucidum extract in the treatment of motor and non motor symptoms in patients with early PD	Parkinson's disease	Experimental group:Reishi Mushroom Extract Treatment;Control group:None;	Xuanwu Hospital of Capital Medical University	NULL	Recruiting	18	80	Both	Experimental group:30;Control group:30;		China
45	EUCTR2021-000541-41-DE (EUCTR)	09/06/2021	29/04/2021	Joint European Research on active and emerging pandemics	European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial - EU-SolidAct	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa	Oslo University Hospital	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	United States;Czechia;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia
46	NCT04346394 (ClinicalTrials.gov)	May 11, 2021	10/3/2020	The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease	The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease: Orthostatic Hypotension and Other Nonmotor Symptoms	Parkinson Disease	Drug: Yohimbine HCl	Nathaniel M. Robbins	NULL	Suspended	N/A	N/A	All	22	Early Phase 1	United States
47	NCT04802733 (ClinicalTrials.gov)	May 3, 2021	12/3/2021	Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson's Disease	Phase 1 Study To Assess the Safety and Tolerability of Human Embryonic Stem Cell-Derived Midbrain Dopamine Neuron Cell Therapy (MSK-DA01) For Advanced Parkinson's Disease	Advanced Parkinson's Disease	Biological: MSK-DA01;Device: MSK-DA01 Cell Delivery Device	BlueRock Therapeutics	Memorial Sloan Kettering Cancer Center	Active, not recruiting	50 Years	78 Years	All	12	Phase 1	United States;Canada
48	NCT04867642 (ClinicalTrials.gov)	April 29, 2021	27/4/2021	A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease	A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, and Pharmacokinetics of UCB0022 in Healthy Participants and Participants With Parkinson's Disease	Healthy Study Participants;Parkinson's Disease	Drug: UCB0022;Other: Placebo	UCB Biopharma SRL	NULL	Active, not recruiting	18 Years	75 Years	All	100	Phase 1	United Kingdom
49	EUCTR2021-000826-89-FR (EUCTR)	23/04/2021	25/03/2021	Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement	Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: APOKINON Product Name: APOKINON Product Code: N04BC07	CHU Rennes	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	20	Phase 4	France
50	EUCTR2021-000867-65-DE (EUCTR)	19/04/2021	16/03/2021	Investigation of the adhesion properties of a newly developed rotigotine-containing patch in patients with Parkinson's disease	Comparative, randomized, open, crossover clinical trial to investigate adhesiveness of a newly developed rotigotine-containing transdermal patch in patients with Parkinson's disease	Idiopathic Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]	Product Name: ROT-TDS 8 mg/24 h INN or Proposed INN: ROTIGOTINE Trade Name: Neupro® 8 mg/24 h Product Name: Neupro® 8 mg/24 h INN or Proposed INN: ROTIGOTINE	Luye Pharma Switzerland AG	NULL	Not Recruiting			Female: yes Male: yes	38	Phase 2	Germany
51	EUCTR2019-000247-27-FR (EUCTR)	31/03/2021	05/03/2019	Study to demonstrate an at least equivalent performance of a new test in brain imaging test compared to the reference examination to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.	Non-inferiority study of the molecular imaging of dopamine transporters using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to distinguish between Parkinson’s Disease and Essential Tremor. - DATTEP	Patients suffering from an essential tremor or with Parkinson's disease. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10015496;Term: Essential tremor;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]	Trade Name: DaTSCAN 74 MBq/ml solution for injection Product Code: [18F] LBT-999	ZIONEXA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	112	Phase 3	France
52	JPRN-jRCTs051200160	24/03/2021	24/03/2021	ZEAL study	Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease: A Randomized Single-Blind Placebo-Controlled Trial - ZEAL	Parkinson's disease Parkinson's disease,Somnipathy;D010300	70 patients with Parkinson's disease were allocated to Zonisamide tablets (Trelief OD tablets) 1T (25mg) or placebo 1T at a time before going to bed by randomizing soft, and the efficacy of zonisamide tablet (Trelief OD tablets) for sleep is investigated comparing the parallel-group before and after administration	Hiroshi Kataoka	NULL	Recruiting	>= 41age old	Not applicable	Both	70	Phase 2-3	Japan
53	NCT04322461 (ClinicalTrials.gov)	March 15, 2021	24/3/2020	Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population	Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKA	Parkinson Disease;Alzheimer Disease	Dietary Supplement: Betaquik MCT supplement	Université de Sherbrooke	Nestlé	Not yet recruiting	60 Years	N/A	All	20	N/A	NULL
54	JPRN-jRCTs041190126	22/02/2021	10/03/2020	Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease	Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease - NaT-PROBEi	Lewy body disease (Parkinson's disease and dementia with Lewy bodies)	Arm zonisamide: 1.Two tablets of zonisamide 25mg after breakfast for 4 weeks 2.Four tablets of zonisamide 25mg after breakfast for 92 weeks Arm placebo: 1.Two tablets of placebo after breakfast for 4 weeks 2.Four tablets of placebo after breakfast for 92 weeks	Katsuno Masahisa	Japan Agency for Medical Research and Development	Not Recruiting	>= 50age old	< 80age old	Both	30	Phase 2	Japan
55	NCT04643327 (ClinicalTrials.gov)	February 9, 2021	18/11/2020	Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease	Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study	Parkinson Disease;Mild Cognitive Impairment;Memory Impairment	Drug: Levetiracetam;Drug: Placebo	The University of Queensland	Johns Hopkins University;Cleveland Clinic Lou Ruvo Center for Brain Health;Royal Brisbane and Women's Hospital;Queensland University of Technology	Recruiting	N/A	N/A	All	28	Phase 2	Australia
56	NCT04590612 (ClinicalTrials.gov)	January 2021	17/9/2020	Improving Quality of Life in Early Parkinson's Disease	The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients	Parkinson Disease;Depression	Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: Citalopram	Western University, Canada	NULL	Not yet recruiting	50 Years	80 Years	All	30	N/A	NULL
57	NCT04658186 (ClinicalTrials.gov)	December 30, 2020	1/12/2020	A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease	A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease	Early-stage Parkinson's Disease	Drug: UCB0599;Drug: Placebo	UCB Biopharma SRL	NULL	Active, not recruiting	40 Years	75 Years	All	490	Phase 2	United States;Canada;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom
58	JPRN-jRCTs031200172	23/12/2020	26/10/2020	Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipation	Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. - CONST-PD	Parkinson's disease, chronic constipation Parkinson's syndrome,chronic constipation,Symptomatic constipation	Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment.	Hatano Taku	Mochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd.	Not Recruiting	>= 20age old	Not applicable	Both	100	N/A	Japan
59	NCT04685265 (ClinicalTrials.gov)	December 22, 2020	17/12/2020	A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's Disease	A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of anle138b, and to Characterise the Effect of Food of anle138b in Mild to Moderate Parkinson's Disease	Parkinson Disease	Drug: anle138b;Drug: Placebo	MODAG GmbH	Aptuit (Verona) Srl, an Evotec Company;Quotient Sciences;Nottingham University Hospitals NHS Trust	Active, not recruiting	40 Years	80 Years	All	72	Phase 1	United Kingdom
60	NCT04651153 (ClinicalTrials.gov)	December 14, 2020	25/11/2020	A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)	A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients With Parkinson's Disease	Parkinson's Disease	Drug: UCB7853;Other: Placebo	UCB Biopharma SRL	NULL	Active, not recruiting	18 Years	80 Years	All	57	Phase 1	Netherlands;United Kingdom
61	NCT04506073 (ClinicalTrials.gov)	November 9, 2020	16/7/2020	Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD	Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease: Phase IIa Double-blind Randomized Placebo Controlled Trial	Parkinson's Disease	Drug: MSC+placebo;Drug: MSC;Drug: Placebo	The University of Texas Health Science Center, Houston	Michael J. Fox Foundation for Parkinson's Research	Active, not recruiting	50 Years	79 Years	All	45	Phase 2	United States
62	NCT04620382 (ClinicalTrials.gov)	November 9, 2020	27/10/2020	Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients	Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients	Neurogenic Orthostatic Hypotension;Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson Disease	Drug: Midodrine;Drug: Placebo pill;Device: Abdominal compression;Device: sham compression	Vanderbilt University Medical Center	National Heart, Lung, and Blood Institute (NHLBI)	Recruiting	40 Years	80 Years	All	31	Early Phase 1	United States
63	NCT04387773 (ClinicalTrials.gov)	November 5, 2020	11/5/2020	Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease	Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease	Parkinson Disease	Drug: GOCOVRI	Oregon Health and Science University	Adamas Pharmaceuticals, Inc.	Completed	50 Years	80 Years	All	8	Phase 4	United States
64	ChiCTR2000039475	2020-11-01	2020-10-29	Cardiac structural and functional study in Parkinson's Disease with Cardiac Autonomic Neuropathy	Cardiac structural and functional study in Parkinson's Disease with Cardiac Autonomic Neuropathy	Parkinson's Disease	PD Group:not available;MSA Group:not available;DM Group:not available;HC Group :not available ;	Guangdong Provincial People's Hospital	NULL	Recruiting	50	80	Both	PD Group:80;MSA Group:20;DM Group:20;HC Group :40;		China
65	NCT03947216 (ClinicalTrials.gov)	October 23, 2020	7/5/2019	Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease.	Study of Pimavanserin Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease	Parkinson Disease	Drug: Active drug: pimavanserin 17mg (2 strength tablets);Drug: Placebo: 2 tablets containing same excipients except active compound;Behavioral: Assessment of severity of ICD (impulse control disorders);Behavioral: Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors;Behavioral: Assessment of quality of life;Behavioral: Assessment of depression;Behavioral: Assessment of cognition;Behavioral: Assessment of severity of Parkinson Disease;Procedure: Blood analysis;Procedure: Cardiac monitoring	University Hospital, Strasbourg, France	NS-PARK;EUCLID Clinical Trial Platform;F-CRIN	Recruiting	35 Years	75 Years	All	130	Phase 2	France
66	NCT04591535 (ClinicalTrials.gov)	September 28, 2020	11/9/2020	PK Study of WD-1603 in Healthy Subjects	An Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed Conditions	Parkinson Disease	Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS	Hong Kong WD Pharmaceutical Co., Limited	NULL	Recruiting	18 Years	45 Years	All	8	Phase 1	India
67	NCT04553978 (ClinicalTrials.gov)	September 18, 2020	13/9/2020	A Single Oral Dose, Crossover Comparative PK Study of WD-1603 in Healthy Subjects Under Fasting Conditions	An Open Label, Balanced, Randomised, 2-treatment, 2-period, 2-sequence, Single Oral Dose, Corssover Comparative PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fasting Conditions	Parkinson Disease	Drug: WD-1603	Hong Kong WD Pharmaceutical Co., Limited	NULL	Not yet recruiting	18 Years	45 Years	All	8	Phase 1	NULL
68	NCT04513340 (ClinicalTrials.gov)	August 13, 2020	12/8/2020	WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects	AN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONS	Parkinson Disease	Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS	Hong Kong WD Pharmaceutical Co., Limited	NULL	Recruiting	18 Years	45 Years	All	8	Phase 1	India
69	NCT04483479 (ClinicalTrials.gov)	July 30, 2020	20/7/2020	Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover)	A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period	Parkinson Disease;Constipation	Drug: Active Investigational Treatment ENT-01	Enterin Inc.	NULL	Completed	30 Years	90 Years	All	28	Phase 2	United States
70	JPRN-UMIN000040889	2020/06/24	24/06/2020	Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease	Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease - Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease	Parkinson's disease	Levodopa-carbidopa continuous infusion gel (LCIG) therapy	Fujita Health University School of MedicineDepartment of Gastroenterology	NULL	Recruiting	20years-old	Not applicable	Male and Female	200	Phase 4	Japan
71	NCT04379050 (ClinicalTrials.gov)	June 8, 2020	1/5/2020	Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease	An Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease	Parkinson's Disease (PD)	Drug: ABBV-951	AbbVie	NULL	Active, not recruiting	30 Years	N/A	All	130	Phase 3	United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom
72	NCT03568968 (ClinicalTrials.gov)	May 15, 2020	14/6/2018	A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease	A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK Study	Parkinson Disease	Dietary Supplement: Nicotinamide Riboside;Drug: Placebo	Haukeland University Hospital	NULL	Recruiting	18 Years	N/A	All	400	N/A	Norway
73	NCT03959540 (ClinicalTrials.gov)	April 28, 2020	23/4/2019	Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease	A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease	Parkinson Disease	Drug: Opicapone;Drug: Levodopa (L-DOPA) + Standard care	Bial - Portela C S.A.	NULL	Completed	75 Years	N/A	All	39		United Kingdom
74	EUCTR2018-002233-37-PL (EUCTR)	23/04/2020	24/01/2020	Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.	A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations.	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA	Impax Laboratories, LLC	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy
75	NCT02967250 (ClinicalTrials.gov)	April 1, 2020	13/9/2016	Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment	7T Magnetic Resonance Spectroscopy Monitoring Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment	Parkinson Disease	Drug: ursodeoxycholic acid	University of Minnesota	NULL	Not yet recruiting	18 Years	N/A	All	20	Phase 1	United States
76	NCT04167540 (ClinicalTrials.gov)	April 1, 2020	7/11/2019	GDNF Gene Therapy for Parkinson's Disease	Open-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's Disease	Parkinson's Disease	Biological: AAV2-GDNF	Brain Neurotherapy Bio, Inc.	Asklepios Biopharmaceutical, Inc.;California Institute for Regenerative Medicine (CIRM)	Active, not recruiting	35 Years	75 Years	All	11	Phase 1	United States
77	NCT04269642 (ClinicalTrials.gov)	March 19, 2020	13/1/2020	SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease	Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease	Early Parkinson's Disease	Drug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mg	Peptron, Inc.	NULL	Active, not recruiting	40 Years	75 Years	All	99	Phase 2	Korea, Republic of
78	EUCTR2018-003941-41-AT (EUCTR)	05/03/2020	19/06/2019	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
79	NCT04260581 (ClinicalTrials.gov)	March 1, 2020	5/2/2020	Is Long-term Use of Amantadine Effective in PD?	Is Long-term Use of Amantadine Effective in Parkinson Disease?	Parkinson Disease	Drug: Determination of drug effects through amantadine cessation	Seoul National University Hospital	NULL	Not yet recruiting	40 Years	N/A	All	32	N/A	Korea, Republic of
80	NCT04154072 (ClinicalTrials.gov)	February 27, 2020	4/11/2019	A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease	Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease	Parkinson Disease	Drug: NLY01;Drug: Vehicle	Neuraly, Inc.	NULL	Active, not recruiting	30 Years	80 Years	All	255	Phase 2	United States;Canada
81	NCT04228172 (ClinicalTrials.gov)	February 24, 2020	7/1/2020	Genotypic Influences on Network Progression in Parkinson's Disease	Genotypic Influences on Network Progression in Parkinson's Disease	Parkinson's Disease	Genetic: DNA/GeneticTesting;Radiation: FDG PET scan;Other: MRI scan;Other: Clinical and neuropsychological assessments	Northwell Health	Michael J. Fox Foundation for Parkinson's Research;The Silverstein Foundation for Parkinson's with GBA	Recruiting	40 Years	75 Years	All	32		United States
82	NCT04251585 (ClinicalTrials.gov)	February 4, 2020	28/1/2020	Intranasal Insulin in Parkinson's Disease	Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease	Parkinson Disease	Drug: Regular Novolin R;Drug: Placebo	HealthPartners Institute	NULL	Recruiting	41 Years	89 Years	All	30	Phase 2	United States
83	EUCTR2018-003941-41-PT (EUCTR)	03/02/2020	21/08/2019	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	258	Phase 3	Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
84	NCT04428983 (ClinicalTrials.gov)	February 3, 2020	20/11/2019	The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease	The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease	Parkinson Disease	Dietary Supplement: Hericium erinaceus mycelium	National Cheng-Kung University Hospital	NULL	Recruiting	50 Years	79 Years	All	80	N/A	Taiwan
85	EUCTR2018-003289-15-DE (EUCTR)	28/01/2020	08/02/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany
86	NCT04305002 (ClinicalTrials.gov)	January 21, 2020	20/2/2020	Exenatide Treatment in Parkinson's Disease	Effect of Exenatide on Disease Progression in Early Parkinson's Disease	Parkinson Disease	Drug: Exenatide;Drug: Placebo	Center for Neurology, Stockholm	Karolinska Institutet	Active, not recruiting	25 Years	80 Years	All	60	Phase 2	Sweden
87	NCT04232969 (ClinicalTrials.gov)	January 20, 2020	10/1/2020	Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease	A Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease	Parkinson's Disease	Drug: Exenatide extended release 2mg (Bydureon)	University College, London	NULL	Active, not recruiting	25 Years	80 Years	All	194	Phase 3	United Kingdom
88	EUCTR2019-001657-42-SK (EUCTR)	14/01/2020	01/10/2019	A study to learn how well the drug AKST4290 works and how safeAKST4290 is in people who have Parkinson's disease that are takingdopamine based medication.	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate theEfficacy and Safety of AKST4290 in Subjects with Parkinson's Disease onStable Dopaminergic Treatment. - N/A	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AKST4290 Product Code: AKST4290 INN or Proposed INN: AKST4290 Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE	Alkahest, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Estonia;Slovakia;Poland;Germany
89	EUCTR2018-003289-15-PT (EUCTR)	13/01/2020	21/08/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Portugal;United States;Estonia;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Denmark;Australia;Peru;Bulgaria;Germany;New Zealand
90	NCT04687878 (ClinicalTrials.gov)	January 1, 2020	28/12/2020	The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients	Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial	Parkinson Disease	Drug: Insulin;Drug: Normal saline	dr.dargahi	NULL	Recruiting	17 Years	N/A	All	40	Phase 2	Iran, Islamic Republic of
91	NCT04152655 (ClinicalTrials.gov)	January 1, 2020	7/10/2019	A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease	A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)	REM Sleep Behavior Disorder;Parkinson Disease	Drug: Idebenone;Drug: Placebo oral tablet	Second Affiliated Hospital, School of Medicine, Zhejiang University	Peking Union Medical College Hospital;Beijing Hospital;Beijing Tiantan Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Jiangsu Province Nanjing Brain Hospital;The First Affiliated Hospital of Anhui Medical University;Huashan Hospital;Tongji Hospital;Second Affiliated Hospital of Soochow University;Guizhou Medical University;The First Affiliated Hospital of Guangzhou Medical University;Peking University Shenzhen Hospital;West China Hospital;Wuhan Union Hospital, China;Sir Run Run Shaw Hospital;The Affiliated Hospital of Hangzhou Normal University;The First Affiliated Hospital of Dalian Medical University;Qilu Hospital of Shandong University	Recruiting	18 Years	N/A	All	180	Phase 2/Phase 3	China
92	EUCTR2018-004156-37-HU (EUCTR)	19/12/2019	18/10/2019	A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)	A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
93	NCT04097080 (ClinicalTrials.gov)	December 15, 2019	18/9/2019	Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease	Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease	Parkinson Disease	Drug: NBTX-001;Drug: Standard of Care	Nobilis Therapeutics Inc.	NULL	Recruiting	18 Years	N/A	All	60	Phase 1	Russian Federation
94	NCT04301492 (ClinicalTrials.gov)	November 20, 2019	17/2/2020	Tolerability, Safety and Efficacy of Vortioxetine	Tolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label Study	Depression	Drug: Vortioxetine	IRCCS San Raffaele Roma	NULL	Recruiting	30 Years	80 Years	All	20	Phase 4	Italy
95	NCT04768023 (ClinicalTrials.gov)	November 18, 2019	14/2/2021	12 Weeks Vitamin D Supplementation and Physical Activity in PD Patients With DBS	Influence of 12 Weeks Vitamin D Supplementation Combined With Physical Activity on Blood and Functional Parameters and Quality of Life in Parkinson's Disease Patients Treated With Deep Brain Stimulation	Vitamin D Deficiency;Parkinson Disease	Drug: Juvit D3;Behavioral: steps per day;Drug: Placebo	Medical University of Gdansk	NULL	Enrolling by invitation	40 Years	90 Years	All	72	N/A	Poland
96	NCT03924414 (ClinicalTrials.gov)	November 15, 2019	2/4/2019	Trial of Parkinson's And Zoledronic Acid	TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease	Parkinson Disease;Osteoporosis;Parkinsonism;Parkinson's Disease and Parkinsonism;Atypical Parkinsonism;Progressive Supranuclear Palsy;Multiple System Atrophy;Vascular Parkinsonism;Dementia With Lewy Bodies	Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj;Other: Placebo	California Pacific Medical Center Research Institute	National Institute on Aging (NIA);University of California, San Francisco;Duke University;University of Pittsburgh;Parkinson's Foundation	Recruiting	60 Years	N/A	All	3500	Phase 4	United States
97	NCT04148391 (ClinicalTrials.gov)	November 14, 2019	30/10/2019	NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)	A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia	Mild Cognitive Impairment;Mild Dementia;Parkinson Disease;Lewy Body Disease	Drug: Placebo Oral Capsule;Drug: NYX-458	Aptinyx	CogState Ltd.;Worldwide Clinical Trials	Active, not recruiting	50 Years	80 Years	All	99	Phase 2	United States
98	NCT04175132 (ClinicalTrials.gov)	November 12, 2019	12/11/2019	Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)	Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's Disease	Healthy;Parkinson Disease	Drug: foliglurax	H. Lundbeck A/S	NULL	Terminated	50 Years	70 Years	All	6	Phase 1	Sweden
99	EUCTR2018-002942-35-GB (EUCTR)	31/10/2019	05/09/2019	A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo, and standard psychological care, for depression in Parkinson’s disease	A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo and standard psychological care for depression in Parkinson’s Disease - Antidepressants Trial in Parkinson's Disease (ADepT-PD)	Depression in Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Escitalopram INN or Proposed INN: Escitalopram oxalate Trade Name: Nortriptyline Product Name: Nortriptyline INN or Proposed INN: Nortriptyline hydrochloride	University College London Comprehensive Clinical Trials Unit	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	408	Phase 3	United Kingdom
100	NCT03652870 (ClinicalTrials.gov)	October 31, 2019	8/8/2018	Antidepressants Trial in Parkinson's Disease	A Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's Disease	Depression;Parkinson Disease	Drug: Nortriptyline;Drug: Escitalopram;Drug: Placebo	University College, London	London North West Healthcare NHS Trust;King's College London;University Hospital Plymouth NHS Trust;NHS Lothian	Recruiting	18 Years	85 Years	All	408	Phase 3	United Kingdom
101	ChiCTR1900026956	2019-10-21	2019-10-27	Minimum alveolar concentration-awake of sevoflurane in patients with Parkinson's disease	Minimum alveolar concentration-awake of sevoflurane in patients with Parkinson's disease	Parkinson’s disease	Parkinson’s disease group:Sevoflurane induction;Non-Parkinson’s disease group:Sevoflurane induction;	The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China	NULL	Pending	40	64	Both	Parkinson’s disease group:30;Non-Parkinson’s disease group:30;	N/A	China
102	NCT04273932 (ClinicalTrials.gov)	October 17, 2019	31/10/2019	Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.	Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.	Parkinson Disease	Drug: Lithium	State University of New York at Buffalo	NULL	Active, not recruiting	45 Years	80 Years	All	19	Phase 1	United States
103	EUCTR2018-003337-15-ES (EUCTR)	17/10/2019	30/04/2019	A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease.	A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease	Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706	Sun Pharma Advanced Research Company (SPARC) Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	504	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Hungary;Czech Republic;Slovakia;Poland;Spain;India
104	EUCTR2018-003289-15-BG (EUCTR)	10/10/2019	24/07/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
105	EUCTR2018-003941-41-BG (EUCTR)	10/10/2019	26/06/2019	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
106	EUCTR2018-002234-21-DE (EUCTR)	23/09/2019	16/05/2019	An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations	AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa	Impax Laboratories, LLC	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia
107	EUCTR2018-003941-41-IT (EUCTR)	17/09/2019	18/01/2021	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: NA Product Code: [TD-9855] INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand;Estonia;Spain;Ukraine;Portugal;United States
108	EUCTR2018-003028-35-GB (EUCTR)	04/09/2019	15/11/2019	A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease.	A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease. - Phase 3 Trial of exenatide for Parkinson’s disease	Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Bydureon Product Name: Bydureon INN or Proposed INN: Exenatide	University College London Comprehensive Clinical Trial Unit	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Kingdom
109	NCT04075318 (ClinicalTrials.gov)	August 29, 2019	5/8/2019	Study of UB-312 in Healthy Participants and Parkinson's Disease Patients	A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's Disease	Parkinson's Disease;Parkinsonism	Biological: UB-312;Biological: Placebo	United Neuroscience Ltd.	Centre for Human Drug Research, Netherlands;Worldwide Clinical Trials;Vaxxinity, Inc.	Active, not recruiting	40 Years	85 Years	All	70	Phase 1	Netherlands
110	NCT04006210 (ClinicalTrials.gov)	August 27, 2019	30/6/2019	Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations	A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Study of the Efficacy, Safety, and Tolerability of Continuous SC ND0612 Infusion vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations	Parkinson's Disease	Combination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mg	NeuroDerm Ltd.	NULL	Active, not recruiting	30 Years	80 Years	All	381	Phase 3	United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom
111	EUCTR2018-003941-41-PL (EUCTR)	23/08/2019	03/06/2019	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	Portugal;United States;Estonia;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Denmark;Australia;Peru;Bulgaria;Germany;New Zealand
112	EUCTR2018-002234-21-ES (EUCTR)	21/08/2019	11/06/2019	An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations	AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa	Impax Laboratories, LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
113	EUCTR2018-003941-41-ES (EUCTR)	13/08/2019	11/06/2019	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	258	Phase 3	United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
114	NCT03976349 (ClinicalTrials.gov)	August 12, 2019	4/6/2019	A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease	A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson's Disease	Parkinson's Disease	Drug: BIIB094;Drug: Placebo	Biogen	Ionis Pharmaceuticals, Inc.	Recruiting	35 Years	80 Years	All	82	Phase 1	United States;Canada;Israel;Norway;Spain;United Kingdom
115	NCT04043338 (ClinicalTrials.gov)	August 11, 2019	24/7/2019	Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects	Parkinson's Disease	Drug: XC130-A10H;Drug: Placebo	Xoc Pharmaceuticals	Celerion	Active, not recruiting	18 Years	75 Years	All	56	Phase 1	United States
116	EUCTR2018-003941-41-GB (EUCTR)	09/08/2019	16/05/2019	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	258	Phase 3	United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
117	ChiCTR1900024459	2019-08-01	2019-07-12	Observational study for cognitive function and life ability of patients with Parkinson's disease after operation	Observational study for cognitive function and life ability of patients with Parkinson's disease after operation	Parkinson's disease	PD group:NO;NPD-S group:NO;PD-N group:NO;	Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University	NULL	Pending	45	90	Both	PD group:30;NPD-S group:30;PD-N group:30;	N/A	China
118	JPRN-UMIN000037422	2019/08/01	01/08/2019	An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease	An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease	Parkinson disease	Prescription istradefylline 20 mg for 1 month, and if there are no side effects, increase to 40 mg and prescribe for 2 months.	Ichinomiya Nishi Hospital	NULL	Complete: follow-up continuing	40years-old	85years-old	Male and Female	25	Not selected	Japan
119	JPRN-UMIN000037421	2019/08/01	01/08/2019	A study on improvement of cognitive function by istradefylline for parkinson disease	An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - A study on improvement of cognitive function by istradefylline for parkinson disease	Parkinson disease	Prescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months. The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26.	Ichinomiya Nishi Hospital	NULL	Complete: follow-up continuing	40years-old	85years-old	Male and Female	25	Not selected	Japan
120	EUCTR2018-003941-41-HU (EUCTR)	30/07/2019	01/08/2019	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
121	EUCTR2018-003289-15-PL (EUCTR)	19/07/2019	07/05/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine chydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
122	NCT03575195 (ClinicalTrials.gov)	July 15, 2019	21/6/2018	Microbiota Intervention to Change the Response of Parkinson's Disease	Microbiota Intervention to Change the Response of Parkinson's Disease	Parkinson Disease	Drug: Rifaximin;Other: Placebo	University of California, San Francisco	Nova Southeastern University;Gateway Institute for Brain Research	Recruiting	30 Years	N/A	All	86	Phase 1/Phase 2	United States
123	EUCTR2018-002144-85-ES (EUCTR)	11/07/2019	12/04/2019	Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study	A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate	AbbVie Deutschland	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3	United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Japan
124	EUCTR2018-002144-85-DK (EUCTR)	08/07/2019	14/03/2019	Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study	A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate	AbbVie Deutschland	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	United States;Canada;Belgium;Spain;Australia;Denmark;Germany;Netherlands;Italy;United Kingdom;Japan
125	EUCTR2018-003941-41-EE (EUCTR)	04/07/2019	29/05/2019	This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Study	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	Portugal;United States;Estonia;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Denmark;Australia;Peru;Bulgaria;Germany;New Zealand
126	NCT05146921 (ClinicalTrials.gov)	July 4, 2019	2/11/2021	Gut Health and Probiotics in Parkinson's (SymPD)	Gut Health and Probiotics in Parkinson's (SymPD)	Parkinson Disease	Dietary Supplement: Multi-strain probiotic;Other: Placebo	King's College Hospital NHS Trust	King's College London	Active, not recruiting	18 Years	N/A	All	60	N/A	United Kingdom
127	EUCTR2018-003289-15-DK (EUCTR)	02/07/2019	14/03/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Denmark;Australia;Bulgaria;Germany;New Zealand
128	ChiCTR1900021708	2019-07-01	2019-03-05	Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphi	Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphism	Parkinson's Disease	Healthy control group:No;tremor-dominant phenotype PD patients group:pramipexole;	Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University	NULL	Pending	50	70	Both	Healthy control group:80;tremor-dominant phenotype PD patients group:80;		China
129	JPRN-UMIN000037390	2019/07/01	16/07/2019	An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy	An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy - Levodopa pharmacokinetics on concomitant use of LCIG therapy and COMT inhibitor	Parkinson's disease	Entacapone 100mg	Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine	Saiseikai Matsuyama Hospital	Pending	20years-old	Not applicable	Male and Female	10	Not selected	Japan
130	NCT03977441 (ClinicalTrials.gov)	July 2019	12/5/2019	the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease	A Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's Disease	Parkinson Disease;Depression;Sleep Disorders;Circadian Rhythm Disorders	Drug: Agomelatine or PIacebo	Second Affiliated Hospital of Soochow University	NULL	Not yet recruiting	30 Years	75 Years	All	240	Phase 4	NULL
131	EUCTR2018-003289-15-ES (EUCTR)	26/06/2019	27/06/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	188	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Denmark;Germany
132	NCT03938922 (ClinicalTrials.gov)	June 13, 2019	18/4/2019	A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease Dementia	A Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.	Parkinson Disease;Dementia	Drug: Active Investigational Treatment ENT-01	Enterin Inc.	NULL	Active, not recruiting	30 Years	90 Years	All	40	Phase 1	United States
133	EUCTR2018-003289-15-HU (EUCTR)	04/06/2019	05/04/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Denmark;Bulgaria;Germany
134	JPRN-UMIN000036952	2019/06/04	04/06/2019	A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.	A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. - A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.	Patients who are suspected Parkinson's disease or related disorders, including dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal lobe degeneration, vascular parkinsonism, drug-induced parkinsonism, normal pressure hydrocephalus, and others.	18F-FDOPA, 11C-Raclopride PET	Nagoya City Rehabilitation Agency	NULL	Recruiting	20years-old	Not applicable	Male and Female	150	Not applicable	Japan
135	ChiCTR1900022534	2019-06-01	2019-04-15	Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial	Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial	non-motor symptoms of Parkinson’s disease	entacapone group:Patients in the entacapone group will be administered entacapone (Novartis; import drug registration certificate number: H20160680), 10 times per day, 200 mg each time, for 3 weeks. ;pramipexole group:Patients in the pramipexole group will be administered pramipexole (Boehringer-Ingelheim; import drug registration certificate number: 20140918) , 3 times per day, 1 mg each time, for 3 weeks.;	Geriatric Hospital of Hainan	NULL	Pending	40	75	Both	entacapone group:194;pramipexole group:194;	N/A	China
136	JPRN-UMIN000036908	2019/05/31	31/05/2019	A dementia study by 11C-PiB, 18F-FDG PET	A dementia study by 11C-PiB, 18F-FDG PET - A dementia study by 11C-PiB, 18F-FDG PET	mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc.	11C-PiB, 18F-FDG PET	Nagoya City Rehabilitation Agency	NULL	Recruiting	20years-old	Not applicable	Male and Female	150	Not applicable	Japan
137	JPRN-jRCTs031180248	29/05/2019	12/03/2019	N/A	Intervention study for the effect of Istradefylline on adjustment of Levodopa in Parkinson's Disease - Istra adjust PD	Parkinson's disease	Arm with treatment of Istradefylline and levodopa Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 1. Dose reduction is possible if the patient has tolerability issues. Patients will visit every 4 weeks from the following day of Week0, and 50mg levodopa will be added of if CGI-S score >=4 every time. Dose reduction is possible if the patient has tolerability issues. Arm without treatment of Istradefylline 50mg levodopa will be added at Week 0. Patients will visit every 4 weeks from the following day of Week0, and 50mg levodopa will be added of if CGI-S score >=4 every time. Dose reduction is possible if the patient has tolerability issues.	Hatano Taku	Kyowa Kirin Co., Ltd	Complete	>= 30age old	<= 84age old	Both	111	N/A	Japan
138	NCT03693872 (ClinicalTrials.gov)	May 15, 2019	1/10/2018	Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals	Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals	Parkinson Disease	Drug: Apomorphine;Drug: Dopaminergic Agonist + Apomorphine	Rennes University Hospital	NULL	Recruiting	18 Years	N/A	All	42	N/A	France
139	EUCTR2018-003289-15-AT (EUCTR)	15/05/2019	22/03/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
140	NCT03671785 (ClinicalTrials.gov)	May 15, 2019	12/9/2018	Study of the Fecal Microbiome in Patients With Parkinson's Disease	A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's Disease	Parkinson Disease	Drug: PRIM-DJ2727;Drug: Placebo oral capsule	The University of Texas Health Science Center, Houston	Kelsey Research Foundation	Active, not recruiting	55 Years	75 Years	All	12	Phase 1	United States
141	EUCTR2018-002233-37-DE (EUCTR)	17/04/2019	08/01/2019	Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.	A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations.	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA	Impax Laboratories, LLC	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy
142	JPRN-jRCTs051180214	12/04/2019	27/03/2019	The usefulness of flutemetamol for diagnostic imaging of neurogenerative disease	The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease - The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease	Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy	Amyloid PET: Given the flutemetamol (3mL) intravenously FDG-PET:Given the FDG scanR (3mL) intravenously	Itoh Yoshiaki	NULL	Recruiting	>= 20age old	Not applicable	Both	100	N/A	Japan
143	EUCTR2018-003289-15-EE (EUCTR)	11/04/2019	30/01/2019	This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)	A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure	Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
144	EUCTR2017-002426-20-FR (EUCTR)	05/04/2019	26/11/2018	Effect of Safinamide on Parkinson’s Disease Related Chronic Pain	A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study	Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE	Zambon SpA	NULL	Not Recruiting			Female: yes Male: yes	177	Phase 4	France;Spain;Austria
145	EUCTR2016-000657-12-GR (EUCTR)	04/04/2019	11/01/2019	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD	Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: - Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: - Other descriptive name: Genz-682452-AU	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	Taiwan;United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden
146	ChiCTR1900026156	2019-04-01	2019-09-24	Research for Parkinson's disease/Parkinson's disease dementia cohort and basic transformation	Research for Parkinson's disease/Parkinson's disease dementia cohort and basic transformation	Parkinson's disease	Parkinson's disease:NO;Parkinson's disease with chronic appendicitis-like lesions:NO;Parkinson's disease without chronic appendicitis-like lesions:NO;	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	NULL	Recruiting			Both	Parkinson's disease:100;Parkinson's disease with chronic appendicitis-like lesions:53;Parkinson's disease without chronic appendicitis-like lesions:47;	N/A	China
147	EUCTR2018-002233-37-CZ (EUCTR)	18/03/2019	11/12/2018	Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.	A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations.	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA	Impax Laboratories, LLC	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy
148	ChiCTR1900021760	2019-03-09	2019-03-08	Effect-site concentration of remifentanil for I-gel insertion in male patients with Parkinson’s disease undergoing deep brain stimulator implantation during target-controlled infusion of propofol	Effect-site concentration of remifentanil for I-gel insertion in male patients with Parkinson’s disease undergoing deep brain stimulator implantation during target-controlled infusion of propofol	Parkinson’s disease	Parkinson’s disease:propofol and remifentanil;Non-Parkinson’s disease:propofol and remifentanil;	The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China	NULL	Recruiting	40	64	Male	Parkinson’s disease:25;Non-Parkinson’s disease:25;	N/A	China
149	NCT03816020 (ClinicalTrials.gov)	March 9, 2019	7/12/2018	NAD-supplementation in Drug naïve Parkinson's Disease	NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease	Parkinson Disease;Neurodegenerative Diseases	Dietary Supplement: Nicotinamide Riboside;Other: Placebo	Haukeland University Hospital	NULL	Completed	18 Years	N/A	All	30	N/A	Norway
150	EUCTR2017-005170-19-FI (EUCTR)	06/03/2019	07/12/2018	A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study	A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions	Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor	Renishaw Neuro Solutions Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 1;Phase 2	Finland;Sweden
151	NCT03820037 (ClinicalTrials.gov)	March 2019	25/1/2019	Relative Bioavailability and Bioequivalence of Opicapone	A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects	Parkinson Disease	Drug: Ongentys;Drug: BIA 9-1067 (test)	Bial - Portela C S.A.	NULL	Not yet recruiting	18 Years	55 Years	All	45	Phase 1	United Kingdom
152	NCT03829657 (ClinicalTrials.gov)	February 22, 2019	10/1/2019	Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure	A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure	Symptomatic Neurogenic Orthostatic Hypotension;MSA;Parkinson's Disease (PD);Pure Autonomic Failure (PAF)	Drug: ampreloxetine;Drug: Placebo	Theravance Biopharma	NULL	Active, not recruiting	30 Years	N/A	All	203	Phase 3	United States;Argentina;Australia;Austria;Bulgaria;Canada;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;New Zealand;Poland;Portugal;Russian Federation;Spain;Ukraine;United Kingdom
153	EUCTR2017-002426-20-IT (EUCTR)	21/02/2019	07/10/2020	Effect of Safinamide on Parkinson's Disease Related Chronic Pain	A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson's Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study	Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE	ZAMBON SPA	NULL	Not Recruiting			Female: yes Male: yes	177	Phase 4	Germany;Italy;France;Spain;Austria
154	NCT03466723 (ClinicalTrials.gov)	February 14, 2019	9/3/2018	miRNAs Profiling in Parkinson's Disease	Novel and Minimal Invasive Biomarkers for Parkinson's Disease: Profiling of Serum Circulating miRNAs and Patho-physiological Implications	Parkinson Disease	Genetic: biomarker identification in Parkinson disease	Neuromed IRCCS	NULL	Active, not recruiting	30 Years	N/A	All	1000		Italy
155	NCT04510922 (ClinicalTrials.gov)	February 11, 2019	9/7/2020	Lundbeck TOMs Orthostatic Hypotension	Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study	Orthostatic Hypotension;Idiopathic Parkinson Disease	Drug: Droxidopa 100 MG [Northera]	Alberto Espay, MD, MSc	Lundbeck LLC	Completed	30 Years	80 Years	All	10	Phase 4	United States
156	NCT03815071 (ClinicalTrials.gov)	February 1, 2019	21/1/2019	A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells	Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease	Parkinson Disease	Drug: Ips-nsc cells	Allife Medical Science and Technology Co., Ltd.	The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital;Henan Provincial People's Hospital;Beijing Hospital	Not yet recruiting	18 Years	60 Years	All	10	Early Phase 1	NULL
157	NCT03790670 (ClinicalTrials.gov)	January 30, 2019	18/12/2018	Biomarker Assessments of Leukine During Treatment of Parkinson's Disease	Safety, Tolerability and Biomarker Assessments of Leukine (Sargramostim) During Extended Timed Treatment for Parkinson's Disease: A Phase I Pilot Study	Parkinson Disease	Drug: sargramostim	University of Nebraska	NULL	Active, not recruiting	35 Years	85 Years	All	7	Phase 1	United States
158	EUCTR2017-003458-18-SE (EUCTR)	23/01/2019	10/12/2018	A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesia	A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia	Parkinson's disease dyskinesia MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IRL790 Product Code: IRL790 INN or Proposed INN: IRL790	Integrative Research Laboratories AB (IRLAB)	NULL	Not Recruiting			Female: yes Male: yes	74	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Sweden
159	EUCTR2017-002426-20-AT (EUCTR)	22/01/2019	03/12/2018	Effect of Safinamide on Parkinson’s Disease Related Chronic Pain	A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study	Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE	Zambon SpA	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 4	Spain;Austria
160	EUCTR2018-002877-23-AT (EUCTR)	21/01/2019	07/12/2018	Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD	Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD	Social functioning in Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Syntocinon 40 IU/ml nasal spray INN or Proposed INN: Synthetic Oxytocin Other descriptive name: OXYTOCIN SYNTHETIC	Abteilung für Neurologie der Medizinischen Universität Innsbruck	NULL	Not Recruiting			Female: no Male: yes	76	Phase 2	Austria
161	NCT03826134 (ClinicalTrials.gov)	January 17, 2019	30/1/2019	A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects	Interventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy Subjects	Parkinson Disease	Drug: [11C]PXT012253	H. Lundbeck A/S	NULL	Completed	20 Years	50 Years	All	7	Early Phase 1	Sweden
162	JPRN-UMIN000035602	2019/01/11	21/01/2019	Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease	Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease - Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease	Parkinson's disease	hydrogen gas16 weeks inhalation two times of the inhalation for 60 minutes per day 8 weeks obsebation after the inhalation placebo gas 16 weeks inhalation two times of the inhalation for 60 minutes per day 8 weeks obsebation after the inhalation	Juntendo University Koshigaya Hospital	NULL	Complete: follow-up complete	40years-old	80years-old	Male and Female	20	Not selected	Japan
163	NCT03659682 (ClinicalTrials.gov)	January 2, 2019	3/9/2018	GLP1R in Parkinson's Disease	Effect of GLPIR Stimulation on Neuroprotection and Inflammation in Parkinson's Disease	Parkinson Disease	Drug: Semaglutide	Oslo University Hospital	NULL	Not yet recruiting	40 Years	75 Years	All	120	Phase 2	NULL
164	NCT03727295 (ClinicalTrials.gov)	January 1, 2019	30/10/2018	Idebenone Treatment of Early Parkinson's Diseasesymptoms	A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor Symptoms	Oxidative Stress is an Important Cause of Parkinson's Disease	Drug: Idebenone/placebo	Second Affiliated Hospital of Soochow University	Qilu Pharmaceutical Co., Ltd.	Not yet recruiting	30 Years	80 Years	All	180	Phase 4	NULL
165	NCT03822364 (ClinicalTrials.gov)	November 26, 2018	18/12/2018	Staccato Apomorphine Single and Multi Dose PK	A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's Disease	Parkinson Disease	Drug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5	Alexza Pharmaceuticals, Inc.	NULL	Completed	18 Years	60 Years	All	56	Phase 1	Netherlands
166	NCT03823638 (ClinicalTrials.gov)	November 20, 2018	20/11/2018	Safety, Tolerability and Effects of Mannitol in Parkinson's Disease	A Phase II Single Center, Randomized, Double Blind and Placebo Controlled Study Assessing the Safety, Tolerability and Effects of Progressively Increased Dose of Oral Mannitol in Parkinson's Disease	Parkinson Disease	Dietary Supplement: Oral D-Mannitol of Placebo	Hadassah Medical Organization	NULL	Recruiting	40 Years	75 Years	All	60	Phase 2	Israel
167	NCT03713957 (ClinicalTrials.gov)	November 12, 2018	18/10/2018	A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment	A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment	Parkinson Disease	Drug: GRF6021;Other: Placebo	Alkahest, Inc.	Michael J. Fox Foundation for Parkinson's Research	Completed	40 Years	85 Years	All	79	Phase 2	United States;Australia;France
168	NCT03733561 (ClinicalTrials.gov)	November 9, 2018	6/11/2018	A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro	A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers	Parkinson Disease	Drug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal Patch	Luye Pharma Group Ltd.	NULL	Completed	18 Years	45 Years	All	40	Phase 1	United States
169	EUCTR2018-001887-46-GB (EUCTR)	08/11/2018	19/06/2019	Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study'	A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial to assess the safety and tolerability Of 30mg/kg daily Ursodeoxycholic Acid (UDCA) in Patients with Parkinson’s Disease (PD) - Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study'	Parkinson’s disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ursonorm Product Name: Ursonorm INN or Proposed INN: Ursodeoxycholic acid	Sheffield Teaching Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
170	NCT03667404 (ClinicalTrials.gov)	November 6, 2018	10/9/2018	Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study	Gut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability Study	Parkinson Disease;Intestinal Bacteria Flora Disturbance;Dietary Modification	Dietary Supplement: maltodextrin;Dietary Supplement: Resistant maltodextrin	Northwestern University	University of Illinois at Chicago	Active, not recruiting	60 Years	N/A	All	30	Phase 2	United States
171	NCT03670953 (ClinicalTrials.gov)	November 6, 2018	12/9/2018	A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations	A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations	Parkinson's Disease (Disorder)	Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placebo	Impax Laboratories, LLC	NULL	Completed	40 Years	N/A	All	631	Phase 3	United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom
172	NCT04629404 (ClinicalTrials.gov)	November 5, 2018	5/11/2020	A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients	A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's Disease	Parkinson Disease	Drug: LY03003;Drug: Placebo	Luye Pharma Group Ltd.	NULL	Completed	30 Years	N/A	All	32	Phase 1	China
173	NCT03727139 (ClinicalTrials.gov)	November 1, 2018	30/10/2018	Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term Safety	AZILECT Tablets Special Drug Use-Results Survey Survey on Long-term Safety	Parkinson's Disease	Drug: Rasagiline	Takeda	NULL	Completed	N/A	N/A	All	1021		Japan
174	NCT03069911 (ClinicalTrials.gov)	November 1, 2018	28/2/2017	Trial of OnabotulinumtoxinA for Depression in Parkinson Disease	Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease	Parkinson Disease;Depression	Biological: OnabotulinumtoxinA;Biological: Control	Johns Hopkins University	NULL	Terminated	18 Years	95 Years	All	3	Phase 1	United States
175	EUCTR2016-002033-30-NL (EUCTR)	31/10/2018	15/11/2017	A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations	A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO	Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
176	EUCTR2017-003415-19-ES (EUCTR)	31/10/2018	20/08/2018	A Clinical Study in Parkinson’s Disease Patients With Moderate to Severe Abnormal Movements to See If JM-010 is Effective and Safe/Tolerable.	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson’s Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations Of JM-010	Parkinson’s Disease Patients With Moderate to Severe Dyskinesia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan	Contera Pharma	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Spain;Germany
177	EUCTR2017-002426-20-ES (EUCTR)	19/10/2018	20/08/2018	Effect of Safinamide on Parkinson’s Disease Related Chronic Pain	A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study	Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE	Zambon SpA	NULL	Not Recruiting			Female: yes Male: yes	177	Phase 4	France;Spain;Austria;Italy
178	EUCTR2018-000346-19-FI (EUCTR)	03/10/2018	09/07/2018	An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.	A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study	Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor	Herantis Pharma Plc	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 1;Phase 2	Finland;Sweden
179	EUCTR2016-004610-95-DE (EUCTR)	01/10/2018	27/02/2018	Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	357	Phase 2	France;United States;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy
180	NCT03229174 (ClinicalTrials.gov)	August 23, 2018	21/4/2017	Brain Perfusion & Oxygenation in Parkinson's Disease With NOH	Evaluation of Brain Perfusion and Oxygenation in PD Patients With Neurogenic Orthostatic Hypotension: 4 Week Comparison of Droxidopa Versus Placebo	Parkinson Disease;Neurogenic Orthostatic Hypotension	Drug: Droxidopa;Drug: Placebo	William Ondo, MD	Lundbeck LLC	Completed	18 Years	85 Years	All	17	Phase 4	United States
181	NCT03567447 (ClinicalTrials.gov)	August 17, 2018	21/5/2018	Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)	Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)	Parkinson Disease;Falls Patient	Drug: Droxidopa;Other: Placebo	St. Joseph's Hospital and Medical Center, Phoenix	H. Lundbeck A/S;Arizona State University	Recruiting	30 Years	83 Years	All	10	Phase 2	United States
182	NCT03675282 (ClinicalTrials.gov)	August 14, 2018	5/9/2018	Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and Controls	Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and Controls	Parkinson Disease;REM Sleep Behavior Disorder;Healthy	Drug: (11C)PE2I;Drug: Ioflupane	Weill Medical College of Cornell University	National Institute of Neurological Disorders and Stroke (NINDS)	Active, not recruiting	20 Years	100 Years	All	82	Phase 1/Phase 2	United States
183	EUCTR2016-004610-95-FR (EUCTR)	08/08/2018	01/03/2018	Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	311	Phase 2	United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden
184	NCT03773796 (ClinicalTrials.gov)	August 6, 2018	19/7/2018	Nabilone for Non-motor Symptoms in Parkinson's Disease	Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy	Parkinson Disease	Drug: Nabilone 0.25 mg	Medical University Innsbruck	NULL	Recruiting	30 Years	100 Years	All	48	Phase 3	Austria
185	JPRN-UMIN000033285	2018/08/01	05/07/2018	The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial	The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial - The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease	Parkinson's disease	Oral bisphosphonate agent group: taking orally Minodronic Acid Hydrate (50mg) 1 tablet per 4 weeks Intravenous bisphosphonate agent group: injecting Zoledronic Acid (5mg) 1 ampule per 48 weeks	Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital	Department of Neurology, Nishi-Niigata Chuo Hospital	Pending	50years-old	Not applicable	Male and Female	100	Not selected	Japan
186	EUCTR2017-005170-19-SE (EUCTR)	30/07/2018	10/04/2018	A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study	A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions	Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor	Renishaw Neuro Solutions Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 1;Phase 2	Finland;Sweden
187	JPRN-UMIN000033409	2018/07/30	17/07/2018	Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial.	Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial. - SkinHeRo	Parkinson's disease	Pretreatment by heparinoid In the pretreatment group, heparinoid is applied daily to the sites (shoulder, upper arm, abdomen, thigh, buttocks on both sides) to be applied rotigotine transdermal patch from the beginning of 1 week before. The dose is one finger tip unit (about 0.5 g) for two palms. The period is 8 weeks. Non-pretreatment by heparinoid. The non-pretreatment group use rotigotine without using heparinoid. The period is 8 weeks.	Wakayama Medical University	NULL	Complete: follow-up complete	20years-old	85years-old	Male and Female	20	Phase 1	Japan
188	NCT03611569 (ClinicalTrials.gov)	July 25, 2018	26/7/2018	Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease	Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease	Healthy;Parkinson Disease	Drug: Lu AF82422;Drug: Placebo	H. Lundbeck A/S	NULL	Completed	18 Years	80 Years	All	74	Phase 1	United States
189	EUCTR2018-001209-95-IT (EUCTR)	05/07/2018	03/08/2021	An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease	An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease - IN 18001	Parkinson's Disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Accordion Pill¿ Carbidopa/levodopa Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA Trade Name: SINEMET - 100 MG + 25 MG COMPRESSE 50 COMPRESSE DIVISIBILI Product Name: Sinemet Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA	INTEC PHARMA LTD	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	Spain;Italy
190	NCT03521635 (ClinicalTrials.gov)	July 3, 2018	11/4/2018	The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa	A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)	Parkinson Disease	Drug: Pramipexole SR;Drug: Pramipexole IR	Boehringer Ingelheim	NULL	Completed	30 Years	N/A	All	98	Phase 4	China
191	JPRN-UMIN000033454	2018/07/01	20/07/2018	A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.	A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. - A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.	Parkinson's Disease	robot assisted balance training (RABT) The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16. traditional balance training (TBT) The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16.	Hyogo College of Medicine	NULL	Complete: follow-up complete	40years-old	80years-old	Male and Female	50	Not selected	Japan
192	NCT03562494 (ClinicalTrials.gov)	June 28, 2018	16/5/2018	VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)	A Randomized, Sham Surgery Controlled, Double-blind, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Moderate to Advanced Parkinson's Disease Patients With Motor Fluctuations	Parkinson's Disease	Biological: VY-AADC02;Other: Sham (Placebo) Surgery	Neurocrine Biosciences	Voyager Therapeutics	Active, not recruiting	40 Years	75 Years	All	85	Phase 2	United States
193	EUCTR2017-001420-21-DE (EUCTR)	18/06/2018	16/02/2018	Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's Disease	A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER.	Early Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: P2B001 INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Product Name: Pramipexole dihydrochloride INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE Product Name: Rasagiline INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Pramipexole dihydrochloride extended-release tablets Product Name: Pramipexole dihydrochloride extended-release tablets INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE	Pharma Two B Ltd	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	France;United States;Canada;Spain;Germany
194	NCT03439943 (ClinicalTrials.gov)	June 13, 2018	13/2/2018	Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease	Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease	Parkinson Disease	Drug: Lixisenatide;Drug: placebo	University Hospital, Toulouse	Cure Parkinson;Réseau NS-Park;EUCLID;Sanofi	Active, not recruiting	40 Years	75 Years	All	156	Phase 2	France
195	EUCTR2018-000346-19-SE (EUCTR)	04/06/2018	09/04/2018	An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.	A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study	Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor	Herantis Pharma Plc	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 1;Phase 2	Finland;Sweden
196	NCT03684122 (ClinicalTrials.gov)	June 1, 2018	23/9/2018	Use of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) in People With Parkinson's (PD).	A Safety and Efficacy Study of the Effects of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) on the Motor and Non-motor Symptoms in People With Parkinson's Disease (PD).	Parkinson Disease	Biological: Injection of Umbilical cord derived MSCs	University of Jordan	NULL	Active, not recruiting	20 Years	75 Years	All	10	Phase 1/Phase 2	Jordan
197	EUCTR2017-002780-17-ES (EUCTR)	21/05/2018	12/02/2018	Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa.	A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension	Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	France;United States;Spain;Austria;Netherlands;Italy
198	EUCTR2016-004610-95-ES (EUCTR)	18/05/2018	07/03/2018	Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	311	Phase 2	United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden
199	EUCTR2017-004475-31-CZ (EUCTR)	09/05/2018	09/05/2018	Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.	Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease	Excessive daytime sleepiness associated with Parkinson’s disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Trade Name: Modiodal Product Name: over-encapsulated Modafinil INN or Proposed INN: MODAFINIL	Theranexus S.A.	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Hungary;Czech Republic;Germany
200	EUCTR2017-002780-17-FR (EUCTR)	26/04/2018	27/02/2018	-	A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension	Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	50	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;France;Spain;Austria;Netherlands;Italy
201	EUCTR2017-004475-31-HU (EUCTR)	17/04/2018	09/02/2018	Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.	Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease	Excessive daytime sleepiness associated with Parkinson’s disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Trade Name: Modiodal Product Name: over-encapsulated Modafinil INN or Proposed INN: MODAFINIL	Theranexus S.A.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Czech Republic;Hungary;United States;France;Germany
202	EUCTR2017-004253-16-AT (EUCTR)	13/04/2018	27/02/2018	Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-Motor symptoms (e.g.sleeping dirsorders, cognitive dysfunction, hallucinations, autonomic dysfunction,...)	Nabilone for non-motor symptoms in Parkinson’s disease: An open-label study to evaluate long-term safety and efficacy	Subject with non-Motor symptoms of Parkinson´s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Nabilone INN or Proposed INN: NABILONE	Medizinische Universität Innsbruck, Universitätsklinik für Neurologie	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Austria
203	EUCTR2017-002780-17-IT (EUCTR)	10/04/2018	04/11/2020	study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion	A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered	Parkinson¿s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa INN or Proposed INN: LEVODOPA Other descriptive name: levodopa	NEURODERM LTD.	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	United States;France;Spain;Austria;Netherlands;Italy
204	EUCTR2016-002033-30-IT (EUCTR)	10/04/2018	20/01/2021	A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations	A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO	Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa / carbidopa solution Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: levodopa / carbidopa solution Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: Carbidopa	NEURODERM LTD.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	France;Hungary;Belgium;Spain;Netherlands;United Kingdom;Italy
205	EUCTR2016-003456-70-DE (EUCTR)	04/04/2018	03/04/2017	A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients	An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations	Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomor	Sunovion Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	106	Phase 3	France;Spain;Austria;Germany;United Kingdom;Italy
206	EUCTR2016-000657-12-AT (EUCTR)	03/04/2018	17/10/2016	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD	Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
207	ChiCTR1800015331	2018-04-01	2018-03-23	Dopaminergic Mechanisms of Temporal Working Memory in Parkinson's Disease	Dopaminergic Mechanisms of Temporal Working Memory in Parkinson's Disease	Parkinson's disease	de novo PD patients:levodopa 4 weeks;de novo PD patients:pramipexole 4 weeks;de novo PD patients:selegiline 4 weeks;	Institute of Psychology, Chinese Academy of Sciences	NULL	Recruiting	50	80	Both	de novo PD patients:50;de novo PD patients:50;de novo PD patients:50;		China
208	EUCTR2017-004297-34-GB (EUCTR)	31/03/2018	22/06/2018	Use of low-dose zolpidem in Parkinson's.	A placebo controlled double blind randomised controlled proof of concept study of zolpidem for the treatment of motor and cognitive deficits in late-stage Parkinson’s - Zolpidem for treatment of motor and cognitive deficits in Parkinson's	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Stilnoct Product Name: Stilnoct Product Code: 207-3120 INN or Proposed INN: Zolpidem Tartrate	Aston University	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 2	United Kingdom
209	EUCTR2018-000405-23-FI (EUCTR)	27/03/2018	21/02/2018	Postitron emission tomography imaging of neuroinflammation in Parkinson´s disease	In vivo PET imaging of neuroinflammation in Parkinson’s disease using the purinergic P2X7 receptor ligand [11C]SMW139 (PRI-PD) - PRI-PD	Parkinson´s disease MedDRA version: 20.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: (2-chloro-5-[11C]methoxy-N-(((3s,5s,7s)-3,5,7-trifluoroadamantan-1-yl)methyl) benzamide) Product Code: [11C]SMW139	Juha Rinne / PET Centre	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	14	Phase 2	Finland
210	EUCTR2016-004610-95-AT (EUCTR)	23/03/2018	04/01/2018	Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	357	Phase 2	United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy
211	NCT03301272 (ClinicalTrials.gov)	March 22, 2018	13/9/2017	Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease	Effectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot Study	Parkinson Disease	Drug: Onabotulinumtoxin A Injection;Other: Placebo	University of North Carolina, Chapel Hill	NULL	Completed	45 Years	80 Years	All	16	Phase 2	United States
212	NCT02940912 (ClinicalTrials.gov)	January 31, 2018	14/10/2016	Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease	Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease	Parkinson Disease	Drug: Apomorphine;Drug: Placebo	Clinique Beau Soleil	NULL	Active, not recruiting	35 Years	90 Years	All	45	Phase 4	France
213	NCT03329508 (ClinicalTrials.gov)	January 29, 2018	30/10/2017	A Phase 3 Study With P2B001 in Subjects With Early Parkinson's	A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.	Parkinson Disease;Early Parkinson's Disease	Drug: P2B001;Drug: Rasagiline;Drug: Pramipexole;Drug: Pramipexole ER	Pharma Two B Ltd.	NULL	Active, not recruiting	35 Years	80 Years	All	525	Phase 3	United States;Canada;Germany;Spain
214	NCT03440112 (ClinicalTrials.gov)	January 29, 2018	26/1/2018	Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm	Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson	Parkinson Disease	Drug: Clarithromycin (Not used as of 4/2020);Drug: Placebo (Not used as of 4/2020);Drug: Transdermal flumazenil (Added 4/2020);Drug: Placebo (Added 4/2020)	Nicolaas Bohnen, MD, PhD	National Institute of Neurological Disorders and Stroke (NINDS)	Recruiting	50 Years	N/A	All	30	Phase 1/Phase 2	United States
215	JPRN-UMIN000030930	2018/01/29	01/01/2019	Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease.	Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. - Effect of febuxostat and inosine on Parkinson's disease	Parkinson's disease	Administration of febuxostat 20 mg and inosine 500 mg twice a day for 58 days	StaGen Co. Ltd.	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	30	Not selected	Japan
216	EUCTR2016-001403-23-HU (EUCTR)	23/01/2018	22/01/2018	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
217	ChiCTR1800014542	2018-01-22	2018-01-20	Up-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's disease	Up-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's disease	Parkinson's Disease	PD group:propofol;NPD group:propofol;	Xuanwu Hospital of CCMU	NULL	Recruiting	18	65	Both	PD group:40;NPD group:40;		China
218	EUCTR2016-003456-70-AT (EUCTR)	04/01/2018	16/11/2017	A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients	An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations	Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomor	Sunovion Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	106	Phase 3	France;Spain;Austria;Germany;United Kingdom;Italy
219	EUCTR2017-003254-17-ES (EUCTR)	21/12/2017	22/11/2017	Safety and efficacy of Safinamide (Xadago®) in apathy associated with Parkinson's disease	A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Safinamide on Apathy in Patients With Parkinson's Disease	Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE	Institut de Recerca Hospital de la Santa Creu i Sant Pau	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 4	Spain
220	EUCTR2017-003458-18-GB (EUCTR)	19/12/2017	27/09/2017	A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesia	A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia	Parkinson's disease dyskinesia MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IRL790 Product Code: IRL790 INN or Proposed INN: IRL790	Integrative Research Laboratories AB (IRLAB)	NULL	Not Recruiting			Female: yes Male: yes	74	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom;Sweden
221	EUCTR2017-000877-35-IT (EUCTR)	04/12/2017	10/11/2020	A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.	Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson's Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson's Disease Patients (CASPAR)	Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Bavisant Product Code: JNJ31-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Product Name: Bavisant Product Code: [JNJ31-31001074] INN or Proposed INN: Bavisant dihydrochloride monohydrate Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate	BENEVOLENTAI BIO	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Czechia;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy
222	JPRN-UMIN000030084	2017/12/01	01/12/2017	Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease	Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease - Practical evaluation of PET studies with three tracers for iPSC derived-neural transplantation	neuroinflammatory disorder, Parkinson's disease, Brain tumor	[18F]GE180 is injected intravenously as 3-4 MBq/Kg. PET is dynamically scanned for 90 minutes. Carbidopa 150mg is administrated orally 1hr before scan.[18F]FDOPA is injected intravenously as 3-4 MBq/Kg. Dynamic PET is scanned for 90 minutes. [18F]FLT is injected intravenously as 3-4 MBq/Kg. Statical PET is scanned after 60 minutes	Kyoto University	NULL	Complete: follow-up complete	50years-old	Not applicable	Male and Female	12	Phase 1,2	Japan
223	NCT03944785 (ClinicalTrials.gov)	November 30, 2017	1/5/2019	Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)	A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets	Idiopathic Parkinson Disease	Drug: XADAGO (safinamide)	Supernus Pharmaceuticals, Inc.	NULL	Completed	30 Years	80 Years	All	164		United States
224	EUCTR2016-002033-30-GB (EUCTR)	27/11/2017	05/09/2017	A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations	A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO	Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
225	NCT03194217 (ClinicalTrials.gov)	November 10, 2017	19/6/2017	BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness	Dose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD).	Excessive Daytime Sleepiness;Parkinson Disease	Drug: BEN-2001;Drug: Placebo	BenevolentAI Bio	NULL	Completed	50 Years	80 Years	All	244	Phase 2	United States
226	NCT03305809 (ClinicalTrials.gov)	November 9, 2017	4/10/2017	A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)	Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)	Lewy Body Dementia	Drug: LY3154207;Drug: Placebo	Eli Lilly and Company	NULL	Completed	40 Years	85 Years	All	344	Phase 2	United States;Canada;Puerto Rico;China
227	EUCTR2016-002033-30-HU (EUCTR)	08/11/2017	19/09/2017	A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations	A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO	Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany
228	NCT02611167 (ClinicalTrials.gov)	November 1, 2017	11/11/2015	Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease	Pilot Phase I Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease	Parkinson's Disease	Biological: Allogeneic bone marrow-derived MSCs (1 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (3 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (6 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (10 x 10 6 MSC/kg)	The University of Texas Health Science Center, Houston	NULL	Completed	45 Years	70 Years	All	20	Phase 1	United States
229	NCT03205956 (ClinicalTrials.gov)	October 19, 2017	29/6/2017	Measuring Parkinson's Disease Progression	Dopamine Buffering Capacity Measured by phMRI as a Novel Biomarker of Disease Progression in PD	Parkinson's Disease	Drug: Levodopa	Kevin J. Black, MD	The Michael J. Fox Foundation for Parkinson's Research	Completed	40 Years	79 Years	All	31	Phase 1	United States
230	EUCTR2017-000877-35-DE (EUCTR)	19/10/2017	04/09/2017	A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.	Dose finding phase IIb study of Bavisant to evaluate its safety and effiCacy in treAtment of exceSsive daytime sleePiness (EDS) in PARkinson’s Disease (PD). CASPAR study. - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR)	Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE	BenevolentAI Bio	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy
231	NCT03205488 (ClinicalTrials.gov)	October 16, 2017	28/6/2017	Nilotinib in Parkinson's Disease	A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants With Parkinson's Disease	Parkinson Disease	Drug: Cohort 1:Nilotinib Oral Capsules (150mg or 300mg);Drug: Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1);Drug: Placebo	Northwestern University	University of Rochester;University of Iowa;Michael J. Fox Foundation for Parkinson's Research	Completed	40 Years	79 Years	All	76	Phase 2	United States
232	NCT03769896 (ClinicalTrials.gov)	October 3, 2017	6/12/2018	Nabilone for Non-motor Symptoms in Parkinson's Disease	Nabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal Study	Parkinson Disease	Drug: Nabilone 0.25 mg;Drug: Placebo	Medical University Innsbruck	NULL	Completed	30 Years	100 Years	All	48	Phase 2	Austria
233	EUCTR2017-001673-17-FI (EUCTR)	03/10/2017	29/08/2017	A study to evaluate the safety and tolerability of IRL752 treatment inpatients with Parkinson's disease dementia.	A randomized, double-blind, placebo-controlled, multi-centre phase IIastudy evaluating the safety and tolerability of IRL752 in patients withParkinson's Disease Dementia	Dementia in Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;System Organ Class: 100000014717;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: IRL752 INN or Proposed INN: IRL752	Integrative Research Laboratories AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Finland;Sweden
234	EUCTR2015-004175-73-FI (EUCTR)	27/09/2017	07/07/2016	A clinical study to test the safety of CDNF by brain infusion in patients with Parkinson's disease.	A Phase I-II, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intermittent Bilateral Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Administered via an Investigational Drug Delivery System to Patients with Idiopathic Parkinson’s Disease (PD) of Moderate Severity.	Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor	Herantis Pharma Plc	NULL	Not Recruiting			Female: yes Male: yes	17	Phase 1;Phase 2	Finland
235	EUCTR2017-000128-81-DE (EUCTR)	20/09/2017	06/07/2017	PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE	PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE	Parkinson’s disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: PF-06649751 - 1mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 5mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 15mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	France;United States;Canada;Spain;Germany
236	EUCTR2017-000192-86-AT (EUCTR)	15/09/2017	10/08/2017	Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...)	Nabilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study	Subjects with non-motor symptoms of Parkinson´s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Nabilone INN or Proposed INN: NABILONE	Medizinische Universität Innsbruck, Universitätsklinik für Neurologie	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Austria
237	EUCTR2016-003961-25-CZ (EUCTR)	07/09/2017	15/05/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Hungary;Czech Republic;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
238	JPRN-jRCTs041180018	04/09/2017	20/12/2018	Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease	Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease - Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease	Parkinson's disease and related diseases	Two drops of 0.05% pilocarpine hydrochloride, which is a parasympathomimetic agent, on the right eye, 2 drops of 0.04% dipivefrin hydrochloride, which is a sympathomimetic agent, to the left eye	katsuno Masahisa	NULL	Complete	>= 40age old	Not applicable	Both	40	Phase 2	Japan
239	EUCTR2017-000128-81-ES (EUCTR)	28/08/2017	12/07/2017	PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE	PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE	Parkinson’s disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: PF-06649751 - 1mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 5mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 15mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	France;United States;Canada;Spain;Germany
240	EUCTR2017-000877-35-CZ (EUCTR)	09/08/2017	05/06/2017	A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.	Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR)	Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE	BenevolentAI Bio	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
241	EUCTR2017-000877-35-GB (EUCTR)	08/08/2017	17/07/2017	A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.	Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR)	Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE	BenevolentAI Bio	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
242	EUCTR2017-000877-35-ES (EUCTR)	03/08/2017	09/06/2017	A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.	Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR)	Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE	BenevolentAI Bio	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United Kingdom;United States;Czech Republic;Poland;Spain;Germany;Italy
243	EUCTR2014-004865-26-GR (EUCTR)	01/08/2017	25/04/2017	26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease	An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study	Non-motor symptoms in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	88	Phase 3	United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden
244	EUCTR2017-000262-30-IT (EUCTR)	10/07/2017	04/11/2020	Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations	Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations - NA	Parkinson's Desease (PD) MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: EXN-44(LEVODOPA) Product Code: EXN-44 Trade Name: Sinemet Product Name: EXN-32 (CARBIDOPA E LEVODOPA) Product Code: EXN-32	DR. REDDY’S LABORATORIES LIMITED	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 2	Italy
245	EUCTR2017-000135-14-ES (EUCTR)	07/07/2017	09/06/2017	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E	Prexton Therapeutics B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	Spain;Austria;Germany;Italy;United Kingdom
246	EUCTR2016-003961-25-DE (EUCTR)	30/06/2017	01/02/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
247	NCT03100149 (ClinicalTrials.gov)	June 27, 2017	29/3/2017	A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease	A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment Extension	Parkinson's Disease	Drug: RO7046015;Drug: Placebo	Hoffmann-La Roche	Prothena Biosciences Limited	Active, not recruiting	40 Years	80 Years	All	316	Phase 2	United States;Austria;France;Germany;Spain
248	NCT03195231 (ClinicalTrials.gov)	June 25, 2017	20/6/2017	Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease	Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.	Antidepressive Agents	Drug: Wuling Powder;Drug: Placebo	Beijing Hospital	Tongji Hospital;Shanghai Tong Ren Hospital;The First Hospital of Hebei Medical University	Not yet recruiting	40 Years	N/A	All	120	Phase 4	NULL
249	EUCTR2015-005814-31-ES (EUCTR)	22/06/2017	21/04/2017	-	A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND	Subjects with advanced Parkinson's disease MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 2	United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
250	EUCTR2017-000135-14-GB (EUCTR)	15/06/2017	17/03/2017	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E	Prexton Therapeutics B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	Spain;Austria;Germany;United Kingdom
251	NCT03083132 (ClinicalTrials.gov)	June 13, 2017	7/3/2017	Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)	Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's Disease	Parkinson Disease	Drug: modafinil 50mg;Drug: Placebo oral capsule	University of Arkansas	NULL	Completed	50 Years	90 Years	All	23	Early Phase 1	United States
252	EUCTR2016-003961-25-ES (EUCTR)	08/06/2017	27/04/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
253	EUCTR2017-000135-14-DE (EUCTR)	06/06/2017	10/03/2017	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E	Prexton Therapeutics B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	Spain;Austria;Germany;Italy;United Kingdom
254	EUCTR2016-003961-25-HU (EUCTR)	31/05/2017	03/04/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
255	EUCTR2017-000135-14-IT (EUCTR)	30/05/2017	04/11/2020	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	Studio di fase IIa, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilit¿ del trattamento orale con PXT002331 (foliglurax) della durata di 28 giorni nella riduzione delle complicazioni motorie dovute alla terapia con levodopa nei pazienti affetti da malattia di Parkinson che manifestano deterioramento da fine dose e discinesia indotta da levodopa (AMBLED) - AMBLED Study	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax	PREXTON THERAPEUTICS B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	France;Spain;Austria;Germany;United Kingdom;Italy
256	EUCTR2017-000135-14-AT (EUCTR)	26/05/2017	08/03/2017	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E	Prexton Therapeutics B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	Spain;Austria;Germany;United Kingdom
257	EUCTR2015-004507-23-FI (EUCTR)	08/05/2017	30/03/2017	Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.	Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC	Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Finland;Latvia;Germany
258	NCT03115827 (ClinicalTrials.gov)	April 18, 2017	9/3/2017	Norepinephrine-targeted Therapy for Action Control in Parkinson Disease	Norepinephrine-targeted Therapy for Action Control in Parkinson Disease	Parkinson Disease	Drug: Droxidopa;Drug: Carbidopa	Vanderbilt University Medical Center	H. Lundbeck A/S;American Academy of Neurology	Completed	18 Years	N/A	All	15	Phase 4	United States
259	EUCTR2016-004629-18-NL (EUCTR)	13/04/2017	17/01/2017	The influence of stress on Parkinson's tremor	The noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach - Noradrenergic basis of Parkinson tremor	Tremor in Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Propranolol Product Name: Propranolol HCl CF 40 mg tablet Product Code: RVG 55618	Radboud University Nijmegen	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	Netherlands
260	JPRN-jRCTs051180185	07/04/2017	26/03/2019	APISJ Study	Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - APISJ Study	Parkinson's disease Parkinson's disease	In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by Istradefylline.	Takahashi Makio	Kyowa Kirin Co., Ltd.	Complete	>= 30age old	Not applicable	Both	30	N/A	Japan
261	EUCTR2016-003961-25-GB (EUCTR)	04/04/2017	16/02/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
262	NCT02953665 (ClinicalTrials.gov)	April 3, 2017	21/10/2016	Safety and Efficacy of Liraglutide in Parkinson's Disease	A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's Disease	Parkinson Disease	Drug: Liraglutide;Drug: Placebo	Cedars-Sinai Medical Center	The Cure Parkinson's Trust;Novo Nordisk A/S	Completed	25 Years	85 Years	All	63	Phase 2	United States
263	JPRN-UMIN000026128	2017/04/01	01/04/2017	Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease	Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease - Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease	Parkinson's disease	administe pilocarpine and dipivefrine administe pilocarpine and dipivefrine	Nagoya University	NULL	Recruiting	40years-old	90years-old	Male and Female	60	Not selected	Japan
264	EUCTR2016-001403-23-GR (EUCTR)	31/03/2017	14/10/2016	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
265	EUCTR2016-001575-71-ES (EUCTR)	16/03/2017	17/01/2017	A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE	A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE	Parkinson's Disease MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751	Pfizer, Inc.	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	France;United States;Spain;Israel;Germany
266	JPRN-UMIN000026492	2017/03/15	15/03/2017	Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease	Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease.	Parkinson's disease	In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline.	Osaka Red Cross Hospital	Clinical Research Center, Wakayama Medical University	Complete: follow-up complete	30years-old	Not applicable	Male and Female	30	Not selected	Japan
267	EUCTR2015-003513-24-SK (EUCTR)	14/03/2017	04/03/2016	OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004	MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA	Intec Pharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	266	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
268	JPRN-jRCTs071180014	08/03/2017	29/01/2019	ODYSSEI Study	Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease - ODYSSEI Study	Parkinson's disease Parkinson's disease	Arm A: Treatment with Istradefylline combined with optimal medical therapy. Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including Istradefylline will be applied to each patient. Arm B: Optimal medical therapy without Istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than Istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without Istradefylline will be applied to each patient.	Tsuboi Yoshio	Kyowa Kirin Co., Ltd.	Not Recruiting	>= 30age old	< 80age old	Both	280	N/A	N A;Japan
269	EUCTR2015-005814-31-CZ (EUCTR)	03/03/2017	01/12/2016	-	A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND	Subjects with advanced Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
270	EUCTR2015-004507-23-HU (EUCTR)	24/02/2017	04/01/2017	Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.	Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC	Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Finland;Latvia;Germany
271	EUCTR2016-001403-23-FI (EUCTR)	22/02/2017	31/08/2016	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
272	EUCTR2016-000657-12-IT (EUCTR)	16/02/2017	08/02/2017	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD	Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 000000 Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 00000 Other descriptive name: Genz-682452-AU	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	276	Phase 2	United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
273	EUCTR2015-005814-31-DE (EUCTR)	07/02/2017	24/05/2016	-	A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND)	Subjects with advanced Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany
274	EUCTR2015-004344-19-DE (EUCTR)	07/02/2017	27/09/2016	An international trial of deferiprone in patients with Parkinson’s disease	A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215	Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE	ApoPharma	NULL	Not Recruiting			Female: yes Male: yes	140	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Canada;Germany;United Kingdom
275	JPRN-UMIN000025645	2017/02/01	17/01/2018	Cross sectional analysis of Intestinal flora of Parkinson's disease:	Cross sectional analysis of Intestinal flora of Parkinson's disease: - Analysis of Intestinal flora of Parkinson's disease	Parkinson's disease	Levodopa/carbidopa intestinal gel	Juntendo University School of Medicine	NULL	Pending	Not applicable	Not applicable	Male and Female	20	Not applicable	Japan
276	EUCTR2016-000657-12-DE (EUCTR)	26/01/2017	17/10/2016	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD	Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
277	JPRN-UMIN000043848	2017/01/10	29/04/2021	The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder	The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder : A randomized controlled trial - SEMPDOABRCT	Overactive bladder	Treatment group receiving daily mirabegron 50mg for 12 weeks Placebo group	Al Zahraa Hospital	NULL	Complete: follow-up complete	40years-old	70years-old	Male and Female	110	Not applicable	Asia(except Japan)
278	EUCTR2016-000657-12-PT (EUCTR)	09/01/2017	25/10/2016	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD	Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	Germany;Norway;Japan;Portugal;United States;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Sweden
279	NCT02954978 (ClinicalTrials.gov)	January 2017	1/11/2016	Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease	A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease	Parkinson Disease;Parkinsons Disease With Dementia	Drug: Placebo Oral Capsule;Drug: Nilotinib 150mg oral capsule [Tasigna];Drug: Nilotinib 300mg oral capsule [Tasigna]	Georgetown University	NULL	Active, not recruiting	40 Years	90 Years	All	75	Phase 2	United States
280	NCT03034564 (ClinicalTrials.gov)	January 2017	25/1/2017	A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease	A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease	Parkinson Disease;Fatigue;Parkinsonism	Drug: Northera;Drug: Placebo Oral Tablet	The Cooper Health System	NULL	Terminated	18 Years	N/A	All	1	Phase 4	United States
281	EUCTR2016-001575-71-DE (EUCTR)	23/12/2016	26/09/2016	A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE	A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751	Pfizer, Inc.	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	France;United States;Spain;Israel;Germany
282	EUCTR2016-002033-30-BE (EUCTR)	19/12/2016	21/11/2016	A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations	A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO	Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 3	Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
283	NCT02906020 (ClinicalTrials.gov)	December 15, 2016	14/9/2016	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant.	Parkinson's Disease	Drug: venglustat GZ/SAR402671;Drug: Placebo	Genzyme, a Sanofi Company	NULL	Terminated	18 Years	80 Years	All	270	Phase 2	United States;Austria;Canada;France;Germany;Greece;Israel;Italy;Japan;Norway;Portugal;Singapore;Spain;Sweden;Taiwan;United Kingdom
284	JPRN-UMIN000024859	2016/12/14	16/11/2016	The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.	The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. - The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.	Parkinson's disease	Switching from Dopamine agonist to Zonisamide. Intervention period of 12 weeks.	Medical Corporation Abe Neurology Clinic	NULL	Complete: follow-up continuing	30years-old	Not applicable	Male and Female	50	Not applicable	Japan
285	ChiCTR2000037957	2016-12-01	2020-09-07	Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease	Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease	Deep brain stimulation in patients with Parkinson's disease	Experimental group:conscious sedation with dexmedetomidine;control group:Pump in normal saline;	Shanghai Jing'an District Central Hospital	NULL	Completed	45	75	Both	Experimental group:27;control group:9;		China
286	NCT02934919 (ClinicalTrials.gov)	December 2016	14/10/2016	Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study	Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study	Impulse Control Disorders;Parkinson Disease	Drug: Nalmefene	University Hospital, Clermont-Ferrand	NULL	Not yet recruiting	18 Years	80 Years	Both	30	Phase 2	France
287	NCT02789020 (ClinicalTrials.gov)	December 2016	20/5/2016	Image Parkinson's Disease Progression Study	Image Parkinson's Disease Progression Study	Parkinson's Disease	Drug: Rasagiline;Other: Placebo;Device: Magnetic Resonance Imaging;Device: functional Magnetic Resonance Imaging;Other: Physical Function Performance Test	University of Florida	National Institute of Neurological Disorders and Stroke (NINDS)	Active, not recruiting	40 Years	77 Years	All	96	Phase 2	United States
288	NCT03000569 (ClinicalTrials.gov)	November 30, 2016	28/11/2016	A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease	A Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's Disease	Parkinson Disease	Drug: SAGE-217;Drug: Levodopa;Drug: Antiparkinsonian Agent(s)	Sage Therapeutics	NULL	Completed	40 Years	75 Years	All	29	Phase 2	United States
289	EUCTR2016-002033-30-FR (EUCTR)	29/11/2016	12/01/2017	A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations	A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO	Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden
290	EUCTR2016-001403-23-SK (EUCTR)	29/11/2016	07/09/2016	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;European Union;Slovakia;Greece;Finland;Spain
291	JPRN-UMIN000024536	2016/11/28	25/10/2016	Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.	Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline)	Parkinson's disease	Treatment with istradefylline combined with optimal medical therapy. Treatment with istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including istradefylline will be applied to each patient. Optimal medical therapy without istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without istradefylline will be applied to each patient.	Fukuoka University	NULL	Complete: follow-up complete	30years-old	80years-old	Male and Female	280	Not applicable	Japan
292	EUCTR2015-004912-39-ES (EUCTR)	25/11/2016	17/05/2016	A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE	A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE	Parkinson's Disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751	Pfizer, Inc.	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	France;United States;Spain;Germany;Japan;United Kingdom
293	NCT02847442 (ClinicalTrials.gov)	November 23, 2016	21/7/2016	Efficacy and Safety of Opicapone in Clinical Practice	Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations	Parkinson's Disease With Wearing-off Motor Fluctuations	Drug: BIA 9-1067;Drug: levodopa/dopa decarboxylase inhibitor	Bial - Portela C S.A.	NULL	Completed	30 Years	N/A	All	518	Phase 4	Germany
294	NCT03007888 (ClinicalTrials.gov)	November 14, 2016	6/12/2016	A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease	A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease	Advanced Parkinson's Disease	Drug: IR CD-LD;Drug: ER CD-LD	Impax Laboratories, LLC	NULL	Completed	40 Years	100 Years	All	28	Phase 2	United States
295	EUCTR2016-001403-23-ES (EUCTR)	14/11/2016	15/11/2016	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
296	EUCTR2016-000657-12-SE (EUCTR)	09/11/2016	12/10/2016	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD	Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden
297	EUCTR2016-001762-29-IT (EUCTR)	08/11/2016	25/05/2017	A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes)	A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) - CTH-201	Parkinson's Disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Trade Name: AVALOX - 400	SUNOVION PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Italy
298	NCT03531060 (ClinicalTrials.gov)	November 8, 2016	10/4/2018	A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia	A Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID).	Parkinson Disease	Drug: IRL790;Drug: Placebo	Integrative Research Laboratories AB	NULL	Completed	50 Years	85 Years	All	15	Phase 1/Phase 2	NULL
299	JPRN-UMIN000025638	2016/11/01	16/01/2017	Adenosine A2A receptors in Parkinson's disease	Adenosine A2A receptors in Parkinson's disease - Adenosine A2A receptors in Parkinson's disease	Parkinson's disease	11C-preladenant-PET scanning	Tokyo Metropolitan Institute of Gerontology	NULL	Complete: follow-up complete	40years-old	89years-old	Male and Female	40	Not selected	Japan
300	ChiCTR-IPR-16009395	2016-11-01	2016-10-14	Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage	Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage	Parkinson’s disease	Butylphthalide group and Control group:Butylphthalide 200mg/time(2 capsules) , three time/day, for 24 weeks;Control:No treatment;	The Second Affiliated Hospital of Soochow University	NULL	Pending	35		Both	Butylphthalide group and Control group:36;Control:36;		China
301	NCT02857244 (ClinicalTrials.gov)	November 2016	25/7/2016	A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients	A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients	Parkinson's Disease	Drug: Duloxetine;Drug: Donepezil;Drug: Modafinil	University of Chicago	NULL	Withdrawn	18 Years	100 Years	All	0	Phase 2	United States
302	NCT03022799 (ClinicalTrials.gov)	November 2016	27/12/2016	Phase I, KM-819 in Healthy Subjects for Parkinson's Disease	A First in Human, Randomized, Double-blind, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Single and Multiple Oral Doses of KM-819 in Healthy Young Adult and Elderly Subjects	Parkinson's Disease	Drug: KM-819;Drug: Placebo	Kainos Medicine Inc.	NULL	Completed	19 Years	45 Years	All	88	Phase 1	Korea, Republic of
303	NCT02968433 (ClinicalTrials.gov)	November 2016	14/11/2016	The Stanford Parkinson's Disease Plasma Study	The Stanford Parkinson's Disease Plasma (SPDP) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Moderate Parkinson's Disease	Parkinson Disease(PD)	Drug: Infusions of young plasma	Stanford University	NULL	Active, not recruiting	50 Years	80 Years	All	15	Phase 1	United States
304	EUCTR2015-001786-10-DE (EUCTR)	24/10/2016	07/04/2016	A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.	A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease	Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: EPI-589 Product Code: EPI-589 INN or Proposed INN: Kinoquinone (proposed) Other descriptive name: (R)-troloxamide quinone	BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Germany;United Kingdom
305	EUCTR2016-000657-12-ES (EUCTR)	20/10/2016	24/10/2016	A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation	Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD	Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: NA Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: NA Other descriptive name: Genz-682452-AU	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	276	Phase 2	United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
306	EUCTR2016-002680-34-ES (EUCTR)	20/10/2016	05/08/2016	Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.	Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.	Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]	Trade Name: Dexdor Product Name: Dexdor INN or Proposed INN: DEXMEDETOMIDINE Other descriptive name: DEXMEDETOMIDINA	Clínica Universidad de Navarra/Universidad de Navarra	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 4	Spain
307	EUCTR2015-002571-24-GB (EUCTR)	14/10/2016	12/02/2019	A Pilot Study to Evaluate the Safety, Tolerability (any side effects of the drug) and Pharmacodynamic (biochemical and physiological effects of drugs). The effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease.	A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease - AiM-PD	Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: AMBROSAN 60mg Tablets Product Name: Ambroxol INN or Proposed INN: Ambroxol hydrochloride	Joint Research Office	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
308	EUCTR2016-002391-27-GB (EUCTR)	07/10/2016	04/08/2016	Opicapone in clinical practice (OPTIPARK)	This action will amend the information submitted in this data field for all relevant applications. Please refer to the guidance under the Amendment tab and consider whether further notification to review bodies is required. - Opicapone in clinical practice (OPTIPARK)_V1	Parkinson's disease (PD) patients with wearing-off motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ongentys Product Name: Ongentys	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Germany;United Kingdom
309	EUCTR2016-002391-27-DE (EUCTR)	05/10/2016	05/08/2016	OPTIPARK	Efficacy and safety of opicapone in clinical practice in Parkinson’s Disease patients with wearing-off motor fluctuations	Parkinson's disease (PD) patients with wearing-off motor fluctuations;Therapeutic area: Not possible to specify	Trade Name: Ongentys Product Name: Ongentys	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Germany;United Kingdom
310	EUCTR2015-005078-39-DE (EUCTR)	21/09/2016	02/03/2016	-	A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease	Subjects with advanced Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	47	Phase 2	United States;Austria;Israel;Germany;Italy
311	JPRN-UMIN000024312	2016/09/20	25/05/2017	Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds.	Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. - Effect of febuxostat and inosine on CNS diseases	Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis	Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks	Tsukuba International Clinical Pharmacology Clinic	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	12	Not selected	Japan
312	EUCTR2016-001403-23-IT (EUCTR)	13/09/2016	06/09/2021	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease.	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparativeinterventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa Product Name: na Product Code: [na] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE	ABBVIE DEUTSCHLAND GMBH & CO. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain;Italy
313	NCT02869945 (ClinicalTrials.gov)	September 2016	4/8/2016	Compensation Mechanisms in Parkinson's Disease	Dopaminergic Denervation and COMT Polymorphism in de Novo Patients With Parkinson's Disease	Parkinson Disease	Genetic: Identification of COMT HH, COMT HL or COMT LL genes;Other: Brain MRI with resting state scan;Other: Brain MPET	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	All	50	N/A	France
314	EUCTR2015-003679-31-NL (EUCTR)	09/08/2016	24/05/2016	New therapeutic strategy in Parkinson’s disease	Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II	De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE	Centre Hospitalier Régional et Universitaire de Lille	NULL	Not Recruiting			Female: yes Male: yes	338	Phase 2	Portugal;Czech Republic;Spain;Austria;Netherlands
315	NCT02452723 (ClinicalTrials.gov)	July 2016	18/5/2015	A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease	A Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's Disease	Parkinson Disease	Biological: ISC-hpNSC	Cyto Therapeutics Pty Limited	NULL	Active, not recruiting	30 Years	70 Years	All	12	Phase 1	Australia
316	NCT02789592 (ClinicalTrials.gov)	July 2016	31/5/2016	Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease	A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson Disease	REM Sleep Behavior Disorder;Parkinson Disease	Drug: Melatonin PR;Drug: Clonazepam;Drug: Melatonin PR placebo;Drug: Clonazepam placebo	Seoul National University Hospital	Kuhnil Pharmaceutical Co., Ltd.	Not yet recruiting	30 Years	N/A	Both	30	Phase 2	Korea, Republic of
317	EUCTR2015-004344-19-FR (EUCTR)	29/06/2016	20/04/2016	An international trial of deferiprone in patients with parkinson’s disease	A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215	Parkinson’s disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE	ApoPharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;France;Canada;Germany;Italy;United Kingdom
318	EUCTR2015-003513-24-BG (EUCTR)	27/06/2016	26/04/2016	OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004	MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA	Intec Pharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	266	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
319	EUCTR2015-003513-24-IT (EUCTR)	23/06/2016	05/11/2020	OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004	Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	INTEC PHARMA LTD	NULL	Not Recruiting			Female: yes Male: yes	266	Phase 3	United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy
320	EUCTR2015-005814-31-IT (EUCTR)	23/06/2016	14/01/2021	Not available	A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND	advanced Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Soluzione di levodopa/carbidopa Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA (LD) INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA (CD)	NEURODERM LTD.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 2	France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
321	EUCTR2015-005626-19-CZ (EUCTR)	23/06/2016	14/04/2016	A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodes	A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 20.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Czech Republic;Canada;Poland;Spain
322	EUCTR2015-003679-31-CZ (EUCTR)	23/06/2016	28/01/2016	New therapeutic strategy in Parkinson’s disease	Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II	De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE	Centre Hospitalier Régional et Universitaire de Lille	NULL	Not Recruiting			Female: yes Male: yes	338	Phase 2	Portugal;Czech Republic;Spain;Austria;Netherlands
323	EUCTR2015-003512-20-PL (EUCTR)	22/06/2016	01/04/2016	Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease	A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients	Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA	Intec Pharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
324	EUCTR2015-004912-39-DE (EUCTR)	14/06/2016	11/02/2016	A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE	A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751	Pfizer, Inc.	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	France;United States;Spain;Germany;Japan;United Kingdom
325	EUCTR2015-005626-19-ES (EUCTR)	13/06/2016	20/04/2016	A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodes	A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, a wholly owned subsidiary of Acorda	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Czech Republic;Canada;Poland;Spain
326	JPRN-jRCTs051180098	09/06/2016	06/03/2019	The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease	A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease	Parkinson's disease;034034	L-Dopa/DCI only : The drug is administered per oral at 300 mg/day. The treatment is started within 14 days after registration and continued until day 365. L-Dopa/DCI + selegiline : L-Dopa/DCI is administered per oral at 300 mg/day and selegiline is administered at 5 mg/day. The treatment is started within 14 days after registration and continued until day 365. L-Dopa/DCI + zonisamide : L-Dopa/DCI is administered per oral at 300 mg/day and zonisamide is administered at 25 mg/day. The treatment is started within 14 days after registration and continued until day 365.	Ito Hidefumi	NULL	Not Recruiting	>= 55age old	< 80age old	Both	120	Phase 2	Japan
327	EUCTR2015-005078-39-IT (EUCTR)	08/06/2016	19/01/2021	NA	A multicenter, parallel-group, rater-blinded, randomized clinical studyinvestigating the efficacy, safety, tolerability and pharmacokinetics of2 dosing regimens of ND0612H, a solution of levodopa/carbidopadelivered via a pump system as a continuous subcutaneous infusion insubjects with advanced Parkinson's disease - NA	advanced Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: soluzione di levodopa/carbidopa Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA	NEURODERM LTD.	NULL	Not Recruiting			Female: yes Male: yes	47	Phase 2	United States;Austria;Israel;Germany;Italy
328	EUCTR2015-003512-20-IT (EUCTR)	08/06/2016	05/11/2020	Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease	A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease	Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	INTEC PHARMA LTD	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy
329	EUCTR2016-000679-25-ES (EUCTR)	31/05/2016	18/03/2016	Clinical study for the assessment of security of candesartan in Parkinson?s disease population and its potential benefit in cognitive impairment associated to Parkinson?s disease.	A prospective, randomized, double-blind and placebo-controlled, parallel group, phase II study to compare the efficacy and safety of candesartan versus placebo on cognitive impairment associated with Parkinson?s disease. Exploratory study.	Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Parapres	INSTITUT DE RECERCA HSCSP	NULL	Not Recruiting			Female: yes Male: yes	56	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Spain
330	EUCTR2015-005078-39-AT (EUCTR)	30/05/2016	09/03/2016	-	A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease	Subjects with advanced Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	47	Phase 2	United States;Austria;Israel;Germany;Italy
331	JPRN-UMIN000009062	2016/05/30	09/10/2012	An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease	An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease - An evaluation of the safety of inosine for patients with Parkinson's disease	Parkinson's disease	Take oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dL	Dept. of Clinical pharmacology and Neurology	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Phase 1	Japan
332	EUCTR2015-003512-20-ES (EUCTR)	18/05/2016	18/03/2016	Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s Disease	A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients	Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA	Intec Pharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
333	EUCTR2015-003513-24-ES (EUCTR)	18/05/2016	18/03/2016	OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004	Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA	Intec Pharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	460	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
334	EUCTR2016-000636-18-GB (EUCTR)	12/05/2016	04/03/2016	Phase 3, placebo controlled study to examine the efficacy, safety and tolerability of APL-130277 in patients with Parkinson's disease.	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes).	Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 19.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE	Sunuvion Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	126	Phase 3	Canada;United States;United Kingdom
335	EUCTR2016-000637-43-GB (EUCTR)	12/05/2016	04/03/2016	Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.	An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes).	Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE	Sunovion Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom
336	JPRN-UMIN000022023	2016/05/10	10/05/2016	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora- - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-	Parkinson diseaseChronic constipation	Study drug group: A 12-week administration of lubiprostone 24 microgrum (adjustable) twice daily after switching from magnesium oxide Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollmen	Dokkyo Medical University	NULL	Complete: follow-up complete	20years-old	90years-old	Male and Female	64	Not selected	Japan
337	JPRN-UMIN000022022	2016/05/10	10/05/2016	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease	Parkinson diseaseChronic constipation	Study drug group: A 12-week administration of lubiprostone 24 microrgrum (adjustable) twice daily after switching from magnesium oxide Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollment	Dokkyo Medical University	NULL	Complete: follow-up complete	20years-old	90years-old	Male and Female	64	Not selected	Japan
338	EUCTR2015-003887-34-PL (EUCTR)	06/05/2016	26/02/2016	A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease	A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease	Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
339	JPRN-UMIN000022187	2016/05/06	06/05/2016	Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease	Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease - Analysis of caffeine absorption in patients with Parkinson's disease	Parkinson&#39;s disease	PD group, 200 mg caffeine administration, qd, 1 day Control group, 200 mg caffeine administration, qd, 1 day	Department of Neurology, Juntendo University	NULL	Complete: follow-up complete	40years-old	60years-old	Male and Female	20	Not applicable	Japan
340	NCT02812147 (ClinicalTrials.gov)	May 2016	25/5/2016	Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease	Effect of L-Dihydoxyphenylserine (L-DOPS, Northera) a Central and Peripheral Norepinephrine Agent on Locomotion, Postural Stability (Balance), and Fall Risk Reduction in Parkinson Disease (PD)	Parkinson Disease	Drug: L-DOPS;Drug: Placebo	St. Joseph's Hospital and Medical Center, Phoenix	Arizona State University, Tempe	Active, not recruiting	30 Years	83 Years	All	20	Phase 2	United States
341	NCT02705755 (ClinicalTrials.gov)	May 2016	7/3/2016	TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)	A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension	Neurogenic Orthostatic Hypotension;Multiple System Atrophy (MSA) With Orthostatic Hypotension;Pure Autonomic Failure;Parkinson Disease;Hypotension, Orthostatic;Orthostatic Hypotension;Pure Autonomic Failure With Orthostatic Hypotension;Parkinson Disease With Orthostatic Hypotension	Drug: TD-9855;Drug: Placebo	Theravance Biopharma	NULL	Completed	40 Years	N/A	All	34	Phase 2	United States
342	NCT02726386 (ClinicalTrials.gov)	May 2016	29/3/2016	A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC Infusion	A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease	Parkinson's Disease	Drug: ND0612	NeuroDerm Ltd.	NULL	Active, not recruiting	30 Years	N/A	All	210	Phase 2	United States;Austria;Czechia;France;Germany;Israel;Italy;Poland;Spain
343	EUCTR2015-003513-24-GB (EUCTR)	28/04/2016	04/03/2016	OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004	MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA	Intec Pharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	266	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
344	EUCTR2015-003512-20-GB (EUCTR)	28/04/2016	03/03/2016	Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease	A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients	Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA	Intec Pharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	420	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
345	EUCTR2015-004507-23-DE (EUCTR)	25/04/2016	13/01/2016	Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.	Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC	Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Finland;Latvia;Germany
346	EUCTR2015-003512-20-SK (EUCTR)	22/04/2016	04/03/2016	Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease	A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients	Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA	Intec Pharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	420	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
347	EUCTR2015-003679-31-PT (EUCTR)	18/04/2016	28/01/2016	New therapeutic strategy in Parkinson’s disease	Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II	De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE	Centre Hospitalier Régional et Universitaire de Lille	NULL	Not Recruiting			Female: yes Male: yes	338	Phase 2	Portugal;Czech Republic;Spain;Austria;Netherlands
348	EUCTR2015-003887-34-DE (EUCTR)	12/04/2016	23/12/2015	A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease	A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease	Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
349	EUCTR2014-005630-60-AT (EUCTR)	12/04/2016	04/12/2015	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT	Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.)	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
350	EUCTR2015-003679-31-AT (EUCTR)	06/04/2016	11/01/2016	New therapeutic strategy in Parkinson’s disease	Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II	De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE	Centre Hospitalier Régional et Universitaire de Lille	NULL	Not Recruiting			Female: yes Male: yes	372	Phase 2	Portugal;France;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom
351	EUCTR2015-005067-17-CZ (EUCTR)	01/04/2016	25/01/2016	A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson’s Disease Patients with OFF episodes	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 3	United States;Czech Republic;Canada;Spain;Poland
352	EUCTR2015-004344-19-GB (EUCTR)	31/03/2016	16/02/2016	An international trial of deferiprone in patients with Parkinson’s disease	A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215	Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE	ApoPharma	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2	France;Canada;Germany;United Kingdom
353	EUCTR2015-001523-24-FR (EUCTR)	25/03/2016	20/04/2016	Evaluation of the pain relief of prolonged-release oxycodone and of L-Dopa, versus placebo, in Parkinson's disease.	Evaluation of the analgesic effects of prolonged-release oxycodone and of L-Dopa, versus placebo, on central neuropathic pain in Parkinson's disease : OXYDOPA trial - OXYDOPA	Central neuropathic pain in Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: oxycontin LP 5mg Product Name: Oxycontin LP 5mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: oxycontin LP 10mg Product Name: Oxycontin LP 10mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: oxycontin LP 20mg Product Name: Oxycontin LP 20mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: Modopar 125 Product Name: Modopar 125 INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: BENSERAZIDE Trade Name: Modopar 62,5 Product Name: Modopar 62,5 INN or Proposed INN: levodopa Other descriptive name: LEVODOPA	UHToulouse	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2;Phase 3	France
354	EUCTR2015-003887-34-IT (EUCTR)	25/03/2016	21/01/2021	A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease	A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease - A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinso	Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE	KYOWA HAKKO KIRIN PHARMA, INC.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy
355	JPRN-jRCTs061180060	22/03/2016	18/03/2019	Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease	Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease	Parkinson's disease;D010300	Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP)	Nagai Masahiro	NULL	Complete	>= 20age old	Not applicable	Both	100	Phase 2	Japan
356	EUCTR2015-003679-31-ES (EUCTR)	21/03/2016	13/01/2016	New therapeutic strategy in Parkinson?s disease	Conservative iron chelation as a disease-modifying strategy in Parkinson?s disease: a multicentre, parallel-group, placebo-controlled, randomized clinical trial of deferiprone - FAIRPARK II	De Novo Parkinson?s disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ferriprox 500 mg Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE	Centre Hospitalier Régional et Universitaire de Lille	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	338	Phase 3	Spain
357	EUCTR2015-004507-23-LV (EUCTR)	15/03/2016	13/01/2016	Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.	Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC	Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Finland;Germany;Latvia
358	EUCTR2015-005067-17-ES (EUCTR)	14/03/2016	17/02/2016	A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson?s Disease Patients with OFF episodes	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson?s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD?)	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, a wholly owned subsidiary of Acorda Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 3	United States;Czech Republic;Canada;Poland;Spain
359	EUCTR2015-004129-15-ES (EUCTR)	07/03/2016	24/02/2016	Subjects participating in a Parkinson Disease cohort are offered to undergo a PET imaging scan requiring an intravenous diagnostic drug (florbetaben) with the aim of identifying markers of disease progression	Evaluation of [18F] florbetaben in subjects participating in the Parkinson?s Progression Markers Initiative (PPMI) Protocol	Parkinson's Disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neuraceq Product Name: 18F florbetaben INN or Proposed INN: FLORBETABEN (18F)	Institute for Neurodegenerative Disorders	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Spain
360	EUCTR2015-003887-34-CZ (EUCTR)	02/03/2016	30/12/2015	A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease	A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease	Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
361	JPRN-UMIN000021236	2016/03/01	01/03/2016	Investigation in effect of aroma therapy using magnetoencepharography	Investigation in effect of aroma therapy using magnetoencepharography - Aroma with MEG	Normal volunteer, Epilepsy patients, Parkinson disease patients	aroma 1 Trans-nasal administration of lavender essence Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. aroma 2 Trans-nasal administration of grapefruit essence Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. fragrant Trans-nasal administration of fragrant Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness.	Osaka University Graduate School of Medicine Department of Neurosurgery	NULL	Complete: follow-up continuing	20years-old	80years-old	Male and Female	10	Phase 1	Japan
362	NCT02994719 (ClinicalTrials.gov)	March 1, 2016	21/12/2015	Gait Analysis in Neurological Disease	Gait Pattern Analysis in Neurological Disease	Parkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington Disease	Drug: Anti-Parkinson medication;Device: Deep Brain Stimulation	Beth Israel Deaconess Medical Center	NULL	Active, not recruiting	18 Years	85 Years	All	120		United States
363	NCT02668497 (ClinicalTrials.gov)	March 2016	26/1/2016	Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy	Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy	Parkinson's Disease	Drug: Botulinum Toxin Type A	Western University, Canada	NULL	Active, not recruiting	18 Years	80 Years	All	50	Phase 2	Canada
364	JPRN-UMIN000020288	2016/02/01	28/12/2015	Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease.	Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. - Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease.	Parkinson's disease	In this research, the duration of evaluation will be 12 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline.	Juntendo University Shizuoka Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	30	Not selected	Japan
365	JPRN-UMIN000020527	2016/02/01	01/02/2016	Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease	Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease	Parkinson's disease	Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years Lactose as a placebo for 2 years	Ehime University Graduate School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	100	Phase 2	Japan
366	EUCTR2015-004238-85-ES (EUCTR)	27/01/2016	10/12/2015	Brain SPECT in premotor stage of Parkinson disease	Ictal brain SPECT in the premotor stage of Parkinson disease	Parkinson disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: CERETEC (TM) Estabilizado Product Name: Ceretec INN or Proposed INN: Ceretec Other descriptive name: TECHNETIUM (99MTC) EXAMETAZIME	IDIBAPS	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Spain
367	EUCTR2015-003679-31-FR (EUCTR)	25/01/2016	25/02/2016	New therapeutic strategy in Parkinson’s disease	Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II	De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE	Centre Hospitalier Régional et Universitaire de Lille	NULL	Not Recruiting			Female: yes Male: yes	338	Phase 2	Portugal;France;Czech Republic;Spain;Austria;Netherlands
368	EUCTR2015-001786-10-GB (EUCTR)	18/01/2016	23/11/2015	A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.	A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease	Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: EPI-589 Product Code: EPI-589 Other descriptive name: (R)-troloxamide quinone	BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Germany;United Kingdom
369	NCT02579473 (ClinicalTrials.gov)	January 2016	13/10/2015	A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214	A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose Titration	Parkinson's Disease	Drug: SER-214	Serina Therapeutics	NULL	Active, not recruiting	40 Years	80 Years	All	20	Phase 1	United States
370	EUCTR2014-002600-24-AT (EUCTR)	30/12/2015	25/09/2015	Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE	Zambon S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
371	EUCTR2014-005630-60-ES (EUCTR)	11/12/2015	05/10/2015	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD	Parkinson´s Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT	Biotie Therapies Inc.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
372	EUCTR2014-002600-24-IT (EUCTR)	11/12/2015	16/02/2018	Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: Safinamide Product Code: na INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO Trade Name: Xadago INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO	ZAMBON SPA	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden
373	EUCTR2014-002600-24-SE (EUCTR)	03/12/2015	30/07/2015	Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE	Zambon S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
374	NCT02616120 (ClinicalTrials.gov)	December 2015	20/11/2015	Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease	Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients	Parkinson's Disease	Drug: SQJZ herbal mixtures;Drug: Placebo	Dongzhimen Hospital, Beijing	NULL	Recruiting	18 Years	80 Years	All	240	Phase 2	China
375	EUCTR2014-002600-24-ES (EUCTR)	19/11/2015	05/10/2015	Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON?S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE	Zambon S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
376	EUCTR2015-002631-17-ES (EUCTR)	19/11/2015	03/11/2015	A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients	An intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients	Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa Product Name: Duodopa Trade Name: Sinemet Plus Product Name: Sinemet Plus	Institut de Recerca del Hospital de la Santa Creu i Sant Pau	NULL	Not Recruiting			Female: yes Male: yes	18	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Spain
377	NCT02565628 (ClinicalTrials.gov)	November 16, 2015	28/9/2015	PF-06669571 In Subjects With Idiopathic Parkinson's Disease	A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.	Idiopathic Parkinson's Disease	Drug: PF-06669571;Drug: Placebo	Pfizer	NULL	Completed	N/A	N/A	All	20	Phase 1	United States
378	JPRN-UMIN000019676	2015/11/10	10/11/2015	The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease	The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease	Parkinson's disease	taking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks taking matching placebo after breakfast for 4 weeks, wash out for 2 weeks, taking modafinil (200 mg/day) after breakfast for 4 weeks	Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine	NULL	Complete: follow-up complete	20years-old	100years-old	Male and Female	20	Not selected	Japan
379	EUCTR2015-000148-40-GB (EUCTR)	09/11/2015	16/09/2015	A trial comparing simvastatin to placebo as a neuronal protective treatment for Parkinson's disease.	Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity. - Simvastatin as a neuroprotective treatment for moderate PD (PD STAT)	Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Simvastatin INN or Proposed INN: Simvastatin	Plymouth Hospitals NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 3	United Kingdom
380	JPRN-UMIN000019654	2015/11/06	06/11/2015	The effect of rich-hydrogen water drinking to gut peptide	The effect of rich-hydrogen water drinking to gut peptide - The effect of rich-hydrogen water drinking to gut peptide	Parkinson's disease, healthy control	hydrogen water natural water	Nagoya graduate school of medicine university	NULL	Pending	20years-old	80years-old	Male and Female	40	Not applicable	Japan
381	JPRN-UMIN000019090	2015/11/04	01/11/2015	Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water	Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water - Dose finding test of reduced form of Coenzyme Q10 for Parkinson's disease	Parkinson's disease	reduced form of CoQ10 300mg 16weeks reduced form of CoQ10 600mg 16weeks reduced form of CoQ10 600mg 16weeks hydrogen water 500ml(Suisosui 7.0) 16weeks	Juntendo University Koshigaya Hospital	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	45	Not selected	Japan
382	JPRN-jRCTs041180070	04/11/2015	07/03/2019	Trerief Impact in PD PET Study	Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS	Parkinson's disease Parkinson's disease;D010300	[1] Zonisamide treatment group Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. [2] Zonisamide non-treatment group Only levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.	Ouchi Yasuomi	NULL	Not Recruiting	Not applicable	< 80age old	Both	20	N/A	Japan
383	EUCTR2014-002600-24-GB (EUCTR)	03/11/2015	28/07/2015	Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE	Zambon S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden
384	NCT04110678 (ClinicalTrials.gov)	November 1, 2015	18/9/2019	Tolerance to NeuroEPO in Parkinson Disease	Nasal Administration of the NeuroEPO in Parkinson Disease: Short-term Tolerance Physician Lead Trial	Parkinson Disease	Drug: NeuroEPO	International Center for Neurological Restoration, Cuba	Center of Molecular Immunology, Cuba;University of Electronic Science and Technology of China	Completed	40 Years	70 Years	All	26	Phase 1/Phase 2	Cuba
385	NCT02668835 (ClinicalTrials.gov)	November 2015	4/12/2015	GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial	GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial	Parkinson Disease;Essential Tremor	Device: Non intervention-Monitoring device;Genetic: Non intervention-Genetic testing	Scripps Translational Science Institute	Michael J. Fox Foundation for Parkinson's Research;Intel Corporation	Completed	18 Years	N/A	All	67		NULL
386	NCT02577523 (ClinicalTrials.gov)	November 2015	6/10/2015	A Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of ND0612H, a Solution of Levodopa/Carbidopa Administered as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease	A Multicenter, Parallel-group, Rater-blinded, Randomized Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of 2 Dosing Regimens of ND0612H, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease	Parkinson's Disease	Drug: ND0612 (Levodopa/Carbidopa solution)	NeuroDerm Ltd.	NULL	Completed	30 Years	80 Years	All	38	Phase 2	United States;Austria;Israel;Italy
387	NCT02632279 (ClinicalTrials.gov)	November 2015	26/11/2015	Tryptophan Depletion in PD Patients Treated With STN DBS	Tryptophan Depletion in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus: Effects on Mood and Motor Functions	Parkinson's Disease	Dietary Supplement: Tryptophan (TRP) depletion;Dietary Supplement: Placebo;Device: Stimulator ON;Device: Stimulator OFF	Maastricht University Medical Center	Netherlands Brain Foundation	Terminated	N/A	N/A	All	7	N/A	Netherlands
388	NCT02758730 (ClinicalTrials.gov)	November 2015	26/4/2016	Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA Patients	A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBA	Parkinson's Disease	Biological: AFFITOPE® PD01A + Adjuvant;Biological: Adjuvant without active component	Affiris AG	University Hospital Tuebingen	Withdrawn	40 Years	80 Years	Both	0	Phase 1	Germany
389	NCT02914366 (ClinicalTrials.gov)	November 2015	8/9/2016	Ambroxol as a Treatment for Parkinson's Disease Dementia	Ambroxol as a Novel Disease Modifying Treatment for Parkinson's Disease Dementia	Parkinson's Disease Dementia	Drug: Ambroxol;Other: Placebo	Lawson Health Research Institute	Weston Brain Institute;Western University, Canada;London Health Sciences Centre	Active, not recruiting	50 Years	N/A	All	55	Phase 2	Canada
390	NCT02271503 (ClinicalTrials.gov)	November 2015	13/10/2014	A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease	A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease	Parkinson's Disease	Drug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mg	Impax Laboratories, LLC	NULL	Completed	40 Years	N/A	All	26	Phase 2	United States
391	EUCTR2014-005630-60-DE (EUCTR)	29/10/2015	07/07/2015	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT	Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.)	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
392	NCT02549092 (ClinicalTrials.gov)	October 26, 2015	11/9/2015	A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)	An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS Study	Advanced Parkinson's Disease	Drug: Optimized Medical Treatment;Drug: Levodopa-Carbidopa Intestinal Gel;Device: Nasojejunal (NJ) tube;Device: Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube	AbbVie	NULL	Completed	30 Years	N/A	All	89	Phase 3	United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden
393	EUCTR2015-003045-26-SE (EUCTR)	23/10/2015	15/09/2015	Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease.	[18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease.	Patients with newly clinically diagnosed untreated idiopathic parkinsonism MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: [18F]FE-PE2I INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane Trade Name: DaTSCAN INN or Proposed INN: IOFLUPANE (123I) Product Name: 15O H2O INN or Proposed INN: [15O]H2O	Umeå University Hospital	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	Sweden
394	JPRN-UMIN000019082	2015/10/10	22/09/2015	the effect of smell dysfunction using hydrogen gas for parkinson disease	the effect of smell dysfunction using hydrogen gas for parkinson disease - the effect of smell dysfunction using hydrogen gas for parkinson disease	parkinson's disease	we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after room air. we measured smell test and urine 8-OHdG before and after room air. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas.	Nagoya University Graduate School of Medicine	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	20	Not selected	Japan
395	JPRN-UMIN000019524	2015/10/01	28/10/2015	Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images	Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS)	Parkinson's Disease	Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. Zonisamide non-treatment group: Only Levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.	Hamamatsu University School of Medicine	NULL	Complete: follow-up complete	Not applicable	80years-old	Male and Female	20	Not applicable	Japan
396	EUCTR2014-005630-60-IT (EUCTR)	23/09/2015	17/01/2022	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 Other descriptive name: TOZADENANT	BIOTIE THERAPIES INC.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Canada;Spain;Austria;Germany;Italy
397	EUCTR2014-005630-60-CZ (EUCTR)	23/09/2015	10/07/2015	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT	Biotie Therapies Inc. (a wholly owned subsidiary of Acorda Therapeutics Inc.)	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
398	EUCTR2014-004865-26-IT (EUCTR)	21/09/2015	29/05/2015	26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease	An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study	Non-motor symptoms in advanced Parkinson's disease MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	88		European Union;Canada;Spain;Australia;Germany;Italy;Sweden
399	EUCTR2014-004865-26-DE (EUCTR)	27/08/2015	22/05/2015	26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease	An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study	Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 3	European Union;Canada;Spain;Australia;Germany;Italy;Sweden
400	EUCTR2015-000373-13-DE (EUCTR)	18/08/2015	18/05/2015	A study to examine the effectiveness and safety of a new drug for involuntary muscle movements in patients with Parkinson’s disease	Phase 2, multicenter, randomized, double-blind, placebo-controlled, four-period cross-over, dose-range finding study to evaluate the safety, tolerability and efficacy of Eltoprazine in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.	Parkinson’s disease levodopa induced dyskinesia (PD-LID) MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE	Amarantus BioScience Holdings, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	France;United States;Germany;Sweden
401	EUCTR2014-004865-26-SE (EUCTR)	05/08/2015	25/05/2015	26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease	An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study	Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 3	United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
402	NCT02917122 (ClinicalTrials.gov)	August 2015	30/6/2016	The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease	The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease	Parkinson Disease;Depression	Device: active tDCS;Drug: Sertraline;Device: sham tDCS	National Cheng-Kung University Hospital	NULL	Active, not recruiting	18 Years	75 Years	Both	40	Phase 1/Phase 2	NULL
403	NCT02337751 (ClinicalTrials.gov)	July 10, 2015	9/1/2015	A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants	A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa	Parkinson's Disease	Drug: TVP-1012 1mg	Takeda	NULL	Completed	30 Years	79 Years	All	198	Phase 3	Japan
404	EUCTR2014-003738-24-AT (EUCTR)	26/06/2015	01/04/2015	A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease	ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY	Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 17.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE	Adamas Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 3	Germany;Spain;Austria;United States
405	EUCTR2014-000657-36-NL (EUCTR)	22/06/2015	03/06/2015	Trial to investigate the efficacy of treatments in apomorphine-induced skin reactions	Open-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study	Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Hydrocortisone cream 10mg/g FNA Fagron Product Name: Hydrocortisone cream Trade Name: Solu-Cortef, powder for solution for injection, 100mg, and 'Act-O-Vial' Product Name: Solu-Cortef Trade Name: APO-go Product Name: Apomorphine	University Medical Center Groningen	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Netherlands
406	EUCTR2014-003739-20-AT (EUCTR)	19/06/2015	01/04/2015	A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease	Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia	Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE	Adamas Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Spain;Austria;Germany
407	EUCTR2014-004865-26-ES (EUCTR)	19/06/2015	15/06/2015	26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease	An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease ? INSIGHTS Study - INSIGHTS Study	Non-motor symptoms in advanced Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 3	Greece;Canada;Sweden;European Union;Italy;Australia;Germany;Spain
408	NCT02450786 (ClinicalTrials.gov)	June 2015	14/5/2015	Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)		Parkinson's Disease	Drug: Donepezil	Yonsei University	NULL	Active, not recruiting	40 Years	N/A	All	80	Phase 2	Korea, Republic of
409	EUCTR2014-005422-35-GB (EUCTR)	28/05/2015	02/04/2015	The role of Buspirone in attenuating involuntary movements (Dyskinesias) in patients with Parkinson's disease.	THE ROLE OF BUSPIRONE IN ATTENUATING LEVODOPA-INDUCED DYSKINESIAS IN PATIENTS WITH PARKINSON'S DISEASE: A CLINICAL AND POSITRON EMISSION TOMOGRAPHY STUDY WITH 11C-PHNO. - The role of buspirone in LIDs in patients with Parkinson’s disease.	Levodopa induced dyskinesias within Parkinson's disease. MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Buspirone Hydrochloride Product Name: Buspirone Hydrochloride INN or Proposed INN: Buspirone Hydrochloride	Imperial College London-Imperial College Healthcare NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	24	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
410	JPRN-jRCTs061180028	11/05/2015	26/02/2019	Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine	A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine	Parkinson's disease;D010300	The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.	Ando Rina	NULL	Complete	20 years old	None	Both	50	Phase 2	Japan
411	EUCTR2014-003799-22-AT (EUCTR)	08/05/2015	12/01/2015	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease	A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 3	Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
412	EUCTR2010-024424-26-SK (EUCTR)	05/05/2015	28/04/2015	Clinical study for the evaluation of the safety and efficacy of masitinib in patients suffering from parkinson's disease	A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo on cognitive impairment associated with Parkinson's disease	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate	AB Science	NULL	Not Recruiting			Female: yes Male: yes	45	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Hungary;Czech Republic;Slovakia;Spain;Romania;Bulgaria;South Africa;Germany
413	NCT02439125 (ClinicalTrials.gov)	May 2015	13/4/2015	A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients	Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease	Parkinson's Disease;Dyskinesia	Drug: Eltoprazine HCl;Drug: Placebo	Amarantus BioScience Holdings, Inc.	NULL	Active, not recruiting	30 Years	85 Years	Both	60	Phase 2	United States
414	EUCTR2014-003738-24-DE (EUCTR)	23/04/2015	21/01/2015	A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease	ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY	Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE	Adamas Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 3	United States;Spain;Austria;Germany
415	EUCTR2014-003739-20-DE (EUCTR)	23/04/2015	21/01/2015	A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease	Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia	Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE	Adamas Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Spain;Austria;Germany
416	EUCTR2014-003799-22-DE (EUCTR)	22/04/2015	04/12/2014	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease	A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 3	Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
417	EUCTR2014-002697-37-GB (EUCTR)	15/04/2015	19/03/2015	Study of Melatonin for treatment of Nocturia in PD	Single-centre open label exploratory phase IIb pilot study of exogenous oral Melatonin for the treatment of Nocturia in adults with Parkinson’s disease - Study of Melatonin for treatment of Nocturia in PD	Parkinson's DiseaseNocturia MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Circadin® Product Name: Melatonin Product Code: AS2 INN or Proposed INN: Melatonin	University College London	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	United Kingdom
418	EUCTR2014-003739-20-FR (EUCTR)	10/04/2015	19/06/2015	A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease	Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia	Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE	Adamas Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;France;Spain;Austria;Germany
419	JPRN-UMIN000017036	2015/04/03	03/04/2015	Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia.	Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. - Association of ghrelin and leptin in cardiovascular autonomic dysfunction	autonomic failure such as Parkinson's disease	blood test of Leptin and Ghrelin blood test of Leptin and Ghrelin	Nagoya University Graduate School of Medicine	NULL	Complete: follow-up complete	40years-old	Not applicable	Male and Female	50	Not applicable	Japan
420	JPRN-UMIN000016591	2015/04/01	20/02/2015	Clinical trial of balance exercise "Assist"	Clinical trial of balance exercise "Assist" - Balance Exercise Assist	Stroke, Parkinson disease, Osteoarthrosis	use of balance exercise assist ordinary balance exercise	Juntendo University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	40	Not applicable	Japan
421	JPRN-UMIN000016734	2015/04/01	01/04/2015	The evaluation of duloxetine effect for the parkinsonism and gait freezing	The evaluation of duloxetine effect for the parkinsonism and gait freezing - The evaluation of effect of duloxetine and parkinsonism	Parkinson's disease	Drug ; Duloxetine Duraion; SEP012014-AUG312016 Doseage; 20mg/day or 40mg/day Times; one time per day P.O.	Department of Neurology, Juntendo University School of Medicine	NULL	Complete: follow-up complete	20years-old	85years-old	Male and Female	30	Not selected	Japan
422	NCT02359448 (ClinicalTrials.gov)	April 2015	4/2/2015	Melatonin for Nocturia in Parkinson's Disease	Single-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's Disease	Parkinson's Disease;Nocturia	Drug: Melatonin	University College, London	NULL	Not yet recruiting	18 Years	N/A	Both	20	Phase 2	United Kingdom
423	EUCTR2014-003739-20-ES (EUCTR)	24/03/2015	16/02/2015	A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease	Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia	Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE	Adamas Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Spain;Austria;Germany
424	EUCTR2014-003738-24-ES (EUCTR)	24/03/2015	16/02/2015	A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease	ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY	Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE	Adamas Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 3	United States;Spain;Austria;Germany
425	EUCTR2014-003799-22-BE (EUCTR)	16/03/2015	16/12/2014	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease	A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	365	Phase 3	Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
426	JPRN-UMIN000016664	2015/03/01	01/03/2015	Effect of nicotine patch in Cognitive function improvement in Parkinson's disease	Effect of nicotine patch in Cognitive function improvement in Parkinson's disease - Effect of nicotine patch in Cognitive function improvement	Parkinson's disease	nicotine patch	Department of Clinical Pharmacology and Neurology Ehime University graduated School of Medicine	NULL	Recruiting	Not applicable	Not applicable	Male and Female	20	Not selected	Japan
427	EUCTR2014-003799-22-CZ (EUCTR)	26/02/2015	26/11/2014	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease	A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 3	Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
428	JPRN-UMIN000016485	2015/02/25	09/02/2015	Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome	Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome - PD-1	Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients	Intravenous injection of 18F-fluoro-dopa and 11C-raclopride PET imaging	Institute of Biomedical Research and Innovation	NULL	Complete: follow-up complete	35years-old	Not applicable	Male and Female	20	Not selected	Japan
429	EUCTR2014-003799-22-HU (EUCTR)	11/02/2015	20/11/2014	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease	A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	365	Phase 3	Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Romania;Germany
430	NCT02337725 (ClinicalTrials.gov)	February 7, 2015	9/1/2015	A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa	Parkinson's Disease	Drug: TVP-1012;Drug: Placebo	Takeda	NULL	Completed	30 Years	80 Years	All	244	Phase 3	Japan
431	EUCTR2014-003799-22-ES (EUCTR)	02/02/2015	16/12/2014	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson?s disease	A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson?s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	365	Phase 3	Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
432	NCT02339064 (ClinicalTrials.gov)	February 2015	31/3/2014	Infusion of Apomorphine: Long-term Safety Study	A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy	Idiopathic Parkinson's Disease	Drug: apomorphine infusion	US WorldMeds LLC	NULL	Active, not recruiting	30 Years	N/A	All	99	Phase 3	United States
433	EUCTR2014-003799-22-GB (EUCTR)	15/01/2015	21/11/2014	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease	A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control	Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	365	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
434	NCT02480803 (ClinicalTrials.gov)	December 19, 2014	4/5/2015	INfusion VErsus STimulation in Parkinson's Disease	Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation	Parkinson's Disease	Drug: Continuous intrajejunal infusion of levodopa-carbidopa;Device: deep brain stimulation	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	ZonMw: The Netherlands Organisation for Health Research and Development	Active, not recruiting	18 Years	N/A	All	66	Phase 4	Netherlands
435	NCT03116308 (ClinicalTrials.gov)	November 21, 2014	12/4/2017	Effect of Food on Opicapone	Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects	Parkinson Disease	Drug: Opicapone (OPC)	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	28	Phase 1	NULL
436	NCT02312232 (ClinicalTrials.gov)	November 2014	2/12/2014	Pharmacokinetic Study in Healthy Males	Pharmacokinetics of Levodopa, Carbidopa, 3-OMD and ODM-104 After Repeated Doses of Different Formulations: an Open, Randomised, Multicentre Study With Crossover Design in Healthy Males	Parkinson's Disease	Drug: levodopa, carbidopa, ODM-104	Orion Corporation, Orion Pharma	NULL	Completed	18 Years	65 Years	Male	20	Phase 1	Finland
437	NCT02281474 (ClinicalTrials.gov)	November 2014	27/10/2014	Nilotinib in Cognitively Impaired Parkinson Disease Patients 001	Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood a-Synuclein	Parkinson's Disease;Parkinson's Disease Dementia;Diffuse Lewy Body Disease	Drug: Nilotinib	Georgetown University	NULL	Completed	40 Years	90 Years	Both	12	Phase 1	United States
438	NCT02240030 (ClinicalTrials.gov)	November 2014	11/9/2014	Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)	Idiopathic Parkinson's Disease	Drug: CVT-301 Low Dose;Drug: CVT-301 High Dose;Other: Placebo	Acorda Therapeutics	NULL	Completed	30 Years	85 Years	All	351	Phase 3	United States;Canada;Czechia;Poland;Spain;Czech Republic
439	NCT02278588 (ClinicalTrials.gov)	November 2014	28/10/2014	Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.	Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.	Parkinson's Disease	Drug: Rasagiline	State University of New York at Buffalo	NULL	Completed	N/A	N/A	All	45		United States
440	NCT02168842 (ClinicalTrials.gov)	November 2014	18/6/2014	Efficacy of Isradipine in Early Parkinson Disease	Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease	Parkinson Disease	Drug: Isradipine;Drug: Placebo (for Isradipine)	University of Rochester	National Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's Research;The Parkinson Study Group	Completed	30 Years	N/A	All	336	Phase 3	United States;Canada
441	EUCTR2014-000335-17-GB (EUCTR)	28/10/2014	23/07/2014	Rotigotine and memory in Parkinson's.	The Effect of Rotigotine on Memory in Idiopathic Parkinson's Disease without Cognitive Impairment - Rotigotine and Memory in Parkinson's.	Idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: rotigotine INN or Proposed INN: Rotigotine Product Name: levodopa CR (controlled release) INN or Proposed INN: levodopa Product Name: Rasagiline INN or Proposed INN: Rasagiline Product Name: Selegiline INN or Proposed INN: selegiline	Research and Development University Hospital of North Staffordshire	Keele University	Not Recruiting			Female: yes Male: yes	0		United Kingdom
442	EUCTR2014-001131-36-ES (EUCTR)	23/10/2014	03/09/2014	A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa	A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias	Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE	Osmotica Pharmaceutical Corp.	NULL	Not Recruiting			Female: yes Male: yes	162	Phase 3	France;United States;Canada;Spain;Germany
443	EUCTR2014-001132-10-ES (EUCTR)	23/10/2014	02/09/2014	A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa	A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias	Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE	Osmotica Pharmaceutical Corp.	NULL	Not Recruiting			Female: yes Male: yes	162	Phase 3	France;United States;Canada;Spain;Germany
444	EUCTR2014-002295-87-IT (EUCTR)	13/10/2014	29/09/2014	A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations.	A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations.	Parkinson's disease patients who suffer motor fluctuations willparticipate in the study MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SINEMET 100 mg + 25 mg compresse Product Name: SINEMET 100 mg + 25 mg compresse Product Code: NA	SynAgile Corporation	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 2	Italy
445	NCT02259049 (ClinicalTrials.gov)	October 2014	3/10/2014	The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease	The Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's Disease	Blood Pressure	Dietary Supplement: L-tyrosine;Dietary Supplement: Sugar Pill	New York Institute of Technology	NULL	Completed	40 Years	84 Years	Both	6	Phase 0	United States
446	NCT02274324 (ClinicalTrials.gov)	October 2014	22/10/2014	Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease	Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease	Parkinson Disease	Dietary Supplement: different diets	Sheba Medical Center	Tel Aviv University	Not yet recruiting	40 Years	80 Years	Both	20	N/A	NULL
447	JPRN-UMIN000016893	2014/09/22	01/04/2015	A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression.	A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine.	PD patients	The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.	Ehime University HospitalDept. of Clinical pharmacology and Neurology	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Phase 2	Japan
448	JPRN-UMIN000014709	2014/07/01	01/08/2014	Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I	Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I - DAT PET with [C-11]PE2I in PD and related disorders	Patients of Parkinson's disease and related disorders	The dosage in the vein of [C-11]PE2I, [C-11]raclopride, and [F-18]FDG for PET/CT imaging.	Tokyo Metropolitan Institute of Gerontology	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	200	Not selected	Japan
449	NCT02472210 (ClinicalTrials.gov)	July 2014	11/6/2015	The Use of Botox in Advanced Parkinson's Patients Experiencing Pain	A Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot Study	Parkinson's Disease	Drug: Botulinum Toxin	University Health Network, Toronto	NULL	Active, not recruiting	18 Years	N/A	Both	14	Phase 4	NULL
450	EUCTR2014-000868-17-ES (EUCTR)	26/06/2014	17/03/2014	Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators	Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators	Parkinson's disease MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]	Trade Name: Dexdor Product Name: Dexdor INN or Proposed INN: DEXMEDETOMIDINE Other descriptive name: DEXMEDETOMIDINA Trade Name: Propofol-Lipuro Product Name: Propofol-Lipuro INN or Proposed INN: PROPOFOL Other descriptive name: PROPOFOL	Clínica Universidad de Navarra/Universidad de Navarra	NULL	Not Recruiting			Female: yes Male: yes			Spain
451	EUCTR2013-000980-10-DK (EUCTR)	06/06/2014	09/01/2014	Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease	TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO	Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride	Britannia Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 3	France;Spain;Austria;Denmark;Netherlands;Germany
452	NCT02780895 (ClinicalTrials.gov)	May 2014	12/5/2016	Parkinsonian Brain Repair Using Human Stem Cells	Human OK99 Allogeneic Stem Cell Transplantation for Patients With Severe Parkinson's Disease	Idiopathic Parkinson Disease	Drug: Human Stem Cells	Celavie Bioscences, LLC	Hospital Angeles del Pedregal	Active, not recruiting	18 Years	75 Years	Both	8	Phase 1	Mexico
453	EUCTR2012-005539-10-DE (EUCTR)	29/04/2014	18/12/2013	Clinical study to investigate the efficacy and safety of two dose levels of NT 201 versus placebo in treating chronic troublesome sialorrhea in various neurological conditions.	Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter study, with an extension period of dose-blinded active treatment, to investigate the efficacy and safety of two dose levels of NT 201 in treating chronic troublesome sialorrhea in various neurological conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation	Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury. MedDRA version: 18.1;Level: PT;Classification code 10039424;Term: Salivary hypersecretion;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A	Merz Pharmaceuticals GmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	United States;Poland;Germany
454	EUCTR2013-002254-70-PL (EUCTR)	28/04/2014	03/02/2014	Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy.	A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease	Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	609	Phase 3	Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
455	EUCTR2013-003363-64-GB (EUCTR)	03/04/2014	11/03/2014	Trial of Exenatide for Parkinson's disease	A randomised, double blind, placebo controlled, single centre, 60 week trial of Exenatide once weekly for the treatment of moderate severity Parkinson’s disease. - Exenatide-PD	Parkinson's Disease MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Bydureon Product Name: Exenatide INN or Proposed INN: exenatide	University College London	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United Kingdom
456	NCT02111122 (ClinicalTrials.gov)	April 2014	8/4/2014	Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease	A Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease	Sleep-wake Disturbances in Motor-phase Parkinson's Disease	Drug: Sodium Oxybate;Drug: Placebo	Christian Baumann	NULL	Completed	18 Years	90 Years	All	16	Phase 2	Switzerland
457	EUCTR2013-002254-70-CZ (EUCTR)	05/03/2014	02/12/2013	Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy.	A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's DiseaseRandomizovaná, multicentrická, dvojite zaslepená, placebem kontrolovaná, 12týdenní studie fáze 3 hodnotící úcinnost perorálního istradefylinu 20 a 40 mg/den v lécbe subjektu se stredne závažnou až závažnou Parkinsonovou nemocí	Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	609	Phase 3	United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany
458	EUCTR2013-000980-10-FR (EUCTR)	03/03/2014	22/11/2013	Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease	TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO	Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride	STADA Arzneimittel AG	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 3	France;Spain;Denmark;Austria;Netherlands;Germany
459	NCT02006121 (ClinicalTrials.gov)	March 3, 2014	22/11/2013	Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease	Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment	Parkinson's Disease	Drug: Apomorphine hydrochloride;Drug: Placebo	Britannia Pharmaceuticals Ltd.	NULL	Completed	30 Years	N/A	All	107	Phase 3	Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom
460	EUCTR2013-002254-70-DE (EUCTR)	28/02/2014	19/11/2013	Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy.	A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease	Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	609	Phase 3	United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany
461	EUCTR2013-002254-70-IT (EUCTR)	21/02/2014	27/11/2013	A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease	A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease	Moderate to severe Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE	Kyowa Hakko Kirin Pharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	609	Phase 3	United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy
462	EUCTR2013-000980-10-ES (EUCTR)	12/02/2014	12/11/2013	Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s disease	TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson?s disease patients with motor complications not well controlled on medical treatment - TOLEDO	Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride	STADA Arzneimittel AG	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 3	France;Spain;Denmark;Austria;Netherlands;Germany
463	EUCTR2013-000980-10-NL (EUCTR)	06/02/2014	27/01/2014	Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease	TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO	Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride	Britannia Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 3	France;Spain;Denmark;Austria;Germany;Netherlands
464	NCT02305316 (ClinicalTrials.gov)	February 2014	28/11/2014	Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone	Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers	Parkinson Disease	Drug: BIA 9-1067 non-micronized;Drug: BIA 9-1067 micronized	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	28	Phase 1	NULL
465	NCT02064166 (ClinicalTrials.gov)	February 2014	13/2/2014	Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.	A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy	Parkinson Disease;Multiple System Atrophy	Drug: Intranasal Insulin	Peter Novak	NULL	Completed	18 Years	N/A	All	15	Phase 2	United States
466	EUCTR2013-002545-10-SE (EUCTR)	08/01/2014	11/11/2013	An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.	An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. - OSU6162Open1309	Parkinsons diseaseHuntingtons diseaseMultiple sclerosBrain traumaStrokeMyalgic encephalomyelitisNarcolepsy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: OSU6162 similar to (-)-OSU 6162	A. Carlsson Research AB	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Sweden
467	NCT02046434 (ClinicalTrials.gov)	January 2014	23/1/2014	Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain	Phenylbutyrate Response As a Biomarker for Alpha-Synuclein Clearance From Brain	Parkinson's Disease	Drug: Glycerol Phenylbutyrate	University of Colorado, Denver	NULL	Active, not recruiting	21 Years	80 Years	All	40	Phase 1	United States
468	NCT02384512 (ClinicalTrials.gov)	January 2014	4/3/2015	Azilect® In Wearing-Off (AIWO)	Azilect® In Wearing-Off (AIWO) Non-interventional Study on Efficacy and Tolerability of Rasagiline (1mg/d) add-on in Ambulatory Parkinson's Disease Patients With Wearing-off Symptoms Diagnosed by Wearing-off Questionnaire (WOQ-32)	Parkinson's Disease	Drug: Azilect®	Teva Pharma GmbH	Anfomed GmbH	Completed	18 Years	N/A	Both	261	N/A	Germany
469	NCT02018406 (ClinicalTrials.gov)	December 2013	30/10/2013	Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury		Neurological Diseases;Ischemic Stroke;Hemorrhagic Stroke;Cerebral Palsy;Atypical Parkinson Disease	Drug: Combination injection of EPO and G-CSF;Drug: Injection of normal saline	Yonsei University	NULL	Active, not recruiting	20 Years	N/A	All	16	Phase 1/Phase 2	Korea, Republic of
470	NCT04044547 (ClinicalTrials.gov)	November 22, 2013	30/7/2019	A Study of LY03003 in Patients With Early-stage Parkinson's Disease	A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections	Parkinson Disease	Drug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheres	Luye Pharma Group Ltd.	Beijing Bozhiyin T&S Co., Ltd.	Completed	18 Years	75 Years	All	60	Phase 1	NULL
471	EUCTR2012-002840-26-RO (EUCTR)	12/11/2013	17/07/2014	Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood	Parkinson's disease MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	504	Phase 4	Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
472	NCT01856738 (ClinicalTrials.gov)	November 2013	14/5/2013	Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease	Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial.	Parkinson's Disease	Drug: Rivastigmine;Drug: Placebo (for rivastigmine)	VU University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);Atrium Medical Center;University Medical Center Groningen;Leiden University Medical Center;University Medical Center Nijmegen;International Parkinson Fonds Germany GmbH;ZonMw: The Netherlands Organisation for Health Research and Development	Terminated	40 Years	N/A	All	91	Phase 4	Netherlands
473	NCT01927055 (ClinicalTrials.gov)	November 2013	16/8/2013	A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy	A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy	Symptomatic Neurogenic Orthostatic Hypotension;Parkinson's Disease;Multiple Systems Atrophy;Pure Autonomic Failure;Dopamine Beta Hydroxylase Deficiency	Drug: Droxidopa;Drug: Placebo	Chelsea Therapeutics	NULL	Terminated	18 Years	N/A	All	61	Phase 3	United States
474	EUCTR2011-004438-32-DE (EUCTR)	23/10/2013	13/08/2013	The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying	A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC	Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 16.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040	GlaxoSmithKline Research and Development Limited	NULL	Not Recruiting			Female: yes Male: yes	70		Australia;Germany;United Kingdom;Sweden
475	EUCTR2013-000980-10-AT (EUCTR)	18/10/2013	31/07/2013	Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease	TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO	Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride	Britannia Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 3	France;Spain;Denmark;Austria;Netherlands;Germany
476	EUCTR2011-002827-17-SK (EUCTR)	17/09/2013	04/03/2013	A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.	A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.	Early stage Parkinson's Disease. MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Local Trade Name, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Local Trade Name, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Local Trade Name, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210		United States;Estonia;Slovakia;Russian Federation;Korea, Republic of
477	EUCTR2013-001881-40-GB (EUCTR)	16/09/2013	05/08/2013	Extension study to Assess the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD)	An Extension Study to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via onvection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease	Parkinson's disease MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Glial Cell Line-Derived Neurotrophic Factor (GDNF) INN or Proposed INN: Liatermin Other descriptive name: r-metHuGDNF	North Bristol NHS Trust (NBT)	NULL	Not Recruiting			Female: yes Male: yes	42	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
478	EUCTR2013-001722-25-NL (EUCTR)	27/08/2013	12/08/2013	Rivastigmine as an early treatment for visual hallucinations in Parkinson’s disease (CHEVAL)	Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson’s disease: a multi-center placebo-controlled trial (CHEVAL) - CHEVAL	Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Rivastigmine CF	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	168	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
479	EUCTR2011-004438-32-SE (EUCTR)	26/08/2013	01/07/2013	The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying	A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC	Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 16.0;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040	GlaxoSmithKline Research and Development Limited	NULL	Not Recruiting			Female: yes Male: yes	70		Australia;Germany;United Kingdom;Sweden
480	JPRN-UMIN000011111	2013/07/16	15/07/2013	Spinal blood flow and metabolism in neurological diseases	Spinal blood flow and metabolism in neurological diseases - Spinal blood flow and metabolism in neurological diseases	motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophy	PET scan study with 11C-flumazenil PET scan study with 18F- FDG PET scan study with 15O-H2O	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences	NULL	Recruiting	20years-old	Not applicable	Male and Female	70	Not applicable	Japan
481	EUCTR2012-001245-40-IT (EUCTR)	05/06/2013	17/05/2013	CLINICAL AND PHARMACOLOGICAL STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)	CLINICAL AND PHARMACOKINETICS STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)	PARKINSON'S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Madopar 200+50 mg Trade Name: LEVODOPA / BENSERAZIDE 200 + 50 MG		NULL	Not Recruiting			Female: yes Male: yes			Italy
482	NCT01765257 (ClinicalTrials.gov)	June 2013	8/1/2013	Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study	Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.	Drug-naïve Patients With Parkinson's Disease;Apathy	Drug: AZILECT®;Drug: Placebo	University Hospital, Clermont-Ferrand	H. Lundbeck A/S, TEVA;CHU Purpan (Toulouse);Hôpital Haut-Levêque (Pessac);Centre Hospitalier de la Côte Basque;Centre Hospitalier Universitaire de Poitiers (Poitiers);CHU de Rennes (Rennes);University Hospital, Lille;CHU Dupuytren (Limoges);University Hospital, Caen;Hôpital Caremeau (NIMES);Centre Hospitalier Pays D'Aix;Hôpital de la Timone (MARSEILLE);University Hospital, Rouen;Centre Hospitalier Universitaire, Amiens;Centre Hospitalier Universitaire de Saint Etienne;Fondation Rothschild Paris	Not yet recruiting	30 Years	70 Years	Both	50	Phase 4	France
483	JPRN-UMIN000010752	2013/05/17	17/05/2013	A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia.	A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. - Donepezil study on Parkinson\'s disease with dementia	Parkinson's disease	donepezil	Kansai Medical University	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	50	Not selected	Japan
484	EUCTR2012-005822-31-IT (EUCTR)	13/05/2013	20/03/2013	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease	A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena)	Parkinson's Disease MedDRA version: 15.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;Serbia;United Kingdom;Italy
485	EUCTR2013-000827-15-IT (EUCTR)	11/05/2013	15/03/2013	LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE	LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE - PARROT	Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Rotigotine Product Name: neurpro Product Code: SPM962	Unità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, Tricase	NULL	Not Recruiting			Female: yes Male: yes			Italy
486	JPRN-UMIN000010596	2013/05/01	01/05/2013	Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo	Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo - MAP-J	Parkinson's disease	Memantine preceding arm Titrate the memantine, administered for 3 months. And tapering memantine and amantadine titrate the dose for 3 months. Amantadine preceding arm Titrate the amantadine, administered for 3 months. And tapering amantadine and memantine titrate the dose for 3 months.	Department of Neurology, Juntendo University School of Medicine	NULL	Complete: follow-up complete	20years-old	Not applicable	Male	40	Not selected	Japan
487	NCT03022201 (ClinicalTrials.gov)	May 2013	23/11/2016	Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease	Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial	Parkinson's Disease,Idiopathic	Drug: DA-9701;Drug: Domperidone;Drug: Placebo domperidone;Drug: Placebo DA-9701	Seoul National University Hospital	NULL	Completed	20 Years	80 Years	All	40	Phase 4	Korea, Republic of
488	EUCTR2012-002840-26-BG (EUCTR)	26/04/2013	06/02/2013	Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood	Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	504	Phase 4	Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
489	EUCTR2011-002827-17-EE (EUCTR)	23/04/2013	08/02/2013	A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.	A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.	Early stage Parkinson's Disease. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: REQUIP-MODUTAB , 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB , 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB , 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210		United States;Estonia;Slovakia;Russian Federation;Korea, Republic of
490	EUCTR2011-002828-41-EE (EUCTR)	23/04/2013	08/02/2013	A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease.	A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease.	Advanced Parkinson's disease. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: REQUIP-MODUTAB, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	406		United States;Taiwan;Estonia;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of
491	EUCTR2012-005822-31-GB (EUCTR)	18/04/2013	05/03/2013	A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease	A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) - Inhaled CVT-301 in Subjects with Parkinson’s Disease	Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;Serbia;Italy;United Kingdom
492	JPRN-UMIN000010778	2013/04/10	22/05/2013	Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1	Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 - EDAP-2	Parkinson disease	5mg donepezil hydrocloride	National Hospital of Utano	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
493	JPRN-UMIN000010371	2013/04/08	01/04/2013	Study of zonisamide ( TRERIEF&reg; tablet 25mg ) to tremor in patients with early Parkinson's disease.	Study of zonisamide ( TRERIEF&reg; tablet 25mg ) to tremor in patients with early Parkinson's disease. - Study of zonisamide to tremor in patients with early Parkinson's disease.	Parkinson's disease	Start 25mg of Zonisamide and carry out observation 24weeks. Evaluate start point, after 4weeks, after 8weeks, after 16weeks, and after 24weeks.	Department of Neurology, University of Yamanashi	NULL	Pending	Not applicable	Not applicable	Male and Female	10	Not selected	Japan
494	EUCTR2012-002608-42-GB (EUCTR)	07/04/2013	01/11/2012	A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain	Parkinson’s disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	478	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
495	EUCTR2011-002828-41-SK (EUCTR)	27/03/2013	04/03/2013	A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease.	A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease.	Advanced Parkinson's disease. MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Requip Modutab, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Requip Modutab, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Requip Modutab, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	406		United States;Estonia;Taiwan;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of
496	EUCTR2012-002840-26-SI (EUCTR)	26/03/2013	18/03/2013	Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	504	Phase 4	United States;Serbia;Slovenia;Slovakia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
497	JPRN-UMIN000009958	2013/03/08	01/03/2013	Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction	Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction - Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction	Parkinson's disease	Donepezil hydrochloride added to standard therapy Placebo added to standard therapy	National Hospital Organization, Sendai-Nishitaga Hospital	NULL	Complete: follow-up complete	55years-old	75years-old	Male and Female	200	Not applicable	Japan
498	EUCTR2012-002840-26-AT (EUCTR)	05/03/2013	06/11/2012	Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	504	Phase 4	United States;Serbia;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
499	JPRN-UMIN000046104	2013/03/01	21/11/2021	Research for the development of assessment strategy and treatment for cognitive impairment of Parkinson's disease	Neuroimaging study for the assessment and treatment of cognitive impairment of the patients with Parkinson's disease - RCIP-Nagoya Study: Research for the cognitive impairment of Parkinson's disease in Nagoya	Parkinson's disease	This study followed a randomized double-blind crossover design for the patients with mild cognitive impairments in PD. Patients in the memantine group were given memantine at 5 mg/day in the first week, and the dose was increased by 5 mg/day per week, with the final dose of 20 mg/day. The patients in the placebo group were given a placebo following the same regimen. During maximum dose administration, fMRI scanning and neuropsychological tests were performed. Group comparisons between memantine and placebo were performed to explore the significant differences.	Nagoya City University	NULL	Complete: follow-up complete	60years-old	75years-old	Male and Female	12	Not applicable	Japan
500	NCT01736176 (ClinicalTrials.gov)	March 2013	27/11/2012	A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease	An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease	Advanced Parkinson's Disease	Drug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets	AbbVie (prior sponsor, Abbott)	NULL	Completed	30 Years	N/A	All	39	Phase 3	United States
501	JPRN-UMIN000010014	2013/02/28	13/02/2013	Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease	Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease - Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease	Parkinson's disesase	hydrogen water made by "Suisosui5.0" placebo-water (nitrogen filling water)	Juntendo University School of Medicine, Neurology	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	200	Not selected	Japan
502	EUCTR2012-002840-26-IT (EUCTR)	18/02/2013	11/01/2013	Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease	A MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PHASE 4 STUDY TO EVALUATE THE EFFICACY OF ROTIGOTINE ON PARKINSON’S DISEASE-ASSOCIATED APATHY, MOTOR SYMPTOMS, AND MOOD	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro INN or Proposed INN: ROTIGOTINE	UCB BIOSCIENCES GMBH	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 4	United States;Hungary;Slovenia;Spain;Ukraine;Turkey;Austria;Bulgaria;Russian Federation;Italy
503	EUCTR2012-002840-26-HU (EUCTR)	11/02/2013	13/12/2012	Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood	Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	504	Phase 4	Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
504	EUCTR2012-000801-64-GB (EUCTR)	09/02/2013	26/11/2012	A study of the effects of medication on memory in Parkinson's Disease	A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease. - Medication and Memory in Parkinson’s Disease (MeMory PaD)	Idiopathic Parkinson's Disease MedDRA version: 17.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mirapexin extended release various strengths Product Name: Pramipexole dihydrochloride monohydrate extended release Product Code: N/A INN or Proposed INN: pramipexole dihydrochloride monohydrate Other descriptive name: Mirapexin Trade Name: Requip prolonged release Product Name: Ropinirole hydrochloride prolonged release INN or Proposed INN: Ropinirole (as hydrochloride) Other descriptive name: Requip XL prolonged-release	University Hospital of North Staffordshire	Keele University	Not Recruiting			Female: yes Male: yes	55	Phase 4	United Kingdom
505	NCT02059733 (ClinicalTrials.gov)	February 2013	7/2/2014	Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism	Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism by 18F-DTBZ PET	Parkinson's Disease	Drug: 18F-DTBZ	Chang Gung Memorial Hospital	NULL	Completed	20 Years	80 Years	All	72	Phase 2	Taiwan
506	EUCTR2012-002840-26-ES (EUCTR)	23/01/2013	29/11/2012	Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	504	Phase 4	Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
507	EUCTR2012-002608-42-DE (EUCTR)	10/01/2013	26/09/2012	A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain	Parkinson’s disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	64		United States;Hungary;Slovakia;Poland;Germany;United Kingdom
508	EUCTR2012-002608-42-HU (EUCTR)	10/01/2013	12/11/2012	A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain	Parkinson’s disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	478		France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
509	EUCTR2012-002840-26-SK (EUCTR)	07/01/2013	09/03/2016	Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood	Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	504	Phase 4	Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
510	JPRN-UMIN000017695	2013/01/01	27/05/2015	Oxybuprocaine for apraxia of lid opening in Parkinson's disease	Oxybuprocaine for apraxia of lid opening in Parkinson's disease - Oxybuprocain for ALO	apraxia of lid opening in Parkinson's disease	Arm 1 intervention consisted of 4%oxybuprocaine eye drop treatment, washout for 24 hours or more, and a saline eye drop treatment Arm 2 intervention consisted of saline eye drop treatment, a washout period, and an oxybuprocaine treatment	Utano National Hospital, National Hospital Organization	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	10	Not selected	Japan
511	EUCTR2012-002608-42-SK (EUCTR)	17/12/2012	09/03/2016	A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease	A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain	Parkinson’s disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE	UCB Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	478		France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
512	NCT01721460 (ClinicalTrials.gov)	November 2012	30/10/2012	Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus	Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery	Parkinson's Disease;Deep Brain Stimulation Surgery	Drug: Dexmedetomidine	University of Wisconsin, Madison	NULL	Completed	18 Years	85 Years	All	6	Phase 4	United States
513	NCT01723228 (ClinicalTrials.gov)	November 2012	5/11/2012	Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease	A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease	Parkinson's Disease	Drug: Rasagiline;Drug: Placebo	Teva Branded Pharmaceutical Products R&D, Inc.	NULL	Completed	45 Years	80 Years	All	170	Phase 4	United States
514	NCT01744496 (ClinicalTrials.gov)	November 2012	5/12/2012	Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain	A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain	Advanced Idiopathic Parkinson's Disease	Drug: Rotigotine;Drug: Placebo	UCB BIOSCIENCES GmbH	NULL	Completed	18 Years	N/A	All	68	Phase 4	United States;Germany;Poland;Slovakia;Hungary;Korea, Republic of
515	NCT01738191 (ClinicalTrials.gov)	November 2012	28/11/2012	Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)	Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)	Parkinson's Disease;Cognitive Impairment	Drug: Atomoxetine;Drug: Placebo	Medical University of South Carolina	Michael J. Fox Foundation for Parkinson's Research	Completed	35 Years	75 Years	All	30	Phase 2	United States
516	NCT01683253 (ClinicalTrials.gov)	November 2012	7/9/2012	Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa	The REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement Therapy	Impulse Control Disorder	Drug: Levodopa/Carbidopa(200mg/50mg);Drug: Dopaminergic Agonists	Sandoz	NULL	Completed	30 Years	80 Years	All	150	Phase 4	Korea, Republic of
517	NCT03652363 (ClinicalTrials.gov)	October 25, 2012	21/8/2018	GDNF in ideopathicParkinsons Disease	A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal (GDNF) Infusions Administered Via Convection Enhanced Delivery (CED) in Subjects With Parkinson&Apos;s Disease	Idiopathic Parkinson Disease	Drug: glial cell line-derived neurotrophic factor	North Bristol NHS Trust	NULL	Completed	35 Years	75 Years	All	42	Phase 2	NULL
518	JPRN-UMIN000009099	2012/10/01	12/10/2012	The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia	The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia - The effect of lidocaine injection in Parkinson's disease patients with camptorcormia	Parkinson's disease	lidocaine injection into the external oblique normal saline injection into the external oblique	Parkinson's disease and Movement Disorder Center	NULL	Recruiting	20years-old	Not applicable	Male and Female	10	Not applicable	Japan
519	NCT01560754 (ClinicalTrials.gov)	October 2012	9/3/2012	Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease	A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess the Disease-modifying Potential of Transdermal Nicotine in Early Parkinson's Disease in Germany and the USA	Parkinson's Disease	Drug: nicotine transdermal patch	James BOYD MD	Michael J. Fox Foundation for Parkinson's Research;Parkinson Study Group (PSG);International Parkinson Fonds (IPF);German Parkinson Study Group (GPS);German Parkinson Society (DPG);Philipps-University Marburg, Germany	Active, not recruiting	30 Years	N/A	Both	160	Phase 2	United States;Germany
520	EUCTR2011-003866-34-GB (EUCTR)	24/09/2012	01/05/2012	Assessing the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD)	A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease	Parkinson's disease MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Glial Cell Line-Derived Neurotrophic Factor (GDNF) INN or Proposed INN: Liatermin Other descriptive name: r-metHuGDNF	North Bristol NHS Trust (NBT)	NULL	Not Recruiting			Female: yes Male: yes	42	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
521	EUCTR2011-004378-27-AT (EUCTR)	04/09/2012	20/07/2012	Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	65		United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
522	NCT01711866 (ClinicalTrials.gov)	September 2012	18/10/2012	A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease	An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4	Advanced Idiopathic Parkinson's Disease	Drug: Rotigotine	UCB BIOSCIENCES GmbH	Otsuka Pharmaceutical Co., Ltd.	Completed	30 Years	80 Years	All	87	Phase 4	United States;Korea, Republic of;Malaysia;Singapore;Taiwan
523	EUCTR2011-004803-19-FI (EUCTR)	16/08/2012	16/05/2012	PET study in PD patients	A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease	Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Finland;Sweden
524	EUCTR2012-000122-21-DK (EUCTR)	10/08/2012	07/06/2012	Improving the blood pressure regulating system in patients with parkinsons disease	Acethylcholineesterase inhibition and orthostatic hypotension in patients with parkinsons disease	Ortostatic hypotension in patients with Parkinsons disease MedDRA version: 14.1;Level: PT;Classification code 10031127;Term: Orthostatic hypotension;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Trade Name: Mestinon Product Name: Mestinon INN or Proposed INN: PYRIDOSTIGMINE BROMIDE Other descriptive name: Mestinon	Department of Neurology, Roskilde Hospital	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Denmark
525	EUCTR2012-001530-34-NL (EUCTR)	09/08/2012	09/08/2012	Vareniciline treatment for Excessive Daytime Sleepiness in Parkinson’s Disease	Varenicline, a partial nicotinic receptor agonist for the treatment of Excessive Daytime Sleepiness in Parkinson’s Disease: a placebo-controlled cross-over study - Vareniciline for Excessive daytime Sleepiness in PArkinson’s disease (VESPA)	Idiopathic Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Champix INN or Proposed INN: VARENICLINE Other descriptive name: VARENICLINE TARTRATE	VU University Medical Center	Center Human Drug Research	Not Recruiting			Female: yes Male: yes	32	Phase 3	Netherlands
526	JPRN-UMIN000008477	2012/07/19	19/07/2012	Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease.	Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. - Clinical study of selegiline to flexion of spine in Parkinson's disease.	Parkinson disease	Selegiline hydrochloride 5mg 8weeks, 7.5mg 8weeks and stop it, followed after 8weeks, and evaluate each points.	Department of Neurology, Juntendo Koshigaya Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Not selected	Japan
527	JPRN-UMIN000008138	2012/07/01	01/07/2012	Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease	Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease - Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease	Parkinson's disease	Silodosin 8mg BID	Juntendo University School of Medicine	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male	100	Not selected	Japan
528	NCT01646255 (ClinicalTrials.gov)	July 2012	18/7/2012	Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients	A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On Levodopa	Idiopathic Parkinson's Disease	Drug: Rotigotine;Drug: Placebo Patch;Drug: L-dopa	UCB Pharma	UCB Trading (Shanghai) Co. Ltd.	Completed	30 Years	N/A	All	346	Phase 3	China
529	EUCTR2011-003053-25-GB (EUCTR)	18/06/2012	01/05/2012	The ReSPonD Study -Rivastigmine to Stabilise gait in Parkinson’s Disease. A study looking at whether Rivastigmine, a drug that can augment mental function, can stabilise walking in people with Parkinson's disease who have fallen.	A randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen. - ReSPonD Study - Rivastigmine to Stabilise gait in Parkinson’s Disease	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Exelon ® Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine	Research and Enterprise Department	NULL	Not Recruiting			Female: yes Male: yes	130	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
530	JPRN-JapicCTI-121880	11/6/2012		Phase II clinical study in patients with Parkinson's disease not taking L-DOPA	A randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease not taking L-DOPA	Parkinson's disease	Intervention name : HP-3000(ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily Control intervention name : HP-3000 placebo Dosage And administration of the control intervention : Transdermal, once daily	Hisamitsu Pharmaceutical Co.,Inc.	NULL		20	79	BOTH		Phase 2	NULL
531	EUCTR2011-002074-23-AT (EUCTR)	05/06/2012	07/05/2012	Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	140		United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
532	JPRN-UMIN000008057	2012/06/01	06/06/2012	Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease	Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease - Effect of enteral formula enriched with omega-3 fatty acid in patients with Parkinson's Disease	Parkinson's Disease	Daily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively.	St. Mariannna University School of Medicine	NULL	Complete: follow-up complete	35years-old	80years-old	Male and Female	25	Not applicable	Japan
533	NCT01993680 (ClinicalTrials.gov)	June 2012	27/4/2012	Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -Treatment	A Monocentric Randomized, Controlled, Double Blind, Crossover Phase II Trial to Show Non-inferiority of the Effect of Pyridostigmine Bromide vs. Fludrocortisone on Symptoms of Autonomic Dysregulation in Parkinson's Disease	Autonomic Disturbances in Parkinson's Disease	Drug: Pyridostigmine bromide;Drug: fludrocortisone	Christian Baumann	NULL	Completed	50 Years	80 Years	All	18	Phase 2	Switzerland
534	NCT02786667 (ClinicalTrials.gov)	June 2012	18/5/2016	Non Motors Aspects in De Novo Parkinson's Disease	Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.	Parkinson Disease;Apathy	Drug: Rotigotine;Drug: Placebo	University Hospital, Grenoble	NULL	Active, not recruiting	30 Years	72 Years	All	199	Phase 3	France
535	EUCTR2011-004378-27-DE (EUCTR)	15/05/2012	24/02/2012	Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	65		France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
536	EUCTR2011-004378-27-SK (EUCTR)	02/05/2012	12/04/2012	Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	65		France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
537	JPRN-UMIN000007896	2012/05/01	07/05/2012	Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes	Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes - Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes	Parkinson's disease and other parkinsonian syndromes	The patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.	Kansai Medical University	NULL	Recruiting	Not applicable	Not applicable	Male and Female	100	Not selected	Japan
538	EUCTR2012-000181-37-GB (EUCTR)	25/04/2012	27/02/2012	A study investigating the safety of CVT-301 in patients with Parkinson's Disease	A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (Off” Episodes)	Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Trade Name: Sinemet® Product Name: SINEMET® Plus 25 mg/100 mg Tablets INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE	Civitas Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Serbia;Israel;United Kingdom
539	EUCTR2011-004438-32-GB (EUCTR)	25/04/2012	18/04/2012	The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying	A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC	Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 20.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040	GlaxoSmithKline Research and Development Limited	NULL	Not Recruiting			Female: yes Male: yes	70	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Germany;United Kingdom;Sweden
540	EUCTR2011-001092-39-IT (EUCTR)	19/04/2012	20/06/2012	efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson's patients with moderate to severe L-dopa induced dyskinesias	A multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson's patients with moderate to severe L-dopa induced dyskinesias	L-dopa induced dyskinesias in Parkinson's patients MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: NA Product Code: AQW051 Other descriptive name: Not established Product Name: NA Product Code: AQW051 Other descriptive name: Not established	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	72		United States;Germany;Italy
541	EUCTR2011-005839-91-ES (EUCTR)	02/04/2012	11/01/2012	Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.	Gabapentin int he disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo. - IMULPARK	PARKINSON´S DISEASE MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: GABAPENTINA KERN PHARMA INN or Proposed INN: GABAPENTINA Other descriptive name: GABAPENTIN	ASOCIACIÓN INSTITUTO BIODONOSTIA	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Spain
542	JPRN-UMIN000007617	2012/04/01	30/03/2012	Effect of lidocaine injection for postural deformities in Parkinson's disease	Effect of lidocaine injection for postural deformities in Parkinson's disease - Lidocaine injection for postural deformities	Parkinson's disease	intramuscular injection of lidocaine	Dept. of Clinical pharmacology and Neurology, Ehime University	NULL	Recruiting	20years-old	80years-old	Male and Female	30	Not selected	Japan
543	NCT01556165 (ClinicalTrials.gov)	April 2012	13/3/2012	Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China	Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China	Parkinson's Disease	Drug: rasagiline;Drug: placebo	H. Lundbeck A/S	NULL	Completed	35 Years	N/A	All	130	Phase 3	China
544	NCT01491529 (ClinicalTrials.gov)	April 2012	12/12/2011	Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease	Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents	Drug: AFQ056;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	30 Years	80 Years	All	154	Phase 2	United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
545	EUCTR2011-002074-23-ES (EUCTR)	30/03/2012	06/02/2012	Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease	L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Farmacéutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes	92		France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
546	EUCTR2011-002074-23-SK (EUCTR)	28/03/2012	30/03/2012	Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	92		United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
547	EUCTR2011-004378-27-HU (EUCTR)	28/03/2012	15/02/2012	Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	65		United States;France;Hungary;Canada;Spain;Austria;Germany;Italy
548	EUCTR2011-004378-27-IT (EUCTR)	27/03/2012	02/03/2012	Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson's patients with L-dopa induced dyskinesias	L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	65		United States;Hungary;Canada;Spain;Austria;Germany;Italy
549	EUCTR2011-002074-23-HU (EUCTR)	21/03/2012	06/02/2012	Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	140		United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
550	EUCTR2011-002074-23-DE (EUCTR)	20/03/2012	06/02/2012	Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	140		France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
551	EUCTR2011-002074-23-IT (EUCTR)	15/03/2012	02/03/2012	Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe Ldopa induced dyskinesias in patients with Parkinson’s disease	L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	92		United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
552	EUCTR2011-002901-31-DE (EUCTR)	08/03/2012	06/10/2011	not applicable	A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain	Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL	Mundipharma Research GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	210		Hungary;Czech Republic;Spain;Germany;United Kingdom
553	NCT02039024 (ClinicalTrials.gov)	March 2012	15/1/2014	Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET	Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET	Parkinson's Disease	Drug: 18F- DTBZ	Chang Gung Memorial Hospital	National Science Council, Taiwan	Completed	20 Years	80 Years	Both	18	Phase 2	Taiwan
554	NCT01491932 (ClinicalTrials.gov)	March 2012	1/12/2011	Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents	Drug: AFQ056	Novartis Pharmaceuticals	NULL	Completed	N/A	N/A	All	129	Phase 2	United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
555	EUCTR2011-004803-19-SE (EUCTR)	22/02/2012	16/12/2011	PET study in PD patients	A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease	Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Finland;Sweden
556	EUCTR2011-005054-59-RO (EUCTR)	21/02/2012	13/06/2013	SYN115 in Parkinson’s disease	A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off - (none)	Parkinson’s disease MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: SYN115 Tablets, 60 mg Product Code: SYN115 INN or Proposed INN: tozadenant Other descriptive name: tozadenant	Biotie Therapies Inc.	NULL	Not Recruiting			Female: yes Male: yes	400		United States;Canada;Argentina;Ukraine;Romania;Chile
557	NCT01673724 (ClinicalTrials.gov)	February 2012	23/8/2012	Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease	Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study	Parkinson's Disease	Drug: pramipexole;Drug: Bromocriptine	Sandoz	NULL	Completed	30 Years	N/A	All	121	Phase 4	Korea, Republic of
558	EUCTR2009-015170-35-GB (EUCTR)	27/01/2012	21/12/2011	Study across 22 UK hospitals investigating if a drug called Donepezil Hydrochloride can help people with an early form of Parkinson's Disease dementia.	Multicentre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated with Parkinson's Disease (MUSTARDD-PD) - Donepezil in Early Dementia Associated with Parkinson's Disease	Parkinson's disease with mild dementia (PDD);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Pridia (Donepezil Hydrochloride) 5mg Product Name: Pridia 5mg INN or Proposed INN: Donepezil hydrochloride Trade Name: Pridia 10mg Product Name: Pridia 10mg INN or Proposed INN: Donepezil hydrochloride	The Newcastle upon Tyne Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	500	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Kingdom
559	NCT01515410 (ClinicalTrials.gov)	January 2012	11/1/2012	Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations	A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations	Parkinson's Disease;Motor Fluctuations	Drug: DM-1992;Drug: Sinemet IR	Depomed	NULL	Completed	30 Years	N/A	All	34	Phase 2	United States
560	EUCTR2011-002901-31-HU (EUCTR)	21/12/2011	13/10/2011	not applicable	A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain	Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL	Mundipharma Research GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	210		Czech Republic;Hungary;Spain;Germany;United Kingdom
561	EUCTR2009-017412-32-IT (EUCTR)	13/12/2011	27/04/2010	RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND	RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND	Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10013363	Trade Name: BOTOX INN or Proposed INN: Botulinum toxin Trade Name: NEUROBLOC INN or Proposed INN: Botulinum toxin	AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI	NULL	Not Recruiting			Female: yes Male: yes			Italy
562	EUCTR2011-002901-31-CZ (EUCTR)	12/12/2011	10/10/2011	not applicable	A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain	Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL	Mundipharma Research GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	210		Hungary;Czech Republic;Spain;Germany;United Kingdom
563	EUCTR2011-002901-31-ES (EUCTR)	30/11/2011	05/10/2011	not applicable	A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain	Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODO	Mundipharma Research GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	Hungary;Czech Republic;Spain;Germany;United Kingdom
564	EUCTR2011-002901-31-GB (EUCTR)	25/11/2011	21/09/2011	A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain	A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - Efficacy of OXN PR in severe Parkinson's disease associated pain	Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: Oxycodone hydrochloride INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL	Mundipharma Research GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	Hungary;Czech Republic;Spain;Germany;United Kingdom
565	EUCTR2009-015162-57-NL (EUCTR)	21/11/2011	11/05/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Merck Sharp & Dohme corp.	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
566	EUCTR2011-002073-30-IT (EUCTR)	14/11/2011	06/03/2012	Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson's disease	L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10043118;Term: Tardive dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	63		United States;European Union;Canada;Spain;Germany;Switzerland;Italy
567	EUCTR2009-015162-57-PT (EUCTR)	04/11/2011	12/08/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
568	NCT02319395 (ClinicalTrials.gov)	November 2011	29/9/2014	Behavioural Addiction and Genetics in Parkinson's Disease	Behavioural Addiction and Genetics in Parkinson's Disease	Parkinson Disease;Impulse Control Disorders	Genetic: Blood Sampling and DNA collection	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	All	332	N/A	France
569	NCT01736891 (ClinicalTrials.gov)	November 2011	27/11/2012	Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations	Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)	Parkinson´s Disease	Drug: Rasagiline;Drug: Placebo	Chongqing Fortune Pharmaceutical Co., Ltd.	Beijing Bionovo Medicine Development Co., Ltd.	Completed	30 Years	75 Years	Both	268	Phase 3	China
570	NCT01291537 (ClinicalTrials.gov)	November 2011	7/2/2011	Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients		Parkinson's Disease	Drug: Duodopa;Drug: best médical treatment	Poitiers University Hospital	NULL	Completed	18 Years	80 Years	Both	56	Phase 2	France
571	NCT01385592 (ClinicalTrials.gov)	November 2011	28/6/2011	Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease	Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders	Drug: AFQ056;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	30 Years	80 Years	Both	78	Phase 2	United States;Canada;France;Germany;Hungary;Italy;Spain
572	NCT01556100 (ClinicalTrials.gov)	November 2011	6/3/2012	Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression	Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression	Parkinson Disease	Drug: 18F-DTBZ AV-133	Chang Gung Memorial Hospital	NULL	Completed	20 Years	N/A	All	40	Phase 2	NULL
573	NCT01457807 (ClinicalTrials.gov)	November 2011	10/10/2011	To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers	A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female Volunteers	Parkinson's Disease	Drug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2	AstraZeneca	NULL	Completed	30 Years	65 Years	Both	24	Phase 1	United Kingdom
574	EUCTR2009-015162-57-PL (EUCTR)	25/10/2011	30/08/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
575	EUCTR2011-000056-42-GB (EUCTR)	07/10/2011	11/08/2011	Sleep efficiency assessed by Polysomnography (PSG sleep lab testing) in advanced Parkinson's disease	A MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF ROTIGOTINE ON SLEEP EFFICIENCY IN PATIENTS WITH ADVANCED PARKINSON’S DISEASE - sleep efficiency assessed by polysomnography in advanced Parkinson's Disease	Advanced Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE	UCB Celltech, UK - Registered Branch of UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
576	JPRN-UMIN000006521	2011/10/01	11/10/2011	Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease	Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole	Parkinson's disease	Rapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks.	Department of Neurology, Juntendo University	NULL	Recruiting	20years-old	Not applicable	Male and Female	30	Not selected	Japan
577	NCT02427646 (ClinicalTrials.gov)	October 2011	22/4/2015	Kinematic-guided BoNT-A Treatment for ET and PD Tremor	Use of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson Disease	Tremor	Drug: BoNT-A	Western University, Canada	NULL	Active, not recruiting	18 Years	80 Years	All	54	Phase 2	NULL
578	NCT01385735 (ClinicalTrials.gov)	October 2011	28/6/2011	Emotion, Mood and Executive Function in Parkinson`s Disease (PD)	Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson`s Disease	Parkinson Disease	Drug: Rasagiline;Drug: Placebo	St. Josef Hospital Bochum	NULL	Not yet recruiting	30 Years	75 Years	Both	70	Phase 4	Germany
579	EUCTR2010-018534-44-CZ (EUCTR)	23/09/2011	04/07/2011	Investigation of Cogane (PYM50028) in early stage Parkinson's disease	A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD	Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol	Phytopharm plc	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 2	United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
580	EUCTR2009-015162-57-IT (EUCTR)	22/09/2011	27/04/2011	A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - ND	A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - ND	Parkinson`s disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Preladenant Product Code: SCH420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH420814 INN or Proposed INN: Preladenant Trade Name: Azilect INN or Proposed INN: Rasagiline	Schering-Plough Research Institute, division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;Czech Republic;Finland;Poland;Spain;Lithuania;Bulgaria;Netherlands;Latvia;United Kingdom;Italy;Sweden
581	NCT01474421 (ClinicalTrials.gov)	September 15, 2011	5/10/2011	Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease	A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias	Dyskinesias;Drug-induced	Drug: AQW051;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	30 Years	85 Years	All	71	Phase 2	United States;France;Germany;Italy
582	EUCTR2011-001148-31-GB (EUCTR)	13/09/2011	17/08/2011	A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1	A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1	Parkinson's disease	Trade Name: Ferrprox (Deferiprone) Product Name: Deferiprone (Ferriprox) INN or Proposed INN: Deferiprone	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
583	EUCTR2010-020299-42-DE (EUCTR)	30/08/2011	26/04/2011	A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients.	A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD	Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE	Philipps-University Marburg	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Germany
584	EUCTR2010-018534-44-HU (EUCTR)	30/08/2011	08/07/2011	Investigation of Cogane (PYM50028) in early stage Parkinson's disease	A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD	Early-Stage Parkinson’s Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol	Phytopharm plc	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 2	France;United States;Serbia;Czech Republic;Hungary;Canada;Poland;Romania;Germany;United Kingdom
585	EUCTR2009-015162-57-GB (EUCTR)	16/08/2011	26/01/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
586	EUCTR2010-021860-13-BG (EUCTR)	04/08/2011	02/06/2011	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
587	EUCTR2010-021394-37-BG (EUCTR)	04/08/2011	02/06/2011	Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms	MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
588	EUCTR2009-015162-57-BG (EUCTR)	04/08/2011	09/06/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
589	NCT01759888 (ClinicalTrials.gov)	August 2011	1/1/2013	Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism	From Mouse Models to Patients: Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism	Parkinson's Disease	Drug: 18F-DTBZ	Chang Gung Memorial Hospital	National Science Council, Taiwan	Completed	20 Years	80 Years	Both	49	Phase 2	Taiwan
590	EUCTR2010-021860-13-IT (EUCTR)	25/07/2011	29/03/2012	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF` PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF`PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson`s Disease (PD) and end-of-dose motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Comtan® INN or Proposed INN: NA	BIAL - PORTELA & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina
591	EUCTR2009-015162-57-LT (EUCTR)	25/07/2011	21/04/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
592	EUCTR2009-015162-57-LV (EUCTR)	19/07/2011	11/05/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153 AM1)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
593	EUCTR2010-023756-82-DE (EUCTR)	13/07/2011	28/04/2011	Study to test influence of parkinson drug of insomnia in parkinson patients	Rasagiline treatment for Sleep disorders in Parkinson´s disease - RaSPar	sleep disturbances/sleep disorders in patients with Parkinson´s disease MedDRA version: 13.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Azilect Other descriptive name: RASAGILINE MESILATE	Dresden University of Technology	NULL	Not Recruiting			Female: yes Male: yes			Germany
594	EUCTR2009-015162-57-SE (EUCTR)	12/07/2011	31/05/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
595	EUCTR2010-020112-11-LT (EUCTR)	29/06/2011	06/04/2011	Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)	A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	585	Phase 3	United States;Serbia;Mexico;Argentina;Ukraine;Croatia;Lithuania;Chile;South Africa;Russian Federation;Latvia;Colombia
596	EUCTR2011-001092-39-DE (EUCTR)	29/06/2011	17/05/2011	efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias	A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesiasin Parkinson’s patients with moderate to severe L-dopa induced dyskinesias	L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AQW051 Product Code: AQW051 Product Name: AQW051 Product Code: AQW051	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	72		France;United States;Germany;Italy
597	EUCTR2010-021860-13-CZ (EUCTR)	24/06/2011	09/11/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
598	EUCTR2010-020112-11-LV (EUCTR)	21/06/2011	08/04/2011	Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)	A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037	Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	585	Phase 3	United States;Serbia;Mexico;Argentina;Ukraine;Lithuania;Croatia;South Africa;Russian Federation;Chile;Colombia;Latvia
599	EUCTR2010-022200-46-LV (EUCTR)	21/06/2011	01/04/2011	Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease.	Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC	Parkinson's disease MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Finland;Lithuania;Germany;Latvia
600	EUCTR2009-015162-57-CZ (EUCTR)	17/06/2011	15/04/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
601	EUCTR2009-015161-31-PL (EUCTR)	08/06/2011	23/02/2011	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
602	EUCTR2009-013552-72-PL (EUCTR)	08/06/2011	23/02/2011	A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)	A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy	Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
603	NCT01652534 (ClinicalTrials.gov)	June 2011	15/8/2011	Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease	Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease	Parkinson's Disease	Drug: Amantadine;Drug: Placebo	Northwestern University	NULL	Terminated	18 Years	85 Years	All	3	Phase 3	United States
604	NCT01528592 (ClinicalTrials.gov)	June 2011	31/1/2012	PharmacoMRI of Parkinson Disease	A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease	Parkinson's Disease	Drug: Carbidopa-Levodopa	Northwestern University	NULL	Completed	30 Years	N/A	All	18	N/A	United States
605	EUCTR2010-022517-25-DE (EUCTR)	30/05/2011	14/02/2011	Safety, tolerability and efficacy of ADX48621 in patients with Parkinson's disease	Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease	Levodopa induced dyskinesia in Parkinson's disease patients MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ADX48621 Product Code: ADX48621 INN or Proposed INN: Dipraglurant	Addex Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United States;France;Austria;Germany
606	EUCTR2008-005492-94-BG (EUCTR)	25/05/2011	23/03/2011	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
607	EUCTR2009-015162-57-ES (EUCTR)	23/05/2011	31/03/2011	Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153)	Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153)	Enfermedad de Parkinson MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Czech Republic;Poland;Bulgaria;Latvia;Netherlands;Sweden
608	EUCTR2010-021394-37-AT (EUCTR)	19/05/2011	05/01/2011	Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms	MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland
609	EUCTR2010-022200-46-FI (EUCTR)	13/05/2011	23/03/2011	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC	Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Finland;Germany;Latvia;Lithuania
610	EUCTR2010-022200-46-LT (EUCTR)	09/05/2011	05/04/2011	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC	Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Finland;Lithuania;Germany;Latvia
611	EUCTR2007-002964-90-BE (EUCTR)	05/05/2011	04/09/2007	A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Estonia;Taiwan;Slovakia;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Belgium;Malaysia;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
612	EUCTR2010-021394-37-SK (EUCTR)	02/05/2011	16/12/2010	Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms	MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
613	NCT01504178 (ClinicalTrials.gov)	May 2011	30/12/2011	Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease	Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease	Parkinson's Disease	Drug: duloxetine;Drug: placebo of duloxetine;Drug: injection of apomorphine;Drug: injection of placebo of apomorphine;Drug: L-Dopa;Drug: injection of placebo of L-Dopa	University Hospital, Toulouse	French Parkinson Association	Completed	30 Years	70 Years	All	28	Phase 3	France
614	EUCTR2010-022366-27-CZ (EUCTR)	21/04/2011	23/11/2010	BIPARK STUDY II	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Idiopathic Parkinson's Disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide	BIAL Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	405		Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India
615	EUCTR2010-022366-27-BE (EUCTR)	18/04/2011	01/02/2011	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Idiopathic Parkinson's Disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide	BIAL Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	405	Phase 3	Czech Republic;Estonia;Belgium;United Kingdom
616	EUCTR2010-022517-25-AT (EUCTR)	15/04/2011	17/02/2011	Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease	Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease	Levodopa induced dyskinesia in Parkinson's disease patients MedDRA version: 14.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ADX48621 Product Code: ADX48621 INN or Proposed INN: Dipraglurant	Addex Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United States;France;Austria;Germany
617	EUCTR2008-005492-94-PT (EUCTR)	14/04/2011	19/01/2011	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
618	EUCTR2009-015161-31-DE (EUCTR)	04/04/2011	24/08/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
619	NCT01313819 (ClinicalTrials.gov)	April 2011	10/3/2011	The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy	A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy	Parkinson`s Disease;Freezing of Gait	Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj	Seoul National University Hospital	NULL	Recruiting	30 Years	80 Years	Both	20	Phase 4	Korea, Republic of
620	EUCTR2009-013552-72-BG (EUCTR)	24/03/2011	26/01/2011	A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)	A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
621	EUCTR2010-022366-27-GB (EUCTR)	23/03/2011	30/11/2010	BIPARK STUDY II	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Idiopathic Parkinson's Disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide	BIAL Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	405	Phase 3	Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India
622	EUCTR2009-015162-57-AT (EUCTR)	17/03/2011	03/02/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
623	EUCTR2008-005492-94-CZ (EUCTR)	14/03/2011	03/01/2011	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		Portugal;United States;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand
624	EUCTR2010-018534-44-DE (EUCTR)	11/03/2011	10/08/2010	Investigation of Cogane (PYM50028) in early stage Parkinson's disease	A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD	Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol	Phytopharm plc	NULL	Not Recruiting			Female: yes Male: yes	408	Phase 2	United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
625	EUCTR2010-021860-13-DE (EUCTR)	09/03/2011	18/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
626	EUCTR2010-021394-37-CZ (EUCTR)	09/03/2011	14/12/2010	Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms	MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Hungary;Czech Republic;Spain;Belgium;Austria;Germany;Italy;Switzerland
627	EUCTR2010-021394-37-DE (EUCTR)	08/03/2011	03/12/2010	Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptoms	MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
628	EUCTR2009-015161-31-GB (EUCTR)	07/03/2011	01/07/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
629	EUCTR2009-013552-72-GB (EUCTR)	07/03/2011	07/07/2010	A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)	A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc	NULL	Not Recruiting			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
630	EUCTR2008-005492-94-FI (EUCTR)	04/03/2011	13/01/2011	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
631	EUCTR2009-015162-57-FI (EUCTR)	02/03/2011	20/01/2011	An Active-Controlled Extension Study to P04938 and P07037 (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
632	EUCTR2010-021394-37-IT (EUCTR)	01/03/2011	28/12/2011	STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976	STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976	subjects with Parkinson’s disease. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: NEUPRO INN or Proposed INN: Rotigotine Trade Name: NEUPRO INN or Proposed INN: Rotigotine Trade Name: NEUPRO INN or Proposed INN: Rotigotine Trade Name: NEUPRO INN or Proposed INN: Rotigotine	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345		Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy
633	NCT01330290 (ClinicalTrials.gov)	March 2011	18/3/2011	Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support	A Multi-site, Non-interventional, Cross-sectional Evaluation of the Caregivers' and the Physicians' Preferred Route of Administration and the Physicians' Rationale for the Choice of Neupro® in Patients With Parkinson Requiring Caregiver Support	Idiopathic Parkinson's Disease	Drug: Neupro®	UCB Pharma	NULL	Completed	18 Years	N/A	All	148	N/A	Germany
634	NCT01294800 (ClinicalTrials.gov)	February 25, 2011	10/2/2011	A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)	A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402)	Parkinson's Disease	Drug: Preladenant;Drug: Placebo tablet to match Preladenant	Merck Sharp & Dohme Corp.	NULL	Completed	30 Years	85 Years	All	450	Phase 2	Japan
635	EUCTR2008-001329-33-GB (EUCTR)	24/02/2011	15/03/2010	Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease	Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies.	Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid	AbbVie Inc	NULL	Not Recruiting			Female: yes Male: yes	275	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom
636	EUCTR2009-015161-31-BG (EUCTR)	17/02/2011	02/02/2011	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
637	EUCTR2010-021860-13-SK (EUCTR)	17/02/2011	09/12/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
638	EUCTR2010-021394-37-ES (EUCTR)	17/02/2011	22/12/2010	Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976	Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976	Enfermedad de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: NEUPRO 2 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 4 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 6 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 8 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Czech Republic;Hungary;Slovakia;Belgium;Spain;Austria;Bulgaria;Germany;Italy
639	EUCTR2010-021394-37-HU (EUCTR)	14/02/2011	13/12/2010	Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinson’s disease	MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland
640	EUCTR2009-017174-20-AT (EUCTR)	09/02/2011	07/12/2010	A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.	A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study	Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	24		Germany;Canada;France;Austria;South Africa
641	NCT01300819 (ClinicalTrials.gov)	February 2011	18/2/2011	Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms	Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease	Idiopathic Parkinson's Disease	Other: Placebo;Drug: Rotigotine	UCB Pharma	NULL	Completed	18 Years	N/A	All	349	Phase 4	Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Hungary;Italy;Romania;Slovakia;Spain;Switzerland
642	EUCTR2009-015161-31-PT (EUCTR)	28/01/2011	29/10/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
643	EUCTR2010-021860-13-AT (EUCTR)	27/01/2011	11/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Germany;Latvia;Netherlands;Bosnia and Herzegovina
644	EUCTR2010-021860-13-RO (EUCTR)	27/01/2011	25/07/2011	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
645	EUCTR2010-021394-37-BE (EUCTR)	25/01/2011	14/12/2010	Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptoms	MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
646	EUCTR2010-021860-13-ES (EUCTR)	24/01/2011	27/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
647	EUCTR2009-015161-31-CZ (EUCTR)	17/01/2011	28/07/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
648	EUCTR2009-013552-72-CZ (EUCTR)	17/01/2011	28/07/2010	A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)	A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy	Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
649	EUCTR2010-022915-21-SE (EUCTR)	12/01/2011	18/11/2010	Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST	Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST	Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	27		Finland;Sweden
650	EUCTR2010-022915-21-FI (EUCTR)	10/01/2011	11/11/2010	Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST	Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST	Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	27		Finland;Sweden
651	NCT01340885 (ClinicalTrials.gov)	January 2011	19/4/2011	Cognitive Decline in Non-demented PD	Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study	Parkinson's Disease	Drug: Strattera;Drug: Exelon;Other: Placebo	Oregon Health and Science University	National Institute of Neurological Disorders and Stroke (NINDS)	Completed	18 Years	N/A	All	9	Phase 4	United States
652	EUCTR2010-021860-13-PT (EUCTR)	22/12/2010	08/11/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
653	EUCTR2010-021860-13-LV (EUCTR)	22/12/2010	14/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
654	EUCTR2008-004146-88-DE (EUCTR)	20/12/2010	15/10/2010	An extension trial to investigate the long-term efficacy and safety of safinamide, as an add-on-therapy in patients with early Parkinson´s disease treated with a stable dose of a dopamine agonist	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;United States;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
655	EUCTR2010-022366-27-EE (EUCTR)	10/12/2010	03/11/2010	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Idiopathic Parkinson's Disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide	BIAL Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	405		Czech Republic;Estonia;Belgium;United Kingdom
656	EUCTR2009-015161-31-NL (EUCTR)	09/12/2010	09/08/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden;United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India
657	EUCTR2009-015161-31-IT (EUCTR)	06/12/2010	28/09/2010	A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND	A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND	Parkinson`s Disease MedDRA version: 9.1;Level: PT;Classification code 10061536	Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Trade Name: Azilect INN or Proposed INN: Rasagiline	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Finland;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden
658	EUCTR2009-013552-72-IT (EUCTR)	06/12/2010	04/11/2010	A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - ND	A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - ND	Parkinson`s Disease MedDRA version: 9.1;Level: PT;Classification code 10061536	Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Trade Name: Azilect INN or Proposed INN: Rasagiline	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;United Kingdom;Italy;Sweden
659	EUCTR2009-015161-31-SE (EUCTR)	02/12/2010	06/10/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
660	EUCTR2009-013552-72-SE (EUCTR)	02/12/2010	06/10/2010	A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)	A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy	Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
661	NCT01244269 (ClinicalTrials.gov)	December 2010	18/11/2010	The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.	Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease.	Parkinson's Disease	Drug: Methylphenidate;Drug: Placebo 10;Drug: Placebo 20	Laval University	Fonds de la Recherche en Santé du Québec;Quebec Memory and Motor Skills Disorders Research Center	Terminated	N/A	75 Years	Both	6	Phase 4	Canada
662	EUCTR2010-021860-13-LT (EUCTR)	30/11/2010	28/09/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina
663	EUCTR2010-020109-34-ES (EUCTR)	29/11/2010	23/09/2010	Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.	Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.	Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamida Product Code: NW-1015 Other descriptive name: Safinamida	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Spain;Italy
664	EUCTR2010-020109-34-IT (EUCTR)	24/11/2010	27/12/2010	A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND	A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND	Cognition in non-demented patients with idiopathic Parkinson’s disease MedDRA version: 9.1;Level: PT;Classification code 10061536	Product Name: SAFINAMIDE Product Code: NW-1015	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Spain;Italy
665	NCT01227265 (ClinicalTrials.gov)	November 19, 2010	22/10/2010	Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)	A Phase 3, 12 Week, Double-blind, Placebo-controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease.	Parkinson Disease;Idiopathic Parkinson Disease;Idiopathic Parkinson's Disease	Drug: Preladenant;Drug: Placebo	Merck Sharp & Dohme Corp.	NULL	Completed	30 Years	85 Years	All	476	Phase 3	Argentina;Chile;Colombia;Croatia;Latvia;Lithuania;Mexico;Russian Federation;Serbia;South Africa;Ukraine;United States
666	NCT01215227 (ClinicalTrials.gov)	November 18, 2010	4/10/2010	An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)	A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153)	Parkinson Disease;Idiopathic Parkinson Disease	Drug: Preladenant;Drug: Rasagiline;Drug: Placebo to preladenant;Drug: Placebo to rasagiline	Merck Sharp & Dohme Corp.	NULL	Terminated	30 Years	85 Years	All	839	Phase 3	Argentina;Austria;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;France;India;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Sweden;Ukraine;United Kingdom;United States
667	EUCTR2010-021860-13-HU (EUCTR)	11/11/2010	27/09/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
668	EUCTR2007-001109-26-GB (EUCTR)	04/11/2010	05/08/2010	A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease	A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease	Patients with bilateral, idiopathic Parkinson's Disease	Product Name: ProSavin INN or Proposed INN: ProSavin	Oxford BioMedica (UK) Ltd	NULL	Not Recruiting			Female: yes Male: yes	27	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
669	EUCTR2009-015161-31-AT (EUCTR)	03/11/2010	17/08/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
670	NCT01060878 (ClinicalTrials.gov)	November 2010	1/2/2010	Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)	Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks	Parkinson's Disease	Drug: PYM50028;Drug: Placebo	Phytopharm	NULL	Completed	35 Years	75 Years	Both	425	Phase 2	United States;Canada;Czech Republic;France;Germany;Hungary;Poland;Romania;Serbia;United Kingdom
671	NCT01190553 (ClinicalTrials.gov)	November 2010	26/8/2010	Pilot Study of Maintenance Therapy With Intravenous AMANTADINE	Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications	Parkinson Disease	Drug: Amantadine	Rabin Medical Center	NULL	Not yet recruiting	30 Years	80 Years	Both	20	N/A	NULL
672	NCT01270711 (ClinicalTrials.gov)	November 2010	9/12/2010	Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)	Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)	Parkinson's Disease;Hyperprolactinemia	Drug: Study Drug	Pfizer	NULL	Completed	N/A	N/A	All	22014	N/A	NULL
673	EUCTR2009-013552-72-ES (EUCTR)	26/10/2010	27/07/2010	Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE	Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE	Enfermendad de Parkinson MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagilina mesilato Other descriptive name: RASAGILINA MESILATO	Schering Corporation, división Schering-Plough Research	NULL	Not Recruiting			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
674	EUCTR2010-018534-44-GB (EUCTR)	22/10/2010	09/08/2010	Investigation of Cogane (PYM50028) in early stage Parkinson's disease	A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD	Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol	Phytopharm plc	NULL	Not Recruiting			Female: yes Male: yes	408	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
675	EUCTR2009-013552-72-HU (EUCTR)	21/10/2010	11/08/2010	A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - Monotherapy	A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - Monotherapy	Parkinson's disease	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Czech Republic;Hungary;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
676	EUCTR2009-015161-31-FR (EUCTR)	19/10/2010	29/07/2010	A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease	A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease	Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesilate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden
677	EUCTR2009-015928-28-SE (EUCTR)	07/10/2010	13/08/2010	A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09	A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09	Dyskinesias related to levodopa treatment in Parkinson´s disease	Product Name: Eltoprazine HCl Product Code: Eltoprazine HCl	PsychoGenics Inc	NULL	Not Recruiting			Female: yes Male: yes	24		Sweden
678	EUCTR2007-002964-90-CZ (EUCTR)	06/10/2010	27/08/2010	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	Hungary;Finland;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;Estonia;France;Spain;Austria
679	EUCTR2010-019418-25-DE (EUCTR)	01/10/2010	19/07/2010	Open label, safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 16.0;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065	Novartis Pharma Sevices AG	NULL	Not Recruiting			Female: yes Male: yes	244		France;Canada;Finland;Australia;Germany;Italy;Japan
680	NCT01173731 (ClinicalTrials.gov)	October 2010	28/7/2010	Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	Parkinson Disease;Dyskinesia, Drug-Induced;Levodopa	Drug: AFQ056	Novartis Pharmaceuticals	NULL	Completed	N/A	N/A	All	66	Phase 2	United States;Australia;Canada;France;Germany;Italy;Finland;Spain
681	EUCTR2010-019418-25-FR (EUCTR)	29/09/2010	15/07/2010	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	244		France;Finland;Germany;Italy
682	EUCTR2009-017238-39-DE (EUCTR)	16/09/2010	28/07/2010	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease	Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 3	France;Belgium;Germany;Italy
683	EUCTR2009-017238-39-FR (EUCTR)	15/09/2010	09/07/2010	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease	Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 3	France;Belgium;Germany;Italy
684	EUCTR2010-019418-25-FI (EUCTR)	08/09/2010	21/07/2010	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias	Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia	Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	244		France;Finland;Germany;Italy
685	EUCTR2009-013552-72-FI (EUCTR)	07/09/2010	02/07/2010	A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)	A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
686	NCT01211587 (ClinicalTrials.gov)	September 2010	28/9/2010	A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease	A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson's Disease (PD) and Cognitive Impairment	Parkinson's Disease With Cognitive Impairments	Drug: safinamide;Drug: placebo	Newron	NULL	Completed	45 Years	80 Years	Both	103	Phase 2	United States;Spain
687	EUCTR2009-017238-39-BE (EUCTR)	27/08/2010	14/07/2010	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease	Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Nacom 100 INN or Proposed INN: CARBIDOPA	Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 3	France;Belgium;Germany;Italy
688	EUCTR2009-015161-31-FI (EUCTR)	17/08/2010	23/06/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938)	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
689	EUCTR2009-017182-38-ES (EUCTR)	26/07/2010	25/05/2010	Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease.	Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease.	Enfermedad de Parkinson idiopática (parálisis agitante) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Estonia;Poland;Spain;Lithuania;Germany;Latvia
690	NCT01155466 (ClinicalTrials.gov)	July 14, 2010	30/6/2010	A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)	A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938)	Parkinson Disease	Drug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Placebo to Preladenant Tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo to Rasagiline capsule	Merck Sharp & Dohme Corp.	NULL	Completed	30 Years	85 Years	All	778	Phase 3	Austria;Brazil;Bulgaria;Canada;Czech Republic;Finland;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States
691	EUCTR2010-018650-12-FR (EUCTR)	13/07/2010	06/05/2010	Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX	Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX	maladie de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: CYMBALTA Product Name: duloxetine Trade Name: APOKINON Product Name: apomorphine Trade Name: MODOPAR Product Name: levodopa Trade Name: MOTILIUM Product Name: dompéridone	CHU de Toulouse	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	France
692	EUCTR2009-017182-38-LT (EUCTR)	10/07/2010	26/04/2010	An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease	An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease	Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	500		Germany;Estonia;Spain;Latvia;Poland;Lithuania
693	EUCTR2009-017182-38-DE (EUCTR)	09/07/2010	07/05/2010	An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.	An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.	Idiopathic Parkinson’s disease (paralysis agitans). MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division	NULL	Not Recruiting			Female: yes Male: yes	500		Estonia;Spain;Poland;Lithuania;Latvia;Germany
694	EUCTR2009-017182-38-PL (EUCTR)	07/07/2010	20/05/2010	An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.	An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.	Idiopathic Parkinson’s disease (paralysis agitans). MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500		Germany;Estonia;Spain;Latvia;Poland;Lithuania
695	NCT01174810 (ClinicalTrials.gov)	July 2010	2/8/2010	Exendin-4 as a Treatment for Parkinson's Disease - Pilot Study	An Open Label, Single Site, 12 Month, Phase II, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exendin-4 (Exenatide) in the Treatment of Patients With Moderate Severity Parkinson's Disease.	Parkinson's Disease	Drug: Exenatide	University College, London	NULL	Active, not recruiting	45 Years	70 Years	Both	40	Phase 2	United Kingdom
696	EUCTR2009-017238-39-IT (EUCTR)	21/06/2010	13/07/2010	A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND	A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND	Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA LEVODOPA Trade Name: NACOM 100 INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone	IMPAX LABORATORIES, INC.	NULL	Not Recruiting			Female: yes Male: yes	56		Germany;France;Italy
697	EUCTR2009-017182-38-LV (EUCTR)	11/06/2010	26/04/2010	An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease	An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease	Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	500		Germany;Estonia;Spain;Latvia;Poland;Lithuania
698	EUCTR2009-013886-24-SE (EUCTR)	08/06/2010	21/12/2009	Efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2	Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246		Czech Republic;Germany;Sweden
699	NCT01176240 (ClinicalTrials.gov)	June 2010	30/7/2010	A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease	A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease	Orthostatic Hypotension;Parkinson's Disease	Drug: Droxidopa;Other: Placebo	Chelsea Therapeutics	NULL	Completed	18 Years	N/A	All	225	Phase 3	United States
700	NCT01141023 (ClinicalTrials.gov)	June 2010	8/6/2010	Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression	The Parkinson's Progression Markers Initiative (PPMI)	Parkinson Disease	Drug: DaTscan	Ken Marek, MD	Institute for Neurodegenerative Disorders	Active, not recruiting	30 Years	N/A	All	1100	Phase 2	United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Norway;Spain;United Kingdom
701	EUCTR2009-016143-19-AT (EUCTR)	26/05/2010	12/05/2010	Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie	Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie	Parkinson's disease	Trade Name: Amantadin-ratiopharm 100mg Other descriptive name: AMANTADINE HYDROCHLORIDE	CHU de Toulouse	NULL	Not Recruiting			Female: yes Male: yes	66		France;Austria
702	EUCTR2010-019354-40-AT (EUCTR)	26/05/2010	26/04/2010	Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom	Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom	Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: Madopar INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE	Universitätsklinik für Neurologie Innsbruck	NULL	Not Recruiting			Female: yes Male: yes	15		Austria
703	EUCTR2009-017182-38-EE (EUCTR)	14/05/2010	26/04/2010	An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease	An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease	Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	500		Germany;Estonia;Spain;Latvia;Poland;Lithuania
704	JPRN-UMIN000003601	2010/05/01	18/05/2010	Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients	Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients - ROPENT trial	Parkinson's disease	Increase dosage of ropinirole Addition of entacapone	Kansai Medical University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	30	Not selected	Japan
705	EUCTR2009-018137-37-GB (EUCTR)	14/04/2010	18/03/2010	An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial	An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Trade Name: Byetta 5 micrograms Product Name: Exenatide 5 micrograms Trade Name: Exenatide 10 micrograms Product Name: Exenatide 10 micrograms	University College London	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
706	NCT00988117 (ClinicalTrials.gov)	April 2010	29/9/2009	The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems	The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)	Parkinsons Disease With Dementia;Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems	Drug: Rivastigmine Patch 9.5 cm2	University of California, San Francisco	Novartis	Completed	55 Years	N/A	All	15	Phase 4	United States
707	EUCTR2009-017174-20-DE (EUCTR)	15/03/2010	07/01/2010	A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.	A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study	Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	24		France;Canada;Austria;South Africa;Germany
708	EUCTR2009-013886-24-DE (EUCTR)	03/03/2010	29/10/2009	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2	Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246		Czech Republic;Germany;Sweden
709	NCT01055379 (ClinicalTrials.gov)	March 2010	22/1/2010	Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn	A Randomised, Double-blind, Placebo-controlled Study to Evaluate if Rasagiline Can Improve Depressive Symptoms and Cognitive Function in Non-demented, Idiopathic Parkinson's Disease Patients: ACCORDO Study	Depressive Symptoms;Parkinson's Disease	Drug: Rasagiline;Drug: Placebo	Lundbeck Italia S.p.A.	Teva Pharmaceutical Industries	Completed	40 Years	80 Years	All	121	Phase 4	Italy
710	NCT01092065 (ClinicalTrials.gov)	March 2010	22/3/2010	Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia	A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia	Parkinson's Disease	Drug: AFQ056 with L-dopa;Drug: Placebo	Novartis	NULL	Completed	30 Years	80 Years	All	23	Phase 2	United States
711	EUCTR2009-017174-20-FR (EUCTR)	24/02/2010	18/01/2010	A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias.	A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias.	Idiopathic Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	France;Austria;Germany
712	EUCTR2007-002963-28-DE (EUCTR)	17/02/2010	22/12/2009	A trial to determine the efficacy and safety of a low (50mg/day) and high dose (100mg / day) of safinamide, as add-on therapy, in patients with early Parkinson´s Disease treated with a sigle dopamin antagonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
713	NCT01154166 (ClinicalTrials.gov)	February 15, 2010	29/6/2010	A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa	A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa	Parkinson Disease	Drug: ReQuip PR;Drug: Placebo	GlaxoSmithKline	NULL	Completed	30 Years	N/A	All	347	Phase 3	China
714	EUCTR2009-014688-37-PL (EUCTR)	09/02/2010	20/01/2010	A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A	A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A	Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA	Impax Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;France;Spain;Poland
715	EUCTR2009-016360-37-SE (EUCTR)	06/02/2010	04/12/2009	TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY	TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY	Parkinsons disease is complicated by dyskinesias and dystonia. Due stabilizing properties, we believe (-)-OSU6162 may alleviate dyskinesias, without causing parkinsonism. Aim: To evaluate in a double-blind cross over pilot study whether OSU6162 attenuates dyskinesias without worsening parkinsonism in PD patients with motor complications using clinical examination and patient diaries.	Product Name: not available Product Code: OSU 6162 similar to (-)-OSU 6162 INN or Proposed INN: not available	Björn Holmberg	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 1;Phase 2	Sweden
716	EUCTR2008-005492-94-BE (EUCTR)	25/01/2010	12/08/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
717	EUCTR2008-005492-94-NL (EUCTR)	18/01/2010	25/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Netherlands;Germany
718	EUCTR2009-017416-33-DE (EUCTR)	18/01/2010	21/12/2009	Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.	Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.	Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE	Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University	NULL	Not Recruiting			Female: yes Male: yes			Germany
719	EUCTR2008-001329-33-CZ (EUCTR)	18/01/2010	03/12/2009	Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease	Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies.	Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid	AbbVie Inc	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 3	Portugal;Czech Republic;Poland;Thailand;Australia;Russian Federation;Israel;United Kingdom;New Zealand;Italy
720	EUCTR2009-012643-42-NL (EUCTR)	06/01/2010	30/11/2009	Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's disease	Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's disease	Parkinson's disease, in particular the symptom Freezing of Gait	Trade Name: Ritalin Product Name: Not applicable Product Code: Not applicable INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Other descriptive name: Ritalin	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
721	JPRN-UMIN000003080	2010/01/01	30/01/2010	Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease	Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease - EDP2010 study	Parkinson's disease	Donepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks) Placebo	Clinical Research Center, Utano National Hospital, National Hospital Organization	NULL	Complete: follow-up complete	40years-old	75years-old	Male and Female	30	Not applicable	Japan
722	JPRN-UMIN000007497	2010/01/01	14/03/2012	Trial of molecular hydrogen water in Parkinson disease	Trial of molecular hydrogen water in Parkinson disease - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease	Parkinson disease	The subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks. Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks.	Department of Neurology, Juntendo University School of Medicine	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	18	Not applicable	Japan
723	NCT01007864 (ClinicalTrials.gov)	January 2010	3/11/2009	Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists	Influence of the Non-Ergot Dopamine Agonist Piribedil on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Oral Non-Ergot Dopamine Agonists	Idiopathic Parkinson's Disease	Drug: piribedil;Drug: pramipexole or ropinirole	Desitin Arzneimittel GmbH	FGK Clinical Research GmbH	Completed	35 Years	80 Years	Both	80	Phase 3	Germany
724	EUCTR2009-014688-37-ES (EUCTR)	30/12/2009	21/10/2009	A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada.	A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada.	Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Sinemet-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA	Impax Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;France;Spain;Poland
725	EUCTR2009-011541-24-NL (EUCTR)	30/12/2009	29/05/2009	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700		Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
726	EUCTR2009-014688-37-DE (EUCTR)	15/12/2009	07/10/2009	A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease	A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease	Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA	Impax Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;France;Spain;Poland
727	EUCTR2008-005492-94-GB (EUCTR)	09/12/2009	01/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
728	EUCTR2009-012897-12-RO (EUCTR)	08/12/2009	30/03/2015	A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor	A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor	Parkinson’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852	Product Name: BIA 9-1067 Product Code: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Restex Tabletten INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE	BIAL-Portela & Ca, SA	NULL	Not Recruiting			Female: yes Male: yes	32		Romania
729	EUCTR2009-014688-37-FR (EUCTR)	04/12/2009	09/10/2009	A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease	A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease	Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	France;Poland;Spain;Germany
730	EUCTR2009-012419-16-DE (EUCTR)	03/12/2009	20/10/2009	Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD	Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD	idiopathic Parkinson's disease MedDRA version: 12.0;Level: PT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Clarium 50 mg Retardtabletten INN or Proposed INN: piribedil	Desitin Arzneimittel GmbH	NULL	Not Recruiting			Female: yes Male: yes			Germany
731	EUCTR2009-013886-24-CZ (EUCTR)	26/11/2009	18/11/2009		A Randomized, Multicenter, 12-Week, Double-blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson Disease, followed by a 9-months Open-Label Extension Phase - HARPS-2	Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246		Germany;Czech Republic;Sweden
732	EUCTR2008-005492-94-FR (EUCTR)	25/11/2009	01/10/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
733	EUCTR2008-005492-94-ES (EUCTR)	23/11/2009	18/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
734	EUCTR2009-013885-14-FR (EUCTR)	23/11/2009	25/09/2009	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase	Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246	Phase 3	France;Spain
735	EUCTR2009-013670-41-CZ (EUCTR)	18/11/2009	07/09/2009	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease	Parkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications. MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: Orfadin INN or Proposed INN: NITISINONE	Synosia Therapeutics AG	NULL	Not Recruiting			Female: yes Male: yes	126		Czech Republic;France
736	EUCTR2009-011093-15-DE (EUCTR)	16/11/2009	23/09/2009	The role of the neurotransmitters dopamine and acetylcholine in the interaction of selective attention and working memory. - Dopamine and Acetylcholine for Attention and Memory	The role of the neurotransmitters dopamine and acetylcholine in the interaction of selective attention and working memory. - Dopamine and Acetylcholine for Attention and Memory	Healthy volunteers MedDRA version: 12.0;Level: LLT;Classification code 10012271;Term: Dementia Alzheimer's type MedDRA version: 12.0;Classification code 10013113;Term: Disease Parkinson's	Trade Name: Nacom INN or Proposed INN: LEVODOPA Other descriptive name: L-Dopa Trade Name: Reminyl INN or Proposed INN: GALANTAMINE Other descriptive name: Galantamine hydrobromide	Otto-von-Guericke University, Medical Faculty, Dpt. of Neurology	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Germany
737	NCT00660673 (ClinicalTrials.gov)	November 13, 2009	15/4/2008	Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD	Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies	Advanced Parkinson's Disease	Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump	AbbVie	IQVIA, formerly Quintiles	Completed	30 Years	99 Years	All	262	Phase 3	United States;Australia;Canada;Czechia;Israel;New Zealand;Poland;Portugal;Russian Federation;Thailand;United Kingdom;Czech Republic
738	EUCTR2009-013885-14-ES (EUCTR)	12/11/2009	23/09/2009	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.	Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson. MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246	Phase 3	France;Spain
739	EUCTR2009-013004-31-IT (EUCTR)	02/11/2009	02/11/2009	Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease	Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease	Patients with Parkinson`s diesease MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease	INN or Proposed INN: Rasagiline INN or Proposed INN: Ropinirole	UNIVERSITA` DEGLI STUDI DI PARMA	NULL	Not Recruiting			Female: yes Male: yes			Italy
740	NCT01028209 (ClinicalTrials.gov)	November 2009	8/12/2009	Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological Conditions		Alzheimer Disease;Parkinson Disease;Multiple Sclerosis	Drug: [18F] PBR06	Institute for Neurodegenerative Disorders	NULL	Terminated	18 Years	N/A	All	12	Phase 1	United States
741	NCT01023282 (ClinicalTrials.gov)	November 2009	1/12/2009	Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients	Randomised, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ACR325 in Parkinson's Disease Patients, With Evaluation of the Effect on Levodopa Induced Dyskinesias as a Secondary Measure	Parkinson's Disease;Tolerability	Drug: ACR325;Drug: Placebo	NeuroSearch A/S	NULL	Completed	30 Years	75 Years	Both	22	Phase 1	Germany
742	NCT01532141 (ClinicalTrials.gov)	November 2009	23/1/2012	Effect of Rasagiline on BIA 9-1067 Pharmacokinetics	Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects	Parkinson Disease	Drug: BIA 9-1067;Drug: Rasagiline	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	25	Phase 1	France
743	NCT01532128 (ClinicalTrials.gov)	November 2009	23/1/2012	Effect of BIA 9-1067 on Rasagiline Pharmacokinetics	Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects	Parkinson Disease	Drug: rasagiline;Drug: BIA 9-1067	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	24	Phase 1	France
744	NCT01519284 (ClinicalTrials.gov)	November 2009	23/1/2012	Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic	A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects	Parkinson Disease	Drug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa/carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mg	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	82	Phase 1	Portugal
745	NCT01007630 (ClinicalTrials.gov)	November 2009	3/11/2009	A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients	A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease	Parkinson's Disease	Drug: Rasagiline;Drug: Placebo	The Parkinson's Institute	Teva Neuroscience, Inc.	Active, not recruiting	N/A	90 Years	Both	36	Phase 4	United States
746	NCT01052831 (ClinicalTrials.gov)	November 2009	15/1/2010	Naltrexone for Impulse Control Disorders in Parkinson's Disease	Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease	Impulse Control Disorder;Parkinson Disease	Drug: Naltrexone;Drug: Placebo	University of Pennsylvania	Michael J. Fox Foundation for Parkinson's Research	Completed	18 Years	85 Years	All	50	Phase 4	United States
747	EUCTR2008-005492-94-HU (EUCTR)	27/10/2009	22/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285		Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
748	EUCTR2008-004146-88-PL (EUCTR)	19/10/2009	31/08/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy
749	EUCTR2009-013670-41-FR (EUCTR)	16/10/2009	11/09/2009	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease	Parkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications. MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: Orfadin INN or Proposed INN: NITISINONE	Synosia Therapeutics AG	NULL	Not Recruiting			Female: yes Male: yes	126	Phase 2	France;Czech Republic
750	EUCTR2008-005492-94-SK (EUCTR)	14/10/2009	22/10/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
751	EUCTR2009-011541-24-GB (EUCTR)	09/10/2009	29/05/2009	A trial to follow-up subjects with Parkinson's disease who participated to the ADAGIO study in order to study the long-term effects of the drug rasagiline	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	Parkinson's Disease MedDRA version: 13.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Romania;Germany;Netherlands
752	EUCTR2008-005492-94-AT (EUCTR)	02/10/2009	03/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
753	EUCTR2008-005492-94-EE (EUCTR)	01/10/2009	15/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
754	EUCTR2006-005186-18-NL (EUCTR)	25/09/2009	29/05/2008	Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations	Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Solvay Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	250		Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
755	EUCTR2009-011541-24-DE (EUCTR)	22/09/2009	27/07/2009	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700		Portugal;France;Hungary;Spain;Netherlands;Germany;Italy;United Kingdom
756	EUCTR2009-011541-24-PT (EUCTR)	09/09/2009	29/07/2009	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700		France;Portugal;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
757	NCT00986414 (ClinicalTrials.gov)	September 2009	29/9/2009	Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease	13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease	Parkinson Disease;Dyskinesias	Drug: AFQ056;Drug: Placebo	Novartis	NULL	Completed	30 Years	80 Years	All	260	Phase 2	Australia;Canada;Finland;France;Germany;Italy;Japan;Spain
758	EUCTR2009-011541-24-ES (EUCTR)	27/08/2009	26/06/2009	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up	Parkinson's Disease Enfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: AZILECT 1 mg comprimidos INN or Proposed INN: RASAGILINA MESILATO Other descriptive name: RASAGILINA MESILATO	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
759	EUCTR2008-004146-88-BG (EUCTR)	13/08/2009	13/07/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
760	EUCTR2008-008712-98-DE (EUCTR)	07/08/2009	13/07/2009	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia	Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	198		France;Finland;Spain;Germany;Italy
761	EUCTR2008-004146-88-PT (EUCTR)	31/07/2009	14/04/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
762	EUCTR2009-011541-24-FR (EUCTR)	17/07/2009	19/06/2009	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
763	EUCTR2009-011541-24-HU (EUCTR)	10/07/2009	05/06/2009	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
764	NCT00909545 (ClinicalTrials.gov)	July 2009	26/5/2009	Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease	A Pilot Phase II Double-Blind, Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients With Early Parkinson Disease	Parkinson Disease	Drug: Isradipine CR 5mg;Drug: Isradipine CR 10mg;Drug: Isradipine CR 20mg;Drug: Placebo	Northwestern University	Michael J. Fox Foundation for Parkinson's Research;Northwestern University Dixon Fund;The Parkinson Study Group	Completed	30 Years	N/A	All	99	Phase 2	United States;Canada
765	EUCTR2009-011541-24-IT (EUCTR)	24/06/2009	26/06/2009	An open-label, multi-center, follow-up study designed to evaluate the long-term effects of rasagiline in Parkinson?s disease subjects who participated in the ADAGIO study - ADAGIO Follow -Up	An open-label, multi-center, follow-up study designed to evaluate the long-term effects of rasagiline in Parkinson?s disease subjects who participated in the ADAGIO study - ADAGIO Follow -Up	Parkinson?s disease MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: AZILECT INN or Proposed INN: Rasagiline	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700		Portugal;France;Hungary;Spain;Germany;Netherlands;United Kingdom;Italy
766	EUCTR2008-004146-88-ES (EUCTR)	16/06/2009	16/04/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
767	EUCTR2008-001966-10-EE (EUCTR)	16/06/2009	13/05/2009		A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Hungary;United Kingdom;Estonia;Austria
768	EUCTR2008-008712-98-FR (EUCTR)	10/06/2009	28/04/2009	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia	Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	234		France;Finland;Spain;Germany;Italy
769	EUCTR2008-004146-88-CZ (EUCTR)	08/06/2009	07/04/2009	An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
770	EUCTR2009-010193-38-LV (EUCTR)	04/06/2009	24/08/2009	A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease	A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease	Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA	IMPAX Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350		Estonia;Latvia;Lithuania
771	EUCTR2009-010193-38-LT (EUCTR)	02/06/2009	26/03/2009	A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease	A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease	Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA	IMPAX Pharmaceuticals a Division of IMPAX Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350		Estonia;Latvia;Lithuania
772	EUCTR2008-001966-10-AT (EUCTR)	27/05/2009	08/04/2009		A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Hungary;United Kingdom;Estonia;Austria
773	EUCTR2008-004146-88-IT (EUCTR)	26/05/2009	27/04/2009	A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study	A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study	Idiopatic Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Safinamide INN or Proposed INN: Safinamide Product Name: Safinamide INN or Proposed INN: Safinamide	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
774	EUCTR2008-001966-10-SK (EUCTR)	25/05/2009	28/05/2009	A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Other descriptive name: NW-1015 Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Estonia;Hungary;Slovakia;Austria;United Kingdom
775	EUCTR2008-004146-88-SK (EUCTR)	25/05/2009	28/05/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
776	EUCTR2008-004146-88-FI (EUCTR)	19/05/2009	06/04/2009	An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
777	EUCTR2008-008712-98-FI (EUCTR)	18/05/2009	08/04/2009	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	moderate to severe levodopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	198		Finland;Germany;France;Spain;Italy
778	EUCTR2008-008712-98-IT (EUCTR)	14/05/2009	05/05/2009	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND	13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND	moderate to severe levodopa induced dyskinesia with Parkinson`s disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia	Product Code: AFQ056 Product Code: AFQ056 Product Code: AFQ056	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	234		Finland;Germany;France;Spain;Italy
779	EUCTR2008-001966-10-GB (EUCTR)	12/05/2009	27/04/2009		A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Hungary;United Kingdom;Estonia;Austria
780	EUCTR2008-000400-81-DE (EUCTR)	11/05/2009	29/01/2009	A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia	A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia	Advanced Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex Product Name: pramipexole INN or Proposed INN: pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Trade Name: Mirapex Product Name: Pramipexole INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate	Abbott Healthcare Products B.V.	NULL	Not Recruiting			Female: yes Male: yes	50		Portugal;Germany;Italy
781	EUCTR2006-000578-53-DE (EUCTR)	08/05/2009	30/10/2008	Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects	Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Abbott Laboratories	NULL	Not Recruiting			Female: yes Male: yes	70		United States;Germany;New Zealand
782	EUCTR2009-010193-38-EE (EUCTR)	07/05/2009	15/04/2009	A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease	A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease	Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA	IMPAX Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350		Estonia;Latvia;Lithuania
783	EUCTR2008-001966-10-HU (EUCTR)	04/05/2009	06/04/2009		A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Hungary;United Kingdom;Estonia;Austria
784	EUCTR2007-002963-28-BG (EUCTR)	03/05/2009	21/05/2009	A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson’s Disease treated with a single dopamine agonist.	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
785	NCT00767546 (ClinicalTrials.gov)	May 2009	5/10/2008	Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients	Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients	Parkinson Disease;Parkinsonism;Seborrheic Dermatitis	Drug: Botulinum toxin	Rabin Medical Center	NULL	Not yet recruiting	18 Years	N/A	Both	40	Phase 1	NULL
786	EUCTR2008-002769-30-IT (EUCTR)	30/04/2009	22/04/2009	A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics	A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics	Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113	Product Name: Safinamide INN or Proposed INN: Safinamide INN or Proposed INN: NACOM levodopa+cardidopa	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes			Italy
787	EUCTR2008-005492-94-IT (EUCTR)	30/04/2009	15/04/2009	OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND	OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND	IDIOPATHIC PARKINSON`S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: SAFINAMIDE Product Code: NW-1015 Product Name: SAFINAMIDE Product Code: NW-1015	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
788	EUCTR2008-008210-38-FR (EUCTR)	16/04/2009	19/03/2009	Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I	Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I	Patients ayant une maladie de Parkinson Patients à un stade évolué de la maladie avec des troubles de la marche sévères MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease MedDRA version: 9.1;Level: PT;Term: Parkinson's disease	Trade Name: EBIXA® Product Name: mémantine Trade Name: L-Dopa/ MODOPAR Product Name: L-Dopa	Chru de Lille	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 3	France
789	EUCTR2007-004234-16-AT (EUCTR)	14/04/2009	10/03/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	520		Finland;Hungary;Czech Republic;Netherlands;France;Austria
790	EUCTR2007-001095-36-SK (EUCTR)	09/04/2009	09/04/2008	The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study	The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study	advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	625	Phase 3	Hungary;Slovakia
791	EUCTR2008-005085-30-DE (EUCTR)	06/04/2009	04/03/2009	Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline	Einfluss von Rasagilin auf das Riechvermögen von Patienten mit idiopathischem Parkinson-Syndrom(Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline) - Olfaction	Idiopathic Parkinson syndrome (IPS), State according to Hoehn & Yahr: maximum III MedDRA version: 13.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Azilect INN or Proposed INN: Rasagilin	Technische Universität Dresden	NULL	Not Recruiting			Female: yes Male: yes			Germany
792	EUCTR2008-000400-81-PT (EUCTR)	03/04/2009	27/01/2009	A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia	A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia	Advanced Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex Product Name: pramipexole INN or Proposed INN: pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Trade Name: Mirapex Product Name: Pramipexole INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate	Solvay Pharmaceuticals BV	NULL	Not Recruiting			Female: yes Male: yes	50		Portugal;Germany;Italy
793	EUCTR2007-004235-37-AT (EUCTR)	02/04/2009	10/03/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	390		Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
794	EUCTR2007-002963-28-PL (EUCTR)	02/04/2009	27/02/2009	A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as an add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy
795	EUCTR2007-002964-90-AT (EUCTR)	02/04/2009	13/02/2008	A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
796	JPRN-UMIN000001841	2009/04/01	02/04/2009	A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life	A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life - RCT with vitamin D for Parkinson disease	Parkinson disease	Vitamin D3 placebo	Jikei University School of Medicine	NULL	Complete: follow-up complete	45years-old	85years-old	Male and Female	120	Not selected	Japan
797	EUCTR2008-000400-81-IT (EUCTR)	31/03/2009	17/04/2009	A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND	A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND	Advanced Parkinson`s Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Trade Name: Mirapex INN or Proposed INN: Pramipexole Trade Name: Mirapex INN or Proposed INN: Pramipexole Trade Name: Mirapex INN or Proposed INN: Pramipexole	SOLVAY PHARMACEUTICALS B.V.	NULL	Not Recruiting			Female: yes Male: yes	50		Portugal;Germany;Italy
798	EUCTR2007-003035-22-AT (EUCTR)	30/03/2009	26/05/2008	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 2;Phase 3	Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
799	EUCTR2008-004447-11-GB (EUCTR)	27/03/2009	07/01/2009	A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease	A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease	Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term:	Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride	Vectura Limited	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	Germany;United Kingdom;Italy
800	EUCTR2007-002963-28-PT (EUCTR)	26/03/2009	07/01/2009	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A-Geneva	NULL	Not Recruiting			Female: yes Male: yes	1036	Phase 3	Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
801	EUCTR2007-002964-90-FR (EUCTR)	09/03/2009	12/11/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1121	Phase 3	France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
802	NCT00767091 (ClinicalTrials.gov)	March 2009	1/9/2008	Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia	A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentric Trial	Parkinson's Disease;Apathy;no Dementia	Drug: rivastigmine;Drug: placebo	University Hospital, Lille	NULL	Completed	15 Years	80 Years	Both	40	Phase 3	France
803	NCT00888004 (ClinicalTrials.gov)	March 2009	23/4/2009	Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients	A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias	Parkinson's Disease;L-dopa Induced Dyskinesia	Drug: AFQ056;Drug: Placebo	Novartis	NULL	Completed	30 Years	85 Years	Both	28	Phase 2	Germany
804	EUCTR2006-005186-18-CZ (EUCTR)	09/02/2009	21/11/2007	Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease	An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Abbott Healthcare Products B.V.	NULL	Not Recruiting			Female: yes Male: yes	320		United States;Portugal;Finland;Thailand;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;New Zealand
805	EUCTR2008-006045-10-FR (EUCTR)	06/02/2009	24/03/2009	Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP	Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP	L’objectif thérapeutique principal dans la maladie de Parkinson est de contrôler les fluctuations motrices. Cependant des fluctuations non motrices (FNM) sont fréquemment observées et semblent corrélées à la sévérité de la maladie. La stabilité dans le temps de l’efficacité du traitement dopaminergique est le moyen le plus pertinent pour améliorer les fluctuations tant motrices que non motrices. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: Apokinon	CHU de Rennes	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France
806	NCT00806468 (ClinicalTrials.gov)	February 2009	9/12/2008	Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease	A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease	Parkinson Disease	Drug: Desmotabs	Johannes Gutenberg University Mainz	NULL	Terminated	18 Years	85 Years	Male	1	Phase 4	Germany
807	EUCTR2007-007853-30-SE (EUCTR)	28/01/2009	21/12/2007	A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump.	A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump.	Idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb - III)	Product Name: sNN0031 Product Code: sNN0031	NeuroNova AB	NULL	Not Recruiting			Female: yes Male: yes			Sweden
808	EUCTR2009-015833-66-IT (EUCTR)	20/01/2009	18/04/2012	Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release	Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release	Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: REQUIP*28CPR 8MG R.P. INN or Proposed INN: ROPINIROLE Other descriptive name: NA Trade Name: REQUIP*21CPR 5MG INN or Proposed INN: ROPINIROLE Other descriptive name: NA Trade Name: MIRAPEXIN*30CPR 0,7MG INN or Proposed INN: PRAMIPEXOLE Other descriptive name: NA	CASA DI CURA PRIVATA S.RAFFAELE - PISANA	NULL	Not Recruiting			Female: yes Male: yes			Italy
809	EUCTR2007-002963-28-CZ (EUCTR)	19/01/2009	30/10/2007	A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
810	EUCTR2007-003035-22-PT (EUCTR)	09/01/2009	01/07/2008	A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	MedDRA version: 18.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate Other descriptive name: N/A	ACADIA Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
811	EUCTR2007-003035-22-IT (EUCTR)	07/01/2009	23/07/2008		A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease - ACP-103-015	Psychosis in Parkinson?s Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: primavanserin tartrate Product Code: ACP-103 INN or Proposed INN: primavanserin tartrate	ACADIA PHARMACEUTICALS INC.	NULL	Not Recruiting			Female: yes Male: yes	486		Portugal;United Kingdom;Belgium;France;Italy;Austria;Sweden
812	EUCTR2008-004906-15-FR (EUCTR)	05/01/2009	16/03/2009	EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson	EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson	Maladie de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: DATSCAN	CHU Toulouse	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
813	EUCTR2004-000148-26-AT (EUCTR)	31/12/2008	26/11/2008	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	Parkinson's Disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol	Schwarz BioSciences Inc.	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden
814	EUCTR2008-003966-25-DE (EUCTR)	23/12/2008	04/11/2008	Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA	Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA	Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10064016;Term: Nocturnal polyuria MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease	Trade Name: Desmotabs® 0,2 mg Tabletten Product Name: Desmotabs® 0,2mg Tabletten INN or Proposed INN: Desmopressin Acetat	Universität Mainz, Klinik und Poliklinik für Neurologie	NULL	Not Recruiting			Female: no Male: yes	20		Germany
815	EUCTR2006-005186-18-GB (EUCTR)	19/11/2008	27/06/2008	Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease	An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Abbott Healthcare Products B.V.	NULL	Not Recruiting			Female: yes Male: yes	320	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
816	EUCTR2007-006721-27-GB (EUCTR)	11/11/2008	25/02/2009	A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.	A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.	idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: CERE-120 Product Code: CERE-120	Ceregene Inc.	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	United Kingdom
817	EUCTR2007-003051-36-BE (EUCTR)	06/11/2008	21/05/2008	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280		Austria;Sweden;Portugal;Spain;Belgium
818	EUCTR2007-003035-22-GB (EUCTR)	05/11/2008	20/12/2007	A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease - ACP-103-015	Psychosis in Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate Other descriptive name: N/a	ACADIA Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
819	NCT00869791 (ClinicalTrials.gov)	November 2008	24/3/2009	A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa	A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa	Parkinson's Disease	Drug: IPX066;Drug: IR CD-LD	Impax Laboratories, LLC	NULL	Completed	30 Years	N/A	All	27	Phase 2	United States
820	NCT00629161 (ClinicalTrials.gov)	November 2008	25/2/2008	Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease		Parkinson Disease	Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant);Drug: placebo	Fudan University	NULL	Recruiting	50 Years	N/A	Both	144	Phase 2/Phase 3	China
821	EUCTR2007-006721-27-AT (EUCTR)	20/10/2008	15/09/2008	A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.	A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.	idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: CERE-120 Product Code: CERE-120	Ceregene Inc.	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Austria;United Kingdom
822	EUCTR2007-004890-24-PT (EUCTR)	07/10/2008	25/06/2008	A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN	A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN	Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy	Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets Product Code: JP-1730/F01 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets Product Code: JP-1730/F02 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets Product Code: JP-1730/F03 INN or Proposed INN: Fipamezole hydrochloride	Juvantia Pharma Ltd	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Portugal;France
823	EUCTR2008-003869-72-PT (EUCTR)	03/10/2008	25/06/2008	A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR	A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR	Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Code: BIA 9-1067	Bial - Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	12		Portugal
824	EUCTR2007-004235-37-IT (EUCTR)	02/10/2008	28/11/2007	Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND	Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND	Patients with advanced idiopathic PD MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole	BOEHRINGER ING.	NULL	Not Recruiting			Female: yes Male: yes	390		Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
825	EUCTR2007-000350-31-IT (EUCTR)	02/10/2008	11/02/2008	A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND	A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND	mild to moderately severe dementia associated with Parkinson?s disease (PDD) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	550		France;Spain;Italy
826	EUCTR2006-005186-18-DE (EUCTR)	30/09/2008	13/11/2008	Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease	An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Abbott Healthcare Products B.V.	NULL	Not Recruiting			Female: yes Male: yes	320		Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
827	EUCTR2008-003225-16-FI (EUCTR)	10/09/2008	30/05/2008	Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla	Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla	Vaikeahoitoinen Parkinsonin tauti potilailla, joille on aiemmin asetettu aivostimulaattori, tai on päädytty päivittäisten oireiden vuoksi aloittamaan Duodopa-infuusio. MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS	Trade Name: Duodopa	Organisation name was not entered	NULL	Not Recruiting			Female: yes Male: yes			Finland
828	EUCTR2007-003051-36-AT (EUCTR)	10/09/2008	29/04/2008	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280		Portugal;Spain;Austria;Sweden
829	EUCTR2007-003051-36-PT (EUCTR)	05/09/2008	27/05/2008	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280		Portugal;Spain;Austria;Sweden
830	EUCTR2007-003035-22-BE (EUCTR)	02/09/2008	21/05/2008	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2;Phase 3	Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
831	NCT00758849 (ClinicalTrials.gov)	September 2008	24/9/2008	Fipamezole in Neurogenic Orthostatic Hypotension	A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients With Multiple System Atrophy or Parkinson's Disease	Symptomatic Neurogenic Orthostatic Hypotension (NOH);Parkinson's Disease;Multiple System Atrophy	Drug: Placebo;Drug: Fipamezole	Juvantia Pharma Ltd	Santhera Pharmaceuticals	Not yet recruiting	30 Years	80 Years	Both	24	Phase 2	France;Portugal
832	EUCTR2007-004235-37-GB (EUCTR)	19/08/2008	26/11/2007	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim	NULL	Not Recruiting			Female: yes Male: yes	390		Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
833	EUCTR2004-005234-39-DE (EUCTR)	11/08/2008	02/12/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	244		Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden
834	NCT00601978 (ClinicalTrials.gov)	August 2008	11/1/2008	Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off	A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off	Parkinson's Disease	Drug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/Entacapone	Novartis Pharmaceuticals	NULL	Withdrawn	45 Years	75 Years	Both	0	Phase 4	United States
835	EUCTR2004-000148-26-HU (EUCTR)	26/07/2008	19/07/2004	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	Parkinson's Disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol	Schwarz BioSciences Inc.	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Finland;Hungary;Czech Republic;Spain;Italy;Sweden
836	EUCTR2007-003051-36-ES (EUCTR)	01/07/2008	05/05/2008	Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psicosis en la enfermedad de Parkinson.Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280		Portugal;Spain;Austria;Sweden
837	EUCTR2007-002963-28-IT (EUCTR)	30/06/2008	04/01/2008	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: safinamide Product Name: safinamide	MERCK SERONO INTERNATIONAL SA	NULL	Not Recruiting			Female: yes Male: yes	666	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
838	EUCTR2007-003051-36-SE (EUCTR)	30/06/2008	16/05/2008	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280		Portugal;Spain;Austria;Sweden
839	EUCTR2007-003134-42-DE (EUCTR)	19/06/2008	20/02/2008	A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.	A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.	Idiopathic Parkinson’s disease and end-of-dose wearing off. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten Product Name: Stalevo INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONE Trade Name: Nacom 100 Product Name: Nacom INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	20		Germany
840	EUCTR2007-003035-22-SE (EUCTR)	11/06/2008	16/05/2008	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2;Phase 3	Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
841	EUCTR2007-002964-90-HU (EUCTR)	03/06/2008	15/11/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A.-Geneva	NULL	Not Recruiting			Female: yes Male: yes	1121	Phase 3	France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
842	EUCTR2007-004235-37-PL (EUCTR)	29/05/2008	16/04/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	390		Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden
843	EUCTR2007-004009-93-IT (EUCTR)	20/05/2008	14/07/2008	Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram	Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram	Depression, anxiety and ICD MedDRA version: 14.1;Level: SOC;Classification code 10037175;Term: Psychiatric disorders;System Organ Class: 10037175 - Psychiatric disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: CIPRALEX INN or Proposed INN: Escitalopram Trade Name: CIPRALEX INN or Proposed INN: Escitalopram	LUNDBECK ITALIA	NULL	Not Recruiting			Female: yes Male: yes			Italy
844	EUCTR2006-006752-35-DE (EUCTR)	06/05/2008	23/03/2007	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
845	NCT01238926 (ClinicalTrials.gov)	May 2008	9/11/2010	Vitamin B6, B12, Folic Acid and Exercise in Parkinson's Disease	Effects of Vitamin Supplementation and Strength Training in Parkinson's Disease	Parkinson's Disease	Dietary Supplement: PD vitamin supplementation;Other: PD exercise intervention;Other: PD vitamin + exercise	New York Institute of Technology	Stony Brook University	Active, not recruiting	50 Years	80 Years	Both	40	N/A	United States
846	EUCTR2007-004235-37-SE (EUCTR)	23/04/2008	25/03/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim AB	NULL	Not Recruiting			Female: yes Male: yes	390		Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
847	EUCTR2007-004234-16-FI (EUCTR)	16/04/2008	12/02/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Finland Ky	NULL	Not Recruiting			Female: yes Male: yes	520		Hungary;Finland;Czech Republic;Netherlands;France;Austria
848	EUCTR2007-002906-23-BG (EUCTR)	16/04/2008	07/07/2008	A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease	A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280		United Kingdom;France;Bulgaria
849	EUCTR2007-001096-10-SK (EUCTR)	11/04/2008	09/04/2008	An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study	An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study	advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Slovakia
850	NCT00753636 (ClinicalTrials.gov)	April 2008	13/9/2008	Parkinson's Disease Isradipine Safety Study	Phase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage II	Parkinson's Disease	Drug: Dynacirc CR (Isradipine)	Northwestern University	Northwestern Memorial Hospital	Completed	30 Years	75 Years	All	31	Phase 2	United States
851	NCT00651183 (ClinicalTrials.gov)	April 2008	31/3/2008	Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment	Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment	Parkinson Disease	Drug: Pramipexole immediate release	Boehringer Ingelheim	NULL	Completed	18 Years	N/A	All	286		Austria
852	EUCTR2007-001096-10-HU (EUCTR)	27/03/2008	15/02/2008	An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study	An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study	advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	500		Hungary
853	EUCTR2007-001095-36-HU (EUCTR)	27/03/2008	06/02/2008	The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study	The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study	advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	625		Hungary
854	EUCTR2007-005033-11-DE (EUCTR)	27/03/2008	04/01/2008	A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease	A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease	Patients with Parkinson's Disease	Product Name: Levodopa-Carbidopa Multilayer Extended Release Tablet Product Code: Levodopa-Carbidopa XL tablet (M) INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet® CR Product Name: Sinemet CR INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	CombinatoRx, Inc	NULL	Not Recruiting			Female: yes Male: yes			Germany
855	EUCTR2007-002964-90-GB (EUCTR)	20/03/2008	14/01/2009	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A - Geneva	NULL	Not Recruiting			Female: yes Male: yes	605	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
856	EUCTR2007-004235-37-HU (EUCTR)	17/03/2008	17/01/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Czech Republic;Hungary;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden
857	EUCTR2007-004234-16-HU (EUCTR)	17/03/2008	17/01/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	520		Finland;Hungary;Czech Republic;Netherlands;France;Austria
858	EUCTR2006-005186-18-PT (EUCTR)	07/03/2008	14/11/2007	An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”	An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Abbott Healthcare Products B.V.	NULL	Not Recruiting			Female: yes Male: yes	320		Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
859	NCT00642356 (ClinicalTrials.gov)	March 2008	19/3/2008	Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off	An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off	Parkinson's Disease	Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa	Novartis	NULL	Terminated	30 Years	85 Years	All	14	Phase 4	United States
860	NCT00727727 (ClinicalTrials.gov)	March 2008	31/7/2008	SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)	Stabilization on, or Change-Over to the Non-Ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Private Practices.	Parkinson's Disease	Drug: Piribedil	Desitin Arzneimittel GmbH	NULL	Completed	18 Years	N/A	Both	750	N/A	Germany
861	EUCTR2007-003035-22-FR (EUCTR)	29/02/2008	15/02/2008	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	486	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
862	EUCTR2007-002964-90-DE (EUCTR)	28/02/2008	17/12/2008	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	484	Phase 3	France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom
863	EUCTR2007-002964-90-EE (EUCTR)	13/02/2008	02/01/2008	A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
864	EUCTR2007-000350-31-ES (EUCTR)	13/02/2008	21/12/2007	Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP)	Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP)	Demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease	Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine	Novartis Farmacéutica S.A	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	France;Spain;Italy
865	EUCTR2006-005186-18-IT (EUCTR)	08/02/2008	14/11/2007		Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa ? Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations - ND	Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Duodopa gel intestinale INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Solvay Pharmaceuticals BV.	NULL	Not Recruiting			Female: yes Male: yes	250		Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy
866	EUCTR2007-002195-34-FR (EUCTR)	04/02/2008	07/12/2007	Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.	Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.	Fatigue symptoms in Parkinson's disease. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: DEBRUMYL Product Code: DC158AM INN or Proposed INN: Heptaminol hydrochloride INN or Proposed INN: Deanol pyroglutamate	PIERRE FABRE MEDICAMENT	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France
867	NCT00855556 (ClinicalTrials.gov)	February 2008	25/2/2009	Parkinson's Disease Genetics Database	Parkinson's Disease Genetics Database	Parkinson's Disease	Genetic: blood draw	North Shore Long Island Jewish Health System	NULL	Terminated	18 Years	N/A	Both	16	N/A	United States
868	NCT00624741 (ClinicalTrials.gov)	February 2008	15/2/2008	Compassionate Use Study of Pergolide in Patients With Parkinson's Disease	Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease	Parkinson Disease	Drug: Pergolide	Valeant Pharmaceuticals International, Inc.	NULL	No longer available	N/A	N/A	Both		N/A	NULL
869	EUCTR2007-002467-27-GB (EUCTR)	24/01/2008	26/11/2007	Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate	Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate	Patients with idiopathic Parkinson's disease and levodopa-induced dyskinesias MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1;Classification code 10061536;Term: Parkinson's disease;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders	Product Name: Topiramate INN or Proposed INN: TOPIRAMATE	Salford Royal NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
870	EUCTR2007-004235-37-ES (EUCTR)	24/01/2008	08/03/2010	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Hungary;Czech Republic;Slovakia;Poland;Spain;Austria;Italy;United Kingdom;Sweden
871	EUCTR2006-005186-18-ES (EUCTR)	23/01/2008	29/11/2007	Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas	Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severas MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Solvay Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
872	EUCTR2007-000350-31-FR (EUCTR)	22/01/2008	25/10/2007	A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD).	A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD).	Mild to moderately severe dementia associated with Parkinson’s disease (PDD). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease	Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	550		France;Spain;Italy
873	EUCTR2006-006752-35-IT (EUCTR)	21/01/2008	24/04/2007	PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVER	PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVER	Idiopathic Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro Trade Name: Neupro Trade Name: Neupro Trade Name: Neupro	SCHWARZ PHARMA	NULL	Not Recruiting			Female: yes Male: yes	336	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
874	EUCTR2007-004235-37-CZ (EUCTR)	21/01/2008	18/12/2007	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	390		Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden
875	EUCTR2007-004234-16-CZ (EUCTR)	21/01/2008	18/12/2007	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	520		Finland;Hungary;Czech Republic;Netherlands;France;Austria
876	EUCTR2007-002964-90-ES (EUCTR)	18/01/2008	30/11/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	1121	Phase 3	France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom
877	EUCTR2007-002963-28-ES (EUCTR)	17/01/2008	16/11/2007	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	1036	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
878	EUCTR2007-004234-16-SK (EUCTR)	14/01/2008	18/04/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	520	Phase 3	France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands
879	EUCTR2007-004235-37-SK (EUCTR)	14/01/2008	16/04/2008	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden
880	EUCTR2007-004234-16-FR (EUCTR)	11/01/2008	19/11/2007	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	BOEHRINGER INGELHEIM	NULL	Not Recruiting			Female: yes Male: yes	520	Phase 3	France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands
881	NCT00725478 (ClinicalTrials.gov)	January 2008	28/7/2008	SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease	Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices.	Parkinson's Disease	Drug: Piribedil	Desitin Arzneimittel GmbH	NULL	Completed	18 Years	N/A	Both	250	N/A	NULL
882	NCT01628965 (ClinicalTrials.gov)	January 2008	25/6/2012	A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients	An Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa	Parkinson's Disease	Drug: SPM 962	Otsuka Pharmaceutical Co., Ltd.	NULL	Completed	N/A	N/A	All	143	Phase 2/Phase 3	Japan
883	NCT00623103 (ClinicalTrials.gov)	January 2008	14/2/2008	Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)	A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)	Parkinson's Disease Dementia	Drug: Rivastigmine capsule;Drug: Rivastigmine transdermal patch	Novartis	NULL	Completed	50 Years	85 Years	All	583	Phase 3	United States;Argentina;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Turkey;United Kingdom
884	NCT00608231 (ClinicalTrials.gov)	January 2008	7/1/2008	Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation	Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation	Parkinson's Disease;Essential Tremor;Dystonia	Drug: Dexmedetomidine Hydrochloride Infusion;Drug: Normal Saline	Vanderbilt University	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 2/Phase 3	United States
885	EUCTR2006-003732-30-IT (EUCTR)	31/12/2007	13/02/2008	Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I	Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I	Diagnosys of Early-stage idiopathic Parkinson's Disease for longest 1 year MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: lisuride TTS INN or Proposed INN: Lisuride Trade Name: mirapexin INN or Proposed INN: Pramipexole	NEUROBIOTEC GMBH	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;Italy;Poland
886	EUCTR2007-000801-30-HU (EUCTR)	20/12/2007	15/11/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
887	EUCTR2007-004654-81-GB (EUCTR)	20/12/2007	16/10/2007	A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients	A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients	Sialorrhoea associated with Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10059812;Term: Sialorrhoea	Trade Name: Catapres ampoules INN or Proposed INN: Clonidine hydrochloride Trade Name: Ditropan elixir INN or Proposed INN: Oxybutynin hydrochloride	Summit (Cambridge) Ltd.	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	United Kingdom
888	EUCTR2006-006907-35-IT (EUCTR)	19/12/2007	20/04/2007	A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER	A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER	Patient with Idiopathic Parkinson Diesease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: rotigotine INN or Proposed INN: rotigotine	SCHWARZ PHARMA	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
889	EUCTR2004-000185-12-GB (EUCTR)	13/12/2007	11/02/2005	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	740	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Finland;Austria;Italy;United Kingdom;Sweden
890	EUCTR2007-002963-28-FI (EUCTR)	12/12/2007	18/10/2007	A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany
891	EUCTR2007-002964-90-NL (EUCTR)	11/12/2007	11/12/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	1121	Phase 3	France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
892	EUCTR2007-002964-90-SK (EUCTR)	06/12/2007	16/04/2008	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 3	France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
893	EUCTR2007-002963-28-SK (EUCTR)	06/12/2007	16/04/2008	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
894	EUCTR2007-002964-90-FI (EUCTR)	04/12/2007	18/10/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	1121	Phase 3	Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
895	EUCTR2007-000801-30-ES (EUCTR)	29/11/2007	12/09/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras	Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726	Phase 3	France;Hungary;Estonia;Czech Republic;Poland;Spain;Lithuania;Latvia;Italy
896	EUCTR2007-004985-41-SE (EUCTR)	29/11/2007	10/10/2007	Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia study	Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia study	Parkinson's disease, G20.9. Different dyskinesias related to advanced Parkinson's disease will be investigated.	Trade Name: Duodopa INN or Proposed INN: levodopa INN or Proposed INN: carbidopa	Department of Neuroscience, neurology	NULL	Not Recruiting			Female: yes Male: yes			Sweden
897	NCT00537017 (ClinicalTrials.gov)	November 23, 2007	27/9/2007	Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)	A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)	Parkinson Disease;Neurodegenerative Diseases;Central Nervous System Diseases;Movement Disorders;Brain Diseases	Drug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatments	Merck Sharp & Dohme Corp.	NULL	Completed	30 Years	N/A	All	140	Phase 2	Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States
898	EUCTR2006-005186-18-FI (EUCTR)	16/11/2007	04/10/2007	Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations	Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Solvay Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	250		Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
899	EUCTR2007-002906-23-GB (EUCTR)	14/11/2007	15/08/2007	A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease	A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280		United Kingdom;Bulgaria;France
900	EUCTR2007-002496-14-FI (EUCTR)	05/11/2007	14/09/2007	Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study.	Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study.	Parkinson’s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Stalevo® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Product Name: 11C-Raclopride Other descriptive name: 11C-Raclopride	Orion Corporation Orion Pharma	NULL	Not Recruiting			Female: yes Male: yes			Finland
901	NCT00584090 (ClinicalTrials.gov)	November 2007	21/12/2007	Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease		Urinary Incontinence;Parkinson's Disease	Drug: Solifenacin Succinate (VESIcare);Drug: Placebo	University of South Florida	NULL	Withdrawn	30 Years	80 Years	Both	0	Phase 4	United States
902	NCT00610103 (ClinicalTrials.gov)	November 2007	22/1/2008	Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa Therapy	A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's Disease	Parkinson's Disease	Drug: apomorphine hydrochloride	Kyowa Kirin Co., Ltd.	NULL	Completed	20 Years	N/A	All	16	Phase 2	Japan
903	NCT00558337 (ClinicalTrials.gov)	November 2007	12/11/2007	Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease	An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients	Parkinson's Disease	Drug: levodopa-carbidopa	Osmotica Pharmaceutical Corp.	NULL	Completed	30 Years	80 Years	Both	78	Phase 2	Argentina
904	NCT00632762 (ClinicalTrials.gov)	November 2007	20/2/2008	Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)	Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.	Parkinson's Disease	Drug: mantadix	University Hospital, Toulouse	NULL	Completed	30 Years	80 Years	Both	80	Phase 4	France
905	NCT00560508 (ClinicalTrials.gov)	November 2007	16/11/2007	A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period	A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER	Parkinson Disease	Drug: Pramipexole Immediate Release;Drug: Pramipexole Extended Release	Boehringer Ingelheim	NULL	Completed	1 Year	N/A	All	112	Phase 2/Phase 3	Japan
906	NCT00605683 (ClinicalTrials.gov)	November 2007	19/12/2007	MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist	A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist	Idiopathic Parkinson's Disease	Drug: Safinamide (as add-on therapy)	Newron	NULL	Completed	30 Years	80 Years	Both	679	Phase 3	United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;Germany;India;Italy;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Spain;Israel
907	EUCTR2007-004234-16-NL (EUCTR)	29/10/2007	17/10/2007	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).	Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim bv	NULL	Not Recruiting			Female: yes Male: yes	520		Finland;Hungary;Czech Republic;Netherlands;France;Austria
908	EUCTR2007-001717-42-FR (EUCTR)	25/10/2007	11/09/2007	A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A	A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A	Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias	Product Name: SCH 420814 Product Code: N/A	Schering Plough Research Institute	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	France;Spain
909	EUCTR2007-002906-23-FR (EUCTR)	25/10/2007	21/08/2007	A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease	A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease	Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2;Phase 3	France;Bulgaria;United Kingdom
910	EUCTR2007-003353-90-NL (EUCTR)	23/10/2007	07/08/2007	A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.	A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.	Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim	NULL	Not Recruiting			Female: yes Male: yes	145	Phase 3	France;Germany;Netherlands
911	EUCTR2007-000801-30-FR (EUCTR)	22/10/2007	23/07/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726	Phase 3	France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy
912	EUCTR2007-003353-90-FR (EUCTR)	17/10/2007	27/08/2007	A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.	A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.	Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	BOEHRINGER INGELHEIM	NULL	Not Recruiting			Female: yes Male: yes	145	Phase 3	France;Germany;Netherlands
913	EUCTR2006-006907-35-GB (EUCTR)	09/10/2007	26/04/2007	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH, UCB Group	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom
914	EUCTR2005-005791-32-SE (EUCTR)	04/10/2007	30/07/2007	Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.	Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.	HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes)	Product Name: HF0220 Product Code: HF0220 Other descriptive name: 7-beta-hydroxyepiandrosterone	Hunter-Fleming Ltd	NULL	Not Recruiting			Female: yes Male: yes	40		United Kingdom;Sweden
915	EUCTR2007-002900-16-DE (EUCTR)	01/10/2007	21/08/2007	A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa	A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa	The main objective of this study is to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias.	Product Code: AFQ056 Product Code: AFQ056	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	34		Germany
916	NCT00547911 (ClinicalTrials.gov)	October 2007	19/10/2007	Augmenting Effects of L-DOPS With Carbidopa and Entacapone	L-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and Entacapone	Parkinson Disease;Multiple System Atrophy;Autonomic Nervous System Diseases	Drug: Droxidopa;Drug: Carbidopa;Drug: Entacapone	National Institute of Neurological Disorders and Stroke (NINDS)	NULL	Terminated	18 Years	N/A	All	14	Phase 1/Phase 2	United States
917	NCT00582673 (ClinicalTrials.gov)	October 2007	21/12/2007	Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa	A Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopa	Parkinson's Disease	Drug: AFQ056;Drug: Placebo	Novartis	NULL	Completed	30 Years	85 Years	Both	31	Phase 2	Germany
918	EUCTR2006-002937-20-HU (EUCTR)	20/09/2007	17/05/2007	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
919	EUCTR2007-002899-34-GB (EUCTR)	18/09/2007	26/06/2007	Pilot Controlled Clinical Trial of Salvia Officinalis (Sage) for cognitive impairments in Parkinson's Disease	Pilot Controlled Clinical Trial of Salvia Officinalis (Sage) for cognitive impairments in Parkinson's Disease	Cognitive impairment in Parkinson's Disease	Product Name: Sage leaf	Newcastle Upon tyne Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
920	EUCTR2007-002874-75-IT (EUCTR)	10/09/2007	14/01/2008	Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005	Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005	Psycosis associated to Parkinson's Disease MedDRA version: 9.1;Level: HLT;Classification code 10027361;Term: Mental disorders due to a general medical condition NEC	Product Name: Melperon	OVATION PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	90		Italy
921	EUCTR2007-000801-30-LT (EUCTR)	07/09/2007	05/07/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
922	EUCTR2007-003353-90-DE (EUCTR)	05/09/2007	08/08/2007	A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.	A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.	Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Pramipexole Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	132		Germany;Netherlands;France
923	NCT00537485 (ClinicalTrials.gov)	September 2007	27/9/2007	A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients	A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa	Early Parkinson's Disease	Drug: SPM 962;Drug: placebo	Otsuka Pharmaceutical Co., Ltd.	NULL	Completed	30 Years	79 Years	All	180	Phase 2/Phase 3	Japan
924	NCT00524914 (ClinicalTrials.gov)	September 2007	4/9/2007	Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study	Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.	Parkinson's Disease	Drug: apomorphine;Drug: placebo	University Hospital, Toulouse	NULL	Completed	30 Years	70 Years	Both	16	N/A	France
925	EUCTR2007-000801-30-PL (EUCTR)	29/08/2007	17/07/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726	Phase 3	Spain;Poland;Lithuania;Latvia;Italy;France;Hungary;Estonia;Czech Republic
926	EUCTR2007-003512-57-FR (EUCTR)	24/08/2007	23/07/2007	Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD)	Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD)	Excessive daytime sleepiness associated to Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10041014;Term: Sleepiness MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease	Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649	Bioprojet	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	France
927	EUCTR2007-000801-30-EE (EUCTR)	22/08/2007	17/07/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
928	EUCTR2006-000859-18-DE (EUCTR)	13/08/2007	05/04/2007	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	Parkinson's Disease Early stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	225		Portugal;Czech Republic;Germany;Netherlands;Estonia;Italy;Lithuania
929	EUCTR2007-000074-23-HU (EUCTR)	10/08/2007	01/06/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 1	Hungary;United Kingdom;Spain;Italy;Austria;Sweden
930	EUCTR2007-000801-30-CZ (EUCTR)	01/08/2007	15/06/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
931	EUCTR2007-000801-30-LV (EUCTR)	27/07/2007	05/07/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
932	EUCTR2006-006752-35-GB (EUCTR)	23/07/2007	13/01/2009	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH, UCB Group	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom
933	EUCTR2007-000801-30-IT (EUCTR)	17/07/2007	13/11/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND	Parkinson's Disease Subjects with Motor Fluctuations MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: E2007	EISAI LTD UK	NULL	Not Recruiting			Female: yes Male: yes	726	Phase 3	France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy
934	NCT00519532 (ClinicalTrials.gov)	July 2007	21/8/2007	Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease	A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease	Parkinson's Disease	Drug: Rotigotine	UCB Pharma	NULL	Terminated	18 Years	N/A	All	84	Phase 3	United States;Australia;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Austria
935	EUCTR2006-006752-35-HU (EUCTR)	22/06/2007	12/04/2007	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
936	EUCTR2006-000678-57-CZ (EUCTR)	18/06/2007	02/08/2006	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	330		Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
937	EUCTR2007-000073-39-CZ (EUCTR)	18/06/2007	18/04/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 1	Hungary;Finland;Czech Republic;Austria
938	EUCTR2007-000074-23-CZ (EUCTR)	18/06/2007	31/05/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 3	Hungary;Czech Republic;Spain;Austria;Italy;United Kingdom;Sweden
939	EUCTR2007-000073-39-SK (EUCTR)	14/06/2007	09/04/2008	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Slovakia;Finland;Austria;Germany
940	EUCTR2007-000073-39-HU (EUCTR)	14/06/2007	31/05/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 1	Finland;Hungary;Czech Republic;Austria
941	EUCTR2007-000074-23-SK (EUCTR)	14/06/2007	09/04/2008	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 3	Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden
942	EUCTR2006-005438-19-DE (EUCTR)	12/06/2007	28/03/2007	An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS	An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS	idiopathic Parkinson´s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch INN or Proposed INN: Rotigotine	SCHWARZ PHARMA Deutschland GmbH	NULL	Not Recruiting			Female: yes Male: yes	30		Germany
943	EUCTR2006-005861-21-IT (EUCTR)	11/06/2007	05/01/2007	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC.	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC.	Patients with idiopathic Parkinson's disease with motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors	NEWRON PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Italy
944	EUCTR2006-000858-45-SE (EUCTR)	05/06/2007	04/04/2007	An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study	An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study	Parkinson's Disease Early Stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;Sweden
945	JPRN-UMIN000000780	2007/06/01	01/08/2007	A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease	A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease - The usefulness of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease	Parkinson's disease	An observation period (2 to 3 weeks) An administration of amantadine hydrochloride (27 days) A wash out period (15 days) An administration of placebo (27 days) An observation period (2 to 3 weeks) An administration of placebo (27 days) A wash out period (15 days) An administration of amantadine hydrochloride (27 days)	Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disorders	Musashi Hospital, National Center of Neurology and Psychiatry, JapanEhime University Hospital	Complete: follow-up complete	20years-old	75years-old	Male and Female	60	Not applicable	Japan
946	EUCTR2007-000074-23-AT (EUCTR)	30/05/2007	05/06/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 1	Hungary;United Kingdom;Spain;Italy;Austria;Sweden
947	EUCTR2007-000073-39-AT (EUCTR)	30/05/2007	05/06/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet	Boehringer Ingelheim Pharma Ges mbH	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 1	Hungary;Finland;Czech Republic;Austria
948	EUCTR2007-000074-23-ES (EUCTR)	29/05/2007	02/03/2010	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+.	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+.	Pacientes varones o mujeres, diagnosticados de enfermedad de Parkinson idiopática, al menos dos años antes, con 30 años o más de edad en el momento del diagnóstico, con un estadío entre 2 y 4 en la escala modificada de Hoehn y Yahr en el periodo on.Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 3	Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden
949	EUCTR2007-000073-39-DE (EUCTR)	29/05/2007	26/02/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 1	Hungary;Czech Republic;Finland;Austria;Germany
950	EUCTR2006-006752-35-ES (EUCTR)	27/05/2007	27/03/2007	RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover	RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover	Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
951	EUCTR2006-006907-35-ES (EUCTR)	27/05/2007	27/03/2007	EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER	EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER	Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
952	EUCTR2006-006907-35-HU (EUCTR)	17/05/2007	12/04/2007	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	Finland;Hungary;United Kingdom;Germany;Spain;Italy;Austria
953	EUCTR2007-000074-23-IT (EUCTR)	17/05/2007	06/04/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND	Patients with advanced idiopathic Parkinson s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Trade Name: Sifrol Trade Name: Sifrol	BOEHRINGER ING.	NULL	Not Recruiting			Female: yes Male: yes	645	Phase 1	Hungary;United Kingdom;Spain;Italy;Austria;Sweden
954	EUCTR2007-000074-23-GB (EUCTR)	11/05/2007	29/03/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 1	Hungary;United Kingdom;Spain;Italy;Austria;Sweden
955	EUCTR2006-006907-35-FI (EUCTR)	09/05/2007	21/03/2007	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
956	EUCTR2006-006752-35-FI (EUCTR)	09/05/2007	21/03/2007	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
957	EUCTR2007-000074-23-SE (EUCTR)	02/05/2007	02/04/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole	Boehringer Ingelheim AB	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 1	Hungary;United Kingdom;Spain;Italy;Austria;Sweden
958	NCT00474058 (ClinicalTrials.gov)	May 2007	14/5/2007	Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine	Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease	Parkinson's Disease	Drug: Rotigotine;Other: Placebo	UCB Pharma	NULL	Completed	18 Years	N/A	All	287	Phase 3	United States;Australia;Austria;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom
959	EUCTR2006-002339-26-PT (EUCTR)	27/04/2007	07/03/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Hungary;Portugal;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
960	EUCTR2006-002937-20-ES (EUCTR)	27/04/2007	26/04/2007	Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras	Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras	Enfermedad de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
961	EUCTR2006-000577-29-DE (EUCTR)	27/04/2007	12/10/2006	Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects	A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue toExperience Persistent Motor Fluctuations	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate Trade Name: Sinemet®25-100 INN or Proposed INN: Levodopa Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate	Abbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories)	NULL	Not Recruiting			Female: yes Male: yes	31		United States;Germany
962	EUCTR2007-000073-39-FI (EUCTR)	25/04/2007	06/03/2007	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)	Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet	Boehringer Ingelheim Finland Ky	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 1	Hungary;Finland;Czech Republic;Austria
963	EUCTR2007-000307-15-IT (EUCTR)	24/04/2007	23/08/2007	Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease.	Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease.	Psicosi associata al morbo di Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Melperon INN or Proposed INN: melperon	OVATION PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	90		Italy
964	EUCTR2006-002339-26-ES (EUCTR)	19/04/2007	30/01/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras.	Levodopa treated Parkinson's disease patients with motor fluctuations.Pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
965	EUCTR2006-006752-35-AT (EUCTR)	17/04/2007	21/05/2007	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover	RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
966	EUCTR2006-006907-35-AT (EUCTR)	17/04/2007	21/05/2007	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
967	EUCTR2006-002339-26-DE (EUCTR)	10/04/2007	22/12/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;United Kingdom;Czech Republic;Germany;Estonia;Spain;Italy;Austria;Sweden;Lithuania
968	NCT00623363 (ClinicalTrials.gov)	April 2007	2/1/2008	Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease		Parkinson's Disease	Drug: piclozotan;Drug: 0.9% sodium chloride (normal saline)	Asubio Pharmaceuticals, Inc.	NULL	Completed	40 Years	85 Years	Both	27	Phase 2	United States;Guatemala;Romania
969	EUCTR2006-006209-94-DE (EUCTR)	15/03/2007	26/01/2007	An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets.	An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets.	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Product Name: Ropinirole Product Code: SK&F101468 INN or Proposed INN: Ropinirole	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	36		Germany
970	EUCTR2006-002937-20-FR (EUCTR)	12/03/2007	12/02/2007	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702	Phase 3	France;Hungary;Czech Republic;Estonia;Spain;Lithuania;Latvia;Italy
971	EUCTR2005-002038-36-GR (EUCTR)	27/02/2007	09/10/2006	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	Patients with Parkinson’s disease dementia or dementia with Lewy Bodies MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease	Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE	H. Lundbeck A/S	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;Greece;Spain;Austria;Germany;Italy;United Kingdom
972	EUCTR2006-005714-12-IT (EUCTR)	27/02/2007	03/08/2007	A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213	A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213	Patients with idiopathic Parkinson's disease who respond to levodopa treatment but who experience peak-effect levodopa-induced dyskinesia and end-of-dose 'wearing-off' motor fluctuations MedDRA version: 6.1;Level: HLT;Classification code 10034005	Product Name: E2007 Product Code: E2007 INN or Proposed INN: OTHER NERVOUS SYSTEM DRUGS Trade Name: SINEMET INN or Proposed INN: levodopa-carbidopa	EISAI LTD UK	NULL	Not Recruiting			Female: yes Male: yes	24		Italy
973	EUCTR2006-005183-91-LT (EUCTR)	14/02/2007	20/12/2006	An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study	An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study	Advanced stage Parkinson's disease with motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	220		Latvia;Lithuania
974	EUCTR2006-005182-20-LT (EUCTR)	13/02/2007	20/12/2006	A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study	A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study	Advanced stage Parkinson's disease with motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS	Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	280		Latvia;Lithuania
975	EUCTR2006-005183-91-LV (EUCTR)	02/02/2007	11/01/2007	An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study	An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study	Advanced stage Parkinson's disease with motor fluctuations.	Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	140		Latvia;Lithuania
976	EUCTR2006-005182-20-LV (EUCTR)	02/02/2007	28/12/2006	A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study	A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study	Advanced stage Parkinson's disease with motor fluctuations.	Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	280		Latvia;Lithuania
977	EUCTR2006-000859-18-NL (EUCTR)	25/01/2007	05/04/2007	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	Parkinson's Disease Early stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	247		Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
978	EUCTR2006-002339-26-HU (EUCTR)	24/01/2007	24/08/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
979	EUCTR2006-000678-57-FR (EUCTR)	09/01/2007	10/10/2006	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;France;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom
980	EUCTR2006-000859-18-PT (EUCTR)	04/01/2007	18/09/2006	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	Parkinson's Disease Early stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	225		Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
981	NCT00465452 (ClinicalTrials.gov)	January 2007	24/4/2007	Impact of Switching to Continuous Release Dopamine Agonists	The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects	Parkinson Disease	Drug: Continuous Release Dopamine Agonists	University of Toledo Health Science Campus	NULL	Completed	55 Years	N/A	Both	15	Phase 3	United States
982	EUCTR2006-000678-57-PT (EUCTR)	29/12/2006	10/08/2006	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	330		Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
983	EUCTR2005-002654-21-NO (EUCTR)	28/12/2006	06/11/2006	A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE	A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE	Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.	Trade Name: Duodopa intestinalgel INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Solvay Pharmaceuticals GmbH	NULL	Not Recruiting			Female: yes Male: yes	75		Norway;Sweden
984	EUCTR2006-002339-26-GB (EUCTR)	28/12/2006	16/10/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Spain;Italy;Austria;Sweden;Lithuania
985	EUCTR2006-000678-57-DE (EUCTR)	22/12/2006	06/10/2006	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	376		Portugal;United Kingdom;Czech Republic;Germany;Netherlands;France;Estonia;Italy;Lithuania
986	EUCTR2006-005509-79-GB (EUCTR)	21/12/2006	07/12/2006	A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease	A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease	Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor off” periods	Product Name: apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride	Vectura Group plc	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	United Kingdom
987	EUCTR2006-003490-27-GB (EUCTR)	19/12/2006	29/09/2006	A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa	A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa	Parkinson's disease MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease	Product Code: BIIB014 Product Code: BIIB014 Product Code: BIIB014	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	137	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
988	EUCTR2006-005860-14-IT (EUCTR)	19/12/2006	17/03/2009	A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND	A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND	PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	NEWRON PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Italy
989	EUCTR2005-000314-12-DE (EUCTR)	19/12/2006	25/01/2007	Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI	Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI	Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006	Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil	Institut de Recherches Internationales Servier	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Spain;Germany
990	EUCTR2006-000858-45-FI (EUCTR)	18/12/2006	26/06/2006	An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study	An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study	Parkinson's Disease Early Stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;Sweden
991	EUCTR2006-002339-26-IT (EUCTR)	16/12/2006	05/06/2007	Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303	Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303	Levodopa treated Parkinson's Disease Patients with Motor Fluctuations MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: E2007	EISAI LTD UK	NULL	Not Recruiting			Female: yes Male: yes	1400	Phase 3	Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;United Kingdom;Italy;Sweden
992	EUCTR2006-002937-20-CZ (EUCTR)	14/12/2006	24/10/2006	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
993	EUCTR2006-002937-20-EE (EUCTR)	11/12/2006	19/10/2006	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
994	EUCTR2006-005140-89-NL (EUCTR)	11/12/2006	01/12/2006	A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study	A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study	This postmarketing Phase I study is performed in healthy volunteers. The IMP rasagiline 1mg is indicated for the treatment of Parkinson's Disease (PD). MedDRA version: 9.1;Level: PT;Classification code 10061536	Trade Name: Selegiline HCl 5 PCH Trade Name: Nardil Product Name: Rasagiline 1mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate Product Name: Rasagiline 2 mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate	TEVA Pharmaceuticals Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Netherlands
995	EUCTR2006-002937-20-LT (EUCTR)	04/12/2006	02/11/2006	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
996	EUCTR2005-002038-36-FR (EUCTR)	01/12/2006	24/08/2010	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	Patients with Parkinson’s disease dementia or dementia with Lewy Bodies	Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE	H. Lundbeck A/S	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;Greece;Spain;Austria;Germany;Italy;United Kingdom
997	NCT00853879 (ClinicalTrials.gov)	December 2006	26/2/2009	An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease	An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease	Parkinson's Disease	Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12;Dietary Supplement: B6, B12, L-methylfolate;Dietary Supplement: B6, B12, Placebo	North Shore Long Island Jewish Health System	NULL	Terminated	30 Years	N/A	Both	150	N/A	United States
998	EUCTR2005-002038-36-DE (EUCTR)	29/11/2006	19/01/2007	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	Patients with Parkinson’s disease dementia or dementia with Lewy Bodies	Trade Name: Ebixa Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE	H. Lundbeck A/S	NULL	Not Recruiting			Female: yes Male: yes	200		United Kingdom;Germany;France;Spain;Italy;Greece;Austria
999	EUCTR2006-001755-36-GB (EUCTR)	20/11/2006	29/09/2006	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone	Orion Corporation Orion Pharma	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Germany;United Kingdom;Sweden
1000	NCT00406029 (ClinicalTrials.gov)	November 20, 2006	30/11/2006	Dyskinesia in Parkinson's Disease (Study P04501)	A Phase 2, 12-Week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias	Parkinson Disease;Movement Disorders;Central Nervous System Diseases;Neurodegenerative Diseases;Brain Diseases	Drug: Preladenant;Drug: Placebo;Drug: L-dopa;Drug: Other Parkinson's Disease treatments	Merck Sharp & Dohme Corp.	NULL	Completed	30 Years	N/A	All	253	Phase 2	Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Italy;New Zealand;Peru;Singapore;South Africa;Spain;United States
1001	EUCTR2006-004112-51-IT (EUCTR)	14/11/2006	04/12/2006	A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND	A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND	Parkinson s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: SIRIO*30CPR EFF 25MG+100MG INN or Proposed INN: Melevodopa and decarboxylase inhibitor Trade Name: SINEMET*50CPR 100MG+25MG INN or Proposed INN: LEVODOPA DC.IT FU INN or Proposed INN: CARBIDOPA FU	VERNALIS DEVELOPMENT LIMITED	NULL	Not Recruiting			Female: yes Male: yes			Italy
1002	EUCTR2006-000678-57-GB (EUCTR)	14/11/2006	30/05/2007	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydro	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	330	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Portugal;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom
1003	EUCTR2006-001793-24-PT (EUCTR)	07/11/2006	31/07/2006	A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available	A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available	Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536	Product Name: Nebicapone Product Code: BIA 3-202 Trade Name: COMTAN® Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202	BIAL - Portela & Cª, SA	NULL	Not Recruiting			Female: yes Male: yes	250		Portugal;Austria
1004	EUCTR2006-000678-57-LT (EUCTR)	07/11/2006	07/09/2006	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	330		Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1005	EUCTR2006-000859-18-LT (EUCTR)	07/11/2006	07/09/2006	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	Parkinson's Disease Early stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	225		Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
1006	EUCTR2006-000678-57-EE (EUCTR)	03/11/2006	01/09/2006	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	330		Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1007	EUCTR2006-000859-18-EE (EUCTR)	03/11/2006	01/09/2006	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	Parkinson's Disease Early stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	225		Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
1008	EUCTR2006-004582-33-GB (EUCTR)	03/11/2006	23/01/2012	A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease	A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease	Hypomobility (off or freezing) episodes associated with advanced Parkinson's disease	Product Name: Apomorphine hydrochloride Product Code: VR040	Vectura Group plc	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	United Kingdom
1009	EUCTR2006-002937-20-LV (EUCTR)	01/11/2006	02/11/2006	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
1010	EUCTR2006-002339-26-CZ (EUCTR)	01/11/2006	21/08/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1011	NCT00397228 (ClinicalTrials.gov)	November 2006	6/11/2006	ALTROPANE® SPECT Imaging in Patients With Parkinson Disease	Optimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson Disease	Parkinson Disease	Drug: ALTROPANE®	Molecular NeuroImaging	Institute for Neurodegenerative Disorders	Completed	30 Years	N/A	Both	27	Phase 2	United States
1012	NCT00387075 (ClinicalTrials.gov)	November 2006	10/10/2006	A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease	Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease	Parkinson Disease	Procedure: [123I]ß-CIT and SPECT imaging;Drug: [123I]ß-CIT	Institute for Neurodegenerative Disorders	United States Department of Defense;Molecular NeuroImaging	Active, not recruiting	50 Years	N/A	All	3000	Phase 2	United States
1013	NCT00335166 (ClinicalTrials.gov)	November 2006	8/6/2006	SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease	A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.	Early Stage Parkinson Disease	Drug: Pardaprunox;Drug: pramipexole;Drug: Placebo Comparator	Solvay Pharmaceuticals	NULL	Completed	30 Years	N/A	Both	330	Phase 3	United States;Australia;Czech Republic;Estonia;France;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom
1014	NCT00491998 (ClinicalTrials.gov)	November 2006	26/6/2007	PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets	Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets	Parkinson's Disease	Drug: V1512;Drug: V1512 and Entacapone	Vernalis (R&D) Ltd	Cita NeuroPharmaceuticals;INC Research	Completed	30 Years	N/A	Both	27	Phase 1/Phase 2	Italy
1015	NCT00360308 (ClinicalTrials.gov)	November 2006	2/8/2006	Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations	Parkinson's Disease	Drug: Placebo;Drug: E2007	Eisai Limited	NULL	Terminated	30 Years	N/A	All	723	Phase 3	France
1016	NCT00400634 (ClinicalTrials.gov)	November 2006	15/11/2006	Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease	Multicenter, Randomized, Double-Blind, Sham Surgery-Controlled Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) to Assess the Efficacy and Safety of Bilateral Intraputaminal (IPu) Delivery in Subjects With Idiopathic Parkinson's Disease	Idiopathic Parkinson's Disease	Drug: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]);Procedure: Sham Surgery	Sangamo Therapeutics	Ceregene	Completed	35 Years	75 Years	All	58	Phase 2	United States
1017	NCT00468078 (ClinicalTrials.gov)	November 2006	30/4/2007	Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients	The Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor Patients	Parkinson's Disease	Procedure: PET/CT;Drug: F-18 FPCIT	Asan Medical Center	NULL	Completed	40 Years	N/A	Both	78	Phase 3	Korea, Republic of
1018	NCT00397696 (ClinicalTrials.gov)	November 2006	7/11/2006	Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease	Evaluation of 5-[123I]-A-85380 and SPECT Imaging as a Marker of Nicotinic Receptor Density in the Brain of Parkinson Disease Subjects	Parkinson Disease	Drug: [123I] 5-IA	Institute for Neurodegenerative Disorders	Department of Defense	Completed	21 Years	N/A	Both	9	Phase 2	United States
1019	NCT00402233 (ClinicalTrials.gov)	November 2006	19/11/2006	A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients	A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID)	Parkinson Disease	Drug: Pramipexole;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	31 Years	N/A	All	312	Phase 4	United States
1020	EUCTR2005-002038-36-GB (EUCTR)	31/10/2006	09/10/2006	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	Patients with Parkinson’s disease dementia or dementia with Lewy Bodies MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease	Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Code: Lu 00-800 INN or Proposed INN: memantine hydrochloride	H. Lundbeck A/S	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Greece;Spain;Austria;Germany;Italy;United Kingdom
1021	EUCTR2006-002339-26-EE (EUCTR)	20/10/2006	15/08/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1022	EUCTR2006-002339-26-SE (EUCTR)	19/10/2006	22/09/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Lithuania;Sweden
1023	EUCTR2006-002339-26-BE (EUCTR)	16/10/2006	24/08/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1024	EUCTR2006-000858-45-SK (EUCTR)	11/10/2006	28/09/2006	An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study	An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study	Parkinson's Disease Early Stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochlo	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Slovakia;Finland;Sweden
1025	EUCTR2006-002339-26-LT (EUCTR)	05/10/2006	07/08/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1026	NCT00391898 (ClinicalTrials.gov)	October 2006	24/10/2006	Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off	A 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With Levodopa	Parkinson's Disease	Drug: Levodopa/carbidopa/entacapone;Drug: Levodopa/carbidopa	Novartis	NULL	Completed	30 Years	80 Years	All	95	Phase 4	Spain
1027	NCT00399477 (ClinicalTrials.gov)	October 2006	10/11/2006	A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease	Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)	Parkinson's Disease	Drug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with Requip	Teva Neuroscience, Inc.	NULL	Completed	30 Years	N/A	Both	200	Phase 4	United States
1028	EUCTR2006-002339-26-AT (EUCTR)	25/09/2006	18/10/2006	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.	Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1029	EUCTR2005-002038-36-AT (EUCTR)	22/09/2006	09/10/2006	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies	Patients with Parkinson’s disease dementia or dementia with Lewy Bodies	Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE	H. Lundbeck A/S	NULL	Not Recruiting			Female: yes Male: yes	200		Germany;United Kingdom;France;Spain;Italy;Greece;Austria
1030	EUCTR2005-005146-39-IT (EUCTR)	14/09/2006	06/12/2006	A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND	A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND	Moderate to severe Parkinson s disease with motor fluctuation and dyskinesias. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Code: SCH 420814 Product Code: SCH 420814	Schering Plough Research Institute	NULL	Not Recruiting			Female: yes Male: yes	160		Italy
1031	EUCTR2006-000678-57-IT (EUCTR)	14/09/2006	26/06/2007	A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND	A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND	Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: Pramipexole INN or Proposed INN: Pramipexole Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308	SOLVAY PHARMACEUTICALS B.V.	NULL	Not Recruiting			Female: yes Male: yes	390		Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1032	EUCTR2006-000859-18-CZ (EUCTR)	11/09/2006	02/08/2006	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study	Parkinson's Disease Early stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	225		Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
1033	EUCTR2004-005234-39-LV (EUCTR)	06/09/2006	29/09/2006	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	244		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1034	EUCTR2005-001006-12-CZ (EUCTR)	06/09/2006	24/08/2006	Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO	Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO	Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated	Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- erg	Axxonis Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2;Phase 3	Czech Republic;Austria;Germany;Italy
1035	EUCTR2005-004949-34-SE (EUCTR)	06/09/2006	27/03/2006	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536	Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim AB	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 4	Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1036	EUCTR2005-005423-34-HU (EUCTR)	04/09/2006	05/07/2006	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	516		Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
1037	NCT00462007 (ClinicalTrials.gov)	September 2006	17/4/2007	Study to Evaluate Initiation of Stalevo in Early Wearing-off	Efficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease Patients	Parkinson's Disease	Drug: Stalevo	Orion Corporation, Orion Pharma	NULL	Completed	35 Years	N/A	Both	115	Phase 4	Germany;Sweden;United Kingdom
1038	EUCTR2005-006033-32-SE (EUCTR)	15/08/2006	22/06/2006	A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study	A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study	Parkinson's Disease Early Stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	440		Finland;Slovakia;Sweden
1039	EUCTR2006-001755-36-SE (EUCTR)	09/08/2006	30/06/2006	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone	Orion Corporation Orion Pharma, FI-02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	100		United Kingdom;Germany;Sweden
1040	EUCTR2005-004314-33-PT (EUCTR)	09/08/2006	10/05/2006	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Hungary;Portugal;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1041	EUCTR2005-004949-34-DE (EUCTR)	04/08/2006	30/03/2006	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536	Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: SIFROL Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1042	EUCTR2006-000678-57-NL (EUCTR)	03/08/2006	04/04/2007	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study	Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori	Solvay pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	330		Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1043	EUCTR2006-001793-24-AT (EUCTR)	31/07/2006	24/07/2006	A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available	A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available	Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536	Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202	BIAL - Portela & Cª, SA	NULL	Not Recruiting			Female: yes Male: yes	250		Portugal;Austria
1044	EUCTR2006-000391-32-NL (EUCTR)	18/07/2006	10/05/2006	A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease	A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease	Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate	Britannia Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3	Germany;Netherlands;United Kingdom
1045	EUCTR2006-003717-41-IT (EUCTR)	13/07/2006	12/07/2007	EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - ND	EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - ND	MOOD DEPRESSION MedDRA version: 6.1;Level: PT;Classification code 10012374		POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI	NULL	Not Recruiting			Female: yes Male: yes			Italy
1046	EUCTR2006-000680-28-ES (EUCTR)	07/07/2006	22/05/2006	Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI	Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI	Enfermedad de Parkinson (Parkinson Disease)	Trade Name: Stalevo 100 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA Trade Name: Sinemet plus Product Name: Sinemet plus (levodopa/carbidopa) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Stalevo 150 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA	NOVARTIS FARMACEUTICA, S.A	NULL	Not Recruiting			Female: yes Male: yes	200		Spain
1047	EUCTR2006-000391-32-DE (EUCTR)	04/07/2006	27/04/2006	A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease	A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease	Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease	Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate	Britannia Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	130		United Kingdom;Germany;Netherlands
1048	NCT00354133 (ClinicalTrials.gov)	July 2006	19/7/2006	Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's Disease	The Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study)	Parkinson Disease	Device: Kinetra and Soletra (neurostimulator, Medtronic);Drug: Best Medical Treatment	German Parkinson Study Group (GPS)	University Hospital Schleswig-Holstein;Assistance Publique - Hôpitaux de Paris;KKS Netzwerk	Active, not recruiting	18 Years	60 Years	All	251	Phase 4	France;Germany
1049	EUCTR2006-000361-11-GB (EUCTR)	23/06/2006	01/02/2006	A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201)	A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201)	Treatment of Parkinson's Disease MedDRA version: 8.0;Classification code 10029205	Product Name: FPFS-1169 INN or Proposed INN: R-(-)-1-(benzofuran-2-yl)-2-propylaminopentane hydrochloride	Fujimoto Pharmaceutical Corporation	NULL	Not Recruiting			Female: yes Male: yes	10	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
1050	EUCTR2005-004314-33-DE (EUCTR)	21/06/2006	01/12/2005	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Portugal;Hungary;United Kingdom;Germany;Estonia;Spain;Italy;Lithuania;Sweden
1051	NCT00331149 (ClinicalTrials.gov)	June 20, 2006	26/5/2006	A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.	Parkinson Disease	Drug: Ropinirole prolonged release;Drug: ropinirole immediate release	GlaxoSmithKline	NULL	Completed	30 Years	N/A	All	343	Phase 3	Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
1052	EUCTR2005-005423-34-DE (EUCTR)	19/06/2006	02/03/2006	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	Parkinson's disease	Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	516		Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
1053	EUCTR2005-004949-34-GB (EUCTR)	19/06/2006	24/03/2006	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536	Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1054	EUCTR2005-006033-32-SK (EUCTR)	13/06/2006	02/05/2006	A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study	A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study	Parkinson's Disease Early Stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	440		Finland;Slovakia;Sweden
1055	EUCTR2006-000391-32-GB (EUCTR)	06/06/2006	21/04/2006	A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease	A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease	Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate	Britannia Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3	Netherlands;Germany;United Kingdom
1056	EUCTR2005-004949-34-ES (EUCTR)	29/05/2006	21/04/2006	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study	Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536	Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	500		Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1057	EUCTR2005-005423-34-ES (EUCTR)	19/05/2006	29/03/2006	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	Parkinson's disease	Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride	GlaxoSmithKline	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 3	Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom
1058	EUCTR2005-004314-33-ES (EUCTR)	19/05/2006	15/03/2006	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Czech Republic;Hungary;Estonia;Belgium;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1059	EUCTR2005-004949-34-FI (EUCTR)	17/05/2006	21/04/2006	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536	Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim	Boehringer Ingelheim Finland Ky	Not Recruiting			Female: yes Male: yes	500	Phase 4	Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1060	EUCTR2005-005423-34-GB (EUCTR)	11/05/2006	17/03/2006	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	Parkinson's disease	Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	516	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom
1061	EUCTR2004-005234-39-LT (EUCTR)	09/05/2006	24/03/2006	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	244		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania
1062	EUCTR2005-005423-34-IT (EUCTR)	08/05/2006	03/10/2006	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release IR Tablets or Ropinirole Prolonged Release / Extended Release PR/XR Tablets in Advanced Stage Parkinson s Disease Subjects who are not Adequately Controlled on L-dopa. - ND	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release IR Tablets or Ropinirole Prolonged Release / Extended Release PR/XR Tablets in Advanced Stage Parkinson s Disease Subjects who are not Adequately Controlled on L-dopa. - ND	Parkinson disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: ropinirole PR/XR tablets Product Code: SKF-101468A INN or Proposed INN: Ropinirole Trade Name: REQUIP*21CPR 0,25MG INN or Proposed INN: Ropinirole Product Name: ropinirole PR/XR tablets Product Code: SKF-101468A INN or Proposed INN: Ropinirole Product Name: ropinirole PR/XR tablets Product Code: SKF-101468A INN or Proposed INN: Ropinirole Trade Name: REQUIP*21CPR 0,5MG INN or Proposed INN: Ropinirole Trade Name: REQUIP*21CPR 1MG INN or Proposed INN: Ropinirole	GlaxoSmithKline R D	NULL	Not Recruiting			Female: yes Male: yes	516		Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
1063	NCT00291733 (ClinicalTrials.gov)	May 2006	14/2/2006	Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease	Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial	Levodopa Induced Dyskinesia	Drug: Levetiracetam;Drug: Placebo	1st Hospital of Social Security Services	UCB Pharma	Active, not recruiting	30 Years	80 Years	Both	50	Phase 2	Greece
1064	EUCTR2005-005791-32-GB (EUCTR)	24/04/2006	17/02/2006	Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.	Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.	HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes)	Product Name: HF0220 Product Code: HF0220 Other descriptive name: 7-beta-hydroxyepiandrosterone	Hunter-Fleming Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):	United Kingdom;Sweden
1065	EUCTR2005-005423-34-CZ (EUCTR)	20/04/2006	03/03/2006	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.	Parkinson's disease	Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	516		Hungary;United Kingdom;Germany;Czech Republic;Spain;Italy
1066	EUCTR2005-006033-32-FI (EUCTR)	20/04/2006	06/03/2006	A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study	A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study	Parkinson's Disease Early Stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	440		Finland;Slovakia;Sweden
1067	EUCTR2005-004949-34-AT (EUCTR)	18/04/2006	21/03/2006	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study	Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536	Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Austria GmbH	NULL	Not Recruiting			Female: yes Male: yes	500		Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden
1068	EUCTR2005-001006-12-AT (EUCTR)	02/04/2006	28/02/2006	Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO	Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO	Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.	Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Trade Name: Sifrol, 0,35 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Sifrol, 0,70 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Cabaseril, 1,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Trade Name: Cabaseril, 2,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]-	Axxonis Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Germany;Czech Republic;Italy;Austria
1069	NCT00646204 (ClinicalTrials.gov)	April 2006	28/12/2007	Namenda (Memantine) for Non-Motor Symptoms in Parkinson's Disease	A 16 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NAMENDA® (MEMANTINE HCL) FOR NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASE	Parkinson's Disease	Drug: Memantine;Drug: placebo	Baylor College of Medicine	Forest Laboratories	Completed	18 Years	80 Years	Both	40	Phase 4	United States
1070	NCT00461942 (ClinicalTrials.gov)	April 2006	17/4/2007	Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients	A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease Patients	Parkinson's Disease	Drug: Green Tea Polyphenols (EGCG/ECG)	Xuanwu Hospital, Beijing	Ministry of Health, China;Michael J. Fox Foundation for Parkinson's Research	Completed	30 Years	N/A	Both	480	Phase 2	China
1071	EUCTR2005-001032-72-PT (EUCTR)	23/03/2006	11/11/2005	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step	Parkinson disease	Trade Name: Stalevo Product Code: ELC200 INN or Proposed INN: levodopa/carbidopa/entacapone Trade Name: SINEMET Product Name: sinemet INN or Proposed INN: levodopa/carbidopa	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	424		Portugal;Czech Republic;Italy
1072	EUCTR2005-001006-12-DE (EUCTR)	09/03/2006	05/09/2006	Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO	Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO	Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated	Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- erg	Axxonis Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2;Phase 3	Czech Republic;Austria;Germany;Italy
1073	EUCTR2005-003788-22-SE (EUCTR)	03/03/2006	19/12/2005	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms	Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim AB	NULL	Not Recruiting			Female: yes Male: yes	354	Phase 1	Finland;Germany;United Kingdom;Spain;Italy;Sweden
1074	EUCTR2005-004314-33-GB (EUCTR)	01/03/2006	29/11/2005	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Czech Republic;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1075	EUCTR2005-004314-33-HU (EUCTR)	01/03/2006	20/12/2005	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1076	NCT00297778 (ClinicalTrials.gov)	March 2006	28/2/2006	Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms	A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms	Parkinson Disease;Depression	Drug: Pramipexole;Other: Placebo	Boehringer Ingelheim	NULL	Completed	30 Years	80 Years	All	296	Phase 4	Austria;Finland;France;Germany;Italy;Netherlands;Norway;Romania;Russian Federation;South Africa;Spain;Sweden;Ukraine;United Kingdom
1077	NCT00141518 (ClinicalTrials.gov)	March 2006	30/8/2005	Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact	A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia	Advanced Idiopathic Parkinson's Disease	Drug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube)	AbbVie (prior sponsor, Abbott)	NULL	Completed	18 Years	99 Years	All	77	Phase 4	Norway;Sweden
1078	EUCTR2005-003788-22-AT (EUCTR)	22/02/2006	18/01/2006	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms	Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Austria GmbH	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 1	Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1079	EUCTR2005-001032-72-CZ (EUCTR)	16/02/2006	12/01/2006	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step		Trade Name: Stalevo 100 mg/25 mg / 200 mg Product Code: ELC200 Trade Name: SINEMET CR Product Name: SINEMET CR	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	424		Portugal;Czech Republic;Italy
1080	EUCTR2005-003788-22-ES (EUCTR)	09/02/2006	28/12/2005	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms	Trade Name: Mirapexin / Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim España S.A.	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 4	Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1081	EUCTR2005-004314-33-SE (EUCTR)	03/02/2006	13/12/2005	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1082	EUCTR2005-004290-19-GB (EUCTR)	03/02/2006	09/01/2006	A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease	A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease	advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536	Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Spain;Austria;Germany;United Kingdom
1083	EUCTR2005-004314-33-BE (EUCTR)	02/02/2006	24/11/2005	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Portugal;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1084	EUCTR2005-004314-33-CZ (EUCTR)	01/02/2006	11/01/2006	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Portugal;Hungary;Estonia;Czech Republic;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1085	EUCTR2005-003788-22-DE (EUCTR)	01/02/2006	07/12/2005	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms	Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	354	Phase 1	Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1086	EUCTR2005-004314-33-LT (EUCTR)	01/02/2006	03/01/2006	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Sweden;Lithuania
1087	NCT00630500 (ClinicalTrials.gov)	February 2006	27/2/2008	Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)	A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies	Dementia Associated With Parkinson's Disease;Dementia With Lewy Bodies	Drug: Memantine;Drug: Placebo	Helse Stavanger HF	King's College London;Lund University	Completed	N/A	N/A	Both	75	Phase 2	Norway;Sweden;United Kingdom
1088	EUCTR2005-004314-33-IT (EUCTR)	31/01/2006	07/09/2007	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND	Parkinson's Desease patients with Motor Fluctuations who are on optimised and stabilised therapy with Levodopa. MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: E2007 Product Name: E2007	EISAI LTD UK	NULL	Not Recruiting			Female: yes Male: yes	900		Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1089	EUCTR2005-004290-19-DE (EUCTR)	25/01/2006	05/12/2005	A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease	A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease	advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536	Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	100		United Kingdom;Germany;Spain
1090	EUCTR2005-004314-33-EE (EUCTR)	17/01/2006	24/11/2005	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1091	EUCTR2005-003788-22-FI (EUCTR)	17/01/2006	07/12/2005	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms	Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole		Boehringer Ingelheim Finland Ky	Not Recruiting			Female: yes Male: yes	318	Phase 1	Finland;Germany;United Kingdom;Spain;Italy;Sweden
1092	EUCTR2005-003788-22-GB (EUCTR)	06/01/2006	11/11/2005	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms	Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 4	Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1093	NCT00272688 (ClinicalTrials.gov)	January 2006	6/1/2006	Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit	Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation	Parkinson Disease	Drug: Levodopa (drug), intraduodenal administration	University Hospital, Akershus	Solvay Pharmaceuticals	Completed	N/A	N/A	Both	10	Phase 4	Norway
1094	EUCTR2005-005120-13-GB (EUCTR)	21/12/2005	02/11/2005	A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease	A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease	Hypomobility (off” or freezing”) episodes associated with advanced Parkinson’s disease	Product Name: Apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride	Vectura Group plc	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	United Kingdom
1095	EUCTR2005-001032-72-IT (EUCTR)	25/11/2005	26/03/2007	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa.	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa.	Parkinson s Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Trade Name: Stalevo INN or Proposed INN: ENTACAPONE INN INN or Proposed INN: LEVODOPA INN INN or Proposed INN: CARBIDOPA INN Trade Name: Sinemet INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA ANIDRA	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	424		Portugal;Czech Republic;Italy
1096	EUCTR2005-002432-10-MT (EUCTR)	25/11/2005	10/10/2005	A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease	A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease	Parkinson Disease late stage	Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride	Solvay Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	60		Malta
1097	EUCTR2005-000444-84-GB (EUCTR)	23/11/2005	13/09/2005	An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O	An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O	Treatment-Associated Dyskinesia in Parkinson's Disease	Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Spain;Austria;Italy;United Kingdom
1098	EUCTR2005-002010-38-DE (EUCTR)	21/11/2005	10/02/2006	Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study	Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study	Advanced Parkinson´s Disease	Product Name: Trivastal Product Code: S 90049 INN or Proposed INN: Piribedil	Institut de Recherches Internationales Servier (I.R.I.S.)	NULL	Not Recruiting			Female: yes Male: yes	80		Germany
1099	EUCTR2005-001416-42-PT (EUCTR)	07/11/2005	25/08/2005	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536	Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate	Teva Pharmaceuticals Industries LtD	NULL	Not Recruiting			Female: yes Male: yes	1100		Hungary;Portugal;Germany;United Kingdom;Spain;Italy
1100	NCT00250393 (ClinicalTrials.gov)	November 2005	4/11/2005	A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease	Placebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy]	Parkinson's Disease	Drug: Istradefylline (KW-6002)	Kyowa Hakko Kirin Company, Limited	NULL	Completed	30 Years	N/A	Both	64	Phase 2	Japan
1101	NCT00256204 (ClinicalTrials.gov)	November 2005	16/11/2005	A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease	A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects	Parkinson's Disease	Drug: Rasagiline Mesylate;Other: Placebo	Teva Pharmaceutical Industries	NULL	Completed	30 Years	80 Years	All	1174	Phase 3	Argentina;Austria;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom;United States
1102	NCT00253084 (ClinicalTrials.gov)	November 2005	11/11/2005	Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease	A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease	Parkinson's Disease	Drug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR Placebo	Impax Laboratories, LLC	NULL	Completed	30 Years	N/A	All	12	Phase 2	United States
1103	NCT00260793 (ClinicalTrials.gov)	November 2005	1/12/2005	Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease	Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease	Parkinson's Disease	Drug: Ropinirole Hydrochloride	Agarwal, Pinky, M.D.	Colorado Neurology;GlaxoSmithKline	Recruiting	25 Years	N/A	Both	20	Phase 3	United States
1104	EUCTR2004-005234-39-IE (EUCTR)	20/10/2005	16/08/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
1105	EUCTR2005-000314-12-ES (EUCTR)	14/10/2005	08/09/2005	Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI	Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI	Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006	Product Name: piribedil Product Code: S 90049 - F36 INN or Proposed INN: piribedil Product Name: piribedil Product Code: S 90049 - F38 INN or Proposed INN: piribedil	Institut de Recherches Internationales Servier	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Spain;Germany
1106	NCT00199381 (ClinicalTrials.gov)	October 2005	12/9/2005	An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001	An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.	Parkinson's Disease	Drug: Istradefylline	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Terminated	30 Years	N/A	All	504	Phase 3	United States
1107	EUCTR2005-001416-42-HU (EUCTR)	27/09/2005	20/06/2005	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536	Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate	Teva Pharmaceuticals Industries LtD	NULL	Not Recruiting			Female: yes Male: yes	1100		Portugal;Hungary;Germany;United Kingdom;Spain;Italy
1108	EUCTR2004-005234-39-FI (EUCTR)	22/09/2005	03/06/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA	NULL	Not Recruiting			Female: yes Male: yes	240		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1109	EUCTR2005-001416-42-GB (EUCTR)	15/09/2005	13/06/2005	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536	Trade Name: Azilect Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: Rasagiline Product Code: TVP-1012	Teva Pharmaceuticals Industries LtD	NULL	Not Recruiting			Female: yes Male: yes	1100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1110	EUCTR2005-000444-84-FI (EUCTR)	08/09/2005	26/07/2005	An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O	An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O	Treatment-Associated Dyskinesia in Parkinson's Disease	Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;United Kingdom;Spain;Italy
1111	EUCTR2005-001416-42-DE (EUCTR)	01/09/2005	17/10/2005	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536	Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate	Teva Pharmaceuticals Industries LtD	NULL	Not Recruiting			Female: yes Male: yes	1100		Portugal;Hungary;United Kingdom;Germany;Spain;Italy
1112	EUCTR2005-001416-42-AT (EUCTR)	24/08/2005	20/07/2005	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO	Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536	Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate	Teva Pharmaceuticals Industries LtD	NULL	Not Recruiting			Female: yes Male: yes	1100		Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1113	EUCTR2005-002654-21-SE (EUCTR)	08/08/2005	14/06/2005	A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE	A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE	Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.	Trade Name: Duodopa intestinal gel INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Solvay Pharmaceuticals GmbH	NULL	Not Recruiting			Female: yes Male: yes			Sweden
1114	EUCTR2004-005234-39-DK (EUCTR)	04/08/2005	31/05/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	240		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1115	NCT00134966 (ClinicalTrials.gov)	August 2005	23/8/2005	A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa	A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa	Parkinson's Disease	Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)	Novartis	NULL	Completed	30 Years	80 Years	All	493	Phase 3	United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic
1116	EUCTR2005-001416-42-ES (EUCTR)	28/07/2005	28/06/2005	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO	Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536	Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate	Teva Pharmaceuticals Industries LtD	NULL	Not Recruiting			Female: yes Male: yes	1100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1117	EUCTR2004-001485-41-GB (EUCTR)	26/07/2005	21/06/2005	A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A	A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A	Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).	Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: carbidopa/levodopa Trade Name: Cabaser Product Name: Cabaseril INN or Proposed INN: Cabergoline Trade Name: DaTSCAN Product Name: DatSCAN INN or Proposed INN: Ioflupane [123 I]	Institute for Neurodegenerative Disorders	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom;Spain
1118	EUCTR2004-002844-93-AT (EUCTR)	20/07/2005	15/06/2005	A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy	A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	1175		Estonia;Spain;Lithuania;Austria;Latvia;Italy;United Kingdom
1119	EUCTR2004-000835-27-ES (EUCTR)	18/07/2005	23/05/2006	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.	Early idiopathic Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10013113	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals S.P.A	NULL	Not Recruiting			Female: yes Male: yes	212	Phase 3	Spain;Italy
1120	EUCTR2005-004290-19-AT (EUCTR)	17/07/2005	06/12/2005	A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease	A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease	advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536	Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	100		Spain;Austria;Germany;United Kingdom
1121	EUCTR2005-001416-42-IT (EUCTR)	14/07/2005	21/06/2005	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects	Neuroprotective early treatment of Parkinson's disease subjects MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: NA Product Code: NA Other descriptive name: NA Product Name: rasagiline Product Code: TVP-1012	TEVA	NULL	Not Recruiting			Female: yes Male: yes			Portugal;Hungary;Germany;United Kingdom;Spain;Italy
1122	EUCTR2005-000444-84-ES (EUCTR)	12/07/2005	22/05/2006	An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O	An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O	Treatment- Associated Dyskinesia in Parkinson´s Disease	Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Spain;Austria;Italy;United Kingdom
1123	EUCTR2004-002844-93-IT (EUCTR)	06/07/2005	21/09/2005		A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. -	Parkinson's Disease. MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: Istradefylline Product Code: KW-6002 Other descriptive name: NA	KYOWA HAKKO UK LTD	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1124	NCT00143026 (ClinicalTrials.gov)	July 2005	31/8/2005	Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States	Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.	Parkinson's Disease	Drug: carbidopa, levodopa, entacapone	Novartis	NULL	Completed	30 Years	N/A	All	184	Phase 4	Australia;Philippines;Taiwan;Thailand
1125	EUCTR2005-000444-84-AT (EUCTR)	22/06/2005	18/05/2005	An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O	An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O	Treatment-Associated Dyskinesia in Parkinson's Disease	Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Spain;Austria;Italy;United Kingdom
1126	EUCTR2005-004314-33-AT (EUCTR)	16/06/2005	05/12/2005	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536	Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1260		Portugal;Hungary;Estonia;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1127	EUCTR2004-005234-39-SE (EUCTR)	08/06/2005	02/05/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	240		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1128	EUCTR2004-005234-39-GB (EUCTR)	27/05/2005	22/03/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet	Orion Corporation, ORION PHARMA, Finland	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
1129	EUCTR2004-002641-12-GB (EUCTR)	16/05/2005	30/06/2005	A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease	A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease	Parkinson's disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Spain;Austria;Italy;United Kingdom
1130	EUCTR2004-002608-13-GB (EUCTR)	16/05/2005	19/04/2005	Pragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s disease	Pragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s disease	Parkinson's Disease with psychosis	Trade Name: Seroquel Product Name: Seroquel Trade Name: Seroquel Product Name: Seroquel	King’s College London & King’s College Hospital	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1131	EUCTR2004-002641-12-ES (EUCTR)	25/04/2005	10/07/2006	A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease	A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease	Parkinson's disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Spain;Austria;Italy;United Kingdom
1132	EUCTR2004-000817-20-IT (EUCTR)	06/04/2005	13/04/2005	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy	Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: istradefylline Product Code: KW-6002 Other descriptive name: NA Trade Name: COMTAN 200* 60 CPR 200 MG Product Name: NA Product Code: NA INN or Proposed INN: Entacapone	KYOWA HAKKO UK LTD	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Italy;Latvia;Lithuania
1133	EUCTR2004-002844-93-ES (EUCTR)	01/04/2005	04/11/2005		A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy -	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	1175		United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1134	EUCTR2004-001593-10-GB (EUCTR)	21/03/2005	25/08/2005	A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1	A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1	Treatment-Associated Dyskinesia in Parkinson's Disease	Product Name: SARIZOTAN Product Code: EMD128130	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Italy;United Kingdom
1135	EUCTR2004-002844-93-EE (EUCTR)	08/03/2005	07/03/2005		A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy -	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	1175		United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1136	EUCTR2004-002598-21-GB (EUCTR)	02/03/2005	07/07/2005	A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease	A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease	Idiopathic Parkinson's disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	Austria;United Kingdom
1137	EUCTR2004-002844-93-LT (EUCTR)	08/02/2005	03/01/2005		A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy -	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	1175		United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1138	EUCTR2004-002650-59-GB (EUCTR)	03/02/2005	30/06/2005	A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a	A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a	Idiopathic Parkinson's disease	Product Name: rotigotine Product Code: SPM 962 INN or Proposed INN: rotigotine	SCHWARZ BIOSCIENCES	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3	United Kingdom
1139	EUCTR2004-001594-25-AT (EUCTR)	02/02/2005	29/12/2004	A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2	A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2	Treatment-Associated Dyskinesia in Parkinson's Disease	Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Finland;Spain;Austria
1140	EUCTR2004-000817-20-AT (EUCTR)	02/02/2005	29/12/2004	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Lithuania;Austria;Latvia;Italy
1141	EUCTR2004-002844-93-GB (EUCTR)	01/02/2005	23/02/2005		A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy -	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	1175		Italy;Latvia;Lithuania;United Kingdom;Estonia;Spain
1142	EUCTR2004-002844-93-LV (EUCTR)	28/01/2005	31/01/2005		A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy -	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	1175		United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1143	EUCTR2004-002641-12-AT (EUCTR)	21/01/2005	17/12/2004	A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease	A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease	Parkinson's disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Spain;Austria;Italy;United Kingdom
1144	NCT00219284 (ClinicalTrials.gov)	January 2005	30/6/2005	Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease	A Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off	Parkinson's Disease With End of Dose Wearing Off	Drug: Carbidopa/levodopa/entacapone	Novartis Pharmaceuticals	NULL	Completed	30 Years	85 Years	All	359	Phase 4	United States;Puerto Rico
1145	EUCTR2004-001594-25-FI (EUCTR)	30/12/2004	26/10/2004	A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2	A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2	Treatment-Associated Dyskinesia in Parkinson's Disease	Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Finland;Spain
1146	EUCTR2004-002598-21-AT (EUCTR)	22/12/2004	17/11/2004	A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease	A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease	Parkinson's Disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	Austria;United Kingdom
1147	EUCTR2004-002609-66-IT (EUCTR)	21/12/2004	03/03/2006	A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease	A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease	Idiopathic Parkinson Disease in early stage MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: rotigotine Product Code: SPM 926 Trade Name: REQUIP 21 CPR 0,25 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 0,5 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 1 MG INN or Proposed INN: Ropinirole Trade Name: REQUIP 21 CPR 2 MG INN or Proposed INN: Ropinirole	SCHWARZ PHARMA	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	Germany;Italy
1148	EUCTR2004-000817-20-ES (EUCTR)	10/12/2004	04/05/2005	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtan Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Italy;Latvia;Lithuania
1149	EUCTR2004-002609-66-DE (EUCTR)	06/12/2004	22/04/2005	A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease	A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease	Parkinson's Disease	Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	Germany;Italy
1150	EUCTR2004-000835-27-IT (EUCTR)	03/12/2004	21/07/2005	A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist	A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist	Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: Safinamide Product Code: NW-1015	NEWRON PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Spain;Italy
1151	EUCTR2004-000185-12-IT (EUCTR)	02/12/2004	27/06/2005	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease	Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU)	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	740		Finland;United Kingdom;Italy;Sweden
1152	EUCTR2004-000833-12-IT (EUCTR)	02/12/2004	15/03/2005	A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist	A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist	Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors	NEWRON PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Spain;Italy
1153	EUCTR2004-001593-10-IT (EUCTR)	02/12/2004	03/01/2005	A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1)	A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1)	Treatment-Associated Dyskinesia in Parkinson's Disease	Product Name: Sarizotan hydrochloride Product Code: EMD 128130 INN or Proposed INN: Sarizotan hydrochloride	MERCK S.P.A.	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	United Kingdom;Italy
1154	EUCTR2004-000833-12-ES (EUCTR)	02/12/2004	23/11/2004	A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist.	A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist.	Early idiopathic Parkinson’s disease MedDRA version: 7.0;Level: LLT;Classification code 10013113	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Spain;Italy
1155	EUCTR2004-000185-12-AT (EUCTR)	25/11/2004	21/10/2004	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name:	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	740		Finland;Austria;Italy;United Kingdom;Sweden
1156	EUCTR2004-001594-25-ES (EUCTR)	24/11/2004	02/11/2004	A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2	A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2	Treatment-Associated Dyskinesia in Parkinson's Disease	Product Name: Sarizotan Product Code: EMD 128130 INN or Proposed INN: Sarizotan Hydrochloride	MERCK KGaA	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Finland;Spain;Austria
1157	NCT01518309 (ClinicalTrials.gov)	November 17, 2004	16/12/2008	An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients	An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients	Parkinson's Disease Psychosis	Drug: pimavanserin tartrate (ACP-103)	ACADIA Pharmaceuticals Inc.	NULL	Completed	N/A	N/A	All	39	Phase 2	United States
1158	EUCTR2004-000185-12-SE (EUCTR)	11/11/2004	03/09/2004	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name:	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	740		Finland;United Kingdom;Italy;Sweden
1159	EUCTR2004-000817-20-GB (EUCTR)	08/11/2004	11/02/2005	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405	Phase 3	Spain;Lithuania;Austria;Latvia;Italy;United Kingdom
1160	NCT03091868 (ClinicalTrials.gov)	November 3, 2004	21/3/2017	Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics	A Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mg	Parkinson Disease	Drug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mg	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	80	Phase 1	Portugal
1161	NCT00243971 (ClinicalTrials.gov)	November 2004	24/10/2005	A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease	A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease	Parkinson's Disease	Drug: SPM 962	UCB Pharma	NULL	Completed	18 Years	N/A	Both		Phase 3	Germany
1162	NCT00229736 (ClinicalTrials.gov)	November 2004	28/9/2005	A Study of AAV-hAADC-2 in Subjects With Parkinson's Disease	A Phase1 Open Label Safety Study of Intrastriatal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase (AAV-hAADC-2) in Subjects With Parkinson's Disease [AAV-hAADC-2-003]	Parkinson's Disease	Genetic: AAV-hAADC-2	Genzyme, a Sanofi Company	NULL	Completed	40 Years	75 Years	Both	10	Phase 1	United States
1163	NCT00199394 (ClinicalTrials.gov)	November 2004	12/9/2005	A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Drug: Istradefylline (KW-6002)	Kyowa Hakko Kirin UK, Ltd.	NULL	Completed	30 Years	N/A	Both	405	Phase 3	United Kingdom
1164	NCT01634360 (ClinicalTrials.gov)	November 2004	3/7/2012	Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations	A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period Dyskinesias	Parkinson's Disease	Drug: Perampanel	Eisai Inc.	NULL	Terminated	N/A	N/A	All	185	Phase 2	NULL
1165	NCT00296946 (ClinicalTrials.gov)	November 2004	23/2/2006	Ipratropium Spray for Drooling Saliva in Parkinson's Disease	Phase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's Disease	Parkinson's Disease	Drug: ipratropium bromide (drug)	University Health Network, Toronto	Parkinson's Disease Foundation	Completed	30 Years	N/A	All	20	Phase 2	Canada
1166	EUCTR2004-000817-20-LV (EUCTR)	22/10/2004	27/10/2004	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Italy;Latvia;Lithuania
1167	EUCTR2004-000361-35-IT (EUCTR)	22/10/2004	23/05/2005	A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS.	A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS.	Parkinson's disease. MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: NA Product Code: E2007 Other descriptive name: NA	EISAI LTD UK	NULL	Not Recruiting			Female: yes Male: yes			Czech Republic;Italy
1168	EUCTR2004-000361-35-CZ (EUCTR)	18/10/2004	22/10/2004	A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS.	A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS.	Parkinson's Disease	Product Name: MARS Product Code: E2007 Other descriptive name: MARS Other descriptive name: MARS Other descriptive name: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	225		Czech Republic;Italy
1169	EUCTR2004-000148-26-ES (EUCTR)	13/10/2004	16/09/2004	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	Parkinson's Disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol	Schwarz BioSciences Inc.	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden
1170	EUCTR2004-000148-26-CZ (EUCTR)	12/10/2004	11/10/2004	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	Parkinson's Disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol	Schwarz BioSciences Inc.	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1171	EUCTR2004-000148-26-SE (EUCTR)	29/09/2004	05/07/2004	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	Parkinson's Disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol	Schwarz BioSciences Inc.	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1172	EUCTR2004-000185-12-FI (EUCTR)	21/09/2004	23/07/2004	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA	NULL	Not Recruiting			Female: yes Male: yes	740		Finland;United Kingdom;Italy;Sweden
1173	EUCTR2004-000817-20-LT (EUCTR)	16/09/2004	07/01/2005	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Italy;Latvia;Lithuania
1174	EUCTR2004-003355-39-AT (EUCTR)	14/09/2004	08/10/2004	A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia.	A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia.	Dementia associated with Parkinson's disease	Trade Name: Aricept 5 mg-Filmtabletten Product Name: Aricept 5mg-Filmtabletten	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	468		Austria
1175	NCT00641186 (ClinicalTrials.gov)	September 2004	18/3/2008	Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)	A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease	Parkinson Disease	Drug: sodium oxybate	Baylor College of Medicine	Jazz Pharmaceuticals	Completed	30 Years	75 Years	All	30	Phase 2	NULL
1176	NCT00099268 (ClinicalTrials.gov)	September 2004	10/12/2004	Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy	A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy	Parkinson's Disease	Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa	Novartis Pharmaceuticals	Orion Corporation, Orion Pharma	Completed	30 Years	70 Years	All	747	Phase 3	United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom
1177	NCT00501969 (ClinicalTrials.gov)	August 2004	16/7/2007	An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease	An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa	Advanced Stage Parkinson's Disease	Drug: Rotigotine	UCB Pharma	NULL	Completed	31 Years	N/A	All	395	Phase 3	Australia;Austria;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;South Africa;Spain;Sweden;United Kingdom
1178	EUCTR2004-000148-26-FI (EUCTR)	30/07/2004	28/06/2004	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A	Parkinson's Disease	Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol	Schwarz BioSciences Inc.	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Czech Republic;Hungary;Finland;Spain;Italy;Sweden
1179	NCT00174239 (ClinicalTrials.gov)	July 2004	9/9/2005	Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.	A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.	Parkinson Disease	Drug: cabergoline;Drug: controlled-release levodopa / carbidopa	Pfizer	NULL	Terminated	18 Years	80 Years	Both	220	Phase 4	Australia;Italy;Spain;United Kingdom
1180	EUCTR2004-000148-26-IT (EUCTR)	14/06/2004	26/07/2007	A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa	A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa	Advanced stage Parkinson's Disease	INN or Proposed INN: rotigotine	SCHWARZ PHARMA	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1181	NCT00211588 (ClinicalTrials.gov)	June 2004	13/9/2005	Galantamine Executive Function in Parkinson's Disease	Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease	Parkinson's Disease	Drug: galantamine	Memorial Hospital of Rhode Island	Ortho-McNeil Neurologics, Inc.	Active, not recruiting	60 Years	85 Years	Both	90	N/A	United States
1182	NCT00244387 (ClinicalTrials.gov)	March 2004	24/10/2005	Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa	A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa	Parkinson Disease, Idiopathic	Drug: SPM 962	UCB Pharma	NULL	Completed	30 Years	N/A	Both	506	Phase 3	Germany
1183	NCT01941732 (ClinicalTrials.gov)	November 2003	10/9/2013	Motor Response to Sildenafil in PD	Motor Response to Acute Challenge to Sildenafil in Parkinsons Disease	Parkinsons Disease;Erectile Dysfunction	Drug: Sildenafil	Bispebjerg Hospital	NULL	Completed	18 Years	80 Years	Male	8	Phase 4	Denmark
1184	NCT00234676 (ClinicalTrials.gov)	October 2003	5/10/2005	POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease	A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study for the Safety, Tolerability and Efficacy of Estrogen Replacement Therapy (Conjugated Equine Estrogens 0.625 mg Daily) in Post Menopausal Women With Parkinson's Disease	Parkinson's Disease	Drug: Premarin ®	The Parkinson Study Group	Wyeth is now a wholly owned subsidiary of Pfizer;Joseph and Rosalyn Newman Foundation	Completed	N/A	75 Years	Female	23	Phase 2	United States
1185	NCT00195143 (ClinicalTrials.gov)	August 2003	15/9/2005	Safety Study of Subthalamic Nucleus Gene Therapy for Parkinson's Disease	Phase I Study of Subthalamic GAD Gene Transfer in Medically Refractory Parkinson's Disease Patients	Parkinson's Disease	Genetic: Surgical infusion of AAV-GAD into the subthalamic nucleus	Neurologix, Inc.	Weill Medical College of Cornell University;North Shore University Hospital	Completed	25 Years	75 Years	Both	12	Phase 1	United States
1186	NCT00381472 (ClinicalTrials.gov)	June 2003	26/9/2006	Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa	A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa	Parkinson Disease	Drug: Ropinirole	GlaxoSmithKline	NULL	Completed	30 Years	N/A	All	393	Phase 3	United States;Belgium;Czech Republic;France;Germany;Hungary;Italy;Poland;Spain
1187	NCT00062738 (ClinicalTrials.gov)	June 2003	12/6/2003	Treatment of Depression in Parkinson's Disease Trial	Treatment of Depression in Patients With Parkinson's Disease	Parkinson Disease;Depression	Drug: paroxetine;Drug: Nortriptyline;Other: placebo	Rutgers, The State University of New Jersey	GlaxoSmithKline	Completed	35 Years	80 Years	All	52	Phase 2	United States
1188	NCT00237263 (ClinicalTrials.gov)	February 2003	7/10/2005	An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States	An Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off	Parkinson's Disease	Drug: Entacapone	Novartis	NULL	Completed	20 Years	N/A	All	285	Phase 2	United States
1189	NCT00209508 (ClinicalTrials.gov)	November 2002	13/9/2005	2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD	Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 2-Year Study To Evaluate The Effects Of GPI 1485 On [123I]b-CIT/SPECT Scanning And Clinical Efficacy In Symptomatic PD Patients Receiving Dopamine Agonist Therapy.	Parkinson's Disease	Drug: GPI 1485	Eisai Inc.	Symphony Neuro Development Company	Completed	40 Years	80 Years	Both	200	Phase 2	NULL
1190	NCT00599196 (ClinicalTrials.gov)	August 2002	24/12/2007	An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease	An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease	Early Stage Parkinson's Disease	Drug: Rotigotine	UCB Pharma	NULL	Completed	30 Years	N/A	All	381	Phase 3	Australia;Austria;Belgium;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;South Africa;Spain;Sweden;Switzerland;United Kingdom
1191	NCT00650104 (ClinicalTrials.gov)	May 2002	27/3/2008	Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164	101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164	Parkinson Disease	Drug: Ropinirole XL (formerly CR)	GlaxoSmithKline	NULL	Completed	30 Years	N/A	All	76	Phase 3	United States;Belgium;France;Netherlands;Norway
1192	NCT00407212 (ClinicalTrials.gov)	January 2002	30/11/2006	A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy	A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease	Parkinson's Disease	Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)	Novartis	NULL	Completed	30 Years	80 Years	Both	301	Phase 1/Phase 2	United States;Brazil;Canada;France;Germany;Italy;Netherlands;Portugal;United Kingdom
1193	NCT00037830 (ClinicalTrials.gov)	November 1999	22/5/2002	GM1 Ganglioside Effects on Parkinson's Disease	The Study of GM1 Ganglioside, A Potential New Parkinson's Disease Medication	Parkinson Disease	Drug: GM1 ganglioside;Drug: Placebo	Thomas Jefferson University	National Institute of Neurological Disorders and Stroke (NINDS)	Completed	39 Years	85 Years	All	94	Phase 2	United States
1194	NCT02177357 (ClinicalTrials.gov)	November 1998	24/6/2014	Pramipexole in Untreated and Levodopa-treated Parkinson's Disease Patients	Pramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational Study	Parkinson Disease	Drug: Pramipexole;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	30 Years	N/A	Both	150	Phase 3	NULL
1195	NCT00203060 (ClinicalTrials.gov)	July 1997	13/9/2005	Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa	A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa	Parkinson's Disease	Drug: Rasagiline Mesylate;Drug: placebo	Teva Neuroscience, Inc.	NULL	Completed	35 Years	N/A	Both	404	Phase 3	United States
1196	NCT00001258 (ClinicalTrials.gov)	November 26, 1993	3/11/1999	Studies of Frontal Lobe Brain Functioning in Schizophrenia	Studies of Frontal Lobe Function During Cognitive Stimulation as Measured With Oxygen-15 Water Positron Emission Tomography in Normal Subjects and Patients With Neuropsychiatric Disorders	Healthy Subjects;Schizophrenia;Parkinson Disease	Drug: Oxygen-15 Water	National Institute of Mental Health (NIMH)	NULL	Completed	18 Years	90 Years	All	1039		United States
1197	EUCTR2006-001755-36-DE (EUCTR)		15/08/2006	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone	Orion Corporation Orion Pharma	NULL	Not Recruiting			Female: yes Male: yes	100		United Kingdom;Germany;Sweden
1198	EUCTR2006-006907-35-DE (EUCTR)		30/01/2007	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER	Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
1199	EUCTR2010-022200-46-DE (EUCTR)		13/04/2011	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease.	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC	Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Finland;Lithuania;Latvia;Germany
1200	EUCTR2009-013552-72-DE (EUCTR)		23/08/2010	A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)	A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy	Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
1201	EUCTR2011-002073-30-DE (EUCTR)		20/09/2011	Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias	12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease	L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	63		France;United States;Hungary;Canada;Spain;Germany;Italy
1202	EUCTR2008-004447-11-DE (EUCTR)		17/10/2008	A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease	A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease	Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term:	Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride	Vectura Limited	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	Germany;Italy;United Kingdom
1203	EUCTR2009-014341-84-DE (EUCTR)		07/10/2009	Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms.	Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms.	idiopathic Parkinson's disease MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 2mg/24h(10cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 4mg/24h (20cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 6mg/24h (30cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 8mg/24h (40cm2) INN or Proposed INN: rotigotine	Schwarz Pharma Deutschland GmbH, UCB Group	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Germany
1204	EUCTR2008-005492-94-DE (EUCTR)		11/08/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Thailand;Chile;Colombia;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand

先頭へ

46. 悪性関節リウマチ

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臨床試験数 : 4,356 /  薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05756179 (ClinicalTrials.gov)	July 2023	21/2/2023	Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis	Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Diosmin and Hesperidin Combination	Alexandria University	NULL	Not yet recruiting	19 Years	65 Years	All	80	Phase 3	NULL
2	NCT05306353 (ClinicalTrials.gov)	May 15, 2023	23/3/2022	CD40L Antagonism in Rheumatoid Arthritis (RA)	Combining a CD40L-Binding Protein (VIB4920) With a TNF-alpha Inhibitor for the Treatment of Inadequately Controlled Rheumatoid Arthritis (ITN092AI)	Rheumatoid Arthritis	Drug: Placebo for VIB4920;Drug: VIB4920 with TNFi;Drug: VIB4920 without TNFi	National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN)	Not yet recruiting	18 Years	70 Years	All	104	Phase 2	United States
3	NCT04585711 (ClinicalTrials.gov)	May 2023	7/10/2020	Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis	Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis	Juvenile Idiopathic Arthritis;Rheumatoid Arthritis;Obesity	Drug: Etanercept Optimal dosing	Duke University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Not yet recruiting	2 Years	65 Years	All	30	Phase 1	United States
4	NCT05622175 (ClinicalTrials.gov)	March 31, 2023	3/11/2022	Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment	A Dose-finding Phase I Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: F8IL10	Philogen S.p.A.	NULL	Not yet recruiting	18 Years	80 Years	All	32	Phase 1	NULL
5	NCT02903212 (ClinicalTrials.gov)	March 2023	1/9/2016	Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis	Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: Autologous apoptotic cells injection	Centre Hospitalier Universitaire de Besancon	NULL	Not yet recruiting	18 Years	80 Years	All	22	Phase 1/Phase 2	NULL
6	NCT05540938 (ClinicalTrials.gov)	February 15, 2023	10/9/2022	Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis	Reevaluation of Original Research Results of Integrated Traditional Chinese and Western Medicine and Transformation of Hospital Preparations: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Wangbi granules;Drug: Wangbi granules simulant	China-Japan Friendship Hospital	Peking Union Medical College Hospital;The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine;The 980th Hospital of PLA Joint Logistics Support Force;The Second Affiliated Hospital of Zhejiang Chinese Medical University;Southwest Hospital, China	Not yet recruiting	18 Years	75 Years	All	340	Phase 4	NULL
7	NCT05725434 (ClinicalTrials.gov)	February 6, 2023	2/2/2023	A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis	A Single-arm, Open-label, Multiple-dose, Phase 3 Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: CT-P47 AI (tocilizumab);Biological: CT-P47 PFS (tocilizumab)	Celltrion	NULL	Not yet recruiting	18 Years	70 Years	All	30	Phase 3	NULL
8	NCT03938701 (ClinicalTrials.gov)	January 2023	25/2/2019	Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38	Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis Using the Fluorescent Tracer OTL38 Targeting the Folate ß Receptor: a Single-center Pilot Study	IBD;Rheumatoid Arthritis	Drug: OTL38;Device: Fluorescence Imaging	University Medical Center Groningen	GlaxoSmithKline;On Target Laboratories, LLC;Amsterdam UMC, location VUmc	Not yet recruiting	18 Years	N/A	All	30	Phase 1	Netherlands
9	NCT05480878 (ClinicalTrials.gov)	December 2, 2022	23/7/2022	Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis	Clinical Study Evaluating the Efficacy of Nitazoxanide and Escitalopram as Adjuvant Therapies in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Placebo;Drug: Nitazoxanide 500Mg Oral Tablet;Drug: Escitalopram 10mg	Tanta University	NULL	Not yet recruiting	18 Years	75 Years	All	90	Phase 3	NULL
10	NCT04170426 (ClinicalTrials.gov)	December 2022	18/11/2019	Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis	Phase 1/2a Clinical Study for Subjects With Rheumatoid Arthritis (RA) Using Multiple Dose Intravenous Infusions of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)	Rheumatoid Arthritis	Biological: autologous adipose derived stem cells	Celltex Therapeutics Corporation	NULL	Not yet recruiting	18 Years	75 Years	All	54	Phase 1/Phase 2	NULL
11	NCT05604885 (ClinicalTrials.gov)	November 30, 2022	31/10/2022	A Dose-range Study of the Safety and Efficacy of Treatment in Adult Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate	A Two-part, Randomized, Double-blind, Multi-center, Placebo-controlled Study of the Dose-range, Safety and Efficacy of 4 and 12 Weeks of Treatment With AP1189 in Adult Rheumatoid Arthritis (RA) Patients With an Inadequate Response to Methotrexate (MTX) Alone - (RESOLVE)	Rheumatoid Arthritis	Drug: AP1189, 60 mg;Drug: AP1189, 80 mg;Drug: AP1189, 100 mg;Drug: Placebo	SynAct Pharma Aps	NBCD A/S	Recruiting	18 Years	85 Years	All	420	Phase 2	Moldova, Republic of
12	NCT05428488 (ClinicalTrials.gov)	November 28, 2022	16/6/2022	Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis	Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis. A Randomized Controlled Trial With an Independent Efficacy Assessor.	Rheumatoid Arthritis	Drug: Abatacept (M3-M12);Drug: TNF Inhibitor (M3-M12);Drug: TNF Inhibitor (M0-M3)	University Hospital, Montpellier	NULL	Recruiting	18 Years	85 Years	All	220	Phase 3	France
13	NCT05375942 (ClinicalTrials.gov)	November 11, 2022	11/5/2022	This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry	Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra	Arthritis, Rheumatoid	Drug: Inflectra	Pfizer	NULL	Completed	18 Years	N/A	All	255		United States
14	NCT05671497 (ClinicalTrials.gov)	November 1, 2022	14/12/2022	The Effect of Cilostazol on Rheumatoid Arthritis Patients	Evaluation of the Effect of Cilostazol on the Clinical Outcomes of Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Drug: Cilostazol 100 MG;Drug: conventional synthetic antirheumatic drugs	Ain Shams University	Misr International University;Al-Azhar University	Recruiting	19 Years	N/A	All	70	Phase 2/Phase 3	Egypt
15	NCT05594680 (ClinicalTrials.gov)	November 1, 2022	18/10/2022	Cilostazol and Methotrexate in Rheumatoid Arthritis	The Phosphodiesterase 3 Inhibitor Cilostazol as Adjunct to Methotrexate in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Cilostazol;Drug: Methotrexate;Drug: Placebo	Tanta University	NULL	Not yet recruiting	18 Years	60 Years	All	70	Phase 3	NULL
16	NCT05447520 (ClinicalTrials.gov)	July 15, 2022	1/7/2022	Montelukast Use in Rheumatoid Arthritis	Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Drug: Montelukast;Drug: Placebo;Drug: Conventional DMARDs	Noha Mansour	NULL	Recruiting	18 Years	80 Years	All	50	Phase 2	Egypt
17	ChiCTR2200058839	2022-07-01	2022-04-17	Evaluation the efficacy and safety of reduced-dose adalimumab in Chinese patients with rheumatoid arthritis (RA): A Multicenter, prospective, parallel-group, real-world study	Evaluation the efficacy and safety of reduced-dose adalimumab in Chinese patients with rheumatoid arthritis (RA): A Multicenter, prospective, parallel-group, real-world study	Rheumatoid arthritis	No reduction group:Treatment of adalimumab;Extended cycle group, reduction group and drug withdrawal group:Treatment of adalimumab;Reduction group and drug withdrawal group:Treatment of adalimumab;Drug withdrawal group:Treatment of adalimumab;	The Second Affiliated Hospital Of Nanchang University	NULL	Pending	18	70	Both	No reduction group:73;Extended cycle group, reduction group and drug withdrawal group:96;Reduction group and drug withdrawal group:96;Drug withdrawal group:78;	Phase 4	China
18	NCT05363917 (ClinicalTrials.gov)	June 15, 2022	2/5/2022	Natrunix Versus Methotrexate in Rheumatoid Arthritis	Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix Versus Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Natrunix with MTX placebo (+folate);Drug: Natrunix placebo with MTX (+folate)	XBiotech, Inc.	NULL	Not yet recruiting	18 Years	N/A	All	150	Phase 2	NULL
19	NCT05363891 (ClinicalTrials.gov)	June 15, 2022	2/5/2022	Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis	Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Natrunix;Drug: Placebo	XBiotech, Inc.	NULL	Not yet recruiting	18 Years	N/A	All	150	Phase 2	NULL
20	NCT05267431 (ClinicalTrials.gov)	June 2022	14/2/2022	Outcomes of Biological Therapy on Rheumatoid Arthritis	Outcomes of Different Biological Therapy on Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Biological Drug	Sohag University	NULL	Not yet recruiting	18 Years	N/A	All	200		Egypt
21	JPRN-jRCTs051220027	25/05/2022	25/05/2022	Examination of the efficacy of Peficitinib reduction in RA patients in sustained remission	Japan post-marketing study of Peficitinib use in RA patients (JASPER-reduction Study)	Rheumatoid arthritis;M0690	RA patients who devided into into Peficitinib 150 mg and 100 mg groups, and their efficacy and safety will be examined among each group.	Hashimoto Motomu	NULL	Recruiting	>= 20age old	Not applicable	Both	60	N/A	Japan
22	NCT05323591 (ClinicalTrials.gov)	May 3, 2022	5/4/2022	Prospective Observational Study of Filgotinib in Female Participants With Rheumatoid Arthritis in France	A Prospective, Non-interventional Study in Female Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years	Rheumatoid Arthritis	Drug: Filgotinib	Galapagos NV	NULL	Recruiting	18 Years	N/A	Female	150		France
23	NCT05166304 (ClinicalTrials.gov)	April 2022	8/12/2021	Rebamipide in Patients With Active Rheumatoid Arthritis	Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rebamipide;Drug: Placebo	October 6 University	NULL	Not yet recruiting	18 Years	60 Years	All	100	Phase 1/Phase 2	NULL
24	JPRN-jRCTs031210665	14/03/2022	14/03/2022	APPRECIATE	A Prospective Interventional Study to Evaluate the Effect of Sarilumab on Bone Destruction in Rheumatoid Arthritis Patients - APPRECIATE	Rheumatoid arthritis	Administration of sarilumab for research purposes Invasion byHr PQCT imaging	Kawahito Yutaka	ASAHI KASEI PHARMA	Recruiting	>= 20age old	Not applicable	Both	55	N/A	Japan
25	NCT05240859 (ClinicalTrials.gov)	February 22, 2022	6/2/2022	Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis	A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: Geleli	Peking University People's Hospital	NULL	Not yet recruiting	N/A	N/A	All	1600		China
26	NCT05245448 (ClinicalTrials.gov)	February 22, 2022	22/1/2022	Tetrandrine in the Treatment of Rheumatoid Arthritis	Comparing the Efficacy of Tetrandrine Combined With Methotrexate and Methotrexate Alone in the Treatment of Rheumatoid arthritis---a Randomized, Double-blinded, Placebo-controlled, Multicenter Study	Rheumatoid Arthritis	Drug: Tetrandrine;Drug: Placebo	Peking University People's Hospital	NULL	Not yet recruiting	18 Years	65 Years	All	240	N/A	China
27	EUCTR2020-000350-96-DE (EUCTR)	11/01/2022	07/07/2021	Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate	A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
28	NCT05053165 (ClinicalTrials.gov)	January 4, 2022	16/9/2021	A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants	A Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of LB-P6 or LB-P8 in Healthy Participants	Rheumatoid Arthritis;Non-Alcoholic Steatohepatitis	Drug: LB-P6;Drug: LB-P8;Drug: Placebo	LISCure Biosciences	NULL	Completed	18 Years	65 Years	All	31	Phase 1	Australia
29	NCT05090124 (ClinicalTrials.gov)	January 1, 2022	20/7/2021	Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis	Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Adalimumab;Drug: Placebo	NHS Greater Glasgow and Clyde	University of Glasgow	Not yet recruiting	18 Years	74 Years	All	50	N/A	NULL
30	NCT04924270 (ClinicalTrials.gov)	January 2022	7/6/2021	Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases	Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial	Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis	Biological: Faecal microbiota transplantation;Other: Placebo	Torkell Ellingsen	Region of Southern Denmark;University of Southern Denmark	Not yet recruiting	18 Years	70 Years	All	200	Phase 2	NULL
31	NCT05153200 (ClinicalTrials.gov)	January 2022	29/11/2021	Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study.	Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study.	Rheumatoid Arthritis	Drug: Upadacitinib;Drug: Adalimumab	Ottawa Hospital Research Institute	The Ottawa Hospital;University of Ottawa	Not yet recruiting	18 Years	N/A	All	40	Phase 4	NULL
32	ChiCTR2100054220	2021-12-04	2021-12-11	Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis related interstitial lung disease	Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis related interstitial lung disease	Rheumatoid arthritis related interstitial lung disease	Tofacitinib group:No;Traditional immunosuppressive therapy group:No;	Yantai Yuhuangding Hospital	NULL	Recruiting	18	90	Both	Tofacitinib group:30;Traditional immunosuppressive therapy group:30;	Phase 4	Chian
33	NCT05152615 (ClinicalTrials.gov)	November 17, 2021	1/12/2021	A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)	A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) in Rheumatoid Arthritis (EASi-RA)	Rheumatoid Arthritis	Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement	NYU Langone Health	NULL	Recruiting	18 Years	N/A	All	50	N/A	United States
34	NCT05080218 (ClinicalTrials.gov)	November 15, 2021	6/10/2021	COVID-19 VaccinE Response in Rheumatology Patients	The SARS-CoV-2 Vaccine Response and Safety in Rheumatology Patients and the Influence of Temporary Interruptions in Immunomodulatory Therapy	Rheumatoid Arthritis;Psoriatic Arthritis;Spondylarthritis	Drug: Upadacitinib;Drug: Abatacept;Drug: Secukinumab;Drug: Tofacitinib;Drug: TNF Inhibitor;Drug: Canakinumab Injection;Drug: Baricitinib;Drug: Ixekizumab	Jeffrey Curtis	University of Alabama at Birmingham;University of Nebraska;University of Pennsylvania;AbbVie;Bristol-Myers Squibb;Novartis;Eli Lilly and Company;Pfizer	Recruiting	18 Years	85 Years	All	1000	Phase 4	United States
35	JPRN-jRCT2071210068	09/11/2021	28/09/2021	Abatacept vs Adalimumab in Early, Seropositive, and SE-positive RA	A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis	Single-blind Treatment Period Arm A Abatacept+MTX Arm B Adalimumab+MTX Open-label Treatment Period Abatacept+MTX	Maldonado A Michael	NULL	Recruiting	>= 20age old	Not applicable	Both	20	Phase 3	Australia;France;Germany;USA;Taiwan;Japan
36	NCT05003934 (ClinicalTrials.gov)	November 7, 2021	6/8/2021	Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for RA	Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: AlloRx	The Foundation for Orthopaedics and Regenerative Medicine	NULL	Recruiting	N/A	N/A	All	20	Phase 1	Antigua and Barbuda;Argentina;Mexico
37	NCT04834557 (ClinicalTrials.gov)	November 1, 2021	2/4/2021	Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis	Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt	Rheumatoid Arthritis	Drug: Placebo;Drug: Digoxin 0.25 mg;Drug: Ursodeoxycholic acid (UDCA) 500 mg	Tanta University	NULL	Recruiting	18 Years	80 Years	All	90	Phase 2	Egypt
38	NCT04680962 (ClinicalTrials.gov)	October 17, 2021	2/12/2020	MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis	A Double-Blind, Randomized, Parallel-Group Study to Investigate the Pharmacokinetic and Clinical Similarity Between MabionCD20, EU-approved MabThera® and US-licensed Rituxan® in Patients With Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: MabionCD20 (candidate biosimilar to rituximab);Biological: MabThera®;Biological: Rituxan®	Mabion SA	Parexel	Not yet recruiting	18 Years	80 Years	All	280	Phase 3	NULL
39	NCT04692493 (ClinicalTrials.gov)	September 22, 2021	15/12/2020	RA-PRO PRAGMATIC TRIAL	A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)	Rheumatoid Arthritis	Drug: targeted synthetic DMARD class;Drug: non-TNFi-biologic class	University of Alabama at Birmingham	Patient-Centered Outcomes Research Institute	Recruiting	18 Years	N/A	All	924	Phase 3	United States
40	EUCTR2020-000350-96-IT (EUCTR)	21/09/2021	22/10/2021	Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate	A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate - -	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: [BMS-188667] INN or Proposed INN: abatacept Trade Name: Humira Product Name: ADALIMUMAB Product Code: [-]	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
41	NCT04909801 (ClinicalTrials.gov)	September 15, 2021	28/5/2021	A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate	Bristol-Myers Squibb	NULL	Active, not recruiting	18 Years	N/A	All	300	Phase 3	Taiwan;United Kingdom;United States;Argentina;Australia;Czechia;France;Germany;Italy;Japan;Mexico;Poland;Spain;Switzerland
42	EUCTR2020-000350-96-PL (EUCTR)	24/08/2021	19/07/2021	Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate	A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
43	NCT05000216 (ClinicalTrials.gov)	August 13, 2021	6/8/2021	COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders	Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)	Rheumatoid Arthritis (RA);Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis (MS);Systemic Sclerosis (SSc);Pediatric SLE;Juvenile Idiopathic Arthritis (JIA);Juvenile Dermatomyositis (JDM);Pediatric-Onset Multiple Sclerosis (POMS)	Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: Continue IS (MMF or MPA);Drug: Continue IS (MTX);Biological: Continue IS (B cell depletion therapy);Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03;Drug: Withhold IS (MMF or MPA);Drug: Withhold IS (MTX);Drug: Withhold IS (B cell depletion therapy);Biological: Moderna mRNA-1273, Bivalent;Biological: BNT162b2, Bivalent	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.	Recruiting	2 Years	N/A	All	2340	Phase 2	United States
44	EUCTR2020-000350-96-FR (EUCTR)	09/08/2021	28/05/2021	Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate	A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
45	EUCTR2020-000350-96-CZ (EUCTR)	02/08/2021	10/06/2021	Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate	A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
46	EUCTR2020-000350-96-ES (EUCTR)	29/07/2021	23/06/2021	Efficacy of Abatacept vs Adalimumab in Early, Autoantibody positive Rheumatoid Arthritis (RA) and who did not respond well to methotrexate	A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have Shared Epitope HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Czechia;Taiwan;Spain;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Argentina;Poland;Australia;Germany;Netherlands;Japan;Sweden
47	ChiCTR2100048802	2021-07-15	2021-07-16	A prospective non-randomized controlled study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method	A prospective cohort study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method	Rheumatoid arthritis with interstitial pneumonia	experimental group:Syndrome Differentiation and Flavoring of Peitushengjin Chinese Medicine Granules;control group:Hydroxychloroquine + prednisone;	Zhejiang Chinese Medical University	NULL	Pending	18	65	Both	experimental group:285;control group:240;	N/A	China
48	ITMCTR2100005066	2021-07-15	2021-07-16	A prospective non-randomized controlled study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method	A prospective cohort study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method	Rheumatoid arthritis with interstitial pneumonia	control group:Hydroxychloroquine + prednisone;experimental group:Syndrome Differentiation and Flavoring of Peitushengjin Chinese Medicine Granules;	Zhejiang Chinese Medical University	NULL	Pending	18	65	Both	control group:240;experimental group:285;	N/A	China
49	EUCTR2019-002205-22-NL (EUCTR)	15/06/2021	11/02/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	185	Phase 2	France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom
50	NCT04888585 (ClinicalTrials.gov)	June 2, 2021	13/5/2021	Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)	Rheumatoid Arthritis (RA)	Drug: ABBV-154;Drug: Placebo	AbbVie	NULL	Active, not recruiting	18 Years	75 Years	All	473	Phase 2	United States;Australia;Canada;Czechia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;France;United Kingdom
51	NCT04885751 (ClinicalTrials.gov)	June 1, 2021	26/4/2021	Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy	Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study	Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis;Other Musculoskeletal Disorder;Gastric Ulcer;Enteritis;NSAID-Associated Gastropathy;NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy	Drug: Eupatilin;Drug: Rebamipide	Seoul National University Boramae Hospital	Dong-A ST Co., Ltd.	Not yet recruiting	19 Years	70 Years	All	50	Phase 4	NULL
52	NCT04885829 (ClinicalTrials.gov)	May 31, 2021	3/5/2021	Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers	A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers	Rheumatoid Arthritis;Giant Cell Arteritis	Drug: Tocilizumab Prefilled Syringe	Syneos Health	Dr. Reddy's Laboratories Limited	Active, not recruiting	18 Years	50 Years	All	300	Phase 1	Australia;India;New Zealand
53	EUCTR2020-005096-12-SE (EUCTR)	31/05/2021	09/04/2021	Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad ledgångsreumatism: en randomiserad, öppen, non-inferiority klinisk studie	Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad reumatoid artrit: en randomiserad, öppen, non-inferiority klinisk studie	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Prednisolon Pfizer Product Name: Prednisolon Pfizer INN or Proposed INN: PREDNISOLONE	Karolinska Universitetssjukhuset	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	166	Phase 4	Sweden
54	JPRN-jRCTs071200107	25/05/2021	03/03/2021	Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: Comparative study with Filgotinib and Tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial	Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: Comparative study with Filgotinib and Tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial	Rheumatoid arthritis	In patients with active RA for whom continuous MTX treatment (including other concurrent csDMARDs) for at least 8 weeks is ineffective, treatment will be switched to filgotinib monotherapy or tocilizumab monotherapy. MTX (including other concomitant csDMARDs) will be discontinued at baseline. Patients who satisfy the eligibility criteria will be randomly allocated to the filgotinib treatment group or the tocilizumab group (ratio of 1:1). The patients in each group will receive each respective drug for 52 weeks. The proportion of patients who reach an American College of Rheumatology 50% improvement response (ACR50) at 12 weeks after commencement of filgotinib monotherapy or tocilizumab monotherapy will be defined as the primary endpoint, and will serve as evidence of the noninferiority of filgotinib monotherapy compared with tocilizumab monotherapy.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	400	N/A	Japan
55	NCT04884880 (ClinicalTrials.gov)	May 14, 2021	30/4/2021	Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis	Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Luo-Fu-Shan Plaster;Drug: The placebo 10g	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Not yet recruiting	18 Years	75 Years	All	180	N/A	China
56	NCT04947137 (ClinicalTrials.gov)	May 12, 2021	10/5/2021	Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept	Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging With Tc99m Tilmanocept	Rheumatoid Arthritis	Drug: Tc99m tilmanocept	Navidea Biopharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	135	Phase 2	United States
57	NCT04871919 (ClinicalTrials.gov)	May 11, 2021	29/4/2021	Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis	A Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving Filgotinib	Rheumatoid Arthritis	Drug: Filgotinib	Galapagos NV	NULL	Recruiting	18 Years	N/A	All	1500		Belgium;Germany;Italy;Netherlands;Spain;United Kingdom
58	NCT04815148 (ClinicalTrials.gov)	April 1, 2021	19/3/2021	MH004 Topical Cream in Healthy Adult Volunteers and Participants With Atopic Dermatitis or Rheumatoid Arthritis	A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and PK of MH004 Topical Cream in Healthy Adult Volunteers and to Investigate Its Efficacy and Safety Profile in Participants With Atopic Dermatitis or Rheumatoid Arthritis	Atopic Dermatitis;Rheumatoid Arthritis	Drug: MH004 Ia(0.1%);Drug: MH004 Ia(0.3%);Drug: MH004 Ia(1%);Drug: MH004 Ia(3%);Drug: MH004 Ib-1(0.1%);Drug: MH004 Ib-1(0.3%);Drug: MH004 Ib-1(1%);Drug: MH004 Ib-2(0.3%);Drug: MH004 Ib-2(1%);Drug: MH004 Ib-2(3%)	Minghui Pharmaceutical Pty Ltd	NULL	Not yet recruiting	18 Years	70 Years	All	72	Phase 1	NULL
59	JPRN-jRCTs071200079	22/03/2021	12/01/2021	Discontinuation of methotrexate in rheumatoid arthritis patients achieving clinical remission by treatment with upadacitinib plus methotrexate (DOPPLER study): Study protocol for an interventional, multicenter, open-label and single-arm clinical trial with clinical, ultrasound and biomarker assessments	Discontinuation of methotrexate in rheumatoid arthritis patients achieving clinical remission by treatment with upadacitinib plus methotrexate (DOPPLER study): Study protocol for an interventional, multicenter, open-label and single-arm clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Starting at baseline (week 0), all patients will receive upadacitinib 15mg/day and continue to receive a stable pre-baseline dosage of MTX until week 24 (Stage I). In addition, if patients achieve a EULAR moderate response or a DAS28-CRP <= 3.2 a week 12, and a DAS28-CRP of < 2.6 at week 24, they will discontinue MTX, and continue upadacitinib monotherapy until week 48 (Stage II). Patients not achieving a EULAR moderate response or a DAS28-CRP <= 3.2 at week 12 or a DAS28-CRP of < 2.6 at week 24 will be excluded from this study.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	155	Phase 4	Japan
60	EUCTR2021-000710-42-NL (EUCTR)	15/03/2021	08/03/2021	Research into the effect of the COVID-vaccine in patients who are treated with rituximab (RTX-COVAC study)	The RTX-COVAC study: humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study. - RTX-COVAC	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Comirnaty Trade Name: COVID-19 Vaccine Moderna Product Name: COVID-19 Vaccine Moderna Trade Name: COVID-19 Vaccine AstraZeneca Product Name: COVID-19 Vaccine AstraZeneca	Sint Maartenskliniek	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 4	Netherlands
61	NCT04559412 (ClinicalTrials.gov)	March 15, 2021	3/9/2020	Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis	Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Device: Sofusa DoseConnect;Drug: Enbrel	Sorrento Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	80 Years	All	11	Phase 1	United States
62	NCT04806113 (ClinicalTrials.gov)	March 11, 2021	12/3/2021	COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases	COVID-19 Vaccine in Immunosuppressed Adults With Autoimmune Diseases	Covid19;Rheumatic Diseases;Rheumatoid Arthritis;SLE	Biological: Moderna COVID-19 vaccine	McGill University Health Centre/Research Institute of the McGill University Health Centre	CHU de Quebec-Universite Laval;Ministere de la Sante et des Services Sociaux	Active, not recruiting	18 Years	N/A	All	220	Phase 3	Canada
63	JPRN-UMIN000043547	2021/03/08	08/03/2021	Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive.	Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. - Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive.	Rheumatoid Arthritis	60 weeks Oral administration of 200mg filgotinib daily	DeparShinshu University School of Medicine	NULL	Recruiting	20years-old	100years-old	Male and Female	100	Not selected	Japan
64	EUCTR2020-002673-10-CZ (EUCTR)	17/02/2021	28/12/2020	A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis	A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY3462817 Product Code: LY3462817 INN or Proposed INN: LY3462817 Other descriptive name: LY3462817 Product Name: LY3462817 Product Code: LY3462817 INN or Proposed INN: LY3462817 Other descriptive name: LY3462817	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;Czechia;Hungary;Czech Republic;Mexico;Poland;United Kingdom
65	EUCTR2019-004369-42-DE (EUCTR)	15/02/2021	27/11/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Not Recruiting			Female: yes Male: yes	542	Phase 3	Serbia;United States;Czechia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Poland;Bulgaria;Georgia;Germany;Moldova, Republic of
66	NCT04757571 (ClinicalTrials.gov)	February 1, 2021	12/2/2021	The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients	The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients. A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.	Rheumatoid Arthritis	Drug: Paroxetine;Drug: Placebo	Sadat City University	NULL	Recruiting	18 Years	60 Years	All	120	Phase 1/Phase 2	Egypt
67	JPRN-jRCTs071200007	28/01/2021	20/04/2020	Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments	Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS. If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	80	Phase 4	Japan
68	ITMCTR2100004302	2021-01-21	2021-01-21	Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene	Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene	difficult-to-treat rheumatoid arthritis	The normal group:No special treatment;Refractory (control group):Methotrexate + folic acid tablets + adalimumab + simulant;Refractory (trial group):Methotrexate + folic acid tablets + Adalimumab + Qingre Tongluo Prescription; Primary untreated group:Do not give any treatment, only before treatment for blood, the group does not consider follow-up treatment, recommended patients to seek medical advice, follow the doctor 's orders;Therapeutic effective group:Continue the original treatment plan;	Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine	NULL	Recruiting	18	70	Both	The normal group:15;Refractory (control group):15;Refractory (trial group):15; Primary untreated group:15;Therapeutic effective group:15;		China
69	ChiCTR2100042440	2021-01-21	2021-01-21	Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene	Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene	difficult-to-treat rheumatoid arthritis	The normal group:No special treatment; Primary untreated group:Do not give any treatment, only before treatment for blood, the group does not consider follow-up treatment, recommended patients to seek medical advice, follow the doctor 's orders;Therapeutic effective group:Continue the original treatment plan;Refractory (trial group):Methotrexate + folic acid tablets + Adalimumab + Qingre Tongluo Prescription;Refractory (control group):Methotrexate + folic acid tablets + adalimumab + simulant;	Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine	NULL	Recruiting	18	70	Both	The normal group:15; Primary untreated group:15;Therapeutic effective group:15;Refractory (trial group):15;Refractory (control group):15;		China
70	ChiCTR2100042328	2021-01-19	2021-01-19	Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene	Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene	Rheumatoid arthritis	The normal group:No special treatment will be given;Primary untreated group:No treatment was given, only blood was drawn before treatment, and follow-up treatment was not considered in this group. Patients were advised to seek medical treatment by themselves and follow the doctor's advice;Therapeutic effective group:Continue with the original regimen;Observation group:Methotrexate + folic acid tablets + Adamumab + Wenyang Tongluo Recipient;The control group:Methotrexate + folic acid tablets + adamulizumab + simulation agent;	Yunnan Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine)	NULL	Recruiting	18	70	Both	The normal group:15;Primary untreated group:15;Therapeutic effective group:15;Observation group:15;The control group:15;		China
71	ITMCTR2100004288	2021-01-19	2021-01-19	Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene	Effect of Wenyang Tongluo Recipe on Cold Syndrome of Rheumatoid Arthritis and Drug Resistant Gene	Rheumatoid arthritis	Observation group:Methotrexate + folic acid tablets + Adamumab + Wenyang Tongluo Recipient;Primary untreated group:No treatment was given, only blood was drawn before treatment, and follow-up treatment was not considered in this group. Patients were advised to seek medical treatment by themselves and follow the doctor's advice;Therapeutic effective group:Continue with the original regimen;The control group:Methotrexate + folic acid tablets + adamulizumab + simulation agent;The normal group:No special treatment will be given;	Yunnan Hospital of Traditional Chinese Medicine (The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine)	NULL	Recruiting	18	70	Both	Observation group:15;Primary untreated group:15;Therapeutic effective group:15;The control group:15;The normal group:15;		China
72	NCT04539964 (ClinicalTrials.gov)	January 11, 2021	31/8/2020	Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis	Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study	Rheumatoid Arthritis	Procedure: Implant Procedure;Drug: Conventional Synthetic DMARD;Device: Active stimulation;Device: Non-active stimulation	SetPoint Medical Corporation	NULL	Recruiting	22 Years	75 Years	All	250	Phase 3	United States
73	NCT04535427 (ClinicalTrials.gov)	January 1, 2021	22/8/2020	Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis	Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: L-arginine;Drug: Placebo	RenJi Hospital	NULL	Not yet recruiting	18 Years	45 Years	All	144	Phase 2	China
74	JPRN-jRCTs071200054	17/12/2020	18/11/2020	Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Rheumatoid arthritis	Rheumatoid arthritis patients with moderate or high disease activity will be introduce for etanercept BS MA within 14 days of case enrollment. The etanercept BS MA is given as a weekly subcutaneous injection of 50 mg for 24 weeks.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	40	Phase 4	Japan
75	NCT04586933 (ClinicalTrials.gov)	December 10, 2020	22/9/2020	Nutrition in Rheumatic Diseases	Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance	Spondyloarthritis;Rheumatoid Arthritis;Polyarthritis	Dietary Supplement: Omega-3;Dietary Supplement: Placebo (soya);Behavioral: Dietary guidance	Haukeland University Hospital	GC Rieber Oils AS	Recruiting	18 Years	75 Years	All	120	N/A	Norway
76	NCT04649697 (ClinicalTrials.gov)	December 1, 2020	26/10/2020	Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients	Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial	Rheumatoid Arthritis	Drug: Rebamipide;Drug: Nanoparticulated Rebamipide;Drug: Clobetasol Propionate	Cairo University	NULL	Not yet recruiting	20 Years	70 Years	All	39	Phase 3	NULL
77	NCT04569890 (ClinicalTrials.gov)	December 1, 2020	20/9/2020	Treatment of Pregnancy RA	Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China	Rheumatoid Arthritis;Pregnancy Related	Drug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: Prednisone	RenJi Hospital	NULL	Not yet recruiting	20 Years	40 Years	Female	100	N/A	China
78	NCT04292067 (ClinicalTrials.gov)	November 23, 2020	26/2/2020	Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis	Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis	Spondyloarthritis;Rheumatoid Arthritis	Biological: Faecal sampling	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	N/A	All	400		France
79	NCT04758689 (ClinicalTrials.gov)	November 20, 2020	11/2/2021	Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients	Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients	Rheumatoid Arthritis	Combination Product: Laser, exercise, and methotrexate;Combination Product: Exercise, and methotrexate	Cairo University	NULL	Completed	65 Years	75 Years	All	60	N/A	Egypt
80	NCT04311567 (ClinicalTrials.gov)	November 7, 2020	5/3/2020	Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease	Effects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV Trial	Rheumatoid Arthritis;Interstitial Lung Disease Due to Systemic Disease (Disorder);RA;ILD	Drug: Tofacitinib;Drug: Methotrexate	Vastra Gotaland Region	Göteborg University	Recruiting	18 Years	80 Years	All	48	Phase 4	Sweden
81	NCT04608344 (ClinicalTrials.gov)	November 4, 2020	23/10/2020	Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants	A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants	Rheumatoid Arthritis	Drug: Atorvastatin;Drug: Pravastatin;Drug: Rosuvastatin;Drug: Filgotinib	Gilead Sciences	Galapagos NV	Completed	18 Years	55 Years	All	27	Phase 1	United States
82	EUCTR2019-000878-30-LV (EUCTR)	29/10/2020	30/07/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
83	EUCTR2020-000658-83-BG (EUCTR)	21/10/2020	07/10/2020	A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate	A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 2	Poland;Ukraine;Georgia;Bulgaria
84	JPRN-jRCTs041200048	02/10/2020	02/10/2020	Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state	Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study	Rheumatoid arthritis	1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. Folic acid is continued if concomitantly used. - Withdrawn group: Week 0 to 12 Reduced after registration. The dose of MTX is reduced to half, regardless of the initial dose. Folic acid is continued if concomitantly used. Week 12 to 52 Discontinued if low disease activity was maintained. Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) CZP and csDMARDs other than MTX Continued at a stable dose and interval throughout the course of the study in both groups. 3) Glucocorticoids Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group. 4) Rescue treatment One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request. - Restoring, restarting, or increasing doses of MTX - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Asai Shuji	Kojima Toshihisa	Recruiting	>= 20age old	Not applicable	Both	114	N/A	Japan
85	NCT04378621 (ClinicalTrials.gov)	October 1, 2020	8/4/2020	Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients	Treatment of Inflammation Versus Hand Training to Prevent and Revert Neuropsychiatric Comorbidity in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Pain;Fatigue;Cognitive Decline;Depression;Brain Diseases;Hand Rheumatism	Drug: TNF-a inhibitor OR JAK inhibitor;Other: Hand training	Vastra Gotaland Region	NULL	Active, not recruiting	45 Years	75 Years	All	212	N/A	Sweden
86	EUCTR2019-002810-37-DE (EUCTR)	23/09/2020	20/02/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany
87	EUCTR2020-002507-19-NL (EUCTR)	07/09/2020	03/09/2020	Research into administration of lower dosed rituximab with an injection	Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: rituximab Trade Name: Rixathon Product Name: rituximab	Sint Maartenskliniek	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36	Phase 4	Netherlands
88	EUCTR2019-004369-42-CZ (EUCTR)	01/09/2020	05/08/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Not Recruiting			Female: yes Male: yes	542	Phase 3	Serbia;Czechia;Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of
89	EUCTR2019-002676-14-SE (EUCTR)	26/08/2020	14/04/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 2	Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Georgia;Bulgaria;Sweden;Bosnia and Herzegovina
90	EUCTR2019-002676-14-BG (EUCTR)	20/08/2020	27/05/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600 (Ritlecitinib) AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: Ritlecitinib/JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 2	Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
91	EUCTR2019-002205-22-DE (EUCTR)	12/08/2020	07/07/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
92	NCT04973787 (ClinicalTrials.gov)	August 1, 2020	22/6/2021	The Role of Microbiome on Biological Therapy Efficacy in axSpA and RA	MicroSpA & MicroRA: The Role of Microbiome on Biological Therapy Efficacy in Axial Spondyloarthritis and Rheumatoid Arthritis - a New Paradigm	Axial Spondyloarthritis;Arthritis, Rheumatoid	Biological: biological disease-modifying antirheumatic drugs (bDMARDs)	Universidade Nova de Lisboa	NOVA Medical School of Universidade NOVA de Lisboa;Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz;Centro Hospitalar Universitário de São João;Centro Hospitalar de Vila Nova de Gaia/Espinho;Centro Hospitalar Universitário de Lisboa Norte - Hospital de Santa Maria;Instituto Português de Reumatologia;Centro Hospitalar Médio Tejo - Hospital Rainha Santa Isabel - Torres Novas;Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro;CHRC-Comprehensive Health Research Centre, FCM|NMS, UNL;iNOVA4Health - Rheumatic Diseases Lab;Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos;Hospital de Braga E.P.E.;Hospital Sousa Martins - Unidade de Saúde Local da Guarda	Recruiting	18 Years	65 Years	All	90		Portugal
93	JPRN-jRCTs071190030	28/07/2020	11/10/2019	Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments	Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade. The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	80	Phase 4	Japan
94	EUCTR2019-002676-14-SK (EUCTR)	27/07/2020	27/04/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz® 11mg Prolonged Release Tablet INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Ritlecitinib Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 2	Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
95	NCT04324892 (ClinicalTrials.gov)	July 12, 2020	25/3/2020	Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study	Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study	Rheumatoid Arthritis	Drug: Treat to target	Chinese University of Hong Kong	NULL	Not yet recruiting	18 Years	N/A	All	110		NULL
96	EUCTR2019-002676-14-CZ (EUCTR)	07/07/2020	11/05/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB), AND TOFACITINIB ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 2	Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Georgia;Bulgaria;Sweden;Bosnia and Herzegovina
97	JPRN-UMIN000040094	2020/07/01	01/07/2020	Development of chronotherapeutics in rheumatoid arthritis	Development of chronotherapeutics in rheumatoid arthritis - Development of chronotherapeutics in rheumatoid arthritis	rheumatoid arthritis	baricitinib 4mg morning baricitinib 4mg evening baricitinib 2mg evening baricitinib 2mg morning	Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo college of Medicine	NULL	Recruiting	18years-old	100years-old	Male and Female	120	Not applicable	Japan
98	JPRN-jRCTs071190046	29/06/2020	20/02/2020	Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with enbrel (Subcutaneous injection of 25 mg once weekly or 25 mg twice weekly or 50 mg once weekly or 50 mg once biweekly) over 24 weeks and persisted with LDA/remission are switched to the same dose of etanercept BS MA from enbrel. In addition, for patients receiving etanercept BS MA 50 mg weekly, the dose will be reduced from 24 weeks to etanercept BS MA 25 mg weekly to test whether LDA/remission persists until week 52.	Kawakami Atsushi	NULL	Not Recruiting	>= 20age old	Not applicable	Both	62	Phase 4	Japan
99	NCT04163016 (ClinicalTrials.gov)	June 19, 2020	24/10/2019	A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)	A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)	Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque Psoriasis	Drug: Pharmacokinetics of certolizumab pegol	UCB Biopharma S.P.R.L.	NULL	Active, not recruiting	18 Years	N/A	Female	22	Phase 1	United States;France;Germany;Spain;Switzerland;Canada;Netherlands
100	EUCTR2019-002810-37-PL (EUCTR)	16/06/2020	11/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany
101	EUCTR2019-002810-37-BG (EUCTR)	15/06/2020	28/04/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United States;Czech Republic;Hungary;Estonia;Poland;Lithuania;Bulgaria;Germany
102	EUCTR2019-001185-15-BG (EUCTR)	29/05/2020	15/05/2020	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2	Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
103	EUCTR2018-003418-41-GB (EUCTR)	18/05/2020	22/11/2019	A comparison of a radioactive imaging method with an existing immunological (involving cells from the Immune System) based method that involves staining of tissues from a patient with a known rheumatoid arthritic joint.	A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]	Trade Name: Lymphoseek Product Name: technetium Tc 99m tilmanocept INN or Proposed INN: not applicable Other descriptive name: TILMANOCEPT	Navidea Biopharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	United States;European Union;United Kingdom
104	NCT04333147 (ClinicalTrials.gov)	May 12, 2020	27/3/2020	Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)	A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: Otilimab (GSK3196165);Drug: csDMARD(s)	GlaxoSmithKline	Iqvia Pty Ltd	Active, not recruiting	18 Years	N/A	All	2916	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Colombia;Czechia;Estonia;Germany;Hungary;India;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Thailand;Ukraine;United Kingdom
105	EUCTR2019-002205-22-BE (EUCTR)	05/05/2020	21/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	185	Phase 2	France;United States;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
106	NCT04350216 (ClinicalTrials.gov)	April 30, 2020	8/4/2020	Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)	Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Atherosclerosis	Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]	Instituto de Investigación Marqués de Valdecilla	NULL	Not yet recruiting	18 Years	100 Years	All	20	Phase 4	NULL
107	EUCTR2019-002810-37-LT (EUCTR)	17/04/2020	03/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
108	NCT04268771 (ClinicalTrials.gov)	April 8, 2020	31/1/2020	A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products	A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis	Biological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®	Dr. Reddy's Laboratories Limited	PPD	Active, not recruiting	18 Years	N/A	All	140	Phase 3	United States
109	NCT04115423 (ClinicalTrials.gov)	April 1, 2020	2/10/2019	A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab	A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database	Infection;Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)	Sungkyunkwan University	Ministry of Food and Drug Safety, Korea	Active, not recruiting	18 Years	N/A	All	9508		Korea, Republic of
110	EUCTR2019-000868-18-DE (EUCTR)	13/03/2020	08/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Czechia;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
111	EUCTR2019-002810-37-HU (EUCTR)	09/03/2020	20/01/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Estonia;Czech Republic;Hungary;Poland;Lithuania;Bulgaria;Germany
112	JPRN-jRCT1041190125	09/03/2020	09/03/2020	PRECIOUS-B study	Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study	Rheumatoid arthritis	1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose. - The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used. Week 12 to 52 - Discontinued if low disease activity was maintained. - Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) BAR - Continued at a stable dose and interval throughout the course of the study. 3) csDMARDs other than MTX - Continued at a stable dose and interval throughout the course of the study. 4) Glucocorticoids - Continued at a stable dose up to week 36, and allowed to taper after week 36. 5) Rescue treatments One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request - Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX. - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids. - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Asai Shuji	NULL	Recruiting	>= 20age old	Not applicable	Both	51	N/A	Japan
113	NCT03895879 (ClinicalTrials.gov)	March 1, 2020	26/3/2019	Use of Tocilizumab Drug Levels to Optimize Treatment in RA	Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)	Rheumatoid Arthritis	Drug: Tocilizumab	Reade Rheumatology Research Institute	ZonMw: The Netherlands Organisation for Health Research and Development	Recruiting	18 Years	N/A	All	98	Phase 4	Netherlands
114	EUCTR2019-001185-15-NO (EUCTR)	19/02/2020	07/11/2019	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2	Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
115	EUCTR2018-003351-37-FR (EUCTR)	19/02/2020	28/05/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	2600	Phase 3;Phase 4	Russian Federation;Romania;Hungary;United States;United Kingdom;Switzerland;Spain;Greece;Austria;Czech Republic;Netherlands;Turkey;Belgium;Denmark;Poland;Italy;South Africa;Israel;Slovakia;France;Australia;Lithuania;Germany
116	EUCTR2019-004101-27-NL (EUCTR)	15/01/2020	12/12/2019	Research into injecting golimumab less frequently by using increased doses	INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’ - INDIGO	rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Sint Maartenskliniek	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	35	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
117	JPRN-UMIN000039116	2020/01/15	15/01/2020	Effects of Sleep Management on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study.	Effects of zolpidem tartrate on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study. - SMAPP	Osteoarthritis, Rheumatoid arthritis	Administration of zolpidem tartrate of 5mg for 7 days after surgery No administration of zolpidem tartrate	Mito medical center, Mito Kyodo General Hospital, University of Tsukuba	NULL	Pending	20years-old	Not applicable	Male and Female	84	Not selected	Japan
118	EUCTR2019-004179-38-SE (EUCTR)	10/01/2020	19/11/2019	Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis	Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA	Patients with early active rheumatoid arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz Trade Name: Metotrexat Orion	Västra Götalandsregionen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	145	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Sweden
119	JPRN-UMIN000042632	2020/01/01	03/12/2020	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis	Rheumatoid arthritis	low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses. The laser apparatuses used for therapy in this study were the following, 1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW. 2.GaAIAs diode laser (830 nm, maximum output power 300 mW). 12 patients placebo laser and naproxen Naproxen is given as tablet 500mg twice per day. 12 patients naproxen Naproxen is given as tablet 500mg twice per day. 10 patients	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	34	Not applicable	Asia(except Japan)
120	NCT04115397 (ClinicalTrials.gov)	January 2020	2/10/2019	Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints	Towards Efficient Prediction and Prevention of Rheumatoid Arthritis	Seropositive Muskuloskeletal Complaints	Drug: Zoledronic Acid;Drug: Placebo	Karolinska Institutet	NULL	Not yet recruiting	18 Years	N/A	All	80	Phase 4	NULL
121	EUCTR2019-000284-24-LT (EUCTR)	18/12/2019	07/11/2019	A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA	Pfizer Inc	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina
122	NCT04136262 (ClinicalTrials.gov)	November 25, 2019	21/10/2019	Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis	Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial	Rheumatoid Arthritis	Drug: Tripterygium wilfordii Hook F (TwHF);Drug: Methotrexate;Other: Dummy Tripterygium wilfordii Hook F (TwHF)	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Recruiting	N/A	N/A	Female	300	Phase 2/Phase 3	China
123	EUCTR2018-004287-56-FR (EUCTR)	21/11/2019	31/01/2020	Methotrexate and Metformin in rheumatoid arthritis patients	Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2	rheumatoid arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: METFORMINE ARROW 500mg Product Name: Metformin Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Acide folique Product Name: Acide folique Product Code: B03BB01 Trade Name: Prednisone Product Name: Prednisone Product Code: H02AB07	CHU de Bordeaux	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	128	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France
124	NCT04227366 (ClinicalTrials.gov)	November 19, 2019	25/12/2019	Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis	An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: BCD-089;Biological: Placebo;Drug: Methotrexat	Biocad	NULL	Completed	18 Years	N/A	All	154	Phase 3	Russian Federation
125	EUCTR2019-000868-18-PL (EUCTR)	15/11/2019	11/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Antihuman granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;China;Japan;Korea, Republic of
126	NCT04038970 (ClinicalTrials.gov)	November 8, 2019	29/7/2019	Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate	A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving Methotrexate	Rheumatoid Arthritis	Biological: KN019, 5mg/kg;Biological: KN019, 10 mg/kg;Biological: Placebo;Combination Product: Methotrexate	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	NULL	Completed	18 Years	N/A	All	145	Phase 2	China
127	EUCTR2019-001185-15-SE (EUCTR)	06/11/2019	01/07/2019	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2	Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
128	EUCTR2019-001793-28-NL (EUCTR)	05/11/2019	05/11/2019	Adalimumab dose reduction aiming low drug levels with control of disease activity (ADDORA-LOW)	Adalimumab dose reduction aiming low serum concentration with control of disease activity (ADDORA-LOW) : a single blind, non-inferiority, randomised clinical trial - ADDORA-Low	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira, Hulio, Amgevita, Hyrimoz, Idacio, Imraldi Product Name: Adalimumab Product Code: D2E7 INN or Proposed INN: ADALIMUMAB	Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	89	Phase 4	Netherlands
129	NCT04485325 (ClinicalTrials.gov)	November 4, 2019	30/4/2020	Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients	Capability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte)	Rheumatic Arthritis	Drug: Tofacitinib;Biological: Etanercept	Dr. Frank Behrens	Pfizer	Recruiting	18 Years	65 Years	All	192	Phase 4	Germany
130	NCT04170504 (ClinicalTrials.gov)	November 2019	14/11/2019	Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis	Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial	Rheumatoid Arthritis	Drug: Qing Re Huo Xue (QRHX);Drug: Methotrexate;Drug: dummy Qing Re Huo Xue (QRHX)	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Not yet recruiting	18 Years	N/A	All	204	Phase 2/Phase 3	NULL
131	EUCTR2019-000867-26-HU (EUCTR)	24/10/2019	28/10/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of
132	EUCTR2019-000868-18-HU (EUCTR)	24/10/2019	28/10/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
133	EUCTR2019-000868-18-LT (EUCTR)	11/10/2019	19/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Czechia;Spain;Lithuania;Italy;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
134	EUCTR2018-003351-37-HU (EUCTR)	07/10/2019	24/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
135	NCT04077567 (ClinicalTrials.gov)	October 1, 2019	29/8/2019	An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis	An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: TS-152	Taisho Pharmaceutical Co., Ltd.	NULL	Active, not recruiting	20 Years	N/A	All	401	Phase 3	Japan
136	EUCTR2019-000868-18-CZ (EUCTR)	20/09/2019	20/08/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Argentina;Hungary;United States;Japan;Ukraine;United Kingdom;Spain;Canada;Czech Republic;Netherlands;Belgium;China;Korea, Republic of;Poland;Italy;South Africa;Lithuania;Germany
137	EUCTR2018-004677-27-BE (EUCTR)	16/09/2019	25/03/2019	Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.	Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy.	Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	Abivax	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Belgium
138	EUCTR2018-003351-37-ES (EUCTR)	05/09/2019	16/09/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Lilly S.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
139	ChiCTR2200057200	2019-09-01	2022-03-03	Multi-angle evaluation of the advantages and disadvantages of different postoperative analgesia methods for total knee replacement: A randomized, controlled trial	Multi-angle evaluation of the advantages and disadvantages of different postoperative analgesia methods for total knee replacement: A randomized, controlled trial	Rheumatoid arthritis, etc.	group PCIA :2ug/kg+ dezocine 20mg+ dolasetron 25mg, diluted to 100mL by adding normal saline, no loading volume was set, background infusion rate was set as 2mL/h, and blous volume was 0.5ml/ time;group PCEA :0.1% ropivacaine, load set at 10mL, background infusion rate of 5mL/h, locking time of 20min, blous dose of 5ml/ time;group CFNBA :0.1% ropivacaine, loading volume 10ml, background infusion rate 5ml/h, locking time 20min, blous volume 5ml/ time;	Quanzhou First Hospital Affiliated to Fujian Medical University	NULL	Completed	60		Both	group PCIA :20;group PCEA :20;group CFNBA :20;		China
140	JPRN-jRCTs071190001	29/08/2019	02/04/2019	Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity	Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity - CROWN study	Rheumatoid arthritis	Patients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are compared 1 year after starting study. Control group combination therapy with subcutaneous CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) and oral MTX (at the same dose before starting the protocol treatment) given for 52 weeks of the protocol treatment, or until the time of discontinuation. Intervention group monotherapy with CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) given for 52 weeks of the protocol treatment, or until the time of discontinuation. The discontinuation criteria for the study are as follows: 1) When subjects requested to discontinue the treatment 2) When the principal investigator or subinvestigator considered that the therapy should be discontinued due to adverse (drug) events 3) When a subject turned out not to fulfil the inclusion criteria or meets the exclusion criteria after starting the study 4) When RA relapses, defined as SDAI over 11, were observed at two consecutive visits 5) When the principal investigator or subinvestigator considered continuation of the study is inappropriate for reasons other than above	Miyazaki Yusuke	Tanaka Yoshiya	Recruiting	>= 16age old	Not applicable	Both	150	Phase 4	Japan
141	NCT04004429 (ClinicalTrials.gov)	August 26, 2019	26/6/2019	A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease	A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease	Rheumatoid Arthritis	Drug: 50 mg AP1189;Drug: AP1189;Drug: Placebo	SynAct Pharma Aps	NULL	Completed	18 Years	85 Years	All	105	Phase 2	Denmark;Norway
142	JPRN-JapicCTI-194928	26/8/2019	22/08/2019	-An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101	An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101	Rheumatoid Arthritis	Intervention name : methotrexate INN of the intervention : methotrexate Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg. Control intervention name : methotrexate INN of the control intervention : methotrexate Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval.	medac GmbH	NULL	complete	20	75	BOTH	100	Phase 3	Japan
143	ITMCTR1900002510	2019-08-08	2019-08-07	Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty	Effects of multiple dose use of tranexamic acid on blood loss and inflammatory factors after total knee arthroplasty in patients with rheumatoid arthritis	Total knee arthroplasty	group 1:Intravenous infusion of 1g of tranexamic acid + 100 ml 3 hours after surgery, intravenous infusion of 100 ml of normal saline 6 and 12 hours after surgery.;group 2:Intravenous infusion of 1g of tranexamic acid + 100 ml of normal saline at 3, 6, and 12 hours after surgery;	Guanghua Hospital, Shanghai University of Traditional Chinese Medicine	NULL	Recruiting	50	75	Both	group 1:38;group 2:38;	Phase 4	China
144	EUCTR2018-004605-57-NL (EUCTR)	06/08/2019	24/07/2019	Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients	Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial (TODORA) - Use of TOcilizumab Drug levels to Optimize treatment in RA (TODORA)	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
145	NCT04068246 (ClinicalTrials.gov)	August 1, 2019	21/8/2019	The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients	The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.	Rheumatoid Arthritis	Drug: Metformin;Drug: Placebo	Sadat City University	NULL	Completed	18 Years	N/A	All	120	Phase 1/Phase 2	Egypt
146	EUCTR2018-004677-27-HU (EUCTR)	25/07/2019	25/07/2019	Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.	Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy.	Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	Abivax	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Belgium
147	EUCTR2018-003330-32-PL (EUCTR)	19/07/2019	06/05/2019	Efficacy and Safety of Oral SKI-O-703 in Refractory Rheumatoid Arthritis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies	Rheumatoid Arthritis Despite Treatment With Conventional Therapies MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cevidoplenib Product Code: SKI-O-703 INN or Proposed INN: Cevidoplenib	Oscotec Inc.	NULL	Not Recruiting			Female: yes Male: yes	148	Phase 2	United States;Serbia;Czech Republic;Poland;Ukraine;Russian Federation;Korea, Republic of
148	EUCTR2018-003933-14-BE (EUCTR)	19/07/2019	24/04/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
149	NCT04018599 (ClinicalTrials.gov)	July 15, 2019	11/7/2019	Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS	A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects	Rheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious Uveitis	Drug: 40 mg MSB11022	Fresenius Kabi SwissBioSim GmbH	PRA Health Sciences	Completed	18 Years	55 Years	All	216	Phase 1	United States
150	EUCTR2016-003682-26-PL (EUCTR)	11/07/2019	17/05/2018	Phase 3 trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of patients suffering of Early Rheumatoid Arthritis	A Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis	Early Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: METHOTREXATE Product Code: METHOTREXATE INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Can-Fite BioPharma, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Serbia;Canada;Poland;Romania;Israel;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
151	NCT04464642 (ClinicalTrials.gov)	July 10, 2019	6/7/2020	Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis	Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Tofacitinib	Dr. Mohammad Mamun Khan	NULL	Active, not recruiting	18 Years	N/A	All	110	Phase 4	Bangladesh
152	EUCTR2019-000660-25-PL (EUCTR)	09/07/2019	20/05/2019	Evaluating Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CT-P17 Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	Poland
153	EUCTR2018-003053-21-PL (EUCTR)	27/06/2019	16/04/2019	A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: ABBV-3373 INN or Proposed INN: ABBV-3373 Trade Name: Humira (adalimumab) Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	United States;Puerto Rico;Poland;Israel
154	NCT03656627 (ClinicalTrials.gov)	June 27, 2019	31/8/2018	Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease	Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease	Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis	Drug: Nivolumab	Alliance Foundation Trials, LLC.	Bristol-Myers Squibb	Terminated	18 Years	N/A	All	7	Phase 1	United States
155	EUCTR2018-003933-14-BG (EUCTR)	21/06/2019	27/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Czechia;Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
156	NCT03912428 (ClinicalTrials.gov)	June 14, 2019	10/4/2019	Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis	Evaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis	Myositis;Inflammatory;Rheumatoid Arthritis;Healthy Volunteers	Drug: Celecoxib;Diagnostic Test: 11C-MC1;Diagnostic Test: 11C-ER176	National Institute of Mental Health (NIMH)	NULL	Recruiting	18 Years	99 Years	All	96	Phase 1	United States
157	EUCTR2019-001185-15-DK (EUCTR)	06/06/2019	12/04/2019	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2	Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
158	EUCTR2018-004539-54-DE (EUCTR)	03/06/2019	10/04/2019	Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy	Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte	Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz Trade Name: Enbrel Trade Name: Celebrex	Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	192	Phase 4	Germany
159	NCT03652961 (ClinicalTrials.gov)	June 2, 2019	23/8/2018	Rheumatoid Arthritis Memory B Cells and Abatacept	Rheumatoid Arthritis Memory B Cells and Abatacept (RAMBA)	Rheumatoid Arthritis	Drug: Abatacept;Drug: DMARDs	NYU Langone Health	Dartmouth-Hitchcock Medical Center;Bristol-Myers Squibb	Active, not recruiting	18 Years	N/A	All	25	Phase 4	United States
160	EUCTR2018-003933-14-CZ (EUCTR)	28/05/2019	29/04/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of
161	EUCTR2018-003933-14-LV (EUCTR)	27/05/2019	07/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of
162	EUCTR2018-004558-30-ES (EUCTR)	16/05/2019	11/04/2019	Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.	Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Spain
163	EUCTR2018-002306-31-GB (EUCTR)	15/05/2019	14/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Germany;United Kingdom
164	EUCTR2019-000505-72-NL (EUCTR)	13/05/2019	18/02/2019	Baricitinib in patients suffering from Rheumatoid Arthritis	Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT)	Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: baricitinib	Transparency in Healthcare	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
165	EUCTR2018-003933-14-ES (EUCTR)	30/04/2019	21/05/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
166	EUCTR2018-002306-31-BE (EUCTR)	30/04/2019	07/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Spain;Poland;Belgium;United Kingdom
167	EUCTR2018-003933-14-EE (EUCTR)	09/04/2019	14/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia
168	EUCTR2018-002306-31-ES (EUCTR)	04/04/2019	12/04/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
169	NCT03669367 (ClinicalTrials.gov)	April 1, 2019	26/7/2018	EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)	EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)	Palindromic Rheumatism, Wrist	Drug: Abatacept Injection;Drug: hydroxycloroquina	Fundacion Clinic per a la Recerca Biomédica	NULL	Not yet recruiting	18 Years	N/A	All	98	Phase 4	NULL
170	NCT03700021 (ClinicalTrials.gov)	April 2019	2/10/2018	Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis	Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis	Drug: Abatacept + csDMARD	New York University School of Medicine	NULL	Not yet recruiting	18 Years	N/A	All	25	Phase 4	United States
171	EUCTR2018-002202-31-BG (EUCTR)	27/03/2019	30/11/2018	A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid Arthritis	A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate	Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BAT1806 INN or Proposed INN: BAT1806 Other descriptive name: TOCILIZUMAB Trade Name: RoActemra Product Name: RoActerma INN or Proposed INN: RoActemra Other descriptive name: TOCILIZUMAB	Bio-Thera Solutions, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	621	Phase 3	Poland;Ukraine;Georgia;Bulgaria;China
172	NCT04057118 (ClinicalTrials.gov)	March 20, 2019	13/8/2019	A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies	Rheumatoid Arthritis	Drug: SKI-O-703;Drug: Placebo	Oscotec Inc.	NULL	Active, not recruiting	18 Years	N/A	All	148	Phase 2	United States;Czechia;Poland;Russian Federation;Ukraine
173	EUCTR2018-002306-31-HU (EUCTR)	08/03/2019	11/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Czech Republic;Hungary;Canada;Spain;Poland;Belgium;United Kingdom
174	NCT03813771 (ClinicalTrials.gov)	March 2019	12/9/2018	Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification	Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.	Rheumatoid Arthritis	Drug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: Hydroxychloroquine	University of Leeds	Samsung Bioepis Co., Ltd.	Not yet recruiting	18 Years	N/A	All	106	Phase 4	United Kingdom
175	EUCTR2018-000666-10-BE (EUCTR)	19/02/2019	16/11/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Germany;United Kingdom
176	EUCTR2018-001690-25-LT (EUCTR)	08/02/2019	29/08/2018	Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	648	Phase 3	Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria
177	EUCTR2018-003162-13-IT (EUCTR)	23/01/2019	08/11/2018	A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib	A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ 5 mg film-coated tablets Product Name: Xeljanz 5mg INN or Proposed INN: TOFACITINIB	AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Italy
178	EUCTR2018-000666-10-ES (EUCTR)	23/01/2019	22/01/2019	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ABBV-105 Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
179	EUCTR2017-004543-20-ES (EUCTR)	22/01/2019	25/10/2018	EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA).	EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA). - PALABA	PALINDROMIC RHEUMATISM;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ORENCIA INN or Proposed INN: ABATACEPT Trade Name: Dolquine INN or Proposed INN: HYDROXYCHLOROQUINE	Fundació Clínic per a la Recerca Biomèdica	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Spain
180	NCT03729349 (ClinicalTrials.gov)	January 15, 2019	1/11/2018	Golimumab for Adherence in Rheumatoid Arthritis	Golimumab for Adherence in Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: Golimumab	Janssen Inc.	NULL	Active, not recruiting	18 Years	85 Years	All	222		Canada
181	EUCTR2018-000666-10-HU (EUCTR)	03/01/2019	29/10/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom
182	ChiCTR1800018338	2019-01-01	2018-09-12	A Clinical Trial for Human Gingiva Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis	A Clinical Trial for Human Gingiva Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Control:Normal Saline iv. besides MTX treatment;Treatment:GMSC iv. besides MTX treatment;	theThird Affiliated Hospital of Sun Yat-sen University	NULL	Pending	18	65	Both	Control:123;Treatment:123;	I (Phase 1 study)	China
183	NCT03574545 (ClinicalTrials.gov)	December 19, 2018	21/6/2018	Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis	A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: ianalumab	Novartis Pharmaceuticals	NULL	Active, not recruiting	18 Years	65 Years	All	48	Phase 1	Germany;Jordan
184	NCT03784261 (ClinicalTrials.gov)	December 17, 2018	17/12/2018	Usefulness of Non TNF Usage in RA Patients	Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Drug: Drug: Salirumab;Drug: Drug: Tocilizmab;Drug: Drug: Abatacept	Shinshu University	NULL	Recruiting	20 Years	100 Years	All	90	Phase 2	Japan
185	EUCTR2018-000666-10-GB (EUCTR)	17/12/2018	24/10/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105, A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom
186	EUCTR2018-001690-25-PL (EUCTR)	11/12/2018	25/09/2018	Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	564	Phase 3	Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Korea, Republic of;Bosnia and Herzegovina
187	NCT04204603 (ClinicalTrials.gov)	November 30, 2018	17/12/2019	A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects With Moderate-to- Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: CKD-506;Drug: Placebo	Chong Kun Dang Pharmaceutical	NULL	Completed	18 Years	65 Years	All	122	Phase 2	Czechia;Georgia;Poland;Russian Federation;Ukraine
188	NCT03729674 (ClinicalTrials.gov)	November 26, 2018	11/10/2018	Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs	Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs	Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease	Drug: Biosimilar;Drug: Originator (legacy) drug	McGill University Health Centre/Research Institute of the McGill University Health Centre	Université de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research Group	Recruiting	18 Years	N/A	All	800		Canada
189	NCT03789292 (ClinicalTrials.gov)	November 26, 2018	27/12/2018	A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: CT-P17 SC;Biological: Humira SC	Celltrion	NULL	Active, not recruiting	18 Years	75 Years	All	564	Phase 3	Bulgaria
190	NCT03755466 (ClinicalTrials.gov)	November 21, 2018	21/11/2018	Examination of Efficacy and Safety of Baricitinib in RA Patients	Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib	Rheumatoid Arthritis	Drug: Baricitinib, olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz]	Shinshu University	NULL	Recruiting	20 Years	N/A	All	90	Phase 2	Japan
191	NCT03980639 (ClinicalTrials.gov)	November 20, 2018	18/1/2019	Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	Rheumatoid Arthritis	Drug: patient treated with DMARD	University Hospital, Toulouse	NULL	Recruiting	18 Years	N/A	All	594226		France
192	NCT03852888 (ClinicalTrials.gov)	November 14, 2018	7/2/2019	Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients	Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients	Rheumatoid Arthritis	Biological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level	CHU de Reims	NULL	Completed	18 Years	N/A	All	62	N/A	France
193	EUCTR2018-001690-25-HU (EUCTR)	13/11/2018	14/08/2018	Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	564	Phase 3	Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina
194	NCT03707535 (ClinicalTrials.gov)	November 12, 2018	12/10/2018	To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: CT-P13;Biological: Remicade	Celltrion	NULL	Completed	18 Years	75 Years	All	270	Phase 3	China
195	NCT03714022 (ClinicalTrials.gov)	November 9, 2018	18/10/2018	A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes	A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy Participants	Rheumatoid Arthritis	Drug: Abatacept	Bristol-Myers Squibb	NULL	Completed	18 Years	55 Years	All	140	Phase 1	United States
196	EUCTR2018-001690-25-BG (EUCTR)	05/11/2018	19/09/2018	Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	648	Phase 3	Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria;Korea, Republic of
197	NCT04267614 (ClinicalTrials.gov)	November 1, 2018	11/2/2020	This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.	Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept	Arthritis Rheumatoid	Drug: Etanercept	Pfizer	NULL	Completed	N/A	N/A	All	1226		Iraq
198	EUCTR2017-004226-15-DK (EUCTR)	26/10/2018	05/01/2018	Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied.	CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art	Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Cannabidiol tablet 10 mg Other descriptive name: CANNABIDIOL Product Name: Dronabinol capsule 2.5. mg INN or Proposed INN: DRONABINOL	King Christian 10th Hospital for Rheumatology	NULL	Not Recruiting			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Denmark
199	NCT03810144 (ClinicalTrials.gov)	October 22, 2018	26/12/2018	Impact of Guided Care With the Vectra DA Multi-biomarker Disease Activity (MBDA) Blood Test	Impact of Guided Care With the Vectra DA Multi-biomarker Disease Activity (MBDA) Blood Test on Clinical Outcomes and Pharmaceutical Utilization in Patients With Rheumatoid Arthritis: A Prospective, Randomized Study	Rheumatoid Arthritis	Genetic: Vectra DA MBDA Test	Sequenom, Inc.	LabCorp	Active, not recruiting	18 Years	N/A	All	500		United States
200	EUCTR2018-001377-24-CZ (EUCTR)	09/10/2018	14/10/2019	Not available.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CKD-506 INN or Proposed INN: Not yet assigned	Chong Kun Dang Pharmaceutical Corporation (CKD)	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Poland;Ukraine;Russian Federation;Georgia
201	NCT03511625 (ClinicalTrials.gov)	October 2, 2018	10/4/2018	The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis	The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study	Rheumatoid Arthritis	Drug: Acthar Injectable Product;Drug: Depo medrol	Attune Health Research, Inc.	Mallinckrodt	Active, not recruiting	18 Years	N/A	All	6	Phase 3	United States
202	ChiCTR1800018637	2018-09-26	2018-09-30	Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis	Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis	rheumatoid arthritis	Gold Standard:Clinical outcome, meet the 2010 ACR/EULAR rheumatoid arthritis classification criteria.;Index test:Human epididymis protein 4,anti-cyclic citrullinated peptide, creatinine, rheumatoid factor;	Affiliated Hospital of North Sichuan Medical College	NULL	Recruiting			Both	Target condition:150;Difficult condition:100		China
203	EUCTR2018-001114-15-NL (EUCTR)	18/09/2018	28/05/2018	Predicting the risk for rheumatoid arthritis with the help of a PET scan.	Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - Early diagnostics in RA	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: [18F]PEG-Folate	VU Medical Center, department of Rheumatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
204	JPRN-JapicCTI-184229	12/9/2018	03/12/2018	Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe	Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe -Medical Information Database Network-based Cohort Study-	Rheumatoid Arthritis	Intervention name : PRALIA 60mg Subcutaneous Injection Syringe(denosumab) INN of the intervention : denosumab Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	DAIICHISANKYO Co., Ltd.	NULL	other			BOTH	2000	NA	Japan
205	NCT03701789 (ClinicalTrials.gov)	September 11, 2018	4/10/2018	Effect of Baricitinib Treatment on Peripheral Bone in RA	Evaluation of Bone Quality in Patients With Rheumatoid Arthritis Treated With Baricitinib: Single Centre, Mode of Action Study (BARE BONE)	Rheumatoid Arthritis;Bone Density;Finger Joints	Drug: Baricitinib	University of Erlangen-Nürnberg Medical School	NULL	Active, not recruiting	18 Years	74 Years	All	15	Phase 3	Germany
206	JPRN-JapicCTI-184029	04/9/2018	09/07/2018	A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy	A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy	Rheumatoid Arthritis (RA)	Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : Usage: Subcutaneous injection every 4 weeks, Dosage: No active ingredients contain	Taisho Pharmaceutical co., LTD	NULL	complete	20	75	BOTH	370	Phase 2-3	Japan
207	EUCTR2015-004386-91-PL (EUCTR)	26/08/2018	20/07/2016	Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.	A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Poland;Germany
208	NCT03636984 (ClinicalTrials.gov)	August 24, 2018	13/8/2018	Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World	Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study	Rheumatoid Arthritis;Ankylosing Spondylitis	Drug: recombinant TNF-a receptor: IgG Fc fusion protein	Zhejiang Hisun Pharmaceutical Co. Ltd.	NULL	Not yet recruiting	18 Years	N/A	All	1000		NULL
209	EUCTR2017-004079-30-PT (EUCTR)	09/08/2018	29/06/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Spain;Belgium;Italy
210	NCT03535519 (ClinicalTrials.gov)	August 7, 2018	14/5/2018	Rheumatoid Arthritis Response to Methotrexate	Rheumatoid Arthritis Ultrasound Response to Methotrexate	Rheumatoid Arthritis	Drug: Methotrexate	Juan Carlos Nieto	Nordic Pharma SAS	Recruiting	18 Years	N/A	All	50		Spain
211	EUCTR2017-004079-30-ES (EUCTR)	10/07/2018	21/03/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rhuematoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
212	EUCTR2017-004079-30-IT (EUCTR)	06/07/2018	10/09/2021	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Spain;Belgium;Italy
213	EUCTR2016-002344-16-GB (EUCTR)	28/06/2018	29/11/2017	Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.	Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Benepali Product Name: Benepali INN or Proposed INN: ETANERCEPT	University of Leeds	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	106	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
214	JPRN-UMIN000033059	2018/06/20	20/06/2018	The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial	The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial - The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial	Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture	A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty	Hokusuikai Kinen Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	120	Not selected	Japan
215	NCT03535402 (ClinicalTrials.gov)	June 1, 2018	9/5/2018	Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics	Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.	Rheumatoid Arthritis	Drug: Sarilumab	Gaylis, Norman B., M.D.	NULL	Active, not recruiting	18 Years	N/A	All	20	Phase 3	United States
216	EUCTR2017-001944-36-ES (EUCTR)	21/05/2018	10/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG592 INN or Proposed INN: AMG 592 Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	137	Phase 1;Phase 2	United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand
217	NCT03378219 (ClinicalTrials.gov)	May 18, 2018	15/12/2017	An Observational Study on Sarilumab-exposed Pregnancies	Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study	Rheumatoid Arthritis -Exposure During Pregnancy	Drug: Sarilumab SAR153191 (REGN88)	Sanofi	Regeneron Pharmaceuticals	Active, not recruiting	N/A	N/A	Female	113		United States;Canada
218	NCT03508713 (ClinicalTrials.gov)	May 13, 2018	4/6/2017	Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND)	Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China	Rheumatoid Arthritis	Drug: disease modified antirheumatic drugs or biological agents	Nanfang Hospital of Southern Medical University	Southern Medical University, China	Not yet recruiting	18 Years	N/A	All	200		NULL
219	EUCTR2016-000933-37-BG (EUCTR)	09/05/2018	12/01/2018	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
220	EUCTR2017-004054-41-BE (EUCTR)	07/05/2018	15/03/2018	COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA	CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020	early active Rheumatoid Arthritis, previously untreated with DMARDs MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: etanercept INN or Proposed INN: ETANERCEPT INN or Proposed INN: LEFLUNOMIDE	University Hospitals Leuven	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Belgium
221	NCT03505008 (ClinicalTrials.gov)	April 18, 2018	16/4/2018	Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan	MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Adalimumab	Keio University	Eisai Co., Ltd.	Active, not recruiting	18 Years	N/A	All	300	Phase 4	Japan;Korea, Republic of;Taiwan
222	JPRN-UMIN000030584	2018/04/18	27/12/2017	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study	Rheumatoid Arthritis	Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR). If the dosage of MTX is maintained >= 10 mg/week and remission (SDAI <= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1). Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR). If SDAI remission is not achieved despite the dosage of MTX is maintained >= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, and be randomized to a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2) and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). Then, the efficacy and safety will be evaluated. Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage	Keio University School of MedicineDivision of Rheumatology, Department of Internal Medicine	Eisai Co., Ltd.	Complete: follow-up complete	18years-old	Not applicable	Male and Female	300	Not selected	Japan,Asia(except Japan)
223	JPRN-jRCT1031180088	18/04/2018	18/01/2019	MIRACLE Study	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study	Rheumatoid Arthritis Rheumatoid Arthritis	Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period). To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle. If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1). If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2), and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week. Subjects in whom MTX at a dosage >=	Kaneko Yuko	Eisai Co., Ltd.	Complete	>= 18age old	Not applicable	Both	300	Phase 4	South Korea;Taiwan;Japan
224	JPRN-jRCTs071180018	13/04/2018	15/02/2019	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT.	Rheumatoid arthritis	Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.	Kawakami Atsushi	NULL	Complete	>= 20age old	Not applicable	Both	44	Phase 4	Japan
225	JPRN-UMIN000030575	2018/03/31	26/12/2017	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.	Rheumatoid arthritis	Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.	Daiichi Sankyo Company, Limited	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	44	Not applicable	Japan
226	EUCTR2017-001944-36-BG (EUCTR)	13/03/2018	24/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG592 INN or Proposed INN: N/A Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	153	Phase 1;Phase 2	United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand
227	ChiCTR1800014872	2018-03-01	2018-02-12	Role of parecoxib sodium in the multimodal analgesia after total knee arthroplasty	Safety and efficacy of parecoxib sodium in the multimodal analgesia after total knee arthroplasty: a prospective randomized controlled trial	osteoarthritis or rheumatoid arthritis	Experimental group:Preoperative intravenous injection of parecoxib sodium and postoperative intravenous patient-controlled analgesia;Control group:Preoperative normal saline injection and postoperative intravenous patient-controlled analgesia;	Peking Union Medical College Hospital	NULL	Pending			Both	Experimental group:50;Control group:50;		China
228	JPRN-UMIN000031692	2018/03/01	12/03/2018	Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty	Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty - Efficacy of intravenous acetaminophen injection for pain management after TKA	knee osteoarthritis rheumatoid arthritis	Study group:Fentanyl sustained intravenous administration given after operation end. And use the Intravenous acetaminophen 4 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight. Control group:Fentanyl sustained intravenous administration given after operation end.	Yamaguchi University	NULL	Recruiting	20years-old	Not applicable	Male and Female	60	Not selected	Japan
229	EUCTR2017-004079-30-BE (EUCTR)	19/02/2018	19/02/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	219	Phase 3	Portugal;Spain;Belgium;Italy
230	EUCTR2017-004348-39-FR (EUCTR)	15/02/2018	16/01/2018	Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients	Association between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate - POLYGLU	rheumatoid arthritis MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: methotrexate Product Code: 1	CHU Saint-Etienne	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 4	France
231	JPRN-UMIN000030760	2018/02/09	09/02/2018	A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology	A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology - A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology	Hip joint disease scheduled for total hip arthroplasty(THA) (Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture)	Using patient specific guide linked with 3D surgical support software for THA	National Hospital Organization Nagoya Medical Center	NULL	Complete: follow-up continuing	20years-old	Not applicable	Male and Female	3	Not selected	Japan
232	EUCTR2016-003630-25-NL (EUCTR)	08/02/2018	06/09/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2640	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
233	EUCTR2017-002753-11-FI (EUCTR)	25/01/2018	08/11/2017	The effect of the new anti-rheumatic drug tofacitinib on cytokine-induced inflammatory pathways in patients with rheumatoid arthritis	The effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA) - TofaSTAT17	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Xeljanz Product Name: Xeljanz Product Code: PRD4862257 Other descriptive name: TOFACITINIB CITRATE Trade Name: Tofacitinib Product Code: PRD4862257	Tampere University Hospital	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 4	Finland
234	JPRN-UMIN000030828	2018/01/15	15/01/2018	The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.	The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. - EVIDENCE study	Rheumatoid ArthritisOsteoporosis	zoledronic acid denosumab	Osaka City University Graduate School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	500	Not selected	Japan
235	EUCTR2016-004038-24-RO (EUCTR)	12/01/2018	26/05/2022	A 12-week study of a new treatment, MBS2320, in Patients with Rheumatoid Arthritis Taking Methotrexate	A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients with Active Rheumatoid Arthritis receiving Methotrexate	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MBS2320 INN or Proposed INN: 4'-chloro-2'-cyano-N-(trans-4-hydroxy-4-methylcyclohexyl)-biphenyl-4-sulphonamide	Modern Biosciences plc	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 2	Romania;Georgia;Moldova, Republic of
236	EUCTR2017-003259-40-ES (EUCTR)	04/01/2018	24/10/2017	Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.	Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.	Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: amoxicilina INN or Proposed INN: AMOXICILLIN Product Name: metronidazol INN or Proposed INN: METRONIDAZOLE Other descriptive name: metronidazol	Dra Beatriz Lozano-Hospital Universitario de Canarias	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	Spain
237	JPRN-UMIN000030237	2018/01/01	03/12/2017	Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial	Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial - Additional postoperative intravenous tranexamic acid administration versus placebo in total knee arthroplasty	Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis	Additional postoperative intravenous tranexamic acid group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. In addition, patients received 1000mg/100mL of tranexamic acid administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery. Placebo group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. Patients received 100 mL of normal saline administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery.	Hokusuikai Kinen Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not selected	Japan
238	JPRN-jRCTs031180050	26/12/2017	07/12/2018	Hydroxychloroquine for Japanese patients with rheumatoid arthritis	Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis	Rheumatoid arthritis;D001172	Treatment with hydroxychloroquine for 24 weeks	Kaneko Yuko	NULL	Not Recruiting	>= 18age old	Not applicable	Both	120	Phase 2-3	Japan
239	EUCTR2017-001970-41-DK (EUCTR)	21/12/2017	15/09/2017	Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial	Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation)	Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Humira Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: L04AB05 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Enbrel Product Name: Etanercept Product Code: L04AB01 INN or Proposed INN: ETANERCEPT	MD, PhD Salome Kristensen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Denmark
240	EUCTR2014-000555-93-ES (EUCTR)	18/12/2017	10/10/2017	Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia	Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia	Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT	Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 3	Czech Republic;Brazil;Spain;Germany
241	EUCTR2017-001717-92-AT (EUCTR)	11/12/2017	17/08/2017	A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA)	A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA	High IFN siganture in patients with rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab (MEDI-546) INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB	Medical University of Vienna	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Austria;Switzerland;Italy
242	NCT03254966 (ClinicalTrials.gov)	November 24, 2017	15/8/2017	Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients	Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: SHR0302;Drug: Placebo	Jiangsu HengRui Medicine Co., Ltd.	NULL	Completed	18 Years	70 Years	All	194	Phase 2	China
243	NCT03334851 (ClinicalTrials.gov)	November 17, 2017	3/11/2017	Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis	A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS	Systemic Lupus Erythematosus;Rheumatoid Arthritis	Drug: PF-06835375;Drug: Placebo	Pfizer	NULL	Completed	18 Years	70 Years	All	74	Phase 1	United States;Puerto Rico
244	EUCTR2017-000838-64-NL (EUCTR)	10/11/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: AZD9567 Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: Prednisolone	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
245	EUCTR2017-003425-15-DK (EUCTR)	10/11/2017	12/09/2017	Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)	Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)	Treatment of synovitis among rheumatoid arthritis patients MedDRA version: 21.0;Level: PT;Classification code 10042868;Term: Synovitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Diprofos Depot INN or Proposed INN: BETAMETHASONE ACIBUTATE Other descriptive name: Binyrebsrkhormon	Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Denmark
246	NCT04178070 (ClinicalTrials.gov)	November 6, 2017	24/11/2019	Phase ? Clinical Trial of Gerilimzumab Injection in Healthy Subjects	A Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase ? Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects.	Rheumatoid Arthritis	Biological: GB224 2mg;Biological: GB224 5mg;Biological: GB224 10mg;Biological: GB224 15mg;Biological: GB224 20mg;Biological: GB224 30mg;Other: Placebo, 2mg;Other: Placebo, 5mg;Other: Placebo, 10mg;Other: Placebo, 15mg;Other: Placebo, 20mg;Other: Placebo, 30mg	Genor Biopharma Co., Ltd.	NULL	Recruiting	18 Years	45 Years	All	58	Phase 1	China
247	NCT03357471 (ClinicalTrials.gov)	November 3, 2017	23/11/2017	Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease	A Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease	Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease	Drug: e-Device	UCB Biopharma S.P.R.L.	NULL	Completed	18 Years	N/A	All	70	Phase 3	United States
248	NCT03387423 (ClinicalTrials.gov)	November 2, 2017	7/12/2017	Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis	ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS	Arthritis, Rheumatoid	Drug: Tofacitinib	Pfizer	NULL	Recruiting	18 Years	N/A	All	1500		Germany
249	JPRN-UMIN000029797	2017/11/02	02/11/2017	Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial	Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial	Osteoarthritis of the hip, Avascular necrosis of the femoral head, Rheumatoid arthritis	The combined tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of fascia, 1000 mg of tranexamic acid (10 mL of 100 mg/mL tranexamic acid) was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously. The intravenous tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of the fascia, 10 mL of normal saline was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.	Hokusuikai Kinen Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	40	Not selected	Japan
250	NCT03329885 (ClinicalTrials.gov)	November 2, 2017	31/10/2017	A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis	A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe Psoriasis	Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis	Drug: BMS-986251;Other: Placebo	Bristol-Myers Squibb	NULL	Terminated	18 Years	70 Years	All	38	Phase 1/Phase 2	Netherlands
251	EUCTR2017-000384-32-BG (EUCTR)	02/11/2017	12/07/2017	Phase IIb in Rheumatoid Arthritis	A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	363	Phase 2	United States;Serbia;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan
252	JPRN-UMIN000029759	2017/11/01	01/11/2017	Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial	Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial - Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial	Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis	Percutaneous periarticular analgesic injection including methylprednisolone 80 mg [2 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.2 mg [0.2 mL] at one day after simultaneous bilateral total knee arthroplasty No percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty	Nekoyama Miyao Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	32	Not selected	Japan
253	JPRN-JapicCTI-173747	01/11/2017	25/10/2017	Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -	Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -	Rheumatoid Arthritis	Intervention name : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab) INN of the intervention : denosumab Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	DAIICHISANKYO Co., Ltd.	NULL	complete			BOTH	1000	NA	Japan
254	NCT03440892 (ClinicalTrials.gov)	November 1, 2017	14/2/2018	Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients	Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin	Rheumatoid Arthritis	Drug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinib	Vastra Gotaland Region	NULL	Recruiting	20 Years	N/A	All	2500		Sweden
255	NCT02647762 (ClinicalTrials.gov)	October 30, 2017	16/12/2015	CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis	A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: CF101 1 mg;Drug: CF101 2 mg;Drug: Placebo;Drug: MTX	Can-Fite BioPharma	NULL	Active, not recruiting	18 Years	75 Years	All	525	Phase 3	Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia
256	NCT03324412 (ClinicalTrials.gov)	October 28, 2017	25/10/2017	Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis	A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Treatment of MTX;Drug: Treatment of MTX and TwHF	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Not yet recruiting	45 Years	70 Years	All	216	Phase 2/Phase 3	NULL
257	NCT03288584 (ClinicalTrials.gov)	October 27, 2017	16/9/2017	Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis	The Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Inflammation	Drug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents.	University of Athens	NULL	Recruiting	18 Years	80 Years	All	60		Greece
258	EUCTR2016-002126-36-IT (EUCTR)	26/10/2017	31/01/2018	A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520/F03-01	F. Hoffmann - Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Spain;Poland;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy
259	EUCTR2017-000149-30-GB (EUCTR)	25/10/2017	05/09/2017	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease - TRAIL1	Rheumatoid arthritis associated interstitial lung disease (RA-ILD);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Esbriet Product Name: Esbriet INN or Proposed INN: Pirfenidone	University Hospitals of Leicester NHS Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Canada;Australia;United Kingdom
260	EUCTR2016-004834-11-GB (EUCTR)	23/10/2017	16/08/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis - CR6086-2-02	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: CR6086 Other descriptive name: CR0686 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: CR6086 Other descriptive name: CR6086 Trade Name: Methotrexate ® 2.5mg Tablets Product Name: Methotrexate ® 2.5mg Tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets	Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
261	JPRN-UMIN000029003	2017/10/01	05/09/2017	Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial	Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial - Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial	Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis	Percutaneous periarticular analgesic injection including methylprednisolone 40 mg [1 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at one day after total knee arthroplasty No percutaneous periarticular analgesic injection at one day after total knee arthroplasty	Nekoyama Miyao Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	40	Not selected	Japan
262	EUCTR2016-005017-45-PL (EUCTR)	27/09/2017	19/06/2017	A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody	NovImmune S.A.	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
263	EUCTR2017-000384-32-CZ (EUCTR)	26/09/2017	26/07/2017	Phase IIb in Rheumatoid Arthritis	A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	363	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;South Africa;Bulgaria;Germany;Japan
264	EUCTR2012-003655-11-FR (EUCTR)	18/09/2017	28/09/2015	Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life	A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis	moderately to severely active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany
265	EUCTR2017-000838-64-SE (EUCTR)	11/09/2017	19/05/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: AZD9567 Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
266	NCT03262740 (ClinicalTrials.gov)	September 11, 2017	24/8/2017	The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients	The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects	Rheumatoid Arthritis	Drug: BMS-986195;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol)	Bristol-Myers Squibb	NULL	Completed	18 Years	40 Years	Female	58	Phase 1	United States
267	EUCTR2016-004834-11-PL (EUCTR)	05/09/2017	17/07/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets	Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
268	EUCTR2016-004834-11-BG (EUCTR)	04/09/2017	01/06/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets	Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
269	EUCTR2017-000838-64-DK (EUCTR)	25/08/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
270	EUCTR2016-004834-11-CZ (EUCTR)	16/08/2017	02/08/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets	Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
271	NCT03327454 (ClinicalTrials.gov)	August 10, 2017	11/10/2017	Benepali® PEN Patient Satisfaction Survey	Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen	Rheumatoid Arthritis;Spondyloarthropathies	Biological: Benepali	Biogen	NULL	Completed	18 Years	N/A	All	500		Germany
272	EUCTR2016-000933-37-SE (EUCTR)	09/08/2017	09/11/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
273	EUCTR2013-005543-90-EE (EUCTR)	07/08/2017	02/06/2017	This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 Biosimilar to Rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
274	EUCTR2015-005309-35-LV (EUCTR)	04/08/2017	19/05/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
275	NCT03215407 (ClinicalTrials.gov)	August 1, 2017	22/6/2017	The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone	The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee	Rheumatoid Arthritis of Knee	Drug: Intra-articular Tocilizumab;Drug: Intra-articular Compound Betamethasone	Chinese PLA General Hospital	NULL	Not yet recruiting	18 Years	65 Years	All	60	Phase 4	NULL
276	EUCTR2016-002126-36-ES (EUCTR)	31/07/2017	02/06/2017	A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors	A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy
277	JPRN-UMIN000028376	2017/07/26	01/08/2017	Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis	Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis - Study of ultrasound detected residual synovitis in rheumatoid arthritis	rheumatoid arthritis	Combination of anti-rheumatic therapy and denosumab Anti-rheumatic therapy alone	Hokkaido Medical Center for Rheumatic Diseases	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	30	Not selected	Japan
278	EUCTR2016-000569-21-NL (EUCTR)	18/07/2017	29/06/2017	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
279	EUCTR2016-001064-11-GB (EUCTR)	18/07/2017	31/03/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade	Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
280	EUCTR2016-000568-41-NL (EUCTR)	18/07/2017	29/06/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
281	EUCTR2016-004834-11-DK (EUCTR)	06/07/2017	11/05/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: see D.3.9.3 'Other descriptive name' below Other descriptive name: CR6086 Trade Name: Methotrexate® 2.5 mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets	Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
282	EUCTR2016-002125-11-ES (EUCTR)	06/07/2017	08/05/2017	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 1;Phase 3	Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of;Estonia;Slovakia;Spain;Ukraine
283	ChiCTR-IPR-17011566	2017-07-01	2017-06-05	The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China	The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China	Rheumatoid Arthritis;M05.901	Sirolimus group: Sirolimus; Non-Sirolimus group:Glucocorticoids and Immunosuppressant;	the Second Hospital of Shanxi Medical University	NULL	Recruiting	18	65	Both	Sirolimus group:200; Non-Sirolimus group:100;		China
284	EUCTR2016-001825-15-IT (EUCTR)	28/06/2017	16/02/2018	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinb Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE	PFIZER INC	NULL	Not Recruiting			Female: yes Male: yes	580	Phase 3	Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy
285	EUCTR2016-001825-15-DE (EUCTR)	26/06/2017	01/03/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	580	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
286	EUCTR2015-005309-35-BG (EUCTR)	22/06/2017	02/05/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm International, LLC.	NULL	Not Recruiting			Female: yes Male: yes	1880	Phase 3	Belarus;United States;Czechia;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
287	EUCTR2016-000933-37-NL (EUCTR)	19/06/2017	18/04/2017	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
288	EUCTR2015-002887-17-FR (EUCTR)	19/06/2017	16/02/2016	Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis	Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors	Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	610	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
289	EUCTR2015-005309-35-GB (EUCTR)	16/06/2017	09/06/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1880	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
290	EUCTR2016-005017-45-GB (EUCTR)	15/06/2017	27/10/2017	A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody	NovImmune S.A.	NULL	Not Recruiting			Female: yes Male: yes	81	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
291	EUCTR2016-000933-37-SK (EUCTR)	15/06/2017	24/04/2017	Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	313	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
292	JPRN-UMIN000027719	2017/06/12	12/06/2017	Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy.	Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy. - Effect of tapering MTX in RA patinents after add-on IGU theraoy.	rheumatoid arthritis/remission	add-on iguratimod tapering MTX continuing the treatment	Osaka Medical College	NULL	Recruiting	20years-old	100years-old	Male and Female	100	Not selected	Japan
293	EUCTR2016-000569-21-FR (EUCTR)	08/06/2017	04/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
294	EUCTR2016-002337-30-HR (EUCTR)	05/06/2017	12/09/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
295	EUCTR2016-002337-30-DE (EUCTR)	24/05/2017	06/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	269	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
296	EUCTR2015-005309-35-DE (EUCTR)	23/05/2017	24/01/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm International LLC	NULL	Not Recruiting			Female: yes Male: yes	1880	Phase 3	United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Estonia;Lithuania;Russian Federation;Colombia
297	EUCTR2015-005309-35-PL (EUCTR)	19/05/2017	17/03/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm International LLC	NULL	Not Recruiting			Female: yes Male: yes	1880	Phase 3	Belarus;United States;Czechia;Estonia;Taiwan;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Georgia;Bulgaria;Latvia;Germany;Korea, Republic of
298	JPRN-UMIN000027250	2017/05/15	08/05/2017	Precision medicine of methotrexate in the patients with rheumatoid arthritis	Precision medicine of methotrexate in the patients with rheumatoid arthritis - Methotrexate precision medicine	Rheumatoid arthritis	MTX administration	Keio UniversityFukuoka Tokushukai Hospital	NULL	Recruiting	20years-old	90years-old	Male and Female	50	Not selected	Japan
299	EUCTR2016-005017-45-HU (EUCTR)	12/05/2017	13/03/2017	A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody	NovImmune S.A.	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
300	EUCTR2016-005017-45-BG (EUCTR)	11/05/2017	06/04/2017	A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody	NovImmune S.A.	NULL	Not Recruiting			Female: yes Male: yes	81	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
301	EUCTR2014-005368-13-IT (EUCTR)	10/05/2017	16/02/2018	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ARCHIGEN BIOTECH LIMITED	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
302	NCT03241108 (ClinicalTrials.gov)	May 10, 2017	26/6/2017	Study of an Anti-TLR4 mAb in Rheumatoid Arthritis	Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: NI-0101;Other: Placebo	NovImmune SA	NULL	Completed	18 Years	N/A	All	90	Phase 2	Bosnia and Herzegovina;Bulgaria;Georgia;Hungary;Moldova, Republic of;Poland;Serbia
303	EUCTR2016-000897-39-DE (EUCTR)	10/05/2017	27/10/2016	An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.	Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
304	EUCTR2016-001825-15-BE (EUCTR)	08/05/2017	28/02/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	680	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
305	EUCTR2016-002337-30-CZ (EUCTR)	03/05/2017	06/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
306	EUCTR2016-000569-21-DE (EUCTR)	02/05/2017	04/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
307	EUCTR2016-000933-37-CZ (EUCTR)	02/05/2017	22/11/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
308	EUCTR2016-001825-15-HU (EUCTR)	01/05/2017	22/03/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	580	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
309	EUCTR2016-000933-37-DE (EUCTR)	27/04/2017	17/10/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
310	EUCTR2016-001064-11-CZ (EUCTR)	20/04/2017	31/03/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade	Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
311	EUCTR2016-000570-37-DE (EUCTR)	19/04/2017	24/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
312	EUCTR2016-000568-41-DE (EUCTR)	19/04/2017	24/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
313	EUCTR2016-002126-36-DE (EUCTR)	18/04/2017	23/11/2016	A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors	A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom
314	EUCTR2016-001064-11-PL (EUCTR)	13/04/2017	12/04/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade	Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom
315	EUCTR2016-002337-30-BG (EUCTR)	11/04/2017	30/01/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
316	EUCTR2016-001825-15-BG (EUCTR)	11/04/2017	07/02/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	680	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Bulgaria;South Africa;Germany;Korea, Republic of
317	EUCTR2016-002337-30-SK (EUCTR)	10/04/2017	08/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc.	,NULL	Not Recruiting			Female: yes Male: yes	230	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
318	EUCTR2016-001064-11-ES (EUCTR)	07/04/2017	07/04/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NI-071 Product Code: NI-071 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade	Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
319	EUCTR2016-001825-15-GB (EUCTR)	03/04/2017	01/03/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	680	Phase 3;Phase 4	Korea, Republic of;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Poland;Australia;South Africa;Bulgaria;Germany
320	EUCTR2016-000897-39-BE (EUCTR)	03/04/2017	02/02/2017	An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.	Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
321	NCT03291457 (ClinicalTrials.gov)	March 30, 2017	20/9/2017	A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice	A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Glucocorticoid Agent	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	101		Belgium
322	EUCTR2016-001825-15-PL (EUCTR)	29/03/2017	08/03/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	680	Phase 3;Phase 4	Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of
323	EUCTR2015-005307-83-RO (EUCTR)	28/03/2017	22/06/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	1575	Phase 3	United States;Czechia;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
324	EUCTR2016-002862-30-PL (EUCTR)	28/03/2017	03/04/2017	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
325	EUCTR2016-002337-30-ES (EUCTR)	27/03/2017	10/03/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
326	EUCTR2011-004720-35-NL (EUCTR)	22/03/2017	22/02/2017	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE INN or Proposed INN: METHOTREXATE INN or Proposed INN: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE INN or Proposed INN: PREDNISOLONE	The Karolinska Institute, ClinTRID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Iceland;Netherlands;Sweden
327	EUCTR2016-002862-30-CZ (EUCTR)	22/03/2017	14/12/2016	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
328	EUCTR2016-000568-41-BG (EUCTR)	21/03/2017	24/01/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
329	EUCTR2016-000570-37-BG (EUCTR)	21/03/2017	13/02/2017	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
330	EUCTR2016-001825-15-CZ (EUCTR)	21/03/2017	21/03/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	680	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
331	EUCTR2016-002337-30-HU (EUCTR)	16/03/2017	06/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06650833 INN or Proposed INN: PF-06650833 100 mg Product Code: PF-06650833 INN or Proposed INN: PF-06650833 20 mg Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
332	EUCTR2015-005309-35-CZ (EUCTR)	16/03/2017	31/01/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm International LLC	NULL	Not Recruiting			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of
333	EUCTR2015-005309-35-HU (EUCTR)	16/03/2017	02/02/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of
334	EUCTR2016-002862-30-DE (EUCTR)	15/03/2017	26/01/2017	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
335	EUCTR2016-000933-37-BE (EUCTR)	14/03/2017	24/11/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
336	EUCTR2015-003289-97-DE (EUCTR)	09/03/2017	30/11/2016	A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis	Protocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	276	Phase 2	United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
337	EUCTR2016-002852-26-DE (EUCTR)	09/03/2017	06/10/2016	MSB11022 in moderately to severely active rheumatoid arthritis	A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA	moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
338	EUCTR2016-001825-15-ES (EUCTR)	09/03/2017	10/03/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	580	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
339	EUCTR2015-005309-35-LT (EUCTR)	06/03/2017	31/01/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm International LLC	NULL	Not Recruiting			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of
340	EUCTR2015-005307-83-LV (EUCTR)	03/03/2017	16/03/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	1575	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
341	EUCTR2016-002126-36-AT (EUCTR)	01/03/2017	11/11/2016	A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors	A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 2	United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany
342	NCT03025308 (ClinicalTrials.gov)	February 28, 2017	17/1/2017	Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Filgotinib;Drug: Placebo to match filgotinib	Galapagos NV	Gilead Sciences	Active, not recruiting	18 Years	N/A	All	2731	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Netherlands
343	EUCTR2014-004868-38-DE (EUCTR)	23/02/2017	25/05/2016	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
344	EUCTR2015-003289-97-ES (EUCTR)	20/02/2017	21/02/2017	A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis	Protocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available	Lilly S.A.	NULL	Not Recruiting			Female: yes Male: yes	276	Phase 2	United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
345	EUCTR2016-002862-30-SK (EUCTR)	16/02/2017	14/12/2016	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
346	EUCTR2016-001825-15-SK (EUCTR)	16/02/2017	14/12/2016	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	680	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
347	EUCTR2016-002862-30-BG (EUCTR)	16/02/2017	10/01/2017	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
348	EUCTR2016-000568-41-PL (EUCTR)	15/02/2017	14/02/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4ml s.c.injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
349	EUCTR2016-000570-37-PL (EUCTR)	15/02/2017	13/02/2017	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Russian Federation;Hong Kong;United States;Malaysia;Thailand;Ireland;Poland;Brazil;Korea, Republic of;Slovakia;Chile;France;Serbia;Bulgaria;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Switzerland;India;Spain;New Zealand;Canada;Czech Republic;Belgium;Taiwan;Italy;Mexico;South Africa;Israel;Australia;Peru;Germany
350	EUCTR2016-000569-21-PL (EUCTR)	15/02/2017	14/02/2017	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
351	EUCTR2016-000568-41-IT (EUCTR)	08/02/2017	17/06/2021	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response toMethotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administeredfor 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate - NA	Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: Filgotinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: Filgotinib Trade Name: Methotrexate INN or Proposed INN: METOTRESSATO SALE SODICO Trade Name: Humira INN or Proposed INN: ADALIMUMAB	GILEAD SCIENCES INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;United Kingdom;Czech Republic;Hungary;Mexico
352	ChiCTR-IPR-17010325	2017-01-31	2017-01-04	The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial	The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial	rheumatic disease;M05.901	Metformin Group:Metformin combined Glucocorticoids and DMARDs;Non-Metformin Group:Glucocorticoids and DMARDs;Metformin combined with Coenzyme Q10 Group:Metformin and Coenzyme Q10 combined Glucocorticoids and DMARDs;	the Second Hospital of Shanxi Medical University	NULL	Pending	18	65	Both	Metformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100;		China
353	EUCTR2016-002862-30-HU (EUCTR)	31/01/2017	23/11/2016	A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-06651600 INN or Proposed INN: not yet assigned	Pfizer Inc 235 East 42nd Street, New York, NY10017 US	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
354	EUCTR2013-003413-18-NL (EUCTR)	30/01/2017	28/09/2015	Arthritis prevention with abatacept	Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA	The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis. MedDRA version: 20.0;Level: PT;Classification code 10003239;Term: Arthralgia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA 125 mg solution for injection	Leiden University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	206	Phase 2	Netherlands;United Kingdom
355	EUCTR2016-000933-37-PT (EUCTR)	30/01/2017	09/11/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Belarus;Portugal;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
356	EUCTR2016-000569-21-BE (EUCTR)	30/01/2017	28/10/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
357	EUCTR2016-000570-37-BE (EUCTR)	30/01/2017	17/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
358	EUCTR2016-000933-37-IT (EUCTR)	17/01/2017	07/09/2021	Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs) - M15-925	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: Orencia 250mg powder for concentrate for solution for infusion Product Name: Abatacept Product Code: NA INN or Proposed INN: ABATACEPT	ABBVIE DEUTSCHLAND GMBH & CO. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	313	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
359	EUCTR2016-000570-37-ES (EUCTR)	13/01/2017	13/01/2017	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
360	EUCTR2016-000569-21-ES (EUCTR)	13/01/2017	13/01/2017	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
361	EUCTR2016-000568-41-ES (EUCTR)	13/01/2017	13/01/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
362	NCT03112213 (ClinicalTrials.gov)	January 12, 2017	10/4/2017	Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment	CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: NSAIDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	135		Germany
363	EUCTR2016-000897-39-HU (EUCTR)	09/01/2017	19/10/2016	An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.	Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	United States;Taiwan;Hungary;Mexico;Belgium;Australia;Germany
364	EUCTR2015-003140-39-PL (EUCTR)	09/01/2017	11/01/2017	A Study to EValuate the Efficacy and Safety of JTE-051 on Subjects with Active Rheumatoid Arthritis (MOVE-RA)	A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA	Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JTE-051 Product Code: JTE-051 INN or Proposed INN: No proposed INN available Other descriptive name: JTE-051	Akros Pharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia
365	NCT02760433 (ClinicalTrials.gov)	January 9, 2017	29/4/2016	Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease	A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy	Rheumatoid Arthritis	Drug: Olokizumab q4w;Drug: Olokizumab q2w;Drug: Placebo q2w	R-Pharm	Quintiles, Inc.;OCT Clinical Trials;Mene Research	Active, not recruiting	18 Years	N/A	All	350	Phase 3	United States;Argentina;Brazil;Colombia;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Russian Federation;Czech Republic;Turkey
366	EUCTR2016-000568-41-CZ (EUCTR)	05/01/2017	21/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
367	EUCTR2016-001532-35-BG (EUCTR)	05/01/2017	14/11/2016	A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.	A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.	Moderate to Severe Rheumatoid Arthritis. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: LNP1955	Lupin Limited	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Hungary;Poland;Bulgaria
368	EUCTR2016-000570-37-CZ (EUCTR)	05/01/2017	22/11/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
369	EUCTR2016-002852-26-BG (EUCTR)	05/01/2017	03/01/2017	MSB11022 in moderately to severely active rheumatoid arthritis	A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA	moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	260	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
370	EUCTR2016-002852-26-GB (EUCTR)	05/01/2017	23/09/2016	MSB11022 in moderately to severely active rheumatoid arthritis	A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA	moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	260	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
371	EUCTR2016-000568-41-BE (EUCTR)	04/01/2017	17/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
372	ChiCTR-IPR-17010307	2017-01-01	2017-01-01	The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China	The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China	Rheumatoid Arthritis;M05.901	Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs;	the Second Hospital of Shanxi Medical University	NULL	Recruiting	18	65	Both	Rapamycin group:200;Non-rapamycin group :100;		China
373	NCT03016884 (ClinicalTrials.gov)	January 2017	1/1/2017	Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients	Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation	Herpes Zoster	Biological: Zostavax vaccine	HaEmek Medical Center, Israel	NULL	Active, not recruiting	50 Years	N/A	All	87	Phase 4	Israel
374	EUCTR2016-000933-37-ES (EUCTR)	28/12/2016	17/11/2016	Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 3	United States;Belarus;Spain;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Latvia;Norway;New Zealand
375	EUCTR2016-000569-21-GB (EUCTR)	23/12/2016	01/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
376	EUCTR2016-000568-41-GB (EUCTR)	23/12/2016	13/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;United States;Serbia;Taiwan;Hong Kong;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
377	EUCTR2016-001496-75-CZ (EUCTR)	20/12/2016	30/09/2016	A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GS-9876 Product Code: GS-9876 INN or Proposed INN: GS-9876 INN or Proposed INN: GS-9876 Product Name: filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria
378	EUCTR2014-004704-29-DE (EUCTR)	19/12/2016	23/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
379	EUCTR2014-004704-29-CZ (EUCTR)	15/12/2016	02/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
380	EUCTR2016-001496-75-PL (EUCTR)	13/12/2016	03/11/2016	A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GS-9876 Product Code: GS-9876 INN or Proposed INN: GS-9876 INN or Proposed INN: GS-9876 Product Name: filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria
381	EUCTR2016-000569-21-HU (EUCTR)	12/12/2016	07/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
382	EUCTR2015-003289-97-SK (EUCTR)	12/12/2016	11/08/2016	A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis	Protocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	276	Phase 2	United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
383	EUCTR2016-002852-26-CZ (EUCTR)	07/12/2016	21/09/2016	MSB11022 in moderately to severely active rheumatoid arthritis	A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA	moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	260	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
384	EUCTR2016-002852-26-LT (EUCTR)	07/12/2016	24/10/2016	MSB11022 in moderately to severely active rheumatoid arthritis	A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA	moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	United States;Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
385	EUCTR2016-000933-37-LV (EUCTR)	06/12/2016	31/10/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Portugal;Belarus;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
386	EUCTR2015-003140-39-BG (EUCTR)	05/12/2016	23/11/2016	A Study to EValuate the Efficacy and Safety of JTE-051 in Subjects with Active Rheumatoid Arthritis (MOVE-RA)	A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA	Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JTE-051 Product Code: JTE-051 INN or Proposed INN: No proposed INN available Other descriptive name: JTE-051	Akros Pharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia
387	EUCTR2016-000568-41-HU (EUCTR)	02/12/2016	19/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
388	EUCTR2016-000570-37-HU (EUCTR)	02/12/2016	19/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Ukraine;Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
389	NCT02982083 (ClinicalTrials.gov)	December 2016	1/12/2016	Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis	Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Raloxifene hydrochloride;Drug: Placebo Oral Tablet	Sara Saeidi Shahri	NULL	Not yet recruiting	50 Years	N/A	Female	40	N/A	NULL
390	NCT02983227 (ClinicalTrials.gov)	November 30, 2016	29/11/2016	A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350	A Phase II Open-Label Extension Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: GDC-0853	Genentech, Inc.	NULL	Completed	18 Years	76 Years	All	496	Phase 2	United States;Argentina;Brazil;Bulgaria;Colombia;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile;Korea, Republic of
391	EUCTR2016-000570-37-SK (EUCTR)	29/11/2016	04/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
392	EUCTR2014-004704-29-BG (EUCTR)	29/11/2016	15/09/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
393	NCT02986139 (ClinicalTrials.gov)	November 29, 2016	2/11/2016	Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis	A Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic Arthritis	Arthritis, Rheumatoid; Arthritis, Psoriatic	Drug: Commercial Formulation Etanercept;Drug: New Formulation Etanercept	Amgen	NULL	Completed	18 Years	N/A	All	111	Phase 3	United States;Puerto Rico
394	NCT02960490 (ClinicalTrials.gov)	November 26, 2016	3/11/2016	A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics	A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics	Rheumatoid Arthritis	Drug: E6011;Drug: Placebo	Eisai Co., Ltd.	NULL	Completed	18 Years	75 Years	All	64	Phase 2	Japan
395	EUCTR2014-004704-29-PL (EUCTR)	25/11/2016	04/10/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany
396	EUCTR2016-000933-37-HU (EUCTR)	24/11/2016	12/10/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Czechia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
397	EUCTR2014-005368-13-DE (EUCTR)	22/11/2016	04/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
398	JPRN-UMIN000026819	2016/11/21	01/04/2017	A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients.	A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients. - A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients.	osteoarthritis of the hip, osteonecrosis of the femoral head, femoral neck fracture, rheumatoid arthritis, rapidly destructive coxarthropathy, septic arthritis of the hip	Dose: Edoxaban group; Edoxaban 15mg per day Enoxaparin gropu; Enoxaparin 2000 IU per day Intervention period: for 10 days after the surgery	Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	80	Not selected	Japan
399	EUCTR2016-002852-26-HU (EUCTR)	15/11/2016	29/09/2016	MSB11022 in moderately to severely active rheumatoid arthritis	A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA	moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: adalimumab Product Code: MSB11022 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	United States;Czech Republic;Hungary;Poland;Lithuania;Bulgaria;Germany;United Kingdom
400	NCT02874092 (ClinicalTrials.gov)	November 15, 2016	17/8/2016	Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis	Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Ticagrelor;Drug: MTX therapy	NYU Langone Health	NULL	Completed	18 Years	N/A	All	9	Phase 4	United States
401	EUCTR2016-000570-37-GB (EUCTR)	14/11/2016	17/10/2016	Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment	A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Methotrexate tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand
402	NCT02996500 (ClinicalTrials.gov)	November 10, 2016	13/10/2016	Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis	Drug: PF-06650833;Drug: Placebo;Drug: Tofacitinib	Pfizer	NULL	Completed	18 Years	75 Years	All	269	Phase 2	United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine
403	EUCTR2015-005307-83-DE (EUCTR)	10/11/2016	24/03/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	1575	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
404	EUCTR2015-005308-27-DE (EUCTR)	08/11/2016	09/05/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Turkey;Russian Federation;Colombia;Germany;Korea, Republic of
405	EUCTR2016-002908-15-NL (EUCTR)	08/11/2016	23/08/2016	REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritis	REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO	Rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Sint Maartenskliniek	NULL	Not Recruiting			Female: yes Male: yes	140	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
406	EUCTR2015-005800-27-PL (EUCTR)	08/11/2016	03/10/2016	Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDs	A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis	Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK3117391 Product Code: GSK3117391 INN or Proposed INN: Not applicable Other descriptive name: GSK3117391	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Poland;Romania;Russian Federation
407	NCT02919761 (ClinicalTrials.gov)	November 7, 2016	26/9/2016	Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis	A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment	Arthritis, Rheumatoid	Drug: Acthar Gel;Drug: Placebo	Mallinckrodt	NULL	Completed	18 Years	N/A	All	259	Phase 4	United States;Argentina;Mexico;Peru;Puerto Rico;Colombia
408	EUCTR2015-003334-27-FI (EUCTR)	02/11/2016	17/06/2016	A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
409	NCT02960438 (ClinicalTrials.gov)	November 2, 2016	3/11/2016	A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate	A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate	Rheumatoid Arthritis	Drug: E6011;Drug: Placebo	Eisai Co., Ltd.	NULL	Completed	18 Years	75 Years	All	190	Phase 2	Japan
410	ChiCTR-INR-16009546	2016-11-01	2016-10-21	The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis	The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis	rheumatoid arthritis;M05.901	IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs;	the Second Hospital of Shanxi Medical University	NULL	Recruiting	18	65	Both	IL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15;		China
411	NCT03067870 (ClinicalTrials.gov)	November 2016	25/2/2017	Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis	Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis	RheumatoId Arthritis;Osteoarthritis, Knee;Osteoarthritis, Hip	Biological: Stem Cell Transplantation	Stem Cells Arabia	NULL	Active, not recruiting	17 Years	75 Years	All	100	Phase 1	NULL
412	EUCTR2015-003334-27-RO (EUCTR)	27/10/2016	28/06/2016	A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: MTX HEXAL 2,5mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand
413	EUCTR2016-002125-11-BG (EUCTR)	27/10/2016	13/10/2016	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;Bulgaria;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of
414	EUCTR2015-003289-97-PL (EUCTR)	25/10/2016	17/08/2016	A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	276	Phase 2	United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
415	EUCTR2015-003289-97-AT (EUCTR)	20/10/2016	12/08/2016	A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis	Protocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	276	Phase 2	United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
416	EUCTR2016-002125-11-CZ (EUCTR)	17/10/2016	21/07/2016	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Estonia;Spain;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Poland;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
417	EUCTR2016-002061-54-IT (EUCTR)	13/10/2016	15/11/2018	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)	Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Italy
418	EUCTR2016-000498-19-BG (EUCTR)	13/10/2016	19/08/2016	A Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Rheumatoid Arthritis	A PHASE II OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA29350 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GDC-0853 Product Code: RO7010939 INN or Proposed INN: not available Other descriptive name: GDC-0853 RO7010939	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	580	Phase 2	United States;Serbia;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
419	JPRN-jRCTs041180071	13/10/2016	07/03/2019	T-ReX study	Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study	Rheumatoid arthritis	At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Kojima Toshihisa	NULL	Complete	>= 20age old	Not applicable	Both	51	N/A	Japan
420	EUCTR2016-000568-41-SK (EUCTR)	11/10/2016	04/10/2016	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
421	EUCTR2014-004704-29-HU (EUCTR)	05/10/2016	08/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
422	EUCTR2015-004858-17-NL (EUCTR)	05/10/2016	28/09/2016	REMission INDuction in very early Rheumatoid Arthritis	REMission INDuction in very early Rheumatoid Arthritis - REMINDRA	Very early Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Methotrexate Product Name: Methotrexate Product Code: MTX INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Golimumab Product Name: Golimumab Product Code: GOL INN or Proposed INN: GOLIMUMAB	University Medical Center Utrecht (UMCU)	NULL	Not Recruiting			Female: yes Male: yes	267	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
423	EUCTR2016-000912-13-PL (EUCTR)	04/10/2016	26/07/2016	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.	subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Spain;Poland;Romania;Germany;Italy;United Kingdom
424	EUCTR2014-004704-29-ES (EUCTR)	03/10/2016	05/08/2016	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 710 Product Code: ABP 710 INN or Proposed INN: ABP 710 Other descriptive name: ABP 710 - Biosimilar to infliximab Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
425	JPRN-UMIN000024025	2016/10/01	01/10/2016	The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study	The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study - ALIBABA study	Rheumatoid Arthritis	receiving 40 mg open-label ADA every other week for 26 weeks with low dose MTX (6mg/week) receiving 40 mg open-label ADA every other week for 26 weeks with high dose MTX (12mg/week)	Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare	NULL	Recruiting	20years-old	Not applicable	Male and Female	80	Not applicable	Japan
426	NCT02805010 (ClinicalTrials.gov)	October 2016	12/6/2016	Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously	A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects	Rheumatoid Arthritis (RA)	Drug: Abatacept;Other: Placebo	Jiangsu Simcere Pharmaceutical Co., Ltd.	Bristol-Myers Squibb	Active, not recruiting	18 Years	45 Years	Both	22	Phase 1	NULL
427	EUCTR2014-005368-13-ES (EUCTR)	23/09/2016	15/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
428	NCT02648035 (ClinicalTrials.gov)	September 22, 2016	5/1/2016	EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis	Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.	Rheumatoid Arthritis	Biological: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	200		Greece
429	EUCTR2014-004904-31-BE (EUCTR)	21/09/2016	29/07/2016	A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remsima (infliximab)	Mundipharma Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 4	Belgium;Netherlands
430	EUCTR2014-005368-13-HU (EUCTR)	19/09/2016	11/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy
431	EUCTR2014-005368-13-CZ (EUCTR)	13/09/2016	13/09/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
432	EUCTR2012-002535-28-NL (EUCTR)	13/09/2016	01/09/2016	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Product Code: L01X CO2 Trade Name: RoActemra Product Name: RoActemra Product Code: L04AC07	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
433	EUCTR2015-003335-35-SI (EUCTR)	12/09/2016	28/09/2016	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
434	EUCTR2015-002729-21-PT (EUCTR)	12/09/2016	27/04/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria	Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
435	EUCTR2016-002125-11-HU (EUCTR)	08/09/2016	11/07/2016	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 1;Phase 3	Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Hungary;Czech Republic;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
436	EUCTR2015-003334-27-SI (EUCTR)	07/09/2016	14/12/2015	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
437	EUCTR2016-000912-13-GB (EUCTR)	05/09/2016	12/06/2017	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.	subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	36	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Poland;Spain;Romania;Germany;Italy;United Kingdom
438	NCT02666443 (ClinicalTrials.gov)	September 2016	24/1/2016	Low Dose Dexamethasone in Supraclavicular Blocks	Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study	Rheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament Injury	Drug: Control intervention (no dexamethasone);Drug: Peri-neural Dexamethasone 1 mg;Drug: Intravenous Dexamethasone 1 mg	University of Calgary	NULL	Recruiting	18 Years	80 Years	Both	306	N/A	Canada
439	EUCTR2016-000912-13-DE (EUCTR)	30/08/2016	29/06/2016	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.	subjects with moderate to severe rheumatoid arthritis. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	36	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Poland;Spain;Romania;Germany;Italy;United Kingdom
440	EUCTR2015-003334-27-LT (EUCTR)	30/08/2016	06/06/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
441	EUCTR2015-003335-35-BG (EUCTR)	29/08/2016	01/08/2016	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
442	EUCTR2016-000335-40-BG (EUCTR)	23/08/2016	08/07/2016	A Study examining the treatment effect and Safety of GDC-0853 when compared With Placebo and a biologic therapy (Adalimumab) in Rheumatoid Arthritis Patients who have not responded or intolerance to Previous therapies.	A TWO-COHORT RANDOMIZED PHASE II, DOUBLEBLIND, PARALLEL GROUP STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS EVALUATING THE EFFICACY AND SAFETY OF GDC-0853 COMPARED WITH PLACEBO AND ADALIMUMAB IN PATIENTS WITH AN INADEQUATE RESPONSE TO PREVIOUS METHOTREXATE THERAPY (COHORT 1) AND COMPARED WITH PLACEBO IN PATIENTS WITH AN INADEQUATE RESPONSE OR INTOLERANCE TO PREVIOUS TNF THERAPY (COHORT 2)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GDC-0853 Product Code: RO7010939 INN or Proposed INN: not available Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
443	EUCTR2016-002125-11-LV (EUCTR)	23/08/2016	01/07/2016	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Korea, Republic of;Bosnia and Herzegovina
444	EUCTR2016-002125-11-EE (EUCTR)	22/08/2016	05/07/2016	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
445	EUCTR2015-004386-91-DE (EUCTR)	22/08/2016	18/05/2016	Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.	A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Poland;Germany
446	EUCTR2015-003334-27-BG (EUCTR)	18/08/2016	18/07/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand
447	NCT02705989 (ClinicalTrials.gov)	August 18, 2016	7/3/2016	Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects	A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy Subjects	Rheumatoid Arthritis	Drug: BMS-986195;Other: Placebo	Bristol-Myers Squibb	NULL	Completed	18 Years	55 Years	All	439	Phase 1	Australia
448	EUCTR2015-003335-35-HU (EUCTR)	18/08/2016	18/03/2016	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
449	EUCTR2016-000064-42-BG (EUCTR)	11/08/2016	28/06/2016	Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis	Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951 Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	64	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;Bulgaria
450	EUCTR2015-003333-95-FI (EUCTR)	10/08/2016	19/04/2016	A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
451	EUCTR2015-003335-35-FI (EUCTR)	10/08/2016	22/04/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
452	EUCTR2016-000393-37-BG (EUCTR)	08/08/2016	17/06/2016	A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.	A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940	UCB Biopharma Sprl	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom
453	EUCTR2016-001532-35-HU (EUCTR)	08/08/2016	15/06/2016	A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.	A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.	Moderate to Severe Rheumatoid Arthritis. MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: LNP1955	Lupin Limited	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Hungary;Bulgaria
454	EUCTR2016-000064-42-HU (EUCTR)	05/08/2016	06/06/2016	Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A	Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Estonia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
455	EUCTR2015-005307-83-BG (EUCTR)	04/08/2016	17/06/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB	R-Pharm International LLC	NULL	Not Recruiting			Female: yes Male: yes	1575	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
456	EUCTR2015-003376-75-BG (EUCTR)	02/08/2016	18/07/2016	A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
457	JPRN-JapicCTI-163317	28/7/2016	13/07/2016	Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis	Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors	Rheumatoid Arthritis	Intervention name : BMS-986142 INN of the intervention : - Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified	Bristol-Myers Squibb K.K.	NULL	complete	18	120	BOTH	408	Phase 2	Japan, Asia except Japan, North America, South America, Europe, Oceania
458	EUCTR2015-003334-27-CZ (EUCTR)	27/07/2016	06/06/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
459	EUCTR2016-000064-42-SK (EUCTR)	27/07/2016	03/05/2016	Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis	Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
460	JPRN-UMIN000021247	2016/07/22	22/07/2016	Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state	Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state - Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study)	Rheumatoid arthritis	Double the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<=10 is maintained.	Nagoya University Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	51	Not selected	Japan
461	EUCTR2015-003333-95-LT (EUCTR)	21/07/2016	09/05/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	Stroke (ischaemic stroke or intracerebral hemorrhage) MedDRA version: 22.1;Level: PT;Classification code 10061256;Term: Ischaemic stroke;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10022754;Term: Intracerebral hemorrhage;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1;Classification code 10042244;Term: Stroke;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Paracetamol Product Name: Paracetamol INN or Proposed INN: Paracetamol Other descriptive name: PARACETAMOL Trade Name: Ceftriaxone Product Name: Ceftriaxone INN or Proposed INN: CEFTRIAXONE Trade Name: Metoclopramide Product Name: Metoclopramide INN or Proposed INN: METOCLOPRAMIDE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Greece;Netherlands;Hungary;Norway;Poland;Italy;United Kingdom;Germany;Estonia
462	EUCTR2015-003335-35-IT (EUCTR)	18/07/2016	28/02/2018	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) - SELECT-BEYOND	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494	ABBVIE DEUTSCHLAND GMBH & CO. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
463	EUCTR2015-003334-27-HU (EUCTR)	13/07/2016	10/06/2016	A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
464	EUCTR2015-003334-27-ES (EUCTR)	08/07/2016	19/01/2016	A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 15 mg Once Daily Monotherapy and ABT-494 30 mg Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Egypt;Hungary;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;New Zealand;Japan
465	EUCTR2016-001618-18-FR (EUCTR)	08/07/2016	09/06/2016	Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients	STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR	glucocorticoid withdrawal in rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Prednisone Product Name: prednisone 5 mg Trade Name: Prednisone Product Name: prednisone 4 mg Trade Name: Prednisone Product Name: prednisone 3 mg Trade Name: Prednisone Product Name: prednisone 2 mg Trade Name: Prednisone Product Name: prednisone 1 mg Trade Name: Hydrocortisone 10mg	CHU Toulouse	NULL	Not Recruiting			Female: yes Male: yes	122	Phase 4	France
466	EUCTR2015-005307-83-PL (EUCTR)	06/07/2016	01/06/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira) Product Code: LO4AB04	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	1575	Phase 3	United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
467	EUCTR2015-003335-35-GB (EUCTR)	05/07/2016	17/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	499	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
468	EUCTR2015-003335-35-GR (EUCTR)	05/07/2016	26/04/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
469	EUCTR2015-003433-10-GB (EUCTR)	05/07/2016	30/03/2016	ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis	GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial	rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB	Hexal, AG	NULL	Not Recruiting			Female: yes Male: yes	308	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
470	NCT03106259 (ClinicalTrials.gov)	June 29, 2016	3/4/2017	Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj	Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj	Rheumatoid Arthritis	Drug: FURESTEM-RA Inj.	Kang Stem Biotech Co., Ltd.	NULL	Active, not recruiting	19 Years	80 Years	All	9	Phase 1	Korea, Republic of
471	EUCTR2015-003334-27-PL (EUCTR)	28/06/2016	08/06/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
472	EUCTR2015-003335-35-NO (EUCTR)	27/06/2016	18/03/2016	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
473	EUCTR2015-003334-27-GR (EUCTR)	22/06/2016	13/05/2016	A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand
474	EUCTR2016-000064-42-CZ (EUCTR)	21/06/2016	08/06/2016	Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis	Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
475	EUCTR2015-002729-21-FI (EUCTR)	21/06/2016	30/03/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria	Rheumatoid artritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
476	EUCTR2015-003334-27-LV (EUCTR)	17/06/2016	08/06/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	975	Phase 3	Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
477	EUCTR2015-003334-27-PT (EUCTR)	17/06/2016	09/06/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	United States;Belarus;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand
478	EUCTR2015-003334-27-IE (EUCTR)	17/06/2016	07/06/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	975	Phase 3	Portugal;Serbia;United States;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Romania;Kazakhstan;Bulgaria;Japan;New Zealand
479	EUCTR2015-003334-27-GB (EUCTR)	15/06/2016	09/06/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
480	EUCTR2015-003332-13-BG (EUCTR)	15/06/2016	25/03/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
481	EUCTR2015-003332-13-LT (EUCTR)	10/06/2016	29/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
482	EUCTR2015-005308-27-HU (EUCTR)	09/06/2016	28/04/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	Colombia;Argentina;Czech Republic;Hungary;United States;Brazil;Korea, Republic of;Poland;Mexico;Germany
483	EUCTR2015-003433-10-RO (EUCTR)	09/06/2016	22/06/2016	ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis	GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial	rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB	Hexal, AG	NULL	Not Recruiting			Female: yes Male: yes	308	Phase 3	United States;Serbia;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
484	EUCTR2015-001275-50-NL (EUCTR)	08/06/2016	10/12/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
485	EUCTR2015-003334-27-HR (EUCTR)	08/06/2016	06/07/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
486	EUCTR2015-003433-10-CZ (EUCTR)	08/06/2016	30/03/2016	ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis	GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial	rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB	Hexal, AG	NULL	Not Recruiting			Female: yes Male: yes	308	Phase 3	Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
487	EUCTR2015-003433-10-IT (EUCTR)	08/06/2016	27/02/2018	ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis	GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial	rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	HEXAL AG	NULL	Not Recruiting			Female: yes Male: yes	308	Phase 3	Serbia;United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
488	NCT02758769 (ClinicalTrials.gov)	June 7, 2016	14/4/2016	Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings	Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings	Rheumatoid Arthritis	Biological: ORENCIA Subcutaneous Injection	Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd	Active, not recruiting	20 Years	N/A	All	303		Japan
489	EUCTR2015-002887-17-BE (EUCTR)	07/06/2016	16/02/2016	Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis	Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors	Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	610	Phase 2	United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Germany;Netherlands;Japan;Korea, Republic of
490	EUCTR2015-005307-83-CZ (EUCTR)	07/06/2016	18/03/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB	R-Pharm International LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1575	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
491	EUCTR2015-005308-27-CZ (EUCTR)	07/06/2016	15/04/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3	Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm International LLC	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	Colombia;Czech Republic;Argentina;Hungary;United States;Brazil;Korea, Republic of;Poland;Mexico;Germany
492	EUCTR2015-003334-27-BE (EUCTR)	07/06/2016	06/06/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand;Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia
493	EUCTR2015-003332-13-GR (EUCTR)	06/06/2016	24/05/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
494	EUCTR2015-003335-35-LV (EUCTR)	03/06/2016	13/04/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
495	JPRN-UMIN000021929	2016/06/01	15/04/2016	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Study	Rheumatoid arthritis	Discontinuation of infliximab	Chiba University	NULL	Complete: follow-up continuing	18years-old	Not applicable	Male and Female	200	Not selected	Japan
496	EUCTR2015-003335-35-PT (EUCTR)	31/05/2016	30/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
497	JPRN-jRCTs031180001	30/05/2016	12/06/2018	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis	Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT	Rheumatoid arthritis	Infliximab Withdrawal	Ikeda Kei	NULL	Complete	>= 18age old	Not applicable	Both	200	Phase 4	Japan
498	EUCTR2015-003433-10-HU (EUCTR)	26/05/2016	14/04/2016	ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis	GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial	rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB	Hexal, AG	NULL	Not Recruiting			Female: yes Male: yes	308	Phase 3	Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
499	EUCTR2015-003433-10-DE (EUCTR)	25/05/2016	07/04/2016	ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis	GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial	rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB	Hexal, AG	NULL	Not Recruiting			Female: yes Male: yes	308	Phase 3	Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
500	NCT02760407 (ClinicalTrials.gov)	May 24, 2016	29/4/2016	Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	Rheumatoid Arthritis	Drug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2w	R-Pharm	Quintiles, Inc.;OCT Clinical Trials	Active, not recruiting	18 Years	N/A	All	1575	Phase 3	United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom;China;Czech Republic
501	EUCTR2015-003335-35-FR (EUCTR)	24/05/2016	17/06/2016	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
502	EUCTR2016-002035-15-FI (EUCTR)	20/05/2016	12/05/2016	Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study	Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia	Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee MedDRA version: 19.0;Level: LLT;Classification code 10031174;Term: Osteoarthrosis;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10031158;Term: Osteo arthritis knees;System Organ Class: 100000004859;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]	Trade Name: Bicain spinal INN or Proposed INN: bupivacaine hydrochloride Other descriptive name: BUPIVACAINE HYDROCHLORIDE Trade Name: Propolipid INN or Proposed INN: propofol Other descriptive name: PROPOFOL	Helsinki University Central Hospital	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 4	Finland
503	EUCTR2015-003335-35-SK (EUCTR)	19/05/2016	22/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
504	EUCTR2014-004719-36-BG (EUCTR)	14/05/2016	05/04/2016	Study of the Efficacy and Safety of Olokizumab in Patients withModerately to Severely Active Rheumatoid Arthritis InadequatelyControlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo Controlled,Multicenter Phase III Study of the Efficacy and Safety of Olokizumab inSubjects with Moderately to Severely Active Rheumatoid ArthritisInadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Belarus;Turkey;Russian Federation;Bulgaria
505	EUCTR2015-003335-35-IE (EUCTR)	13/05/2016	10/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
506	EUCTR2015-003335-35-CZ (EUCTR)	11/05/2016	15/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
507	EUCTR2015-003332-13-CZ (EUCTR)	11/05/2016	06/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Portugal;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
508	EUCTR2015-003332-13-HR (EUCTR)	11/05/2016	06/07/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
509	EUCTR2015-003332-13-HU (EUCTR)	10/05/2016	05/05/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Portugal;Belarus;Serbia;United States
510	EUCTR2015-003335-35-SE (EUCTR)	10/05/2016	16/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
511	JPRN-UMIN000022364	2016/05/10	20/05/2016	Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis	Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis - Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis	Osteoprotic patients with rheumatoid arthritis	The selection criteria is based on which treatment each patient wants to take Minodronate group: oral intake 50mg per month Minodronate plus active vitamin D group: oral intake 50mg minodronate per month and eldecalcitol 0.75ug per day after breakfast	Department of Orthopaedic Surgery Shinshu University School of Medicine	NULL	Complete: follow-up complete	50years-old	100years-old	Male and Female	140	Not applicable	Japan
512	EUCTR2015-003433-10-ES (EUCTR)	09/05/2016	22/07/2016	ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis	GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial	rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Adalimumab Product Code: GP2017 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB	Hexal, AG	NULL	Not Recruiting			Female: yes Male: yes	308	Phase 3	Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of
513	EUCTR2015-003332-13-ES (EUCTR)	09/05/2016	19/01/2016	A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
514	EUCTR2015-005307-83-LT (EUCTR)	04/05/2016	25/03/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB	R-Pharm	NULL	Not Recruiting			Female: yes Male: yes	1575	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
515	EUCTR2015-003335-35-AT (EUCTR)	04/05/2016	14/04/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Puerto Rico;Russian Federation;Hong Kong;United States;Portugal;Greece;Austria;Sweden;Latvia;Ireland;Brazil;Korea, Republic of;Slovakia;Slovenia;Chile;France;Bulgaria;Colombia;Argentina;Hungary;United Kingdom;Switzerland;Spain;New Zealand;Canada;Czech Republic;Turkey;Belgium;European Union;Norway;Finland;Denmark;Mexico;Italy;Israel;Australia;Germany
516	EUCTR2015-003335-35-BE (EUCTR)	04/05/2016	10/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
517	EUCTR2015-002729-21-HU (EUCTR)	04/05/2016	11/02/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria	Rheumatoid artritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
518	EUCTR2015-003335-35-DK (EUCTR)	03/05/2016	14/03/2016	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
519	EUCTR2015-003335-35-DE (EUCTR)	03/05/2016	09/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
520	NCT02538341 (ClinicalTrials.gov)	May 2016	18/8/2015	Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)	Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)	Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease	Biological: Herpes Zoster Vaccine;Drug: Placebo	University of Alabama at Birmingham	Oregon Health and Science University	Active, not recruiting	50 Years	N/A	All	617	Phase 2	United States
521	NCT01815411 (ClinicalTrials.gov)	May 2016	14/3/2013	Effect of Andosan in Patients With Rheumatoid Arthritis	Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Dietary Supplement: Mushroom extract	Egil Johnson	ImmunoPharma AS	Completed	19 Years	75 Years	All	10	N/A	Norway
522	NCT02665910 (ClinicalTrials.gov)	May 2016	24/1/2016	Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients	A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA	Rheumatoid Arthritis	Drug: SHR0302;Drug: SHR0302 placebo comparator	Jiangsu HengRui Medicine Co., Ltd.	NULL	Not yet recruiting	18 Years	70 Years	Both	48	Phase 1	China
523	EUCTR2015-003335-35-ES (EUCTR)	29/04/2016	11/03/2016	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
524	EUCTR2015-003332-13-PL (EUCTR)	26/04/2016	12/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
525	EUCTR2015-002729-21-DE (EUCTR)	25/04/2016	02/02/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - GLORIA	Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
526	EUCTR2015-003332-13-IE (EUCTR)	22/04/2016	08/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
527	EUCTR2015-003332-13-NO (EUCTR)	22/04/2016	21/04/2016	A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
528	EUCTR2015-003332-13-FI (EUCTR)	22/04/2016	19/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
529	EUCTR2015-003332-13-PT (EUCTR)	22/04/2016	08/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Belarus;Portugal;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
530	EUCTR2015-002729-21-SK (EUCTR)	22/04/2016	25/02/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria	Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
531	EUCTR2015-002887-17-NL (EUCTR)	20/04/2016	22/02/2016	Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis	Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors	Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	610	Phase 2	United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
532	EUCTR2015-003333-95-AT (EUCTR)	20/04/2016	12/04/2016	A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
533	EUCTR2015-003332-13-AT (EUCTR)	20/04/2016	01/06/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Poland;Belgium;Brazil;Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
534	EUCTR2015-003332-13-LV (EUCTR)	20/04/2016	12/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Puerto Rico;Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland
535	EUCTR2014-004868-38-IT (EUCTR)	16/04/2016	06/11/2020	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. - A study comparing the use of etanercept and methotrexate, used either alone or in combination, for m	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ENBREL - 50 MG SOLUZIONE INIETTABILE IN SIRINGA (VETRO DA 1 ML) PRERIEMPITA - USO SOTTOCUTANEO 12 SIRINGHE PRERIEMPITE + 24 TAMPONI IMBEVUTI DI ALCOL Product Name: Enbrel Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: METOTREXATO SANDOZ - 2.5 MG COMPRESSE 50 COMPRESSE IN FLACONE PP Product Name: methotrexate Product Code: [NA] INN or Proposed INN: METOTREXATO	AMGEN INC.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	France;Portugal;Hungary;Czech Republic;Greece;Spain;Bulgaria;Germany;United Kingdom;Italy
536	EUCTR2015-003333-95-DK (EUCTR)	15/04/2016	07/04/2016	A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
537	EUCTR2015-003332-13-DK (EUCTR)	15/04/2016	07/04/2016	A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
538	EUCTR2015-003332-13-IT (EUCTR)	15/04/2016	28/02/2018	A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs - SELECT-NEXT	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: N.A.	ABBVIE DEUTSCHLAND GMBH & CO. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Italy;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Japan;Colombia;Switzerland;Portugal;Serbia;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Barbados;Russian Federation;Chile;Israel
539	EUCTR2015-003332-13-GB (EUCTR)	14/04/2016	11/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
540	EUCTR2015-003332-13-BE (EUCTR)	13/04/2016	07/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
541	EUCTR2015-002887-17-AT (EUCTR)	29/03/2016	18/01/2016	Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis	Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors	Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986142 Product Code: BMS-986142 INN or Proposed INN: BMS986142 Product Name: BMS-986142 Product Code: BMS-986142 INN or Proposed INN: BMS986142	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	610	Phase 2	United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
542	EUCTR2015-002887-17-ES (EUCTR)	28/03/2016	13/01/2016	Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis	Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors	Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	610	Phase 2	United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
543	NCT02720523 (ClinicalTrials.gov)	March 22, 2016	22/3/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Rheumatoid Arthritis	Drug: Placebo;Drug: Upadacitinib	AbbVie	NULL	Active, not recruiting	18 Years	N/A	All	197	Phase 2/Phase 3	Japan
544	NCT02706847 (ClinicalTrials.gov)	March 15, 2016	18/2/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Rheumatoid Arthritis	Drug: Upadacitinib;Drug: Placebo	AbbVie	NULL	Completed	18 Years	99 Years	All	499	Phase 3	United States;Australia;Austria;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Korea, Republic of;Latvia;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Argentina;Brazil;Bulgaria;Chile;Colombia;Czech Republic;Denmark;Hong Kong;Italy;Mexico;Norway;Slovenia
545	EUCTR2014-004868-38-PT (EUCTR)	07/03/2016	18/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	France;United States;Portugal;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
546	JPRN-UMIN000021492	2016/03/01	20/03/2016	To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.	To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. - Switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.	Rheumatoid arthritis	switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.	Inoue Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	40	Not selected	Japan
547	JPRN-UMIN000021157	2016/03/01	29/02/2016	Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate	Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate - Clinical trial for Adverse event related to Weekly dosage regimens of Methotrexate(ADDMe trial)	Rheumatoid arthritis	administration of weekly MTX dose at once. administration by dividing three times of weekly MTX dose.	Yokohama Minami Kyousai Hospital	AYUMI Pharmaceutical corporation	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	120	Not applicable	Japan
548	EUCTR2015-002634-41-DE (EUCTR)	25/02/2016	10/11/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
549	EUCTR2015-002634-41-BG (EUCTR)	24/02/2016	21/12/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
550	EUCTR2015-002924-17-BE (EUCTR)	24/02/2016	27/01/2016	A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis	A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis	Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Nanocort INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE Trade Name: Depo Medrol Product Name: Depo Medrol	Sun Pharma Global FZE	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Belgium;Netherlands
551	NCT02706873 (ClinicalTrials.gov)	February 23, 2016	18/2/2016	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Placebo to Upadacitinib;Drug: Methotrexate;Drug: Placebo to Methotrexate;Drug: Upadacitinib	AbbVie	NULL	Completed	18 Years	N/A	All	1002	Phase 3	United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Kazakhstan;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Malaysia;Netherlands
552	EUCTR2012-002009-23-DE (EUCTR)	22/02/2016	09/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
553	EUCTR2015-001275-50-RO (EUCTR)	10/02/2016	22/02/2016	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy
554	EUCTR2014-004868-38-HU (EUCTR)	09/02/2016	11/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	Greece;Canada;Argentina;Czech Republic;Hungary;United States;Italy;Bulgaria;France;Portugal;Germany;Spain
555	EUCTR2015-001275-50-HU (EUCTR)	09/02/2016	04/12/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
556	EUCTR2014-004868-38-BG (EUCTR)	02/02/2016	22/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
557	NCT02683564 (ClinicalTrials.gov)	February 2016	9/2/2016	BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study	A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study	Rheumatoid Arthritis	Drug: BOW015;Drug: Remicade	Epirus Biopharmaceuticals (Switzerland) GmbH	NULL	Not yet recruiting	18 Years	80 Years	Both	548	Phase 3	NULL
558	NCT03332719 (ClinicalTrials.gov)	February 2016	21/4/2016	Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis	Multicentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Etanercept;Drug: Methotrexate	Gema Biotech S.A.	QUID-Quality in Drugs and Devices Latin American Consulting SRL	Completed	19 Years	99 Years	All	168	Phase 3	Argentina
559	EUCTR2015-002809-12-BG (EUCTR)	27/01/2016	02/12/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
560	EUCTR2014-004868-38-GR (EUCTR)	26/01/2016	02/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	France;Portugal;United States;Hungary;Czech Republic;Canada;Greece;Argentina;Spain;Bulgaria;Germany
561	EUCTR2015-002634-41-PL (EUCTR)	20/01/2016	16/12/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of
562	EUCTR2014-004868-38-ES (EUCTR)	19/01/2016	13/01/2016	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	720	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
563	JPRN-UMIN000018931	2016/01/17	07/09/2015	Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial	Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial - Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial	Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis	1000 mg of intravenous acetaminophen (100 ml) after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery. 100ml of intravenous normal saline after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery.	Nekoyama Miyao Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
564	EUCTR2014-000358-13-DE (EUCTR)	14/01/2016	31/07/2015	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Trade Name: Zostavax® Product Name: Zostavax	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
565	EUCTR2014-004673-16-DE (EUCTR)	12/01/2016	15/07/2015	Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.	Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: RoActemra Product Code: L04AC07 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	226	Phase 4	Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland
566	EUCTR2014-004868-38-FR (EUCTR)	12/01/2016	18/01/2016	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	720	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;France;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
567	EUCTR2015-003332-13-SK (EUCTR)	12/01/2016	04/11/2015	A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
568	EUCTR2015-002634-41-HU (EUCTR)	07/01/2016	16/10/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
569	EUCTR2012-002009-23-HU (EUCTR)	07/01/2016	29/09/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Latvia
570	NCT03855007 (ClinicalTrials.gov)	January 1, 2016	15/2/2019	The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment	Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China	Arthritis, Rheumatoid	Drug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: Pred	Qilu Hospital of Shandong University	NULL	Active, not recruiting	16 Years	90 Years	All	200	Phase 4	China
571	NCT02652273 (ClinicalTrials.gov)	January 2016	8/1/2016	Inhibition of Co-Stimulation in Rheumatoid Arthritis	Inhibition of Co-Stimulation in Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Abatacept	NHS Greater Glasgow and Clyde	University of Glasgow	Not yet recruiting	18 Years	N/A	Both	25	Phase 4	United Kingdom
572	NCT02878161 (ClinicalTrials.gov)	January 2016	12/7/2016	Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World	Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway	Rheumatoid Arthritis	Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary)	Fen Li	NULL	Enrolling by invitation	18 Years	75 Years	Both	240	Phase 4	NULL
573	NCT02608112 (ClinicalTrials.gov)	December 31, 2015	16/11/2015	Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year	Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	291		France
574	EUCTR2014-000352-29-HR (EUCTR)	29/12/2015	01/02/2016	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
575	EUCTR2015-002809-12-ES (EUCTR)	23/12/2015	30/10/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
576	EUCTR2014-004868-38-CZ (EUCTR)	21/12/2015	03/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	Greece;Canada;Czech Republic;Argentina;Hungary;United States;Italy;Bulgaria;France;Portugal;Germany;Spain
577	EUCTR2015-001275-50-AT (EUCTR)	20/12/2015	23/11/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
578	EUCTR2015-004173-32-DK (EUCTR)	18/12/2015	20/10/2015	Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.	Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.	Rheumatic diseases MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Benepali INN or Proposed INN: ETANERCEPT Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Department of Clinical Biochemestry, Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 4	Denmark
579	EUCTR2015-002634-41-ES (EUCTR)	17/12/2015	30/10/2015	Long-term study of BI695501 in patients with active rheumatoid arthritis	Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of
580	NCT02675426 (ClinicalTrials.gov)	December 17, 2015	11/12/2015	A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	Rheumatoid Arthritis	Drug: Placebo;Drug: Upadacitinib	AbbVie	NULL	Active, not recruiting	18 Years	99 Years	All	661	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hong Kong;Hungary;Ireland;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Brazil;Colombia;Czech Republic;Denmark;Israel;Netherlands;Norway;Serbia;Singapore
581	EUCTR2015-000665-30-DE (EUCTR)	17/12/2015	14/07/2015	Coherus Open-Label Safety Extension Study	An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES	Rheumatoid arthritisChronic Plaque Psoriasis MedDRA version: 19.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: BGX-0214	Coherus BioSciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	447	Phase 3	France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom
582	EUCTR2015-001275-50-IT (EUCTR)	17/12/2015	05/11/2020	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis.	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive - ND	Early Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: [BMS-188667] INN or Proposed INN: ABATACEPT Other descriptive name: ND Trade Name: Methotrexate Ebewe Product Name: Methotrexate Product Code: [na] INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate Product Code: [na] INN or Proposed INN: METOTREXATO Other descriptive name: METHOTREXATE	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;Finland;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
583	EUCTR2015-001275-50-ES (EUCTR)	15/12/2015	10/12/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
584	EUCTR2015-003334-27-SK (EUCTR)	11/12/2015	04/11/2015	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	975	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand
585	EUCTR2015-001275-50-SE (EUCTR)	09/12/2015	04/12/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
586	EUCTR2012-002009-23-GB (EUCTR)	09/12/2015	07/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
587	EUCTR2015-001275-50-FI (EUCTR)	08/12/2015	08/12/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
588	EUCTR2015-001275-50-GB (EUCTR)	04/12/2015	26/11/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
589	NCT02629159 (ClinicalTrials.gov)	December 1, 2015	10/12/2015	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	Rheumatoid Arthritis	Drug: Placebo for Adalimumab;Drug: Adalimumab;Drug: Placebo for Upadacitinib;Drug: Upadacitinib	AbbVie	NULL	Active, not recruiting	18 Years	N/A	All	1629	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands
590	EUCTR2015-001275-50-DE (EUCTR)	01/12/2015	24/11/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
591	NCT02944799 (ClinicalTrials.gov)	December 2015	27/6/2016	Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis	Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone Mass	Rheumatoid Arthritis;Osteoporosis	Drug: Placebo;Drug: Alendronate;Drug: Calcium;Drug: Vitamin D	University of Aarhus	NULL	Active, not recruiting	18 Years	N/A	All	69	Phase 2	Denmark
592	EUCTR2015-001275-50-FR (EUCTR)	30/11/2015	04/12/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
593	EUCTR2015-002809-12-CZ (EUCTR)	27/11/2015	02/10/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
594	JPRN-JapicCTI-153081	26/11/2015	26/11/2015	Effects of Abatacept in Patients With Early Rheumatoid Arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive	Rheumatoid Arthritis	Intervention name : Abatacept + Methotrexate INN of the intervention : Abatacept + Methotrexate Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week Control intervention name : Methotrexate INN of the control intervention : Methotrexate Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally Control intervention name : Abatacept Placebo INN of the control intervention : Abatacept Placebo Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week Control intervention name : Methotrexate Placebo INN of the control intervention : Methotrexate Placebo Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week	Bristol-Myers Squibb K.K.	ONO PHARMACEUTICAL CO., LTD.	complete	18		BOTH	1000	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
595	EUCTR2012-002009-23-BG (EUCTR)	25/11/2015	15/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
596	EUCTR2012-002009-23-ES (EUCTR)	20/11/2015	15/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
597	NCT02557100 (ClinicalTrials.gov)	November 19, 2015	4/9/2015	Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis	A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis	Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	80	Phase 4	United States;Canada;Mexico;Algeria
598	EUCTR2013-002777-22-IT (EUCTR)	19/11/2015	04/12/2013	Targeted Ultrasound in Rheumatoid Arthritis (TURA)	Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Humira INN or Proposed INN: ADALIMUMAB	University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 4	France;Hungary;Spain;Denmark;Germany;United Kingdom;Japan;Italy
599	NCT03172325 (ClinicalTrials.gov)	November 18, 2015	24/5/2017	Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA	A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active Controlled Clinical Trial to Determine the Non-inferior Efficacy and Safety of CinnoRA® (Adalimumab, CinnaGen Co.) Versus Humira® for Treatment of Active RA	Active Rheumatoid Arthritis	Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone	Cinnagen	NULL	Completed	18 Years	75 Years	All	136	Phase 3	Iran, Islamic Republic of
600	NCT02512575 (ClinicalTrials.gov)	November 18, 2015	6/7/2015	A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.	A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.	Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid Arthritis	Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone	AstraZeneca	NULL	Completed	18 Years	55 Years	Male	72	Phase 1	Germany
601	EUCTR2015-002809-12-LV (EUCTR)	17/11/2015	21/09/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
602	EUCTR2015-002809-12-HU (EUCTR)	17/11/2015	26/08/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
603	EUCTR2014-004673-16-FR (EUCTR)	16/11/2015	05/08/2015	Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.	Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	226	Phase 4	Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland
604	EUCTR2013-000337-13-PT (EUCTR)	13/11/2015	11/11/2015	Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)	Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA	Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 3	United States;Serbia;Portugal;Germany
605	EUCTR2012-002009-23-CZ (EUCTR)	13/11/2015	30/09/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
606	EUCTR2015-002924-17-NL (EUCTR)	12/11/2015	06/10/2015	A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis	A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis	Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Nanocort INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE Trade Name: Depo Medrol Product Name: Depo Medrol	Sun Pharma Global FZE	NULL	Not Recruiting			Female: yes Male: yes	330	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Belgium;Netherlands
607	EUCTR2012-003876-38-PL (EUCTR)	10/11/2015	16/11/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
608	EUCTR2012-002009-23-LT (EUCTR)	06/11/2015	02/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
609	NCT02780323 (ClinicalTrials.gov)	November 2, 2015	19/5/2016	Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis	A Multi-center, Double-blind, Active-controlled, Randomized, Parallel-group Clinical Trial to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: CELBESTA®;Drug: CELEBREX®;Drug: CELEBREX® placebo;Drug: CELBESTA® placebo	Dong-A ST Co., Ltd.	NULL	Completed	19 Years	N/A	All	119	Phase 4	Korea, Republic of
610	JPRN-UMIN000018848	2015/11/01	29/08/2015	Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis	Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis - Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis	Rheumatoid arthritis	control: continue the present treatment intervention: reduce the dosage of methotrexate by half every 3 months and discontinue intervention: extend the interval of biologics to one and a half times every 3 months and discontinue	Keio University Hospital	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	900	Not applicable	Japan
611	NCT02543931 (ClinicalTrials.gov)	November 2015	6/8/2015	Curcuma Longa L in Rheumatoid Arthritis	Phase Ib Randomized, Double-Blind, Placebo-Controlled Study of Meriva in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Meriva;Drug: placebo	University of Arizona	Vanderbilt University;National Center for Complementary and Integrative Health (NCCIH);National Institutes of Health (NIH)	Terminated	18 Years	N/A	Both	3	Phase 1	United States
612	NCT02534896 (ClinicalTrials.gov)	November 2015	25/8/2015	To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis	To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis	Active Rheumatoid Arthritis	Drug: Treatment I;Drug: Treatment II;Drug: Treatment III	Sun Pharmaceutical Industries Limited	NULL	Terminated	18 Years	90 Years	All	150	Phase 3	Belgium;Netherlands
613	NCT02723760 (ClinicalTrials.gov)	November 2015	10/3/2016	99mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis Patients	Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: 99mTc-3PRGD2	First Affiliated Hospital of Fujian Medical University	NULL	Recruiting	20 Years	70 Years	Both	40	Phase 0	China
614	NCT02552940 (ClinicalTrials.gov)	October 31, 2015	16/9/2015	An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice	A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	nv Roche sa	Completed	18 Years	N/A	All	140		Belgium;Luxembourg
615	EUCTR2012-002009-23-SK (EUCTR)	27/10/2015	07/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
616	EUCTR2014-003453-34-PL (EUCTR)	26/10/2015	29/09/2015	Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.	A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Poland;South Africa;Bulgaria;Germany;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina
617	EUCTR2012-002009-23-LV (EUCTR)	23/10/2015	08/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Latvia;Germany
618	EUCTR2012-002009-23-PL (EUCTR)	22/10/2015	08/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
619	EUCTR2014-000352-29-BG (EUCTR)	21/10/2015	31/08/2015	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
620	EUCTR2015-001275-50-CZ (EUCTR)	21/10/2015	29/09/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate Ebewe Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
621	EUCTR2014-003307-30-GB (EUCTR)	16/10/2015	25/08/2015	Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis	A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Celltech, UK Registered Branch of UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	102	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Hungary;Slovakia;Russian Federation;United Kingdom
622	EUCTR2014-000110-61-DE (EUCTR)	15/10/2015	04/05/2015	Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 PFS INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Code: FKB327 AI INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	680	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
623	EUCTR2015-000581-58-CZ (EUCTR)	14/10/2015	16/06/2015	A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra INN or Proposed INN: tocilizumabum Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Revmatologicky ustav Praha	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	Czech Republic
624	EUCTR2012-002009-23-EE (EUCTR)	12/10/2015	06/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
625	JPRN-UMIN000020833	2015/10/09	01/02/2016	The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study.	The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study. - The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis.	Rheumatoid arthritis	Administer MTX 6-16mg/week for 12 weeks to patients with MDA-RA. If patients can't take MTX, administer IGU 25-50mg/day or Tac 1.5-3.0mg/day for 12 weeks. Administer ADA 40mg/2weeks for 24weeks additionally, in case of MDA taking MTX or IGU, Tac for 12 weeks. If patients maintain remission for 24weeks, discontinue ADA by their own will, after 48 weeks administering ADA.	Zenjinkai Shimin-no-mori Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	240	Not selected	Japan
626	EUCTR2014-003453-34-DE (EUCTR)	08/10/2015	26/05/2015	Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.	A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. -	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
627	EUCTR2014-003453-34-IT (EUCTR)	05/10/2015	19/01/2021	Study of a new drug's effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate	A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate. - -	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 Other descriptive name: Anticorpo monoclonale anti GM-CSF umano	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Czechia;Taiwan;Estonia;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Bulgaria;Netherlands;Germany
628	NCT02778789 (ClinicalTrials.gov)	October 2015	16/5/2016	Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers	Non Randomized Parallel-group Clinical Study to Compare the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers.	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: TNF-alpha Inhibitor	University of Erlangen-Nürnberg Medical School	NULL	Completed	18 Years	N/A	All	66		Germany
629	EUCTR2015-003638-28-DK (EUCTR)	30/09/2015	28/08/2015	Treatment of osteoporosis in patients with rheumatoid arthritis.	ALOSTRAAlendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass. - ALOSTRA	Rheumatoid arthritis and osteoporosis MedDRA version: 20.0;Level: LLT;Classification code 10031289;Term: Osteoporosis, unspecified;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Alendronat Teva INN or Proposed INN: Alendronic Acid Other descriptive name: ALENDRONIC ACID	Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Denmark
630	EUCTR2015-002284-42-FI (EUCTR)	18/09/2015	28/08/2015	The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit	INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT	rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify	Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab	READE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1650	Phase 1	Finland
631	EUCTR2014-003453-34-CZ (EUCTR)	16/09/2015	23/06/2015	Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.	A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
632	NCT02605642 (ClinicalTrials.gov)	September 10, 2015	2/9/2015	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade	PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)	Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis	Drug: CT-P13	Pfizer	Hospira, now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	All	351		Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy
633	EUCTR2014-003453-34-ES (EUCTR)	03/09/2015	03/07/2015	Study of a new drug's effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.	A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Taiwan;Estonia;Spain;Ukraine;Russian Federation;Chile;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Bulgaria;Netherlands;Germany
634	NCT05116228 (ClinicalTrials.gov)	September 1, 2015	21/3/2018	Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission	Randomized, Prospective, Active-comparator Controlled, Patient-blinded Study to Demonstrate Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis Patients in Low Disease Activity and Remission - the REDOREM Study	Rheumatoid Arthritis;Remission	Drug: 500mg RTX Group;Drug: 1000mg RTX Group	Medical University of Vienna	NULL	Terminated	18 Years	N/A	All	21	Phase 4	Austria
635	NCT02553018 (ClinicalTrials.gov)	September 2015	16/9/2015	Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe	A National, Randomized, Open-label Study Comparing Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated With Methotrexate Administered by Auto-injector Versus Administration by Conventional Subcutaneous Injection.	Arthritis, Rheumatoid	Drug: Methotrexate	Nordic Pharma SAS	NULL	Completed	18 Years	N/A	All	278	Phase 3	France
636	JPRN-UMIN000027241	2015/08/31	03/05/2017	the change of IMT of carotide artery in RA with treatment of tocilizumab	the change of IMT of carotide artery in RA with treatment of tocilizumab - the change of IMT of carotide artery in RA with treatment of tocilizumab	rheumatoid arthritis	tofacitinib	hiroshima clinic	NULL	Complete: follow-up complete	18years-old	80years-old	Male and Female	50	Not applicable	Japan
637	EUCTR2014-003453-34-GB (EUCTR)	24/08/2015	13/07/2015	Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.	A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;South Africa;Bulgaria;Germany
638	EUCTR2013-003177-99-AT (EUCTR)	17/08/2015	07/05/2015	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
639	EUCTR2013-003177-99-FI (EUCTR)	12/08/2015	12/02/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
640	EUCTR2014-004887-39-PL (EUCTR)	08/08/2015	07/07/2015	A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis	An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis	Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd	NULL	Not Recruiting			Female: yes Male: yes			Poland
641	EUCTR2015-000665-30-GB (EUCTR)	30/07/2015	20/05/2015	Coherus Open-Label Safety Extension Study	An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES	Rheumatoid arthritisChronic Plaque Psoriasis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: BGX-0214	Coherus BioSciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	447	Phase 3	France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom
642	EUCTR2012-003876-38-HU (EUCTR)	28/07/2015	22/05/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
643	EUCTR2015-000665-30-IT (EUCTR)	27/07/2015	28/02/2018	Coherus Open-Label Safety Extension Study	An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES	Rheumatoid arthritisChronic Plaque Psoriasis MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: etanercept Product Code: CHS-0214 INN or Proposed INN: ETANERCEPT Other descriptive name: ETANERCEPT	COHERUS BIOSCIENCES, INC.	NULL	Not Recruiting			Female: yes Male: yes	447	Phase 3	France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;United Kingdom;Italy
644	EUCTR2014-004673-16-IT (EUCTR)	27/07/2015	04/06/2021	Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.	PROSPECTIVE, MULTICENTRE, PLACEBO CONTROLLED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY OF MAINTENANCE TREATMENT WITH TOCILIZUMAB WITH OR WITHOUT GLUCOCORTICOID DISCONTINUATION IN RHEUMATOID ARTHRITIS PATIENTS - NA	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE Product Name: NA Product Code: RO487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton, 5 mg, tablets INN or Proposed INN: PREDNISONE	F. HOFFMANN - LA ROCHE LTD.	NULL	Not Recruiting			Female: yes Male: yes	226	Phase 4	France;Serbia;Egypt;Lebanon;Turkey;Russian Federation;Germany;Switzerland;Italy
645	EUCTR2015-000665-30-ES (EUCTR)	24/07/2015	01/06/2015	Coherus Open-Label Safety Extension Study	An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES	Rheumatoid arthritisChronic Plaque Psoriasis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: BGX-0214	Coherus BioSciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	447	Phase 3	France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom
646	EUCTR2014-003453-34-HU (EUCTR)	23/07/2015	27/05/2015	Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.	A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
647	EUCTR2012-002535-28-ES (EUCTR)	22/07/2015	10/07/2015	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom
648	EUCTR2012-003876-38-DE (EUCTR)	21/07/2015	29/04/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
649	EUCTR2015-000833-64-FR (EUCTR)	17/07/2015	02/07/2015	N/A	N/A	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ORENCIA Trade Name: MABTHERA Trade Name: ROACTEMRA	CHU Amiens-Picardie	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 4	France
650	EUCTR2014-003034-42-BG (EUCTR)	15/07/2015	11/05/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
651	EUCTR2014-003034-42-BE (EUCTR)	13/07/2015	18/05/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
652	EUCTR2014-003033-26-CZ (EUCTR)	08/07/2015	05/12/2014	A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
653	EUCTR2014-000110-61-ES (EUCTR)	06/07/2015	01/06/2015	Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
654	NCT02518620 (ClinicalTrials.gov)	July 2015	6/8/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061	Rheumatoid Arthritis	Biological: ALX-0061	Ablynx	NULL	Completed	18 Years	74 Years	All	406	Phase 2	Belgium;Bulgaria;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Macedonia, The Former Yugoslav Republic of
655	EUCTR2014-003034-42-DE (EUCTR)	29/06/2015	18/03/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
656	EUCTR2014-003034-42-ES (EUCTR)	19/06/2015	14/04/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
657	EUCTR2014-003012-36-BG (EUCTR)	19/06/2015	12/03/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
658	EUCTR2014-003453-34-EE (EUCTR)	18/06/2015	14/05/2015	Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.	A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
659	EUCTR2014-003012-36-CZ (EUCTR)	10/06/2015	05/01/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
660	EUCTR2014-000358-13-HR (EUCTR)	08/06/2015	10/11/2015	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
661	EUCTR2014-001471-31-DE (EUCTR)	02/06/2015	04/02/2015	This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
662	EUCTR2015-000538-31-DE (EUCTR)	01/06/2015	07/04/2015	Application into the joint of opioids in chronic arthritis of the knee joint	NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint	chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA. MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Morphine Hexal INN or Proposed INN: Morphinsulfat Other descriptive name: MORPHINE SULFATE Trade Name: Triam 40 mg Lichtenstein INN or Proposed INN: TRIAMCINOLONACETONID Other descriptive name: TRIAMCINOLONACETONID EP	Charité University medicine Berlin	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Germany
663	JPRN-UMIN000017495	2015/06/01	26/11/2015	Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab	Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab - Methotraxate and Adalimumab study, to Space and TapEr for Rheumatoid arthritis patients at maintenance period (MASTER study)	rheumatoid arthritis(RA)	dose maintain group: no change of treatment MTX reducing group: reduce 2mg/week of MTX at ever 8 weeks. If remission is maintained at MTX 2mg/week, MTX will be stopped. ADA spacing group: space the intervals of ADA for 1week at ever 8 weeks. If remission is maitained at the 6 weeks-intervals of ADA, ADA is stopped.	Keio University School of Medicine, Japan.	NULL	Recruiting	Not applicable	Not applicable	Male and Female	75	Not selected	Japan
664	EUCTR2010-021184-32-BG (EUCTR)	27/05/2015	14/04/2015	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 1;Phase 2	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
665	EUCTR2014-003012-36-ES (EUCTR)	27/05/2015	02/02/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
666	EUCTR2014-003012-36-DE (EUCTR)	21/05/2015	29/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
667	EUCTR2014-003033-26-DE (EUCTR)	21/05/2015	18/12/2014	A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
668	NCT02402686 (ClinicalTrials.gov)	May 20, 2015	25/3/2015	Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)	Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	353		Hungary
669	JPRN-UMIN000017440	2015/05/18	07/05/2015	In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study.	In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. - RAXEL study	Rheumatoid arthritis	for 3 months Tofacitinib 5mg BID everyday for 3 months Tofacitinib 5mg BID everyday for 3 months Methotrexate6mg-16mg/week	Graduate School of Medicine and School of Medicine, Chiba Universitythe department of allergy and clinical immunology	NULL	Complete: follow-up complete	18years-old	90years-old	Male and Female	134	Phase 4	Japan
670	EUCTR2013-004019-37-DK (EUCTR)	13/05/2015	24/02/2015	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Australia;Denmark;Bulgaria;Germany;New Zealand
671	EUCTR2014-000110-61-CZ (EUCTR)	11/05/2015	04/05/2015	Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 PFS INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Code: FKB327 AI INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	680	Phase 3	Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru
672	EUCTR2014-003034-42-HU (EUCTR)	08/05/2015	03/03/2015	An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis	A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
673	EUCTR2013-004569-16-DE (EUCTR)	07/05/2015	26/11/2014	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany;Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy
674	EUCTR2011-004720-35-NO (EUCTR)	04/05/2015	26/01/2015	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Sweden
675	EUCTR2014-005418-45-SE (EUCTR)	04/05/2015	18/03/2015	Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)	Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE	Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Plaquenil INN or Proposed INN: HYDROXYCHLOROQUINE	Christine Bengtsson	Solveig Wållberg-Jonsson	Not Recruiting			Female: yes Male: yes		Phase 2	Sweden
676	NCT02566967 (ClinicalTrials.gov)	May 2015	1/10/2015	An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective	An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to Target	Rheumatoid Arthritis	Drug: tofacitinib	Norman B. Gaylis, MD	NULL	Completed	18 Years	N/A	All	20	Phase 3	United States
677	EUCTR2014-002945-23-ES (EUCTR)	30/04/2015	09/02/2015	A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who?s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.	A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis.	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Estonia;Czech Republic;Spain;Russian Federation;Latvia;United Kingdom
678	EUCTR2013-004569-16-GR (EUCTR)	30/04/2015	29/01/2015	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany
679	EUCTR2014-001471-31-BG (EUCTR)	29/04/2015	21/04/2015	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
680	EUCTR2014-003033-26-BG (EUCTR)	29/04/2015	19/02/2015	A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Serbia;United States;Spain;Czech Republic;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
681	EUCTR2010-021184-32-PL (EUCTR)	21/04/2015	06/02/2015	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 1;Phase 2	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
682	EUCTR2014-003307-30-SK (EUCTR)	16/04/2015	02/02/2015	Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis	A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BUMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Celltech, UK Registered Branch of UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of
683	EUCTR2014-003307-30-HU (EUCTR)	16/04/2015	22/01/2015	Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis	A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BIMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Celltech, UK Registered Branch of UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of
684	EUCTR2014-001471-31-RO (EUCTR)	08/04/2015	05/10/2015	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Australia;Bulgaria;Germany;New Zealand
685	EUCTR2014-002541-22-DE (EUCTR)	02/04/2015	09/12/2014	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 3	United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
686	JPRN-UMIN000016606	2015/04/01	01/04/2015	Efficacy and safety of electroporation and MTX combination therapy for the patients with RA	Efficacy and safety of electroporation and MTX combination therapy for the patients with RA - Combination therapy of electroporation and MTX for the patients with RA	rheumatoid arthritis	* Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US). * Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US. After three minutes, perform electroporation for four angles with US gel. * Condition of electroporation is 50V/cm 250ms 4puluse. * Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline. * Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US). * Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US. * Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline.	Osaka City University Medical School, Department of Orthopedic Surgery	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	60	Phase 2	Japan
687	NCT02423538 (ClinicalTrials.gov)	April 2015	7/4/2015	First-in-Human Single Ascending Dose of SHR0302	A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers	Rheumatoid Arthritis	Drug: SHR0302;Drug: SHR0302 placebo comparator	Jiangsu HengRui Medicine Co., Ltd.	NULL	Active, not recruiting	18 Years	45 Years	Both	64	Phase 1	China
688	EUCTR2014-003307-30-CZ (EUCTR)	31/03/2015	03/02/2015	Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis	A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BIMEKIZUMAB Product Code: UCB4940 INN or Proposed INN: Bimekizumab Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Celltech, UK Registered Branch of UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Czech Republic;Moldova, Republic of
689	JPRN-UMIN000016950	2015/03/27	03/04/2015	Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept	Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept - Clinical outcome in patients with RA switched to TNF blocker after tocilizumab or abatacept	rheumatoid arthritis	Infliximab or adalimumab or golimumab	Osaka Medical College	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
690	EUCTR2015-000089-72-IT (EUCTR)	26/03/2015	06/02/2015	abatacept in obese and overweight RA patiens	FAT GENE EXPRESSION IN OVERWEIGHT AND OBESE PATIENTS WITH PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT AND CLINICAL RESPONSE	MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ORENCIA Product Name: Orencia abatacept	Policlinico Gemelli-CIC- UCSC	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	Italy
691	EUCTR2010-021184-32-GB (EUCTR)	25/03/2015	12/06/2015	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
692	NCT02486302 (ClinicalTrials.gov)	March 24, 2015	28/6/2015	A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.	A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT	Rheumatoid Arthritis;Psoriatic Arthritis;Axial Spondyloarthritis;Plaque Psoriasis	Drug: Etanercept	Pfizer	NULL	Completed	18 Years	N/A	All	1534		Germany
693	EUCTR2014-001471-31-HU (EUCTR)	23/03/2015	23/01/2015	This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
694	EUCTR2014-003012-36-BE (EUCTR)	23/03/2015	18/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
695	EUCTR2014-003033-26-BE (EUCTR)	23/03/2015	25/11/2014	A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
696	EUCTR2014-004419-35-GB (EUCTR)	18/03/2015	02/02/2015	Inhibition of Co-Stimulation in Rheumatoid Arthritis	Inhibition of Co-Stimulation in Rheumatoid Arthritis - Inhibition of Co-Stimulation in Rheumatoid Arthritis (ICoSRA)	Rheumatoid Arthritis: patients who are dual ACPA and HLA-DR4 positive MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Abatacept Product Name: Abatacept INN or Proposed INN: Abatacept	NHS Greater Glasgow and Clyde	University of Glasgow	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
697	EUCTR2013-004569-16-BG (EUCTR)	18/03/2015	05/01/2015	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany
698	EUCTR2014-000352-29-FR (EUCTR)	16/03/2015	18/06/2015	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
699	EUCTR2012-001176-10-BG (EUCTR)	16/03/2015	04/11/2014	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand
700	EUCTR2013-004569-16-HR (EUCTR)	16/03/2015	29/04/2015	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
701	EUCTR2013-005524-42-NL (EUCTR)	10/03/2015	27/03/2014	STAtins to Prevent Rheumatoid Arthritis (STAPRA)	Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial - STAtins to Prevent Rheumatoid Arthritis (STAPRA)	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039080;Term: Rheumatoid factor positive;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Atorvastatin Product Name: Atorvastatin Product Code: C10AA05 INN or Proposed INN: ATORVASTATIN	Reade	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 4	Netherlands
702	EUCTR2014-003012-36-HU (EUCTR)	10/03/2015	30/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
703	EUCTR2014-001471-31-CZ (EUCTR)	04/03/2015	27/01/2015	This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.	Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand
704	JPRN-UMIN000015433	2015/03/01	01/11/2014	Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients	Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients - Safety study of MTX once daily administration in RA patients	rheumatoid arthritis	methotrexate	Department of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama	NULL	Recruiting	20years-old	Not applicable	Male and Female	35	Not selected	Japan
705	NCT02287922 (ClinicalTrials.gov)	March 2015	5/11/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate	Rheumatoid Arthritis	Biological: ALX-0061;Biological: Placebo;Biological: Tocilizumab	Ablynx	NULL	Completed	18 Years	74 Years	All	251	Phase 2	United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of
706	EUCTR2013-004148-49-FR (EUCTR)	23/02/2015	18/06/2015	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
707	EUCTR2014-003033-26-ES (EUCTR)	20/02/2015	07/01/2015	A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
708	NCT02373813 (ClinicalTrials.gov)	February 20, 2015	12/1/2015	Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: etanercept pre-filled syringe subcutaneous injection;Drug: Oral methotrexate;Drug: Placebo for etanercept subcutaneous injection;Drug: Placebo for methotrexate;Dietary Supplement: Folic acid (non-investigational product)	Amgen	NULL	Completed	18 Years	N/A	All	371	Phase 3	United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic
709	EUCTR2013-002805-76-BG (EUCTR)	20/02/2015	10/10/2014	A 24-week placebo-controlled clinical study to evaluate the adequate dose,efficacy and safety of 3 doses of namilumab combined with methotrexatein subjects with moderate to severe rheumatoid arthritis.	A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS.	Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 2	Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom
710	EUCTR2014-002945-23-CZ (EUCTR)	18/02/2015	21/11/2014	A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.	A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis.	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Estonia;Czech Republic;Spain;Russian Federation;United Kingdom
711	EUCTR2014-002945-23-GB (EUCTR)	18/02/2015	04/11/2014	A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.	A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis.	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	36	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Estonia;Czech Republic;Spain;Russian Federation;United Kingdom
712	EUCTR2014-001114-26-SE (EUCTR)	18/02/2015	26/08/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
713	EUCTR2014-003033-26-HU (EUCTR)	17/02/2015	26/11/2014	A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
714	EUCTR2014-002541-22-ES (EUCTR)	16/02/2015	22/12/2014	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	340	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
715	EUCTR2014-001114-26-NL (EUCTR)	13/02/2015	24/09/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden
716	EUCTR2014-002541-22-HU (EUCTR)	11/02/2015	15/12/2014	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	340	Phase 3	United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of
717	EUCTR2013-004569-16-HU (EUCTR)	03/02/2015	18/11/2014	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
718	EUCTR2013-003530-33-GB (EUCTR)	02/02/2015	22/05/2014	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	494	Phase 2	United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand
719	NCT02373202 (ClinicalTrials.gov)	February 2015	12/2/2015	A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)	A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine	Sanofi	Regeneron Pharmaceuticals	Completed	20 Years	N/A	All	91	Phase 3	Japan
720	NCT02633332 (ClinicalTrials.gov)	February 2015	30/11/2015	Use of Well Known Drugs for New Destination - RA Improvement (RANT)	Observational Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Rheumatoid Arthritis Not Responding to Commonly Used Treatments	Rheumatoid Arthritis;Autoimmune Diseases;Disorder of Synovium;Sjogren's Syndrome;Acute and Chronic Inflammation;Disorder of Pleura and Pleural Cavity;Felty's Syndrome;Rheumatoid Nodules	Drug: Vitamin D3;Drug: Lipitor®;Drug: Acycloguanosine;Drug: Tetracycline;Drug: methotrexate;Drug: etanercept	Università Popolare Homo & Natura	NULL	Completed	18 Years	75 Years	Both	15	Phase 1	Italy
721	NCT02357069 (ClinicalTrials.gov)	February 2015	29/1/2015	A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy	Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX	Arthritis, Rheumatoid	Drug: Enbrel;Drug: LBEC0101	LG Life Sciences	Mochida Pharmaceutical Company, Ltd.	Active, not recruiting	20 Years	75 Years	Both	372	Phase 3	Japan;Korea, Republic of
722	NCT02330445 (ClinicalTrials.gov)	February 2015	18/12/2014	6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection	Phase I/II Open Label Evaluation of Safety and Feasibility of 6 Months IV PRTX-100 Administrations in Previous Rheumatoid Arthritis Study Participants and Development of Immunological Samples for Assay Development From Normal Volunteers	Arthritis, Rheumatoid	Drug: PRTX-100	Protalex, Inc.	NULL	Completed	18 Years	N/A	All	13	Phase 1/Phase 2	United States
723	EUCTR2013-004019-37-BG (EUCTR)	26/01/2015	02/09/2014	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand
724	EUCTR2014-002541-22-CZ (EUCTR)	26/01/2015	09/12/2014	Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis	A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Humira, 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 3	Romania;Peru;South Africa;Germany;Korea, Republic of;Czech Republic;Hungary;Puerto Rico;Poland;United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom
725	EUCTR2014-000109-11-DE (EUCTR)	22/01/2015	08/10/2014	Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	730	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
726	EUCTR2014-003255-54-CZ (EUCTR)	21/01/2015	24/10/2014	A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis	A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RGB-03 INN or Proposed INN: RITUXIMAB Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Gedeon Richter Plc	NULL	Not Recruiting			Female: yes Male: yes	142	Phase 1;Phase 3	Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany
727	EUCTR2014-000109-11-BG (EUCTR)	21/01/2015	10/10/2014	Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	730	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
728	NCT03719469 (ClinicalTrials.gov)	January 20, 2015	6/9/2018	Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis	Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea	Rh Disease	Dietary Supplement: Green tea group	King Saud University	NULL	Completed	18 Years	85 Years	All	150		NULL
729	EUCTR2013-004019-37-DE (EUCTR)	19/01/2015	24/07/2014	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand
730	EUCTR2012-002535-28-IT (EUCTR)	16/01/2015	04/11/2014	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Portugal;Spain;Belgium;Netherlands;United Kingdom;Italy
731	EUCTR2013-003530-33-BE (EUCTR)	15/01/2015	19/09/2014	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	494	Phase 2	United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand
732	EUCTR2013-004569-16-SK (EUCTR)	14/01/2015	21/11/2014	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany
733	EUCTR2014-000358-13-ES (EUCTR)	13/01/2015	22/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
734	EUCTR2011-002067-20-FR (EUCTR)	13/01/2015	23/08/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892		United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany
735	EUCTR2013-003530-33-BG (EUCTR)	09/01/2015	06/11/2014	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	494	Phase 2	United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand
736	EUCTR2010-021184-32-HU (EUCTR)	09/01/2015	27/10/2014	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 1;Phase 2	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
737	EUCTR2013-005543-90-BG (EUCTR)	06/01/2015	22/10/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
738	EUCTR2014-000352-29-EE (EUCTR)	05/01/2015	07/08/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand;Colombia
739	ChiCTR-INR-16009274	2015-01-01	2016-09-25	The multi-center clinical research in TCM diagnosis and treatment norms on Rheumatoid arthritis of piweikuixu-shirezuluo symptoms	The multi-center clinical research in TCM diagnosis and treatment norms on Rheumatoid arthritis of piweikuixu-shirezuluo symptoms	Rheumatoid arthritis	RA No.1+fengshi mud:RA No.1+fengshi mud;MTX+LEF Group:MTX+LEF;RA No.1+fengshi mud+MTX+LEF Group:RA No.1+fengshi mud+MTX+LEF;	Zhejiang Chinese Medical University	NULL	Recruiting	18	65	Both	RA No.1+fengshi mud:150;MTX+LEF Group:150;RA No.1+fengshi mud+MTX+LEF Group:150;		China
740	NCT02371096 (ClinicalTrials.gov)	January 2015	5/2/2015	Comparative Pharmacokinetic Trial of RGB-03 and MabThera		Rheumatoid Arthritis	Drug: MabThera (rituximab);Drug: RGB-03	Gedeon Richter Plc.	NULL	Not yet recruiting	18 Years	75 Years	Both		Phase 1	NULL
741	NCT02309359 (ClinicalTrials.gov)	January 2015	27/11/2014	A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis	Biological: ALX-0061;Other: Placebo;Drug: Methotrexate	Ablynx	NULL	Completed	18 Years	74 Years	All	345	Phase 2	United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of
742	JPRN-UMIN000012650	2014/12/31	21/12/2013	In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique.	In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique. - Kinematic analysis of total knee arthroplasty.	osteoarthritis or rheumatoid arthritis of the knee joint	Fluoroscopy was performed to continuously capture the knee from the lateral direction in a weight-bearing position and knee bending position.	Dept. of orthopedic surgery, Osaka Medical College	NULL	Recruiting	20years-old	90years-old	Male and Female	60	Not selected	Japan
743	EUCTR2014-000109-11-CZ (EUCTR)	18/12/2014	09/10/2014	Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	680	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
744	EUCTR2014-000443-33-DE (EUCTR)	18/12/2014	07/07/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02) (RApsody) - ETA 302	Rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	620	Phase 3	United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
745	JPRN-UMIN000020663	2014/12/16	21/01/2016	A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.	A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib. - A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.	Rheumatoid arthritis	Period :12 months Patients take Tofacitinib 5mg twice a day.	Kyusyu University Hospital Medicine and biosystemic science	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Not applicable	Japan
746	EUCTR2014-002945-23-EE (EUCTR)	16/12/2014	27/11/2014	A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.	A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis.	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	9	Phase 2	Czech Republic;Estonia;Spain;Russian Federation;United Kingdom
747	JPRN-UMIN000015794	2014/12/15	10/12/2014	Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study )	Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study ) - RISOTTO(sodium RISedrOnate for sTeroid induced osTeOporosis with rheumatoid arthritis)	osteoporosis, rheumatoid arthritis	monthly risedronate sodium 75mg for 6 months monthly placebo for 6 months	Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of Medicine	NULL	Complete: follow-up continuing	20years-old	Not applicable	Male and Female	165	Phase 4	Japan
748	EUCTR2014-001114-26-GR (EUCTR)	12/12/2014	02/12/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	334	Phase 4	Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
749	EUCTR2014-001114-26-IE (EUCTR)	11/12/2014	14/08/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
750	EUCTR2014-000352-29-DE (EUCTR)	11/12/2014	13/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
751	EUCTR2013-003530-33-NL (EUCTR)	11/12/2014	22/05/2014	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	520	Phase 2	United States;Serbia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Puerto Rico;Belgium;Australia;Bulgaria;South Africa;Latvia;Netherlands;Moldova, Republic of
752	EUCTR2014-000109-11-ES (EUCTR)	09/12/2014	04/11/2014	Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.	A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate.	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Fujifilm Kyowa Kirin Biologics Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
753	EUCTR2014-000352-29-HU (EUCTR)	05/12/2014	09/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
754	EUCTR2014-000358-13-CZ (EUCTR)	04/12/2014	04/08/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
755	EUCTR2014-000993-20-SE (EUCTR)	04/12/2014	02/09/2014	Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseases	Dosing of intraarticular triamcinolone hexacetonid for knee synovitis in chronic polyarthritis	Psoriatic arthritis and rheumatoid arthritis with synovitis of the knee;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: triamcinolone hexacetonide (Lederspan) Product Name: triamcinolone hexacetonid (Lederspan) Product Code: 9512 Trade Name: triamcinolone hexacetonide (Lederspan) Product Name: triamcinolone hexacetonid (Lederspan) Product Code: 9512	Center for Research and Development Uppsala University/County Council of Gävleborg	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Sweden
756	EUCTR2014-000358-13-PL (EUCTR)	03/12/2014	24/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
757	NCT02876874 (ClinicalTrials.gov)	December 2014	3/2/2015	Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage	the Relationship Between the Activity of Rheumatoid Arthritis(RA) and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic Vessels	Rheumatoid Arthritis;Lymph Node Mass;Lymphatic Vessel; Dilatation	Drug: indocyanine green(ICG)	Shanghai University of Traditional Chinese Medicine	NULL	Recruiting	18 Years	65 Years	Both	21	N/A	China
758	EUCTR2013-001417-32-BG (EUCTR)	27/11/2014	16/09/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Moldova, Republic of
759	EUCTR2014-001114-26-GB (EUCTR)	25/11/2014	14/08/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
760	EUCTR2013-003984-72-CZ (EUCTR)	24/11/2014	14/04/2014	A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone.	Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;South Africa;Latvia
761	EUCTR2013-003530-33-CZ (EUCTR)	24/11/2014	09/05/2014	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	494	Phase 2	United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand
762	EUCTR2013-002622-23-GR (EUCTR)	20/11/2014	23/10/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
763	EUCTR2014-002374-36-SE (EUCTR)	19/11/2014	27/08/2014	A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity.	A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-STAR	Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra Trade Name: Methotrexate Trade Name: Metoject Trade Name: Azathioprine Trade Name: Leflunomide	The Karolinska Institutet, ClinTRID	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 4	Sweden
764	EUCTR2013-005543-90-DE (EUCTR)	19/11/2014	16/06/2014	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: RITUXIMAB Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
765	NCT02281552 (ClinicalTrials.gov)	November 18, 2014	30/10/2014	A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate	Rheumatoid Arthritis	Drug: Tofacitinib	Pfizer	NULL	Completed	20 Years	N/A	All	209	Phase 3	Japan
766	EUCTR2014-001114-26-ES (EUCTR)	17/11/2014	01/09/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	334	Phase 4	Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
767	EUCTR2014-000358-13-EE (EUCTR)	13/11/2014	07/08/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
768	EUCTR2014-001114-26-FR (EUCTR)	13/11/2014	18/06/2015	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	334	Phase 4	Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden
769	EUCTR2014-000358-13-GB (EUCTR)	12/11/2014	12/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
770	EUCTR2014-000358-13-RO (EUCTR)	10/11/2014	10/03/2015	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
771	EUCTR2014-001114-26-DE (EUCTR)	10/11/2014	08/08/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
772	EUCTR2014-000352-29-LT (EUCTR)	06/11/2014	08/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
773	EUCTR2014-000358-13-BG (EUCTR)	06/11/2014	28/10/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
774	EUCTR2013-002805-76-ES (EUCTR)	06/11/2014	19/08/2014	A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study.	A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study.	Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	324	Phase 2	United States;Spain;Russian Federation;Colombia;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Korea, Republic of
775	EUCTR2014-001114-26-AT (EUCTR)	05/11/2014	10/10/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
776	EUCTR2013-004019-37-HU (EUCTR)	04/11/2014	31/07/2014	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 2	Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand;Poland;Czech Republic;Hungary;Canada
777	JPRN-UMIN000015616	2014/11/04	10/11/2014	Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction	Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction - Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction	rheumatoid arthritis	Adalimumab plus Methotrexate Tocilizumab plus Methotrexate	Biologic Mate Study Group	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	300	Not selected	Japan
778	EUCTR2014-001114-26-HU (EUCTR)	04/11/2014	10/09/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden
779	NCT02293902 (ClinicalTrials.gov)	November 2014	13/11/2014	A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)	A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy	Rheumatoid Arthritis	Drug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acid	Sanofi	Regeneron Pharmaceuticals	Completed	20 Years	75 Years	All	243	Phase 3	Japan
780	NCT02551575 (ClinicalTrials.gov)	November 2014	26/8/2015	Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis	Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial	Rheumatoid Arthritis	Drug: Treatment of MTX and HCQ;Drug: Treatment of TCM;Drug: Integrative Medicine	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Active, not recruiting	18 Years	65 Years	Both	468	Phase 2/Phase 3	China
781	NCT02296775 (ClinicalTrials.gov)	November 2014	18/11/2014	Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis		Rheumatoid Arthritis	Biological: DRL_RI;Biological: Rituxan;Biological: MabThera	Dr. Reddy's Laboratories Limited	NULL	Completed	18 Years	65 Years	All	276	Phase 1/Phase 2	India;Ukraine
782	NCT02030028 (ClinicalTrials.gov)	November 2014	6/1/2014	ACTH Gel Therapy in Rheumatoid Arthritis	Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: ACTHAR gel	Dana Ascherman	Mallinckrodt	Completed	18 Years	100 Years	All	20	N/A	United States
783	NCT02319642 (ClinicalTrials.gov)	November 2014	15/12/2014	An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044	A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.	Rheumatoid Arthritis	Drug: Certolizumab Pegol	UCB Pharma SA	Parexel	Completed	18 Years	N/A	All	347	Phase 3	China
784	NCT02287610 (ClinicalTrials.gov)	November 2014	6/11/2014	A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis	A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting	Rheumatoid Arthritis	Drug: RAYOS (delayed-release prednisone)	Horizon Pharma Ireland, Ltd., Dublin Ireland	NULL	Completed	18 Years	N/A	All	75	N/A	NULL
785	NCT02342977 (ClinicalTrials.gov)	November 2014	18/12/2014	Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty:	Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: A Randomized Double -Blinded, Placebo-controlled Pilot Study.	Osteoarthritis;Rheumatoid Arthritis;Avascular Necrosis	Drug: Placebo;Drug: Lacosamide	Indiana University School of Medicine	VA Office of Research and Development	Withdrawn	18 Years	70 Years	Both	0	Phase 2	United States
786	EUCTR2014-000352-29-GB (EUCTR)	29/10/2014	09/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
787	EUCTR2014-000443-33-PL (EUCTR)	29/10/2014	21/07/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302	Rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus BioSciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	620	Phase 3	United States;Belarus;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;South Africa;Germany;Japan
788	EUCTR2014-000352-29-CZ (EUCTR)	27/10/2014	05/08/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU Product Name: Adalimumab-Pfizer Product Code: PR-06410293 INN or Proposed INN: ADALIMUMAB	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
789	EUCTR2014-000443-33-ES (EUCTR)	24/10/2014	04/07/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302	Rheumatoid arthritis MedDRA version: 17.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Belarus;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan
790	EUCTR2014-000443-33-IT (EUCTR)	24/10/2014	24/06/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302	Rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Belarus;Spain;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan
791	EUCTR2014-000352-29-ES (EUCTR)	23/10/2014	29/10/2014	A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE	RHEUMATOID ARTHRITIS MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab-Pfizer Product Code: PF-06410293 INN or Proposed INN: ADALIMUMAB Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	560	Phase 3	Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand
792	EUCTR2013-004019-37-RO (EUCTR)	22/10/2014	05/03/2015	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Denmark;Australia;Bulgaria;Germany;New Zealand
793	EUCTR2013-004148-49-PL (EUCTR)	21/10/2014	27/08/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Georgia;Germany;Japan
794	EUCTR2013-004148-49-BG (EUCTR)	20/10/2014	01/09/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia
795	EUCTR2014-000443-33-GB (EUCTR)	20/10/2014	26/06/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02)(RApsody) - ETA 302	Rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus BioSciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	620	Phase 3	United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
796	EUCTR2014-001114-26-IT (EUCTR)	20/10/2014	16/09/2014	A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring	A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	334	Phase 4	Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
797	EUCTR2013-004019-37-CZ (EUCTR)	15/10/2014	05/09/2014	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-122 Product Code: ABT-122 INN or Proposed INN: na Other descriptive name: ABT-122 Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand
798	EUCTR2013-002805-76-GB (EUCTR)	09/10/2014	30/12/2013	A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis.	A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS.	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	108	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Germany;Japan;United Kingdom
799	EUCTR2013-002805-76-DE (EUCTR)	06/10/2014	27/01/2014	A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study.	A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) followed by a 48-week active extension study.	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	324	Phase 2	Czech Republic;Mexico;Argentina;Poland;Brazil;Spain;Russian Federation;Bulgaria;Colombia;Germany;United Kingdom;Korea, Republic of
800	EUCTR2014-001299-79-DK (EUCTR)	06/10/2014	07/07/2014	Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment	Pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA	Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy MedDRA version: 18.0;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Prevenar 13 INN or Proposed INN: pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE Trade Name: Pneumovax INN or Proposed INN: pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)	Department of Infectious Diseases, Odense University Hospital	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Denmark
801	EUCTR2014-000706-34-GB (EUCTR)	06/10/2014	18/07/2014	A Study to Determine the Body's Immune Response To a Vaccination for Herpes Zoster In Subjects Who Have Rheumatoid Arthritis and Receive Tofacitinib (CP-690,550) (the drug being tested) or Placebo	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (CP-690,550) OR PLACEBO WITH BACKGROUND METHOTREXATE TREATMENT	RHEUMATOID ARTHRITIS MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tofacitinib citrate Product Code: CP-690,550 – 10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2	United States;Hungary;Germany;United Kingdom
802	EUCTR2014-000358-13-LT (EUCTR)	03/10/2014	11/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany
803	EUCTR2014-000859-91-FR (EUCTR)	03/10/2014	18/06/2015	Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde.	Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. - LYRITUX	Cette étude portera donc sur une population de patients atteints de polyarthrite rhumatoïde (PR) actives et ayant présenté un échec ou une contre-indication à au moins un anti-TNFa, et n’ayant jamais reçu de rituximab. MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB	CHRU de TOURS	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	France
804	NCT02270632 (ClinicalTrials.gov)	October 1, 2014	16/10/2014	A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX	A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.	Rheumatoid Arthritis	Drug: F8IL10;Drug: MTX;Drug: Placebo	Philogen S.p.A.	NULL	Active, not recruiting	18 Years	74 Years	All	27	Phase 2	Germany;Italy;Switzerland
805	JPRN-UMIN000015217	2014/10/01	01/10/2014	Identification of Antibodies Involved in Atherosclerosis Progression and Evaluation of Orencia`s Efficacy on Antibodies, Atherosclerosis Biomarkers and Structural Markers in Orencia-Treated Patients with Rheumatoid Arthritis Complicated by Atherosclerosis	Identification of Antibodies Involved in Atherosclerosis Progression and Evaluation of Orencia`s Efficacy on Antibodies, Atherosclerosis Biomarkers and Structural Markers in Orencia-Treated Patients with Rheumatoid Arthritis Complicated by Atherosclerosis - Orencia Atherosclerosis And Rheumatoid Arthritis Study(ORACLE Arthritis Study)	RA patients aged 20 years or older and have never been treated with biological products or molecular targeted drug therapy.	Abatacept	Yokohama City University Graduate School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	40	Not applicable	Japan
806	JPRN-UMIN000015462	2014/10/01	17/10/2014	Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study)	Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study) - Clinical study on rheumatoid arthritis treated with tofacitinib	Rheumatoid arthritis	Continue current treatment Tofacitinib discontinuation MTX discontinuation	School of Medicine, University of Occupational and Environmental Health, Japan	NULL	Recruiting	18years-old	Not applicable	Male and Female	400	Not selected	Japan
807	NCT02148640 (ClinicalTrials.gov)	October 2014	23/5/2014	The NOR-SWITCH Study	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY	Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic	Drug: Innovator infliximab;Drug: Biosimilar infliximab	Diakonhjemmet Hospital	South-Eastern Norway Regional Health Authority	Completed	18 Years	N/A	All	482	Phase 4	Norway
808	EUCTR2014-000358-13-LV (EUCTR)	26/09/2014	11/09/2014	A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis	A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A	Moderately to severely active Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate Product Code: CP-690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	1080	Phase 3;Phase 4	Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany
809	EUCTR2011-005689-39-SK (EUCTR)	24/09/2014	07/07/2014	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 2	United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
810	EUCTR2012-002945-40-DE (EUCTR)	22/09/2014	01/04/2014	BI695501 compared to adalimumab in patients with active rheumatoid arthritis	Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 3	United States;Serbia;Estonia;Thailand;Spain;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of
811	EUCTR2013-004555-21-GR (EUCTR)	22/09/2014	21/03/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
812	EUCTR2013-002358-57-BE (EUCTR)	18/09/2014	15/07/2014	A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Spain;Belgium;Australia;Netherlands;United Kingdom
813	EUCTR2013-002805-76-CZ (EUCTR)	11/09/2014	17/07/2014	A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis.	A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS.	Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB Product Name: Namilumab Product Code: MT203 INN or Proposed INN: namilumab Other descriptive name: NAMILUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 2	Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom
814	EUCTR2011-004720-35-FI (EUCTR)	10/09/2014	09/09/2014	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Finland;Denmark;Sweden
815	EUCTR2014-000443-33-HU (EUCTR)	09/09/2014	06/06/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02) (RApsody) - ETA 302	Rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	620	Phase 3	United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
816	EUCTR2013-003177-99-NL (EUCTR)	09/09/2014	25/02/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
817	EUCTR2013-005543-90-PL (EUCTR)	09/09/2014	11/07/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
818	EUCTR2012-003654-86-BG (EUCTR)	04/09/2014	21/05/2014	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
819	EUCTR2011-005689-39-NL (EUCTR)	01/09/2014	23/06/2014	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Spain;Poland;Russian Federation;Germany;Netherlands;Korea, Republic of
820	JPRN-UMIN000014624	2014/09/01	23/07/2014	Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study.	Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study. - EPOCA	Osteoarthritis, Rheumatoid arthritis	Administration of celecoxib from 2 hours after TKA surgery Administration of celecoxib from 2 days after TKA surgery	Mito medical center, Mito Kyodo General Hospital, University of Tsukuba	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	120	Phase 4	Japan
821	NCT02097264 (ClinicalTrials.gov)	September 2014	24/3/2014	A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Inflammation;Rheumatoid Arthritis	Drug: NNC0109-0012;Drug: Adalimumab;Drug: placebo	Novo Nordisk A/S	NULL	Withdrawn	18 Years	75 Years	Both	0	Phase 2	Ireland;Portugal;Spain;United Kingdom
822	NCT02154425 (ClinicalTrials.gov)	September 2014	30/5/2014	A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers	A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)	Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid Arthritis	Procedure: Breast milk sampling;Biological: Certolizumab Pegol	UCB BIOSCIENCES, Inc.	PPD;Parexel	Completed	18 Years	N/A	Female	17	Phase 1	United States;Netherlands;Switzerland;France
823	EUCTR2013-005543-90-HU (EUCTR)	26/08/2014	13/05/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany
824	EUCTR2012-002945-40-BG (EUCTR)	21/08/2014	05/08/2014	BI695501 compared to adalimumab in patients with active rheumatoid arthritis	Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 3	Serbia;United States;Estonia;Spain;Thailand;Ukraine;Russian Federation;Chile;Hungary;Poland;Malaysia;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of
825	EUCTR2013-004148-49-HU (EUCTR)	13/08/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
826	EUCTR2014-002056-40-NO (EUCTR)	12/08/2014	13/06/2014	A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH	Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning	Diakonhjemmet Hospital AS	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 4	Norway
827	EUCTR2013-002622-23-DE (EUCTR)	06/08/2014	27/03/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
828	EUCTR2013-004604-19-DE (EUCTR)	06/08/2014	03/06/2014	Effect of Adalimumab plus Methortrexat (MTX) versus Placebo plus MTX on cartilage in early RA patients	Delayed Gadolinium-enhanced Magnetic resonance Imaging (MRI) of Cartilage - A pilot study to measure the effect of Adalimumab plus Methotrexat (MTX) versus Placebo plus MTX on cartilage in early rheumatoid arthritis (RA) patients	patients with early progressive rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]	Trade Name: Humira 40mg Injektionslösung Product Name: Humira	Heinrich-Heine-Universität Düsseldorf	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	Germany
829	JPRN-UMIN000014737	2014/08/01	01/08/2014	The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity.	The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity. - Two Birds trial	rheumatoid arthritis	Denosumab group: Denosumab 60mg is administered by subcutaneous injections every 6 months (at baseline, at 6 months and at 12 months). All patients are to take vitamin D. BP group: Patients take BP continuously. All patients are to take vitamin D.	Yokohama City University Medical Center	NULL	Complete: follow-up complete	50years-old	90years-old	Male and Female	286	Not selected	Japan
830	NCT02219191 (ClinicalTrials.gov)	August 2014	16/7/2014	Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases	The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases	Rheumatoid Arthritis	Drug: puerarin tablet 50 mg;Drug: Atorvastatin tablet 20 mg	Chengdu PLA General Hospital	NULL	Active, not recruiting	18 Years	75 Years	All	150	N/A	China
831	NCT02234960 (ClinicalTrials.gov)	August 2014	5/9/2014	Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)	TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	102	N/A	Poland
832	EUCTR2013-002358-57-NL (EUCTR)	30/07/2014	24/02/2014	A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom
833	EUCTR2013-002622-23-ES (EUCTR)	29/07/2014	25/04/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500 INN or Proposed INN: Not applicable	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
834	EUCTR2013-003530-33-LV (EUCTR)	28/07/2014	17/06/2014	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494 Product Name: ABT-494 30mg INN or Proposed INN: ABT-494 Product Name: ABT-494 15mg INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	494	Phase 2	United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Netherlands;Latvia;New Zealand
835	EUCTR2013-004148-49-DE (EUCTR)	28/07/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany
836	EUCTR2013-003177-99-GB (EUCTR)	17/07/2014	11/03/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
837	EUCTR2013-004148-49-LT (EUCTR)	14/07/2014	23/05/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina
838	EUCTR2013-003177-99-CZ (EUCTR)	10/07/2014	05/02/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	Mexico;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
839	EUCTR2012-002945-40-ES (EUCTR)	07/07/2014	29/04/2014	BI695501 compared to adalimumab in patients with active rheumatoid arthritis	Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Colombia;France;Hungary;Mexico;Argentina;Poland;Malaysia;Belgium;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of
840	EUCTR2013-004148-49-GB (EUCTR)	03/07/2014	06/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
841	JPRN-UMIN000016928	2014/07/03	26/03/2015	Targeted Ultrasound in Rheumatoid Arthritis	Targeted Ultrasound in Rheumatoid Arthritis - TURA	Rheumatoid arthritis	If DAS28 increased by >0.6 from baseline, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week. If DAS28 increased by >0.6 from baseline or total PD score is 4 or greater, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.	Leeds University	NULL	Recruiting	18years-old	Not applicable	Male and Female	400	Not selected	Japan,Europe
842	JPRN-UMIN000015175	2014/07/01	17/09/2014	Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial.	Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. - STAR study	Rheumatoid Arthritis	Subcutaneous Tocilizumab 162mg every other week. Subcutaneous Abatacept 125mg every week.	St.Marianna University School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	120	Not selected	Japan
843	NCT02011334 (ClinicalTrials.gov)	July 2014	4/12/2013	A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.	A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	285	Phase 3	Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay
844	EUCTR2013-003984-72-ES (EUCTR)	30/06/2014	09/05/2014	A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone.	Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia
845	EUCTR2013-001417-32-ES (EUCTR)	30/06/2014	22/05/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden
846	EUCTR2013-004654-13-RO (EUCTR)	27/06/2014	30/05/2014	The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis	An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: ABP 501	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	425	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
847	EUCTR2013-003530-33-ES (EUCTR)	26/06/2014	17/03/2014	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	520	Phase 2	United States;Serbia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Puerto Rico;Belgium;Australia;Bulgaria;South Africa;Latvia;Netherlands;Moldova, Republic of
848	EUCTR2013-005013-13-PL (EUCTR)	25/06/2014	31/03/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
849	EUCTR2013-002622-23-NL (EUCTR)	24/06/2014	17/02/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500 INN or Proposed INN: Rituximab	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
850	JPRN-UMIN000014311	2014/06/24	24/06/2014	Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis	Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis - Examination of the clinical remission and functional remission in Infliximab using an increase-in-quantity protocol	rheumatoid arthritis	The quantity of Infliximab is increased.	Institute of Health Biosciences,The University of Tokushima Graduate School	NULL	Pending	20years-old	75years-old	Male and Female	10	Not selected	Japan
851	EUCTR2013-003984-72-SK (EUCTR)	23/06/2014	15/04/2014	A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone.	Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia
852	EUCTR2013-004148-49-CZ (EUCTR)	20/06/2014	05/06/2014	RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS	A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab-Pfizer Product Code: PF-06438179 INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-Pfizer Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Infliximab-EU	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	614	Phase 3	United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan
853	EUCTR2010-019262-86-BE (EUCTR)	20/06/2014	04/03/2014	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
854	EUCTR2013-001417-32-LT (EUCTR)	19/06/2014	07/04/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of
855	EUCTR2013-003530-33-HU (EUCTR)	18/06/2014	26/03/2014	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib 3mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 12mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 30mg INN or Proposed INN: Upadacitinib Product Name: Upadacitinib 15mg INN or Proposed INN: Upadacitinib	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	494	Phase 2	United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand
856	EUCTR2012-003686-17-SI (EUCTR)	17/06/2014	03/04/2014	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
857	EUCTR2012-002535-28-PT (EUCTR)	06/06/2014	25/02/2014	Not applicable	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
858	EUCTR2013-002622-23-HU (EUCTR)	03/06/2014	02/04/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
859	EUCTR2013-002790-22-HU (EUCTR)	02/06/2014	03/04/2014	To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)	An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	120		United States;Estonia;Czech Republic;Hungary;Argentina;Poland;Russian Federation;Chile
860	EUCTR2013-001417-32-DE (EUCTR)	02/06/2014	18/02/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden
861	JPRN-UMIN000013546	2014/06/01	31/03/2014	The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus	The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus	rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis	take a glass of grapefruit juice every day do not take grapefruit juice	Department of Rheumatology and Clinical Immunology, Kyoto University Hospital	NULL	Pending	16years-old	80years-old	Male and Female	20	Not applicable	Japan
862	EUCTR2012-001176-10-PL (EUCTR)	31/05/2014	28/04/2014	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
863	EUCTR2013-003984-72-LV (EUCTR)	30/05/2014	28/03/2014	A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone.	Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	270	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia
864	EUCTR2013-002790-22-EE (EUCTR)	30/05/2014	07/05/2014	To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)	An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	120		United States;Hungary;Czech Republic;Estonia;Argentina;Poland;Russian Federation;Chile
865	NCT02046616 (ClinicalTrials.gov)	May 28, 2014	24/1/2014	A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	133	Phase 3	Denmark;Finland;Norway;Sweden
866	EUCTR2011-004720-35-DK (EUCTR)	28/05/2014	24/02/2014	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Netherlands;Norway;Iceland;Sweden
867	EUCTR2013-001417-32-HU (EUCTR)	27/05/2014	17/03/2014	A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 3	Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of
868	EUCTR2013-003493-27-GR (EUCTR)	27/05/2014	16/04/2014	Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work.	A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: QAL964 Other descriptive name: QAL964	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	42		Hungary;Greece;Ukraine;Romania;Russian Federation
869	EUCTR2012-002945-40-HU (EUCTR)	27/05/2014	04/04/2014	BI695501 compared to adalimumab in patients with active rheumatoid arthritis	Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of
870	EUCTR2012-003654-86-LV (EUCTR)	26/05/2014	24/04/2014	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone.	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone	moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Australia;Peru;Bulgaria;Germany;Latvia;New Zealand
871	EUCTR2012-004339-21-PL (EUCTR)	25/05/2014	23/04/2014	To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis	A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy - SARIL-RA-EASY	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Mexico;Poland;Russian Federation;Chile;South Africa
872	EUCTR2013-004654-13-DE (EUCTR)	22/05/2014	03/02/2014	The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis	An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: ABP 501	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	425	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
873	EUCTR2013-002790-22-CZ (EUCTR)	21/05/2014	08/04/2014	To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)	An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	United States;Hungary;Estonia;Czech Republic;Argentina;Poland;Russian Federation;Chile
874	EUCTR2013-003984-72-HU (EUCTR)	20/05/2014	04/04/2014	A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone.	Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co.KG	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia
875	EUCTR2013-003413-18-GB (EUCTR)	13/05/2014	04/04/2014	Arthritis prevention with abatacept	Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA	The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis. MedDRA version: 20.0;Level: PT;Classification code 10003239;Term: Arthralgia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA 125 mg solution for injection	King’s College London	Guy's and St. Thomas' NHS Foundation Trust;Leiden University Medical Center	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	206	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Netherlands;United Kingdom
876	EUCTR2012-002945-40-EE (EUCTR)	09/05/2014	10/04/2014	BI695501 compared to adalimumab in patients with active rheumatoid arthritis	Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695501 INN or Proposed INN: - Other descriptive name: BI 695501 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 3	United States;Serbia;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;New Zealand;Korea, Republic of
877	EUCTR2013-002622-23-PT (EUCTR)	09/05/2014	28/02/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
878	EUCTR2010-019262-86-SE (EUCTR)	09/05/2014	24/03/2014	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
879	EUCTR2012-001176-10-HR (EUCTR)	08/05/2014	05/09/2014	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
880	EUCTR2013-003177-99-ES (EUCTR)	07/05/2014	17/03/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
881	EUCTR2012-002535-28-BE (EUCTR)	28/04/2014	28/03/2014	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActemra Product Name: RoActemra	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	160	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
882	EUCTR2013-005013-13-BG (EUCTR)	28/04/2014	23/04/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
883	EUCTR2013-003177-99-SK (EUCTR)	28/04/2014	10/03/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
884	EUCTR2012-001176-10-NL (EUCTR)	18/04/2014	28/12/2013	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China
885	EUCTR2013-004654-13-BG (EUCTR)	14/04/2014	18/03/2014	An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: ABP 501	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	425	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
886	EUCTR2013-004654-13-PL (EUCTR)	13/04/2014	03/04/2014	The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis	An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: ABP 501	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	425	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
887	EUCTR2013-003177-99-SE (EUCTR)	11/04/2014	05/02/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
888	EUCTR2013-003493-27-HU (EUCTR)	08/04/2014	30/01/2014	Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work.	A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: QAL964 Other descriptive name: QAL964	Novartis Pharma Services AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	42		Hungary;Ukraine;Russian Federation
889	EUCTR2013-005013-13-LT (EUCTR)	08/04/2014	13/02/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
890	EUCTR2013-004555-21-AT (EUCTR)	07/04/2014	02/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
891	EUCTR2013-004555-21-SK (EUCTR)	07/04/2014	23/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
892	EUCTR2013-002358-57-CZ (EUCTR)	04/04/2014	11/12/2013	A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom
893	EUCTR2013-005013-13-CZ (EUCTR)	03/04/2014	13/02/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
894	EUCTR2013-004555-21-HU (EUCTR)	02/04/2014	23/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany
895	EUCTR2013-002622-23-BE (EUCTR)	02/04/2014	26/03/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
896	JPRN-UMIN000013440	2014/04/01	18/03/2014	To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.	To evaluate the efficacy and safety of subcutaneous and intravenous abatacept. - Subcutaneous and abatacept versus intravenous abatacept.	Rheumatoid arthritis	SC abatacept IV abatacept Extension of SC abatacept	Osaka Medical College	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	50	Not selected	Japan
897	EUCTR2013-004555-21-DE (EUCTR)	31/03/2014	17/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Bosnia and Herzegovina;Korea, Republic of
898	EUCTR2012-003655-11-BG (EUCTR)	27/03/2014	19/02/2014	Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life	A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis	moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	739	Phase 2	United States;Czechia;Spain;Guatemala;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of
899	EUCTR2013-002622-23-BG (EUCTR)	27/03/2014	21/03/2014	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: Bi 695500	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	250		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
900	EUCTR2013-005001-31-ES (EUCTR)	25/03/2014	07/02/2014	Study on the ability of zoledronic acid to prevent worsening of radiographs of hands and feet of patients with rheumatoid arthritis diagnosed less than 2 years ago and who have few symptoms in their joints by making treatment with the drugs commonly used for the management of disease.	Randomized clinical trial on the prevention of radiographic progression with zoledronic acid in patients with early rheumatoid arthritis and low disease activity - Prevention of radiographic progression in rheumatoid arthritis with zoledronic acid	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Zoledronic acid Product Name: Zoledronic acid INN or Proposed INN: ZOLEDRONIC ACID	Dra. Carmen Gómez Vaquero (Servicio de Reumatología del Hospital Universiari de Bellvitge - Idibell)	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Spain
901	EUCTR2013-004654-13-ES (EUCTR)	25/03/2014	28/01/2014	The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis	An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: ABP 501 Other descriptive name: ABP 501	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	425	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
902	EUCTR2010-020992-21-DE (EUCTR)	25/03/2014	08/07/2011	Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis	A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable	AB Science	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2	Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina
903	EUCTR2013-000525-31-RO (EUCTR)	24/03/2014	12/02/2015	The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis	A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
904	EUCTR2013-004555-21-PT (EUCTR)	24/03/2014	07/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
905	EUCTR2010-019262-86-NO (EUCTR)	24/03/2014	08/10/2010	Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1940	Phase 3	United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden
906	EUCTR2013-003780-65-IT (EUCTR)	24/03/2014	03/12/2013	Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis	A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors	Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 14.1;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	France;United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy
907	EUCTR2013-003780-65-HU (EUCTR)	19/03/2014	21/01/2014	Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis	A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitorsRevised Protocol Number 02 incorporating Amendment 06 andAdministrative Letter 02	Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 17.1;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	France;United States;Hungary;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy
908	EUCTR2012-003686-17-GR (EUCTR)	18/03/2014	16/01/2014	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
909	EUCTR2012-003194-25-HR (EUCTR)	17/03/2014	03/09/2014	Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MabionCD20 INN or Proposed INN: Rituximab Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Mabion S.A.	NULL	Not Recruiting			Female: yes Male: yes	863	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia
910	JPRN-UMIN000013362	2014/03/15	06/03/2014	Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis.	Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis. - PRESERVATION OF REMISSION MAINTAENANCE BY LOW DOSE ETANERCEPT	Rheumatoid Arthritis	Methotrexate Etanercept	Takarazuka city hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	60	Not selected	Japan
911	EUCTR2013-002358-57-ES (EUCTR)	11/03/2014	05/12/2013	A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Spain;Australia;Netherlands;United Kingdom
912	EUCTR2013-001492-20-PT (EUCTR)	05/03/2014	24/01/2014	A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate	A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	Portugal;Spain;Ireland;United Kingdom
913	ChiCTR-TCS-14004252	2014-03-04	2014-02-12	A multicenter study for the evaluation of efficacy & safety of buprenorphine transdermal patch (Norspan or Sovenor transdermal patch) in patients with non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, when an opioid	A multicenter study for the evaluation of efficacy & safety of buprenorphine transdermal patch (Norspan or Sovenor transdermal patch) in patients with non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, when an opioid	osteoarthritis, rheumatoid arthritis, lower back pain, joint/muscle pain	case series:Norspan 5mg patch (1 patch per week), and the dose can be titrated up to maximum 40mg patch in the titration period (maximun 42 days). Patient will then be using the optimum dosage for 11 weeks, and follow-up for another 2 weeks after treatment period, maximum 19 weeks;	The Chinese University of Hong Kong	NULL	Pending	18	80	Both	case series:15;	I (Phase 1 study)	NULL
914	NCT02046603 (ClinicalTrials.gov)	March 4, 2014	24/1/2014	A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent	Open-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	162	Phase 3	United Kingdom
915	EUCTR2013-004555-21-LV (EUCTR)	03/03/2014	02/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina
916	EUCTR2012-003635-31-AT (EUCTR)	26/02/2014	02/07/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	595	Phase 2	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
917	EUCTR2013-004051-20-ES (EUCTR)	26/02/2014	27/12/2013	NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY	NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY	RHEUMATOID ARTHRITIS;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra 20 mg/ml concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: ROACTEMRA	FUNDACIÓN ESPAÑOLA DE REUMATOLOGIA	NULL	Not Recruiting			Female: yes Male: yes	122	Phase 4	Spain
918	EUCTR2012-003654-86-AT (EUCTR)	26/02/2014	08/07/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone	moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Serbia;United States;Spain;Guatemala;Ukraine;Lithuania;Austria;Israel;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;New Zealand
919	EUCTR2013-004654-13-HU (EUCTR)	24/02/2014	14/01/2014	The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis	An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: ABP 501	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	425		Bulgaria;Germany;United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania
920	EUCTR2012-001176-10-DE (EUCTR)	24/02/2014	05/12/2013	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
921	EUCTR2013-002007-34-SE (EUCTR)	20/02/2014	23/01/2014	Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.	Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	137	Phase 3	Finland;Denmark;Sweden
922	EUCTR2012-001176-10-PT (EUCTR)	18/02/2014	09/12/2013	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
923	EUCTR2013-004654-13-CZ (EUCTR)	12/02/2014	03/01/2014	The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis	An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: ABP 501	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	425	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
924	EUCTR2013-004654-13-GB (EUCTR)	12/02/2014	17/01/2014	The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis	An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: ABP 501	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	425	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
925	EUCTR2013-002007-34-FI (EUCTR)	10/02/2014	14/11/2013	Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.	Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound. - TOZULTRA	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	137	Phase 3	Finland;Denmark;Sweden
926	JPRN-UMIN000016844	2014/02/07	20/03/2015	The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors	The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors - The aggressive clinical tight control study(TACTICS trial)	Rheumatoid arthritis	infliximab: standard strategy infliximab: aggressive strategy golimumab: standard strategy golimumab: aggressive strategy	Takarazuka city hospital	NULL	Recruiting	20years-old	90years-old	Male and Female	80	Not applicable	Japan
927	EUCTR2013-002358-57-HU (EUCTR)	05/02/2014	21/12/2013	A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT 494 3mg INN or Proposed INN: ABT 494 Product Name: ABT 494 12mg INN or Proposed INN: ABT 494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom
928	NCT02173587 (ClinicalTrials.gov)	February 2014	22/6/2014	Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis	Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Dietary Supplement: Mussel oil capsules;Dietary Supplement: Corn oil capsules	Zhejiang University	Sir Run Run Shaw Hospital	Active, not recruiting	18 Years	75 Years	Both	56	N/A	China
929	EUCTR2013-002777-22-DK (EUCTR)	31/01/2014	11/12/2013	Targeted Ultrasound in Rheumatoid Arthritis (TURA)	Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Humira INN or Proposed INN: ADALIMUMAB	University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	230	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
930	EUCTR2013-002777-22-ES (EUCTR)	31/01/2014	02/12/2013	Targeted Ultrasound in Rheumatoid Arthritis (TURA)	Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Humira INN or Proposed INN: ADALIMUMAB	University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
931	EUCTR2013-001492-20-ES (EUCTR)	31/01/2014	16/01/2014	A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate	A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	Portugal;Spain;Ireland;United Kingdom
932	NCT01987479 (ClinicalTrials.gov)	January 30, 2014	8/11/2013	A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis	Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR	Rheumatoid Arthritis	Drug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	150	Phase 3	Netherlands
933	EUCTR2013-002777-22-HU (EUCTR)	28/01/2014	28/11/2013	Targeted Ultrasound in Rheumatoid Arthritis (TURA)	Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Humira INN or Proposed INN: ADALIMUMAB	University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
934	EUCTR2012-001176-10-IT (EUCTR)	22/01/2014	28/10/2013	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
935	EUCTR2011-005689-39-DE (EUCTR)	20/01/2014	24/05/2013	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 2	United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
936	EUCTR2012-001176-10-BE (EUCTR)	14/01/2014	23/12/2013	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
937	EUCTR2010-019262-86-GB (EUCTR)	13/01/2014	16/10/2013	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2000	Phase 3	Portugal;Belarus;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden
938	EUCTR2012-001176-10-AT (EUCTR)	13/01/2014	13/12/2013	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia
939	JPRN-UMIN000012364	2014/01/10	25/11/2013	Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis.	Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis. - Research for an appropriate use of tramadol / acetaminophen combination tablets for patient with rheumatoid arthritis.	rheumatoid arthritis	Tramadol / acetaminophen combination tablets will be administrated by 1 tablets / time/ qid and every 4 hours for pain relief. Step by step dose up administration schedule over 4weeks will be applied at beginning of treatment as bellows; *Day1-Day7(1 tablet/day, after night meal) *Day8-Day14(1 tabletX2 times /day, after morning and night meal) *Day15-Day21(1 tabletX3 times /day, after morning, afternoon and night meal *Day22-Day30(1 tabletX4 times /day, after morning, night meal and before bedtime) Once dose reached to 1 tabletX4 times /day, then treatment will be continue up to 24 weeks.	Osaka City University Medical School, Department of Orthopedic Surgery	NULL	Complete: follow-up complete	25years-old	75years-old	Male and Female	31	Not applicable	Japan
940	EUCTR2012-001176-10-GB (EUCTR)	10/01/2014	20/12/2013	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
941	EUCTR2013-000525-31-DE (EUCTR)	10/01/2014	06/08/2013	The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis	A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
942	NCT02001987 (ClinicalTrials.gov)	January 2014	29/11/2013	A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy	A Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Methotrexate;Drug: csDMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	139	Phase 3	France
943	EUCTR2012-003686-17-LT (EUCTR)	31/12/2013	21/11/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
944	JPRN-UMIN000012690	2013/12/28	27/12/2013	Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment	Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment - STARR-SMARRT	Rheumatoid Arthritis	tocilizumab+tacrolimus+Bucillamine tocilizumab	National hospital organization Chiba east national hospital Clinical Research Center	NULL	Complete: follow-up complete	20years-old	99years-old	Male and Female	60	Not applicable	Japan
945	EUCTR2013-001492-20-GB (EUCTR)	24/12/2013	18/10/2013	A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate	A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Other descriptive name: NNC0109-0012 Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	Portugal;Hungary;Czech Republic;Spain;Belgium;Poland;Ireland;Germany;Netherlands;Italy;United Kingdom
946	EUCTR2013-004006-26-DK (EUCTR)	18/12/2013	18/12/2013	OPAL	Optical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with Rheumascan	Detection of synovitis and tenosynovitis in the hands of patients with rheumatoid arthritis; Diagnostic performance of optical imaging in comparison with ultrasound and magnetic resonance imaging. MedDRA version: 16.1;Level: LLT;Classification code 10067132;Term: Synovitis wrist;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ICG-Pulsion INN or Proposed INN: 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl}-1,1-dimethyl-3-(sulfobutyl)-1H-benz[e]-indolium hydroxide,inner salt Other descriptive name: INDOCYANINE GREEN	Knowledge Centre for Rheumatology and Back Diseases	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Denmark
947	EUCTR2013-002777-22-DE (EUCTR)	17/12/2013	22/11/2013	Targeted Ultrasound in Rheumatoid Arthritis (TURA)	Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Humira INN or Proposed INN: ADALIMUMAB	University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 4	France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
948	EUCTR2013-002150-79-BE (EUCTR)	16/12/2013	24/10/2013	A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patients	TOSCARA: An open-label, single-arm study to evaluate the efficacy, safety and tolerability of tocilizumab (TCZ) subcutaneous in TCZ-naïve patients with active rheumatoid arthritis - TOSCARA	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-02 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	N.V. Roche S.A.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	Belgium
949	EUCTR2013-000525-31-BG (EUCTR)	13/12/2013	21/11/2013	The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis	A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: N/A Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
950	EUCTR2011-004720-35-IS (EUCTR)	13/12/2013	06/12/2013	NORD-STAR	A multicenter, randomized, single-blinded, phase 4 study in patients with early rheumatoid arthritis to compare 1) active conventional therapy versus three biologic treatments, and 2) two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra Trade Name: Metoject	The Karolinska Instutute, ClinTRID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Finland;Denmark;Norway;Iceland;Sweden
951	EUCTR2013-002007-34-DK (EUCTR)	09/12/2013	09/12/2013	Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.	Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	137	Phase 3	Finland;Denmark;Sweden
952	EUCTR2012-003686-17-HR (EUCTR)	05/12/2013	01/09/2014	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
953	JPRN-UMIN000018816	2013/12/05	26/08/2015	Study on the relationship between arthritis and sleep disturbance	Study on the relationship between arthritis and sleep disturbance - Sleep study in arthritis	Rheumatoid Arthritis	Treatment with melatonin-mimetics, ramelteon. Treatment with biological disease-modifying anti-rheumatic drugs.	Shunichi Shiozawa	Rheumatic Diseases Center, Kohnan Kakogawa Hospital	Complete: follow-up complete	20years-old	Not applicable	Male and Female	200	Not applicable	Japan
954	JPRN-UMIN000012473	2013/12/03	04/12/2013	Study for variations of safety and efficacy profile caused by division of weekly dose of methotrexate(preliminary study)	Study for variations of safety and efficacy profile caused by division of weekly dose of methotrexate(preliminary study) - SAME study	Rheumatoid arthritis	administration of weekly MTX dose at once administration by dividing three times of weekly MTX dose	Yokohama Minami Kyousai HospitalSanten Pharmaceutical CO.,Ltd.	Santen Pharmaceutical CO.,Ltd.	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	40	Not applicable	Japan
955	EUCTR2012-003686-17-SE (EUCTR)	02/12/2013	05/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
956	EUCTR2013-000114-38-DE (EUCTR)	29/11/2013	29/05/2013	A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)	A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b)	Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	304	Phase 2	Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
957	NCT03736044 (ClinicalTrials.gov)	November 25, 2013	11/10/2018	Reconstitution of CD4+CD25highCD127low/-Tcell	Analysis of T Cell Population to Obtain a Free-drug Remission in Patients Affected by Rheumatoid Athritis in Remission Phase Induced by TNF-blocker Therapy	Rheumatoid Arthritis	Drug: TNF-blockers suspension in patients with rheumatoid arthritis	University Hospital of Ferrara	NULL	Completed	18 Years	N/A	All	48	Phase 1	NULL
958	NCT01941095 (ClinicalTrials.gov)	November 20, 2013	30/8/2013	A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis	Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	100	Phase 3	Greece
959	EUCTR2013-001999-38-PL (EUCTR)	17/11/2013	11/10/2013	A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore	A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: not assigned yet Other descriptive name: TNF-Kinoid	Neovacs SA	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2	Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of
960	EUCTR2013-000525-31-PL (EUCTR)	17/11/2013	10/10/2013	The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis	A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
961	EUCTR2013-002777-22-GB (EUCTR)	14/11/2013	07/10/2013	Targeted Ultrasound in Rheumatoid Arthritis (TURA)	Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Humira INN or Proposed INN: ADALIMUMAB	University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine	NULL	Not Recruiting			Female: yes Male: yes	310	Phase 4	France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom
962	EUCTR2013-003658-26-NL (EUCTR)	13/11/2013	18/10/2013	Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study	Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study	Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Prednison Product Name: Prednison INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Plaquenil Product Name: hydroxycholoquine INN or Proposed INN: hydroxychloroquine sulfate Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Sulfasalazine Product Name: Sulfasalazine INN or Proposed INN: Sulfasalazine Other descriptive name: SULFASALAZINE	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
963	JPRN-UMIN000012257	2013/11/12	11/11/2013	Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial	Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial - Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial	osteoarthritis, rheumatoid arthritis, avascular necrosis of femoral condyle	A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty	Nekoyama Miyao Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	74	Not selected	Japan
964	EUCTR2013-003486-34-DK (EUCTR)	04/11/2013	04/11/2013	Treatment of Tenosynovitis among rheumatoid arthritis patients	Systemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study - SULTAN	MedDRA version: 16.0;Level: LLT;Classification code 10042869;Term: Synovitis and tenosynovitis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Diprofos Depot INN or Proposed INN: BETAMETHASONE ACIBUTATE Other descriptive name: Binyrebarkhormon Trade Name: Natriumklorid 9mg/ml INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE	Knowledge Centre for Rheumatology and Back Diseases	NULL	Not Recruiting			Female: yes Male: yes			Denmark
965	NCT02005757 (ClinicalTrials.gov)	November 2013	4/12/2013	Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)	Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug	Rheumatoid Arthritis	Drug: Bredinin tablet 150mg;Drug: Bredinin tablet 50mg	Chong Kun Dang Pharmaceutical	NULL	Recruiting	20 Years	80 Years	Both	60	Phase 2	Korea, Republic of
966	NCT02293590 (ClinicalTrials.gov)	November 2013	30/10/2014	RICE: Remission by Intra-articular Injection Plus CErtolizumab	An Open Label, Randomised Study to Compare the Efficacy of Certolizumab Pegol (CZP) Plus a Dynamic or Fixed Dose Treatment Strategy in Patients With Rheumatoid Arthritis, a Phase II Study	Rheumatoid Arthritis	Drug: Certolizumab Pegol	Rüdiger B. Müller	UCB Pharma	Completed	18 Years	N/A	All	43	Phase 2	Switzerland
967	NCT01855789 (ClinicalTrials.gov)	November 2013	14/5/2013	A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate in Participants With Moderate to Severe Active Rheumatoid Arthritis		Rheumatoid Arthritis	Drug: Placebo;Drug: Tocilizumab;Drug: methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	718	Phase 3	United States
968	NCT02254655 (ClinicalTrials.gov)	November 2013	18/11/2013	The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis	The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial	Rheumatoid Arthritis	Drug: Puerarin injection 400 mg;Drug: Control	Chengdu PLA General Hospital	NULL	Completed	18 Years	75 Years	All	119	Phase 2	China
969	NCT01990157 (ClinicalTrials.gov)	November 2013	5/11/2013	Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis	Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective	Rheumatoid Arthritis	Drug: TAB08	Theramab LLC	NULL	Completed	18 Years	65 Years	All	18	Phase 1/Phase 2	Russian Federation
970	NCT02027298 (ClinicalTrials.gov)	November 2013	18/11/2013	Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study	Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study	Primary Sjogren's Syndrome;Secondary Sjogren's Syndrome;Inflammatory Arthritis;Rheumatoid Arthritis	Drug: Abatacept	The Cleveland Clinic	Bristol-Myers Squibb	Withdrawn	18 Years	N/A	All	0	Phase 2	United States
971	NCT01980836 (ClinicalTrials.gov)	November 2013	4/11/2013	Effect of Tocilizumab to the Cellular Immune Response to Influenza Vaccine	The Effect of Tocilizumab on the Cellular Immune Response to Seasonal Influnza Vaccine in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Cellular Immune Response	Biological: Seasonal influenza vaccine	Tel-Aviv Sourasky Medical Center	NULL	Not yet recruiting	18 Years	N/A	Both	40	Phase 4	Israel
972	NCT01951170 (ClinicalTrials.gov)	November 2013	23/9/2013	An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis	An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute)	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	52	Phase 3	Australia
973	EUCTR2012-001176-10-ES (EUCTR)	31/10/2013	05/09/2013	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
974	EUCTR2013-001999-38-CZ (EUCTR)	30/10/2013	24/07/2013	A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore	A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: not assigned yet Other descriptive name: TNF-Kinoid	Neovacs SA	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2	Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of
975	EUCTR2013-001999-38-HU (EUCTR)	30/10/2013	16/07/2013	A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore	A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: not assigned yet Other descriptive name: TNF-Kinoid	Neovacs SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	Serbia;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of
976	EUCTR2012-004074-25-DE (EUCTR)	30/10/2013	29/07/2013	Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis	Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA	Early rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon Other descriptive name: PREDNISOLONE Trade Name: PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten Product Name: PredniHEXAL INN or Proposed INN: Prednisolon	Ruhr-Universität Bochum	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Germany
977	EUCTR2013-002341-11-GB (EUCTR)	25/10/2013	26/07/2013	This is a study in healthy subjects to look at the effect of tocilizumab (RoActemra) on a type of white blood cell	A SINGLE BLIND PHASE IV PHARMACODYNAMIC STUDY TO EVALUATE NEUTROPHIL DISTRIBUTION KINETICS AND FUNCTION FOLLOWING SINGLE-DOSE TOCILIZUMAB TREATMENT IN HEALTHY SUBJECTS	healthy volunteers (intended indication: Rheumatoid Arthritis) MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: no Male: yes		Phase 4	United Kingdom
978	EUCTR2012-003686-17-GB (EUCTR)	24/10/2013	06/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
979	EUCTR2013-000342-19-NL (EUCTR)	24/10/2013	08/10/2013	A clinical trial where patients with Rheumatoid Arthritis are treated with the study drug tocilizumab, subcutaneous (injection in the skin), with or without other non-biological anti-rhematic drugs, to study the safety and efficacy of the drug.	MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Roche Nederland B.V.	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Netherlands
980	EUCTR2013-002429-52-IE (EUCTR)	23/10/2013	15/08/2013	STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS	A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab SC Other descriptive name: TOCILIZUMAB SC	Roche Farma S.A	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Spain;Ireland
981	EUCTR2013-000114-38-BG (EUCTR)	23/10/2013	09/09/2013	A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)	A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b)	Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	304	Phase 2	Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
982	EUCTR2013-000525-31-CZ (EUCTR)	21/10/2013	17/07/2013	The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis	A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
983	EUCTR2013-002429-52-PT (EUCTR)	21/10/2013	08/08/2013	STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS	A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Roche Farma S.A.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Spain;Ireland
984	JPRN-UMIN000012399	2013/10/16	26/11/2013	Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis	Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis - Rheumascan Pilot Study	Rheumatoid arthritis	Patients with active rheumatoid arthritis (1)Assessment of tender and swollen joints by physical examination (2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands (3)Gadolinium-enhanced MRI of the hand with more severe arthritis (4)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG) Healthy subjects (1)Assessment of tender and swollen joints by physical examination (2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands (3)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG)	Tokyo Medical and Dental University	Diagnostic Imaging Center, Ochanomizu Surugadai Clinic	Complete: follow-up complete	20years-old	Not applicable	Male and Female	9	Not applicable	Japan
985	EUCTR2012-003724-20-RO (EUCTR)	14/10/2013	28/07/2014	A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.	A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone	Rheumatoid Arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: IPI 145 INN or Proposed INN: - Other descriptive name: IPI-145 Product Code: IPI 145 INN or Proposed INN: - Other descriptive name: IPI-145 Product Code: IPI 145 INN or Proposed INN: - Other descriptive name: IPI-145	Infinity Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	316	Phase 2	Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand
986	EUCTR2013-000525-31-ES (EUCTR)	12/10/2013	01/08/2013	The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis	A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 INN or Proposed INN: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
987	EUCTR2013-001999-38-BE (EUCTR)	07/10/2013	11/07/2013	A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore	A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: not assigned yet Other descriptive name: TNF-Kinoid	Neovacs SA	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2	Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of
988	EUCTR2013-000054-22-GB (EUCTR)	01/10/2013	07/08/2013	OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT	OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT - ACT-MOVE	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R	Roche Products Limited	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	United Kingdom
989	JPRN-UMIN000011891	2013/10/01	01/10/2013	Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis.	Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis. - GLORIA study	Rheumatoid Arthritis	Golimumab	St.Marianna University School of Medicine	NULL	Complete: follow-up complete	20years-old	70years-old	Male and Female	50	Not selected	Japan
990	NCT02538757 (ClinicalTrials.gov)	October 2013	18/8/2015	Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE)	Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE)	Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory Arthritis	Biological: Herpes Zoster Vaccine;Drug: Placebo	University of Alabama at Birmingham	Oregon Health and Science University	Active, not recruiting	50 Years	N/A	All	125	Phase 2	United States
991	NCT01773681 (ClinicalTrials.gov)	October 2013	16/1/2013	Novel Imaging Markers for Rheumatoid Arthritis	Novel Imaging Markers for Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Cimzia;Device: Magnetic Resonance Imaging (MRI);Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)	University of California, San Francisco	NULL	Completed	18 Years	N/A	All	30		United States
992	EUCTR2012-003635-31-BG (EUCTR)	27/09/2013	25/09/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	595	Phase 2	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
993	EUCTR2013-000525-31-HU (EUCTR)	26/09/2013	30/09/2013	The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis	A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
994	EUCTR2012-003654-86-DE (EUCTR)	26/09/2013	03/06/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone	moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
995	EUCTR2013-000114-38-SK (EUCTR)	25/09/2013	03/07/2013	A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)	A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b)	Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	304	Phase 2	Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
996	EUCTR2013-000944-25-HU (EUCTR)	19/09/2013	16/07/2013	Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis	A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	454		Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan
997	EUCTR2013-000114-38-HU (EUCTR)	19/09/2013	12/06/2013	A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)	A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b)	Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	304	Phase 2	Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
998	EUCTR2012-005733-37-GB (EUCTR)	18/09/2013	23/07/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
999	EUCTR2012-005674-61-LV (EUCTR)	13/09/2013	13/09/2013	Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis	A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Allogeneic Mesenchymal Precursor Cells Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS	Mesoblast, Inc	NULL	Not Recruiting			Female: yes Male: yes	90		Serbia;Hungary;Estonia;Czech Republic;Belgium;Poland;Croatia;Latvia
1000	EUCTR2012-005674-61-EE (EUCTR)	12/09/2013	02/09/2013	Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis	A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Allogeneic Mesenchymal Precursor Cells Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS	Mesoblast, Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Serbia;Hungary;Czech Republic;Estonia;Belgium;Poland;Croatia;Latvia
1001	EUCTR2013-000359-42-GR (EUCTR)	12/09/2013	27/08/2013	Not applicable	Multicenter, open label, phase IIIb study to evaluate the safety and tolerability of subcutaneous tocilizumab as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs in patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04	ROCHE HELLAS S.A.	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Greece
1002	EUCTR2012-005674-61-BE (EUCTR)	11/09/2013	30/08/2013	Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis	A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Allogeneic Mesenchymal Precursor Cells Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS	Mesoblast, Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Serbia;Hungary;Estonia;Czech Republic;Poland;Belgium;Croatia;Latvia
1003	EUCTR2012-001984-66-NO (EUCTR)	11/09/2013	17/10/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910	Phase 3	United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Germany;Norway;New Zealand
1004	NCT01907230 (ClinicalTrials.gov)	September 10, 2013	14/7/2013	Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients	Propylactic Use of Entecavir for Biological Agents Associated Hepatitis B Virus Reactivation in Inflammatory Arthritis Patients: a Randomized Controlled Trial	Rheumatoid Arthritis;Hepatitis B Reactivation;Exposure to Hepatitis B Virus	Drug: Entecavir	Taipei Veterans General Hospital, Taiwan	NULL	Active, not recruiting	20 Years	90 Years	All	115	Phase 4	Taiwan
1005	EUCTR2012-001176-10-LT (EUCTR)	09/09/2013	20/06/2013	Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003	A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	2165	Phase 3	Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
1006	EUCTR2013-000114-38-LT (EUCTR)	09/09/2013	02/07/2013	A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)	A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b)	Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	304	Phase 2	United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
1007	EUCTR2012-003635-31-DE (EUCTR)	05/09/2013	30/04/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.	moderately to severely active rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	595	Phase 2	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
1008	EUCTR2013-000114-38-CZ (EUCTR)	04/09/2013	12/06/2013	A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)	A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b)	Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	304	Phase 2	United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
1009	EUCTR2012-003654-86-ES (EUCTR)	03/09/2013	12/07/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone	moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Germany;Latvia;New Zealand
1010	EUCTR2012-003635-31-LV (EUCTR)	02/09/2013	06/08/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	595	Phase 2	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
1011	JPRN-JapicCTI-132209	01/9/2013		Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA (REASSURE-E)	A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Intervention name : AIN457 INN of the intervention : Secukinumab Dosage And administration of the intervention : Subjects will receive 150 mg secukinumab s.c. Control intervention name : null	Novartis Pharma K.K.	NULL		18		BOTH	454	Phase 3	NULL
1012	NCT01948388 (ClinicalTrials.gov)	September 2013	9/9/2013	The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients	Study of The Effect of Corticotrophin in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients From a Clinical and Structural Perspective As Measured by a Clinical Disease Activity Index Score and Bone Edema, Synovitis and Erosions on Magnetic Resonance Imaging	Rheumatoid Arthritis	Drug: corticotrophin 80 units	Gaylis, Norman B., M.D.	NULL	Completed	18 Years	N/A	All	20	Phase 4	United States
1013	NCT01995201 (ClinicalTrials.gov)	September 2013	1/11/2013	A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis	A Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	N/A	Both	401	Phase 3	Ireland;Portugal;Spain
1014	NCT01901900 (ClinicalTrials.gov)	September 2013	10/7/2013	Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA.	A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Secukinumab (AIN457)	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	Both	196	Phase 3	United States;Argentina;Canada;Guatemala;Hungary;India;Italy;Japan;Mexico;Thailand;Colombia;Panama;Puerto Rico
1015	NCT01955603 (ClinicalTrials.gov)	September 2013	24/9/2013	A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis	A Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis	Drug: NNC0215-0384;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	Both	24	Phase 1	Germany;Hungary;Poland;Russian Federation
1016	EUCTR2012-003635-31-CZ (EUCTR)	28/08/2013	31/05/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	595	Phase 2	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
1017	EUCTR2012-004342-14-DK (EUCTR)	27/08/2013	19/04/2013	A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs	A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509 INN or Proposed INN: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2;Phase 3	United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1018	EUCTR2013-000525-31-GB (EUCTR)	27/08/2013	02/07/2013	The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis	A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 501 Product Code: ABP 501 Other descriptive name: Biosimilar product to adalimumab Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany
1019	EUCTR2013-002429-52-ES (EUCTR)	23/08/2013	12/07/2013	STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS	A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Roche Farma S.A	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Spain;Ireland
1020	EUCTR2012-004090-16-NL (EUCTR)	20/08/2013	02/05/2013	Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.	A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 655064	Boehringer Ingelheim B.V	NULL	Not Recruiting			Female: yes Male: yes	106		Czech Republic;Poland;Spain;Germany;Netherlands;New Zealand
1021	EUCTR2011-005649-10-DE (EUCTR)	19/08/2013	18/07/2012	An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.	A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1022	EUCTR2012-002181-12-SE (EUCTR)	19/08/2013	09/07/2012	A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	Active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: None Other descriptive name: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
1023	EUCTR2012-005733-37-CZ (EUCTR)	16/08/2013	15/05/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
1024	EUCTR2012-003654-86-HU (EUCTR)	15/08/2013	17/05/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
1025	EUCTR2012-005026-30-HU (EUCTR)	15/08/2013	20/02/2013	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1026	EUCTR2012-002181-12-AT (EUCTR)	08/08/2013	25/06/2013	A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	Active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 Other descriptive name: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the SPONSOR or Merck)	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden
1027	EUCTR2011-005689-39-CZ (EUCTR)	07/08/2013	23/05/2013	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
1028	EUCTR2013-000114-38-EE (EUCTR)	06/08/2013	13/06/2013	A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)	A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b)	Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tregalizumab Product Code: BT061 INN or Proposed INN: Tregalizumab Other descriptive name: A INN or Proposed INN: Tregalizumab Other descriptive name: B INN or Proposed INN: Tregalizumab Other descriptive name: C INN or Proposed INN: Tregalizumab Other descriptive name: D INN or Proposed INN: Tregalizumab Other descriptive name: E	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	304	Phase 2	Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Sweden
1029	EUCTR2010-020892-22-NL (EUCTR)	03/08/2013	10/08/2011	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1030	EUCTR2013-001569-17-IT (EUCTR)	02/08/2013	04/06/2013	A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.	A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	Roche S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 3	Italy
1031	EUCTR2012-005733-37-LV (EUCTR)	02/08/2013	22/05/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584		Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
1032	EUCTR2012-000439-17-LV (EUCTR)	02/08/2013	05/06/2013	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis	active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MK-8457 Product Code: MK-8457	MERCK SHARP & DOHME CORP.	NULL	Not Recruiting			Female: yes Male: yes	434	Phase 2	United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1033	EUCTR2013-000944-25-IT (EUCTR)	02/08/2013	06/06/2013	Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis	A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension	Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Farma S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	454		Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan
1034	NCT01915537 (ClinicalTrials.gov)	August 2013	30/7/2013	Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients	A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis	Rheumatoid Arthritis(RA)	Drug: Infliximab group;Drug: Classic DMARDs treatment group	Zhang, Xiao, M.D.	Central South University;Tianjin Medical University General Hospital;Xijing Hospital	Not yet recruiting	18 Years	70 Years	Both	170	N/A	China
1035	EUCTR2012-003686-17-LV (EUCTR)	24/07/2013	05/07/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
1036	EUCTR2012-003686-17-PL (EUCTR)	24/07/2013	04/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany;Japan;Sweden
1037	EUCTR2012-003635-31-ES (EUCTR)	23/07/2013	10/06/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.	moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	595	Phase 2	Latvia;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand;Serbia;United States;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru
1038	EUCTR2012-003686-17-BE (EUCTR)	18/07/2013	31/05/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden;United States;Portugal;Taiwan;Slovakia
1039	EUCTR2012-002323-15-HR (EUCTR)	17/07/2013	30/03/2015	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1040	EUCTR2011-005648-93-GB (EUCTR)	12/07/2013	30/05/2013	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis Protocol Ref: CD-IA-CAM-3001-1109 - An Open-label of Mavrilimumab in Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany
1041	EUCTR2012-003686-17-HU (EUCTR)	11/07/2013	07/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
1042	EUCTR2012-005733-37-LT (EUCTR)	11/07/2013	20/05/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584		Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
1043	EUCTR2012-005733-37-BG (EUCTR)	10/07/2013	21/05/2013	A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB2 (infliximab biosimilar) Product Code: SB2 INN or Proposed INN: INFLIXIMAB Trade Name: Remicade® Product Name: Remicade INN or Proposed INN: INFLIXIMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
1044	EUCTR2012-003635-31-HU (EUCTR)	09/07/2013	22/04/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	595	Phase 2	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
1045	EUCTR2012-003644-71-BE (EUCTR)	08/07/2013	06/02/2013	Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure	A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	France;Hong Kong;Spain;Poland;Belgium;Australia;Russian Federation;Israel;Chile;Netherlands;Colombia;New Zealand
1046	EUCTR2011-005648-93-PT (EUCTR)	05/07/2013	03/04/2013	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400		Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany
1047	EUCTR2011-005649-10-GB (EUCTR)	05/07/2013	11/03/2013	An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.	A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis Protocol:CD-IA-CAM-3001-1107 - Mavrilimumab versus Anti tumor Necrosis Factor in Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB	MedImmune Limited	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1048	EUCTR2012-003686-17-ES (EUCTR)	04/07/2013	26/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib	Lilly S.A.	NULL	Not Recruiting			Female: yes Male: yes	3000	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
1049	EUCTR2012-003686-17-DK (EUCTR)	04/07/2013	07/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
1050	EUCTR2012-003686-17-DE (EUCTR)	04/07/2013	13/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
1051	EUCTR2012-001984-66-LV (EUCTR)	03/07/2013	25/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
1052	EUCTR2012-001984-66-IT (EUCTR)	02/07/2013	07/05/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
1053	EUCTR2012-003223-38-DE (EUCTR)	01/07/2013	08/04/2013	Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04	RHEUMATOID ARTHRITIS MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	157	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
1054	NCT01851070 (ClinicalTrials.gov)	July 2013	19/4/2013	A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa Inhibitor	A Double-blind, Randomized, Placebo-controlled, Dose-escalation, Multi-center Study a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa Inhibitor	Rheumatoid Arthritis	Drug: Allogeneic Mesenchymal Precursor Cells;Drug: Normal Saline	Mesoblast, Ltd.	PPD	Completed	18 Years	80 Years	All	48	Phase 2	United States;Australia
1055	NCT02236481 (ClinicalTrials.gov)	July 2013	8/9/2014	Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes	No-profit Study to Ensure Normal Clinical Practice, to Evaluate the Efficacy of Anakinra in Reducing the Glycated Haemoglobin in Patients Affected by Rheumatoid Arthritis and Diabetes; Randomized, Open Label, Parallel Group,Controlled Clinical Study	Diabetes Mellitus, Type 2;Arthritis, Rheumatoid	Drug: Anakinra;Drug: TNF alpha inhibitors	Prof. Roberto Giacomelli	NULL	Terminated	18 Years	N/A	All	41	Phase 4	Italy
1056	NCT02519387 (ClinicalTrials.gov)	July 2013	15/7/2015	Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity	Multicentre Study for Evaluation of the Efficacy and Safety of Buprenorphine Transdermal Patch (SOVENOR®) 5mg and 10mg in Patients With Non-malignant Pain of Moderate Intensity Due to Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain and Joint/Muscle Pain, When an Opioid is Necessary for Obtaining Adequate Analgesia	Osteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle Pain	Drug: Buprenorphine Transdermal Patch	Mundipharma Pharmaceuticals Sdn. Bhd.	NULL	Completed	40 Years	N/A	All	78	Phase 4	Malaysia
1057	EUCTR2012-004090-16-CZ (EUCTR)	27/06/2013	14/02/2013	Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.	A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 655064 INN or Proposed INN: BI 655064	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	106	Phase 1;Phase 2	Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand
1058	EUCTR2011-005689-39-HU (EUCTR)	27/06/2013	22/05/2013	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc, 235 East 42nd Street, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
1059	EUCTR2012-003686-17-NL (EUCTR)	26/06/2013	25/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3000	Phase 3	Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
1060	EUCTR2012-001984-66-DE (EUCTR)	26/06/2013	06/03/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand
1061	EUCTR2011-005689-39-ES (EUCTR)	26/06/2013	24/06/2013	A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)	A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)	Ankylosing Spondylitis (AS) MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
1062	EUCTR2012-003635-31-BE (EUCTR)	26/06/2013	03/04/2013	Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone	Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.	moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: GLPG0634 INN or Proposed INN: Propsoed INN - FILGOTINIB Other descriptive name: GLPG0634	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	595	Phase 2	United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
1063	EUCTR2012-001984-66-LT (EUCTR)	20/06/2013	23/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
1064	EUCTR2012-003686-17-CZ (EUCTR)	17/06/2013	31/05/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
1065	NCT01881308 (ClinicalTrials.gov)	June 17, 2013	17/6/2013	Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis	REmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority Design	Rheumatoid Arthritis	Drug: TNF inhibitors;Drug: Synthetic DMARD(s);Drug: Co-medication: Synthetic DMARDs	Diakonhjemmet Hospital	The Research Council of Norway;South-Eastern Norway Regional Health Authority	Completed	18 Years	80 Years	All	320	Phase 4	Norway
1066	EUCTR2012-003724-20-DE (EUCTR)	13/06/2013	04/02/2013	A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.	A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone	Rheumatoid Arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145	Infinity Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	316	Phase 2	Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Colombia;Germany;New Zealand
1067	EUCTR2012-003686-17-PT (EUCTR)	12/06/2013	14/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
1068	EUCTR2012-003686-17-AT (EUCTR)	11/06/2013	07/06/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3350	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
1069	EUCTR2012-003686-17-FR (EUCTR)	07/06/2013	21/09/2015	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3000	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
1070	EUCTR2012-001984-66-HU (EUCTR)	06/06/2013	14/03/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - SARIL-RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
1071	EUCTR2012-003686-17-SK (EUCTR)	05/06/2013	02/05/2013	A Phase 3 Study in Rheumatoid Arthritis	A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	3000	Phase 3	Croatia;Germany;Japan;Sweden;Canada;Argentina;Brazil;Belgium;Poland;Romania;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico
1072	EUCTR2012-003536-23-PL (EUCTR)	05/06/2013	22/04/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden
1073	NCT01961271 (ClinicalTrials.gov)	June 2013	7/10/2013	Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain	Multicentre Study To Evaluate Efficacy And Safety Of Buprenorphine Transdermal Patch (Norspan) In Chronic Non-Malignant Pain Of Moderate To Severe Intensity Due To Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain And Joint / Muscle Pain, When Opioid Is Needed For Analgesia	Osteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle Pain	Drug: Buprenorphine transdermal patch	Mundipharma Pte Ltd.	Mundipharma Korea Ltd;Mundipharma (Hong Kong) Ltd;Mundipharma Distribution GmBH (Philippine Branch)	Completed	18 Years	80 Years	All	114	Phase 4	Hong Kong;Korea, Republic of;Philippines
1074	NCT01878318 (ClinicalTrials.gov)	June 2013	6/6/2013	A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs	Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs	Rheumatoid Arthritis	Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 4	Venezuela
1075	NCT01885819 (ClinicalTrials.gov)	June 2013	18/6/2013	Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis	Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Autologous stromal vascular fraction cells	Translational Biosciences	NULL	Withdrawn	18 Years	N/A	All	0	Phase 1/Phase 2	Panama
1076	JPRN-UMIN000014485	2013/05/24	01/12/2014	Golimumab study for development of tight control and biologics-free condition.	Golimumab study for development of tight control and biologics-free condition. - Go-sunrising study	rheumatoid arthritis	Treatment with Golimumab for patients with rheumatoid arthritis	Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	40	Not selected	Japan
1077	EUCTR2012-000609-58-CZ (EUCTR)	22/05/2013	21/06/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1078	EUCTR2012-000610-11-CZ (EUCTR)	22/05/2013	20/06/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	298	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany
1079	EUCTR2012-003536-23-GB (EUCTR)	21/05/2013	15/03/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
1080	EUCTR2012-003724-20-BG (EUCTR)	20/05/2013	20/03/2013	A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.	A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone	Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145	Infinity Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	316	Phase 2	Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand
1081	EUCTR2012-001984-66-FI (EUCTR)	17/05/2013	24/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
1082	EUCTR2012-005026-30-PL (EUCTR)	17/05/2013	08/03/2013	A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	596		Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1083	EUCTR2012-002339-27-ES (EUCTR)	16/05/2013	16/05/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib	Lilly S.A.	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1084	EUCTR2012-001984-66-GR (EUCTR)	15/05/2013	23/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
1085	EUCTR2012-005026-30-CZ (EUCTR)	15/05/2013	22/02/2013	A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	596		Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1086	EUCTR2012-003223-38-GB (EUCTR)	14/05/2013	12/02/2013	Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04	RHEUMATOID ARTHRITIS MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	157	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
1087	EUCTR2012-003439-41-NL (EUCTR)	14/05/2013	27/03/2013	A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1088	EUCTR2013-000337-13-DE (EUCTR)	13/05/2013	12/02/2013	Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)	Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA)	Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 3	Serbia;Portugal;Germany
1089	EUCTR2012-001984-66-CZ (EUCTR)	13/05/2013	27/03/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand
1090	EUCTR2012-005026-30-LT (EUCTR)	10/05/2013	21/02/2013	A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	498		Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1091	EUCTR2010-019262-86-SK (EUCTR)	02/05/2013	04/03/2013	Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2100	Phase 3	Portugal;United States;Belarus;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;New Zealand;Sweden
1092	EUCTR2012-003536-23-NL (EUCTR)	01/05/2013	22/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		Mexico;Argentina;Poland;Belgium;Brazil;Romania;Norway;Netherlands;Sweden;United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary
1093	EUCTR2012-001984-66-ES (EUCTR)	25/04/2013	09/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
1094	EUCTR2012-001984-66-GB (EUCTR)	25/04/2013	04/03/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
1095	EUCTR2011-003538-16-PL (EUCTR)	23/04/2013	08/03/2013	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
1096	EUCTR2012-004090-16-DE (EUCTR)	23/04/2013	06/11/2012	Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.	A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 655064	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	106		Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand
1097	EUCTR2010-022243-38-NL (EUCTR)	23/04/2013	13/12/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy - SIRROUND-T	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	840		United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
1098	EUCTR2012-002322-73-LT (EUCTR)	16/04/2013	28/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1099	EUCTR2012-002323-15-GR (EUCTR)	15/04/2013	29/03/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3Study Evaluating the Efficacy and Safety of Baricitinib(LY3009104) in Patients with Moderately to Severely ActiveRheumatoid Arthritis Who Have Had an InadequateResponse to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of
1100	EUCTR2011-002894-48-NO (EUCTR)	11/04/2013	06/09/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1101	EUCTR2012-003439-41-LT (EUCTR)	11/04/2013	31/12/2012	A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1102	EUCTR2012-004342-14-LT (EUCTR)	11/04/2013	29/01/2013	A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs	A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509 INN or Proposed INN: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2/3	United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1103	EUCTR2012-005026-30-BG (EUCTR)	10/04/2013	05/03/2013	A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	596		Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
1104	EUCTR2012-003881-42-RO (EUCTR)	09/04/2013	23/07/2014	A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab	A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Puerto Rico;Romania;Germany
1105	EUCTR2012-003536-23-NO (EUCTR)	09/04/2013	12/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Germany;Sweden
1106	EUCTR2012-003536-23-SE (EUCTR)	08/04/2013	07/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
1107	EUCTR2011-004017-17-GB (EUCTR)	08/04/2013	11/01/2013	Tocilizumab and Remission in early rheumatoid arthritis	Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the changes in expression of JAK-STAT and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients with Early Rheumatoid Arthritis (TREMERA). - TREMERA	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RoActemra	The University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1108	EUCTR2012-003536-23-BE (EUCTR)	04/04/2013	07/01/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Netherlands;Germany;Norway;Sweden
1109	EUCTR2012-003439-41-DK (EUCTR)	04/04/2013	22/03/2013	A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1110	EUCTR2012-003057-29-CZ (EUCTR)	02/04/2013	12/09/2012	A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.	A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients	XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)	Xencor Inc.	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 2	Hungary;Czech Republic;Slovakia
1111	JPRN-UMIN000009887	2013/04/01	01/04/2013	Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6	Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6 - Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6	Rheumatoid Arthritis	When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg. When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha. If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.	Department of Orthopaedic surgery, Tohoku University Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not applicable	Japan
1112	EUCTR2012-003536-23-ES (EUCTR)	01/04/2013	04/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
1113	NCT01764997 (ClinicalTrials.gov)	April 2013	8/1/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX	Rheumatoid Arthritis	Drug: Sarilumab;Drug: Etanercept;Drug: Methotrexate;Drug: Placebo (for sarilumab);Drug: Placebo (for etanercept);Drug: Adalimumab	Sanofi	Regeneron Pharmaceuticals	Terminated	18 Years	N/A	All	776	Phase 3	United States;Argentina;Australia;Brazil;Chile;Colombia;Czechia;Ecuador;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
1114	EUCTR2011-003538-16-CZ (EUCTR)	29/03/2013	08/11/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1115	EUCTR2011-002896-40-PL (EUCTR)	29/03/2013	11/02/2013	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01	RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
1116	EUCTR2012-003536-23-IT (EUCTR)	29/03/2013	05/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
1117	EUCTR2012-002324-32-SE (EUCTR)	27/03/2013	20/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN	Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1118	EUCTR2011-003538-16-DE (EUCTR)	26/03/2013	10/12/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Czech Republic;Hungary;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
1119	EUCTR2010-019262-86-CZ (EUCTR)	26/03/2013	30/03/2011	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2025	Phase 3	United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1120	EUCTR2012-002322-73-SI (EUCTR)	26/03/2013	19/03/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1121	EUCTR2011-002840-29-RO (EUCTR)	25/03/2013	16/06/2016	A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate	A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of
1122	EUCTR2012-002322-73-DE (EUCTR)	21/03/2013	21/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	Romania;Hungary;Japan;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Belgium;Taiwan;Mexico;South Africa;Israel;Australia;Germany;Russian Federation;United States;Portugal;Greece;Latvia;Netherlands;China;Korea, Republic of;Poland;Slovakia;Slovenia;France;Lithuania;Croatia;Argentina
1123	EUCTR2012-002339-27-GB (EUCTR)	21/03/2013	04/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	660	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Romania;Germany;Japan;Korea, Republic of
1124	JPRN-UMIN000010286	2013/03/21	21/03/2013	Maintenance Trial by Orencia in Rheumatoid Arthritis	Maintenance Trial by Orencia in Rheumatoid Arthritis - MATADOR Study	Rheumatoid Arthritis	Patients whose RA status is in low disease activity after 24 weeks of treatment with abatacept receive the reduced dosage of abatacept.	Hokkaido University Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	150	Not selected	Japan
1125	EUCTR2012-002339-27-DE (EUCTR)	21/03/2013	21/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1126	EUCTR2012-002323-15-GB (EUCTR)	21/03/2013	21/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	525	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Spain;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1127	EUCTR2012-005275-14-NO (EUCTR)	19/03/2013	04/02/2013	Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs	Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND	Rheumatoid arthritis (RA) MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning. Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte	Diakonhjemmet Hospital AS	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 4	Norway
1128	EUCTR2011-003538-16-PT (EUCTR)	14/03/2013	13/12/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		United States;Portugal;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1129	EUCTR2012-003536-23-EE (EUCTR)	13/03/2013	12/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Netherlands;Norway;Sweden
1130	EUCTR2012-003536-23-FI (EUCTR)	13/03/2013	19/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
1131	EUCTR2012-003881-42-DE (EUCTR)	13/03/2013	09/01/2013	A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab	A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Romania;Germany
1132	EUCTR2012-002324-32-GR (EUCTR)	12/03/2013	26/02/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN	Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE INN or Proposed INN: METHOTREXATE	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	United States;Portugal;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Sweden;Korea, Republic of
1133	EUCTR2012-003644-71-ES (EUCTR)	12/03/2013	21/12/2012	Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure	A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	168		France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia
1134	EUCTR2012-003629-40-CZ (EUCTR)	11/03/2013	23/11/2012	An Efficacy And Safety Study of CNTO6785 In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: CNTO6785 Product Code: CNTO6785 INN or Proposed INN: CNTO6785	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	Philippines;Czech Republic;Argentina;Thailand;Poland;Russian Federation;Colombia;China;India
1135	EUCTR2011-005648-93-SK (EUCTR)	11/03/2013	06/02/2013	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany
1136	EUCTR2011-005649-10-SK (EUCTR)	11/03/2013	06/02/2013	An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.	A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1137	EUCTR2012-002339-27-BE (EUCTR)	11/03/2013	19/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany;Japan;Korea, Republic of
1138	EUCTR2011-003538-16-IT (EUCTR)	08/03/2013	14/01/2013	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SARILUMAB Product Code: SAR153191 INN or Proposed INN: sarilumab Product Name: SARILUMAB Product Code: SAR153191 INN or Proposed INN: sarilumab	SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand
1139	EUCTR2012-003536-23-HU (EUCTR)	07/03/2013	16/01/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
1140	EUCTR2011-006020-20-PL (EUCTR)	05/03/2013	19/11/2012	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects	Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development, Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria
1141	EUCTR2011-006021-23-PL (EUCTR)	05/03/2013	04/01/2013	.	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Hungary;Czech Republic;Mexico;Belgium;Poland;Bulgaria;Germany
1142	EUCTR2011-006058-94-DE (EUCTR)	04/03/2013	27/08/2012	Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents	A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	234	Phase 3	United States;Portugal;Panama;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of
1143	NCT01768572 (ClinicalTrials.gov)	March 2013	11/1/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists	Rheumatoid Arthritis	Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	202	Phase 3	United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic
1144	NCT02036931 (ClinicalTrials.gov)	March 2013	14/1/2014	A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System	A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System	Noninflammatory Degenerative Joint Disease;Rheumatoid Arthritis	Device: Metal on Polyethylene articulation;Drug: Ceramic on Polyethylene articulation;Device: Ceramic on Ceramic articulation	Zimmer Biomet	NULL	Active, not recruiting	18 Years	N/A	All	315		United States;France;Germany;Ireland;Netherlands;Spain
1145	EUCTR2012-003223-38-ES (EUCTR)	27/02/2013	04/03/2013	Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04	RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	157		United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
1146	EUCTR2012-004342-14-EE (EUCTR)	26/02/2013	31/01/2013	A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs	A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509 INN or Proposed INN: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2/3	United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1147	JPRN-UMIN000010126	2013/02/25	26/02/2013	Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease	Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD	Interstitial lung disease related to rheumatoid arthritis	In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on. In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.	Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	34	Not applicable	Japan
1148	EUCTR2012-002324-32-BE (EUCTR)	25/02/2013	19/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1149	EUCTR2012-000609-58-BE (EUCTR)	20/02/2013	14/06/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany
1150	EUCTR2012-000610-11-BE (EUCTR)	20/02/2013	14/06/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany
1151	EUCTR2012-002322-73-ES (EUCTR)	20/02/2013	06/03/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Lilly S.A.	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
1152	EUCTR2012-003536-23-CZ (EUCTR)	20/02/2013	03/01/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden
1153	EUCTR2011-003538-16-AT (EUCTR)	19/02/2013	14/01/2013	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1154	EUCTR2012-003724-20-HU (EUCTR)	19/02/2013	20/12/2012	A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.	A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone	Rheumatoid Arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145 Product Code: IPI 145 Other descriptive name: IPI-145	Infinity Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	316	Phase 2	Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand
1155	EUCTR2012-004090-16-ES (EUCTR)	19/02/2013	29/11/2012	Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.	A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 655064 INN or Proposed INN: BI 655064	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	130		Czech Republic;Spain;Australia;Netherlands;Germany;New Zealand
1156	EUCTR2011-003538-16-GR (EUCTR)	18/02/2013	14/01/2013	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;Japan;New Zealand
1157	EUCTR2012-005370-62-IT (EUCTR)	18/02/2013	11/01/2013	clinical study to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes.	No-profit” clinical study for the improvement of clinical practice, to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes; randomized, open label, parallel group, controlled clinical study.	rheumatoid arthritis and type 2 diabetes mellitus as comorbidity. MedDRA version: 14.1;Level: LLT;Classification code 10037740;Term: RA;System Organ Class: 100000004859 MedDRA version: 14.1;Level: PT;Classification code 10012601;Term: Diabetes mellitus;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: KINERET*SC 7SIR 100MG 0,67ML INN or Proposed INN: ANAKINRA	OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILA	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Italy
1158	EUCTR2011-005649-10-CZ (EUCTR)	18/02/2013	11/12/2012	An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.	A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Brazil;Germany
1159	EUCTR2012-002322-73-GB (EUCTR)	15/02/2013	21/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1160	EUCTR2011-003538-16-HU (EUCTR)	14/02/2013	14/11/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1161	JPRN-UMIN000010033	2013/02/14	14/02/2013	To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy	To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy - To investigate the efficacy of tocilizumab in RA patients with moderate disease activity	Rheumatoid Arthritis	Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks.	Daihei Kida	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	20	Not selected	Japan
1162	EUCTR2012-002339-27-CZ (EUCTR)	13/02/2013	04/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1163	EUCTR2012-002339-27-SK (EUCTR)	12/02/2013	05/02/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1164	EUCTR2012-002322-73-SK (EUCTR)	12/02/2013	05/02/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1165	EUCTR2011-006344-71-DE (EUCTR)	08/02/2013	25/04/2012	Treatment with eggs of pig whipworm for patients with rheumatoid arthritis, who are insufficiently treated with methotrexate	Trichuris suis ova (TSO) as a additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Trichuris suis ova Product Name: Trichuris suis ova Product Code: TSO INN or Proposed INN: Trichuris suis ova Other descriptive name: Pig whipworm eggs	Immanuel Krankenhaus Berlin	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Germany
1166	EUCTR2012-002323-15-DK (EUCTR)	08/02/2013	08/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of
1167	EUCTR2010-022242-24-BG (EUCTR)	07/02/2013	11/12/2012	A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;Bulgaria;South Africa;Japan;Korea, Republic of
1168	EUCTR2011-006018-15-HU (EUCTR)	06/02/2013	30/11/2012	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development, Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Czech Republic;Hungary;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia
1169	EUCTR2012-002324-32-IT (EUCTR)	06/02/2013	11/01/2013	A phase 3 study in moderate to severe rheumatoid arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib Trade Name: Maxtrex INN or Proposed INN: METHOTREXATE Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib Trade Name: Maxtrex INN or Proposed INN: METHOTREXATE	ELI LILLY AND COMPANY	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1170	EUCTR2011-002894-48-BG (EUCTR)	06/02/2013	20/11/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1171	EUCTR2012-000439-17-HU (EUCTR)	05/02/2013	20/11/2012	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis	active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.	NULL	Not Recruiting			Female: yes Male: yes	342	Phase 2	United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of
1172	EUCTR2011-005649-10-HU (EUCTR)	05/02/2013	27/11/2012	An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.	A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1173	EUCTR2012-003194-25-LT (EUCTR)	04/02/2013	24/09/2012	Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MabionCD20 INN or Proposed INN: Rituximab Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB	Mabion S.A.	NULL	Not Recruiting			Female: yes Male: yes	863		Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia
1174	EUCTR2011-003538-16-LT (EUCTR)	04/02/2013	05/11/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		United States;Portugal;Hong Kong;Taiwan;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
1175	EUCTR2012-002339-27-PT (EUCTR)	01/02/2013	02/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1176	EUCTR2011-006021-23-CZ (EUCTR)	01/02/2013	06/12/2012	.	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany
1177	EUCTR2012-002324-32-GB (EUCTR)	31/01/2013	21/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN	Moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	550	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany;Japan;Korea, Republic of;Sweden
1178	EUCTR2011-003538-16-SK (EUCTR)	29/01/2013	08/03/2013	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
1179	EUCTR2012-002323-15-BE (EUCTR)	28/01/2013	20/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1180	EUCTR2011-002894-48-DE (EUCTR)	25/01/2013	24/07/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	459		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
1181	EUCTR2012-002323-15-PL (EUCTR)	25/01/2013	19/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1182	EUCTR2011-006021-23-BG (EUCTR)	25/01/2013	13/12/2012	A two-year, open-label clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who completed a previous study of ASP015K	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany;Colombia
1183	EUCTR2012-002322-73-GR (EUCTR)	24/01/2013	13/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB INN or Proposed INN: METHOTREXATE	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Switzerland;France;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1184	EUCTR2012-003439-41-EE (EUCTR)	24/01/2013	02/01/2013	A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Estonia;Lithuania;Denmark;South Africa;Netherlands
1185	EUCTR2012-003881-42-BE (EUCTR)	24/01/2013	18/12/2012	A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab	A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Slovakia;Puerto Rico;Belgium;Romania;Germany
1186	EUCTR2012-002324-32-DE (EUCTR)	23/01/2013	21/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN	Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1187	EUCTR2012-003881-42-SK (EUCTR)	23/01/2013	27/04/2016	A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab	A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Slovakia;Puerto Rico;Belgium;Romania;Germany
1188	EUCTR2012-002322-73-CZ (EUCTR)	22/01/2013	04/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1189	EUCTR2012-002322-73-BE (EUCTR)	21/01/2013	19/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1190	EUCTR2012-002760-27-BG (EUCTR)	21/01/2013	09/11/2012	Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	345		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1191	EUCTR2012-002535-28-GB (EUCTR)	21/01/2013	14/12/2012	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActemra Product Name: RoActemra	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
1192	EUCTR2011-002894-48-ES (EUCTR)	18/01/2013	29/10/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 INN or Proposed INN: Not applicable Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
1193	EUCTR2012-002324-32-PT (EUCTR)	18/01/2013	02/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN	Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1194	EUCTR2012-002322-73-PT (EUCTR)	18/01/2013	02/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1195	EUCTR2011-001122-18-BG (EUCTR)	18/01/2013	28/08/2012	A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Name: Ustekinumab Product Code: CNTO1275 Other descriptive name: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria
1196	EUCTR2012-002323-15-NL (EUCTR)	17/01/2013	17/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
1197	EUCTR2012-002322-73-NL (EUCTR)	17/01/2013	17/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: baricitinib Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1198	EUCTR2011-003538-16-ES (EUCTR)	16/01/2013	29/11/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-? Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
1199	EUCTR2012-004631-22-BE (EUCTR)	15/01/2013	11/12/2012	TapERA:Tapering Etanercept in Reumatoid Artritis.	TapERA:Maintaining remission in RA while tapering Etanercept. - TapERA	reumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel Product Name: Enbrel Product Code: EMEA/H/C000262	University Hospitals Leuven	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	Belgium
1200	EUCTR2012-002339-27-HU (EUCTR)	14/01/2013	22/11/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
1201	EUCTR2012-002181-12-HU (EUCTR)	14/01/2013	28/11/2012	A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	Active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 Other descriptive name: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden
1202	EUCTR2012-002324-32-AT (EUCTR)	14/01/2013	09/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN	Moderately to severely active rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib INN or Proposed INN: METHOTREXATE Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate 2.5 mg tablets INN or Proposed INN: METHOTREXATE	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
1203	EUCTR2012-002322-73-HU (EUCTR)	14/01/2013	27/11/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
1204	EUCTR2012-002323-15-AT (EUCTR)	14/01/2013	08/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1205	EUCTR2011-006020-20-BG (EUCTR)	11/01/2013	04/01/2013	A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA)	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects	Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development, Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria
1206	EUCTR2012-002322-73-LV (EUCTR)	11/01/2013	21/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.	A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 Other descriptive name: baricitinib Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1280	Phase 3	United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
1207	EUCTR2012-000439-17-PL (EUCTR)	10/01/2013	13/11/2012	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis	active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: MK-8457 (free acid) Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: MK-8457 (free acid)	Merck Sharpe & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	342	Phase 2	United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1208	EUCTR2011-006018-15-BG (EUCTR)	10/01/2013	28/12/2012	A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who are having insufficient relief from methotrexate	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development, Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia
1209	EUCTR2012-002181-12-IT (EUCTR)	10/01/2013	06/11/2012	A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti- TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	Active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;Hungary;Brazil;Australia;Peru;Denmark;South Africa;New Zealand;Sweden
1210	EUCTR2011-002067-20-GR (EUCTR)	10/01/2013	13/12/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892		United States;Portugal;Greece;Spain;Ireland;Austria;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1211	EUCTR2012-002323-15-ES (EUCTR)	09/01/2013	09/01/2013	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib Product Name: baricitinib Product Code: LY3009104 INN or Proposed INN: N/A Other descriptive name: baricitinib	Lilly S.A.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
1212	EUCTR2012-002339-27-IT (EUCTR)	07/01/2013	21/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib	ELI LILLY AND COMPANY	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Portugal;Taiwan;Slovakia;Spain;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Germany;Japan;Korea, Republic of
1213	NCT02089087 (ClinicalTrials.gov)	January 7, 2013	13/3/2014	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients	A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Biological: CFZ533;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	55 Years	All	75	Phase 1	United States;Taiwan
1214	EUCTR2012-000610-11-IT (EUCTR)	07/01/2013	25/09/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: 0109-0012A 100 mg/ml Product Name: NA Product Code: 0109-0012A 50 mg/ml Product Name: NA Product Code: 0109-0012A 25 mg/ml	NOVO NORDISK	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1215	EUCTR2012-000609-58-IT (EUCTR)	07/01/2013	25/09/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics - NN8226-3612	Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: 0109-0012A 100 mg/ml Product Name: NA Product Code: 0109-0012A 50 mg/ml Product Name: NA Product Code: 0109-0012A 25 mg/ml	NOVO NORDISK	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1216	EUCTR2012-001618-40-PL (EUCTR)	04/01/2013	31/10/2012	Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate.	Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.	Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tabalumab Product Code: LY2127399 Other descriptive name: TABALUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	180		United States;Czech Republic;Argentina;Poland;Russian Federation
1217	EUCTR2011-006021-23-HU (EUCTR)	04/01/2013	24/10/2012	.	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Czech Republic;Hungary;Mexico;Poland;Belgium;Bulgaria;Germany
1218	EUCTR2011-005649-10-PT (EUCTR)	04/01/2013	10/09/2012	An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.	A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1219	ChiCTR-TRC-13003948	2013-01-01	2013-12-05	The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern	The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern	rheumatoid arthritis	Control:Methotrexate 10mg qw PO + Leflunomide 10mg qd PO ;EA combined with medicine group:M+L+SEA+ZJSM ;	Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine	NULL	Completed	18	70	Both	Control:60;EA combined with medicine group:60;		China
1220	JPRN-UMIN000007404	2013/01/01	01/03/2012	Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate.	Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate. - Comparison between concomitant therapy of non-biologic anti-rheumatic drugs and therapy with MTX dose escalation aiming for remission on RA patient (CONAMON Study)	Rheumatoid arthritis	Dose escalation of methotrexate Concomitant therapy of methotrexate and bucillamine	KONAMON Study Group	NULL	Recruiting	Not applicable	Not applicable	Male and Female	90	Not applicable	Japan
1221	NCT01767844 (ClinicalTrials.gov)	January 2013	8/1/2013	Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients?	Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? A Randomised Controlled Pilot Trial	Rheumatoid Arthritis	Dietary Supplement: Creatine;Dietary Supplement: Placebo	Bangor University	NULL	Active, not recruiting	18 Years	N/A	Both	43	N/A	United Kingdom
1222	NCT01793519 (ClinicalTrials.gov)	January 2013	14/2/2013	Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis	Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial	Rheumatoid Arthritis	Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Placebo	Georgetown University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Maryland, College Park;Washington D.C. Veterans Affairs Medical Center;Medstar Health Research Institute;Patient-Centered Outcomes Research Institute;Arthritis and Pain Associates of PG County;Arthritis & Rheumatism Associates, P.C.;Rheumatology Associates of Baltimore, L.L.C.;The Arthritis Clinic of Northern Virginia, P.C.;Arthritis and Rheumatic Disease Associates, P.C.	Recruiting	18 Years	N/A	All	290	Phase 4	United States
1223	NCT01389388 (ClinicalTrials.gov)	January 2013	16/4/2010	Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint Disease	Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases	Carotid Artery Plaque;Ankylosing Spondylitis;Rheumatoid Arthritis	Drug: Rosuvastatin	Diakonhjemmet Hospital	NULL	Completed	35 Years	80 Years	Both	114	N/A	Norway
1224	EUCTR2012-002323-15-IT (EUCTR)	18/12/2012	19/12/2012	A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON	Moderately to severely active rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib Product Name: BARICITINIB Product Code: LY3009104 Other descriptive name: Baricitinib	ELI LILLY AND COMPANY	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Netherlands;Japan;Korea, Republic of
1225	EUCTR2011-006018-15-CZ (EUCTR)	12/12/2012	03/08/2012	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development, Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia
1226	EUCTR2011-006020-20-CZ (EUCTR)	12/12/2012	03/08/2012	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects	Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development, Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria
1227	EUCTR2011-006058-94-PT (EUCTR)	11/12/2012	23/10/2012	Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents	A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2	Rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	234	Phase 3	Panama;Portugal;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of
1228	EUCTR2010-020992-21-GR (EUCTR)	11/12/2012	06/12/2012	Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis	A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4,5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable	AB Science	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Slovakia;Greece;Thailand;Spain;Poland;Turkey;Romania;Monaco;Germany;India
1229	JPRN-UMIN000009425	2012/12/06	01/12/2012	A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient	A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient - Go-Go trial	Rheumatoid Arthritis	The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity. Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year. Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.	Osaka City University Medical School	NULL	Recruiting	20years-old	Not applicable	Male and Female	150	Phase 4	Japan
1230	EUCTR2010-022243-38-BE (EUCTR)	04/12/2012	06/09/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	840		Portugal;Serbia;United States;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1231	EUCTR2011-006058-94-GR (EUCTR)	04/12/2012	23/10/2012	Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents	A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	234	Phase 3	Panama;Portugal;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of
1232	EUCTR2011-005376-42-BG (EUCTR)	03/12/2012	28/08/2012	A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis	A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0114-0006B INN or Proposed INN: N/A	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	60		Serbia;Hungary;Spain;Poland;Russian Federation;Bulgaria;Latvia
1233	JPRN-UMIN000013885	2012/12/01	05/05/2014	Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study	Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study - Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study	rheumatoid arthiritis	RA patients were scheduled to receive TCZ once a month after 24 weeks. Serum NT-pro BNP concentrations were measured simultaneously on stored baseline and 24 week samples.	Itabashi Chuo Medical Center	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not applicable	Japan
1234	EUCTR2012-002181-12-ES (EUCTR)	27/11/2012	23/08/2012	A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-alpha Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	Active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: MK8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
1235	EUCTR2010-022243-38-GB (EUCTR)	21/11/2012	29/06/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	840	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1236	EUCTR2011-006021-23-BE (EUCTR)	19/11/2012	25/10/2012	.	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany
1237	JPRN-UMIN000011181	2012/11/19	12/07/2013	Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial	Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial - Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial	Osteoarthritis of knee, rheumatoid arthritis	A continuous epidural infusion containing ropivacaine and morphine for pain after simultaneous bilateral total knee arthroplasty A periarticular multimodal drug injection including ropivacaine, morphine, bosmin, methylprednisolone, and ketoprofen for pain after simultaneous bilateral total knee arthroplasty	Nekoyama miyao hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	60	Not selected	Japan
1238	EUCTR2011-002894-48-GR (EUCTR)	16/11/2012	19/10/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1239	EUCTR2012-002181-12-GR (EUCTR)	16/11/2012	08/10/2012	A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	Active rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
1240	EUCTR2011-001122-18-CZ (EUCTR)	15/11/2012	10/07/2012	A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Name: Ustekinumab Product Code: CNTO1275 Other descriptive name: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Korea, Democratic People's Republic of;Turkey;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Argentina;Singapore;Peru;Bulgaria
1241	EUCTR2010-022243-38-IT (EUCTR)	14/11/2012	11/12/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	JANSSEN-CILAG INTERNATIONAL N.V.	NULL	Not Recruiting			Female: yes Male: yes	990		Portugal;United States;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;Canada;Argentina;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Korea, Republic of
1242	EUCTR2012-002760-27-ES (EUCTR)	14/11/2012	23/01/2013	Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Farmaceutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes	345		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1243	EUCTR2012-003057-29-HU (EUCTR)	13/11/2012	19/09/2012	A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.	A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients	XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.	Xencor Inc.	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 2	Czech Republic;Hungary;Slovakia
1244	EUCTR2012-003057-29-SK (EUCTR)	12/11/2012	19/09/2012	A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.	A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients	XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 15.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.	Xencor Inc.	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 2	Hungary;Czech Republic;Slovakia
1245	EUCTR2012-002181-12-GB (EUCTR)	12/11/2012	21/08/2012	A Phase IIa Proof Of Concept study to evaluate Safety, Tolerability and Efficacy in Subjects with Rheumatoid Arthritis	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	Active rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
1246	EUCTR2012-002760-27-SK (EUCTR)	12/11/2012	11/10/2012	Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	345		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1247	EUCTR2010-019262-86-PT (EUCTR)	09/11/2012	09/08/2012	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	Poland;Belgium;Brazil;Belarus;Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Ecuador;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Romania;Norway;Germany;New Zealand;Sweden
1248	EUCTR2011-005648-93-BG (EUCTR)	09/11/2012	16/08/2012	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany
1249	EUCTR2011-002894-48-PT (EUCTR)	09/11/2012	09/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 INN or Proposed INN: No Active Name Specified Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1250	EUCTR2012-002760-27-IT (EUCTR)	08/11/2012	30/10/2012	A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis.	A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	345		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
1251	EUCTR2012-002760-27-DE (EUCTR)	06/11/2012	25/09/2012	Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	345		Romania;Bulgaria;Germany;United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil
1252	EUCTR2012-001618-40-CZ (EUCTR)	05/11/2012	03/08/2012	Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate.	Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.	Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tabalumab Product Code: LY2127399 Other descriptive name: TABALUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	180		United States;Czech Republic;Argentina;Poland;Russian Federation
1253	EUCTR2012-001760-30-IT (EUCTR)	05/11/2012	25/07/2012	Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.	Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB	OSSERVATORIO EPIDEMIOLOGICO GISEA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
1254	JPRN-UMIN000009088	2012/11/01	12/10/2012	Bio Logic MateTM clinical performance test for IFX Efficacy prediction	Bio Logic MateTM clinical performance test for IFX Efficacy prediction - Bio Logic MateTM clinical performance test for IFX Efficacy prediction	rheumatoid arthritis	IFX plus methotrexate	Bio Logic Mate Study Group	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	150	Not selected	Japan
1255	EUCTR2012-000609-58-GB (EUCTR)	01/11/2012	20/06/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany
1256	NCT01711359 (ClinicalTrials.gov)	November 2012	18/10/2012	A Study in Participants With Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis	Drug: Baricitinib;Drug: Methotrexate;Drug: Baricitinib Placebo;Drug: MTX Placebo;Drug: Folic Acid	Eli Lilly and Company	NULL	Completed	18 Years	N/A	All	588	Phase 3	United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Greece;India;Italy;Japan;Korea, Republic of;Mexico;Portugal;Puerto Rico;Russian Federation;South Africa;Sweden;United Kingdom
1257	NCT01741493 (ClinicalTrials.gov)	November 2012	3/12/2012	A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494	A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494	Rheumatoid Arthritis	Drug: ABT-494;Drug: Placebo;Drug: Tofacitinib	AbbVie (prior sponsor, Abbott)	NULL	Completed	18 Years	75 Years	All	67	Phase 1	United States
1258	NCT01725230 (ClinicalTrials.gov)	November 2012	7/11/2012	Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib	An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily	Rheumatoid Arthritis	Drug: Fostamatinib;Drug: Rosuvastatin;Drug: Simvastatin	AstraZeneca	NULL	Completed	18 Years	55 Years	Both	42	Phase 1	United States
1259	NCT01689532 (ClinicalTrials.gov)	November 2012	18/9/2012	A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine	A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine	Arthritis, Rheumatoid	Drug: Sirukumab 100 mg;Drug: Sirukumab 50 mg;Drug: Placebo	Janssen Pharmaceutical K.K.	GlaxoSmithKline	Completed	20 Years	N/A	All	122	Phase 3	Japan
1260	NCT01749787 (ClinicalTrials.gov)	November 2012	6/12/2012	Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis	A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: PRTX-100 at 1.5 mcg/kg;Drug: PRTX-100 at 3.0 mcg/kg;Drug: PRTX-100 at 6.0 mcg/kg;Drug: PRTX-100 at 12.0 mcg/kg;Drug: PRTX-100 at 240 mcg;Drug: Placebo;Drug: PRTX-100 at 420 mcg	Protalex, Inc.	NULL	Completed	18 Years	N/A	Both	61	Phase 1	United States
1261	NCT01709760 (ClinicalTrials.gov)	November 2012	16/10/2012	A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA	A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: ENIA11;Drug: Placebo	Mycenax Biotech Inc.	NULL	Unknown status	20 Years	N/A	All	91	Phase 3	Taiwan
1262	EUCTR2011-002840-29-CZ (EUCTR)	31/10/2012	05/09/2012	A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate	A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of
1263	NCT01636843 (ClinicalTrials.gov)	October 30, 2012	6/7/2012	A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate	A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate	Inflammation;Rheumatoid Arthritis	Drug: NNC0109-0012;Drug: placebo	Novo Nordisk A/S	NULL	Terminated	18 Years	75 Years	All	298	Phase 2	United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Spain;Ukraine;Czech Republic
1264	NCT01741688 (ClinicalTrials.gov)	October 26, 2012	30/11/2012	An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis	A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab	Rheumatoid Arthritis	Biological: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	16	N/A	Peru
1265	EUCTR2011-002840-29-HU (EUCTR)	25/10/2012	04/09/2012	A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate	A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of
1266	EUCTR2011-005634-19-BG (EUCTR)	24/10/2012	19/10/2012	A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany
1267	EUCTR2010-021146-22-GB (EUCTR)	23/10/2012	25/10/2012	Alemtuzumab and rheumatoid arthritis - a study to look at the function of the immune system	Alemtuzumab and rheumatoid arthritis - an immunisation study - Alemtuzumab and rheumatoid arthritis - an immunisation study	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome) Product Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994)	The Newcastle upon Tyne Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	United Kingdom
1268	EUCTR2011-002896-40-DE (EUCTR)	23/10/2012	02/07/2012	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01	RHEUMATOID ARTHRITIS MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab-Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US	NULL	Not Recruiting			Female: yes Male: yes	195		United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
1269	EUCTR2010-022243-38-ES (EUCTR)	22/10/2012	21/08/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	990		United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of
1270	EUCTR2011-002840-29-LV (EUCTR)	22/10/2012	25/10/2012	A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate	A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg Product Code: JNJ-38518168-ZBQ INN or Proposed INN: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of
1271	EUCTR2011-005649-10-ES (EUCTR)	22/10/2012	19/07/2012	An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.	A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany
1272	EUCTR2012-000535-36-PL (EUCTR)	18/10/2012	13/09/2012	A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.	Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100		United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
1273	EUCTR2012-000610-11-ES (EUCTR)	17/10/2012	09/07/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1274	EUCTR2011-002894-48-HU (EUCTR)	16/10/2012	16/08/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	459		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
1275	EUCTR2010-022243-38-PT (EUCTR)	15/10/2012	27/08/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	840		United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1276	EUCTR2012-002573-62-SE (EUCTR)	12/10/2012	14/08/2012	Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab	Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab	Rheumatoid arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Humira	The Karolinska Institute, ClinTRID	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	Sweden
1277	EUCTR2007-002066-35-SK (EUCTR)	10/10/2012	15/04/2008	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira®	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy
1278	EUCTR2011-005648-93-HU (EUCTR)	09/10/2012	17/04/2012	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400		Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany
1279	EUCTR2012-002760-27-HU (EUCTR)	09/10/2012	03/09/2012	Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	345		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1280	EUCTR2011-002894-48-EE (EUCTR)	08/10/2012	08/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1281	EUCTR2011-005649-10-GR (EUCTR)	03/10/2012	05/10/2012	An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.	A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Czech Republic;Mexico;Argentina;Brazil;Germany;Hungary;Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France
1282	EUCTR2011-005648-93-GR (EUCTR)	03/10/2012	05/10/2012	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany
1283	JPRN-JapicCTI-132091	01/10/2012		A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents	A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents	Rheumatoid Arthritis	Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : subcutaneously 75mg, 150mg Control intervention name : null	Novartis Pharma K.K.	NULL		18		BOTH	234	Phase 3	NULL
1284	JPRN-UMIN000008812	2012/10/01	01/10/2012	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy	Rheumatoid arthritis	tocilizumab monotherapy	Department of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical Universitity	NULL	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Not selected	Japan
1285	JPRN-UMIN000010315	2012/10/01	26/03/2013	Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment	Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment - PROUD study	rheumatoid arthritis	In patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab.	Osaka City University Medical School	Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine.The center for rheumatic diseases. Nara Medical University.Rheumatology. Kitano Hospital.	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
1286	JPRN-UMIN000018101	2012/10/01	26/06/2015	Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study	Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study - Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study	Osteoarthritis, rheumatoid arthritis, osteonecrosis	To determine whether postoperative VTE is present and to evaluate the efficacy and safety of edoxaban for the prevention of patients undergoing TKA, OWHTO, or CWHTO, angiography of the pulmonary artery and deep veins of the lower limbs is performed in all patients on postoperative day 7. Levels of coagulation and fibrinolysis markers are evaluated on the preoperative day and on postoperative days 1, 3, 7, and 14.	Yokohama City University School of Medicine	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	100	Not selected	Japan
1287	NCT01709578 (ClinicalTrials.gov)	October 2012	15/10/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists	Rheumatoid Arthritis	Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	546	Phase 3	United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong
1288	NCT01770379 (ClinicalTrials.gov)	October 2012	16/10/2012	Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFa Agents.	A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents	Rheumatoid Arthritis	Biological: Secukinumab (AIN457);Biological: Placebo	Novartis Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	242	Phase 3	United States;Argentina;Brazil;Colombia;Czech Republic;Dominican Republic;Germany;Greece;Guatemala;India;Italy;Japan;Korea, Republic of;Panama;Portugal;South Africa;Ecuador;Puerto Rico
1289	NCT01619176 (ClinicalTrials.gov)	October 2012	5/6/2012	Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood	Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: methotrexate;Drug: non-steroidal anti-inflammatory drug (NSAID);Drug: leflunomide;Procedure: Acupuncture	Chinese Academy of Sciences	Shanghai GuangHua Hospital of integrated traditional and western medicine	Completed	18 Years	65 Years	Female	15	N/A	China
1290	EUCTR2011-004419-22-BG (EUCTR)	29/09/2012	22/06/2012	Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate	A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1291	JPRN-jRCTs032180245	28/09/2012	12/03/2019	Wear of 32mm OXINIUM head on XLPE: Multicenter RCT Study	Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 32mmOX multicenter study	Hip osteoarthritis, Rheumatoid arthritis Hip osteoarthritis, Rheumatoid arthritis	Arm A: Oxidized zirconium alloy (OXINIUM) femoral head Arm B: Standard cobalt chromium alloy head Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE)	Kume Shinichiro	NULL	Not Recruiting	>= 20age old	<= 75age old	Both	352	Phase 4	Japan
1292	EUCTR2012-002760-27-CZ (EUCTR)	27/09/2012	13/08/2012	Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	345		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1293	EUCTR2011-006058-94-CZ (EUCTR)	26/09/2012	19/07/2012	Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents	A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: SECUKINUMAB	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	234	Phase 3	Portugal;Panama;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of
1294	NCT01711814 (ClinicalTrials.gov)	September 26, 2012	19/10/2012	A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Arthritis, Rheumatoid	Drug: peficitinib	Astellas Pharma Global Development, Inc.	Janssen Biotech, Inc.	Completed	18 Years	N/A	All	611	Phase 2	United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic
1295	EUCTR2012-000610-11-DE (EUCTR)	25/09/2012	03/07/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1296	EUCTR2012-000609-58-DE (EUCTR)	25/09/2012	27/06/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1297	EUCTR2012-002181-12-DK (EUCTR)	24/09/2012	24/09/2012	A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA	A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - RADIUS-010	Active rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Denmark;Peru;Australia;South Africa;New Zealand;Sweden
1298	EUCTR2011-005634-19-DE (EUCTR)	19/09/2012	02/05/2012	A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany
1299	EUCTR2011-005648-93-DE (EUCTR)	19/09/2012	11/05/2012	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany
1300	EUCTR2011-002894-48-GB (EUCTR)	14/09/2012	06/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
1301	EUCTR2011-002894-48-NL (EUCTR)	10/09/2012	14/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	459		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
1302	EUCTR2011-005648-93-ES (EUCTR)	10/09/2012	24/05/2012	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany
1303	EUCTR2011-006020-20-HU (EUCTR)	07/09/2012	29/06/2012	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects	Rheumatoid Arthritis MedDRA version: 15.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ASP015K Product Code: ASP015K INN or Proposed INN: ASP015K hydrobromide Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Product Code: ASP015K INN or Proposed INN: ASP015K hydrobromide Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Product Code: ASP015K INN or Proposed INN: ASP015K hydrobromide Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development, Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	275	Phase 2	United States;Czech Republic;Hungary;Mexico;Poland;Ukraine;Bulgaria
1304	EUCTR2012-000535-36-DE (EUCTR)	05/09/2012	15/06/2012	A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.	Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100		United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
1305	NCT01682512 (ClinicalTrials.gov)	September 5, 2012	10/8/2012	Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis	Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.	Arthritis, Rheumatoid	Drug: BI 695500;Drug: Rituxan®;Drug: MabThera®	Boehringer Ingelheim	NULL	Terminated	18 Years	80 Years	All	294	Phase 3	United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;Sweden
1306	EUCTR2010-022243-38-DE (EUCTR)	05/09/2012	21/06/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	840		United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1307	EUCTR2011-006058-94-IT (EUCTR)	04/09/2012	13/09/2012	Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents	A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents	Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: SECUKINUMAB	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	234	Phase 3	Portugal;Panama;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of
1308	EUCTR2010-022243-38-AT (EUCTR)	04/09/2012	01/08/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	840		United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1309	NCT01647451 (ClinicalTrials.gov)	September 2012	19/7/2012	A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis	A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis	Drug: NNC0114-0006;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	All	62	Phase 2	Bulgaria;Hungary;Latvia;Poland;Russian Federation;Serbia;Spain
1310	NCT01635686 (ClinicalTrials.gov)	September 2012	4/7/2012	Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers	A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers	Rheumatoid Arthritis	Drug: DWP422 25mg;Drug: ENBREL 25MG PFS INJ.	Daewoong Pharmaceutical Co. LTD.	NULL	Not yet recruiting	20 Years	45 Years	Male	38	Phase 1	Korea, Republic of
1311	NCT01640938 (ClinicalTrials.gov)	September 2012	12/7/2012	Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis	A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Secukinumab (AIN457)	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	Both	259	Phase 3	United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Russian Federation;Slovakia;Spain;Romania
1312	EUCTR2012-000535-36-BE (EUCTR)	28/08/2012	05/06/2012	A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.	A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany
1313	EUCTR2011-006070-73-DE (EUCTR)	28/08/2012	24/02/2012	Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis	A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM	Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	130		United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany
1314	EUCTR2011-002067-20-IT (EUCTR)	23/08/2012	13/09/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwide	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate	Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira INN or Proposed INN: ADALIMUMAB	UCB PHARMA SA/NV.	NULL	Not Recruiting			Female: yes Male: yes	892		United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1315	EUCTR2012-000535-36-SK (EUCTR)	23/08/2012	14/06/2012	A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.	A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100		United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
1316	EUCTR2012-000439-17-DE (EUCTR)	15/08/2012	10/04/2012	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis	active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: NA Other descriptive name: MK-8457 Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: NA Other descriptive name: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	434	Phase 2	United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1317	EUCTR2011-002896-40-GB (EUCTR)	14/08/2012	11/06/2012	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	195	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Israel;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
1318	EUCTR2012-000609-58-HU (EUCTR)	13/08/2012	18/06/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1319	EUCTR2012-000610-11-HU (EUCTR)	13/08/2012	18/06/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
1320	EUCTR2011-002894-48-BE (EUCTR)	02/08/2012	18/07/2012	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.	Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	459	Phase 1;Phase 3	United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden
1321	EUCTR2012-000535-36-CZ (EUCTR)	02/08/2012	18/06/2012	A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.	Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	100		United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany
1322	EUCTR2011-005648-93-CZ (EUCTR)	01/08/2012	24/04/2012	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400		Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany
1323	EUCTR2011-005634-19-CZ (EUCTR)	01/08/2012	24/04/2012	A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany
1324	NCT01636817 (ClinicalTrials.gov)	August 2012	6/7/2012	A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics	A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics	Inflammation;Rheumatoid Arthritis	Drug: NNC0109-0012;Drug: placebo	Novo Nordisk A/S	NULL	Terminated	18 Years	75 Years	All	239	Phase 2	United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom;Czech Republic
1325	NCT01705730 (ClinicalTrials.gov)	July 31, 2012	10/10/2012	A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy	Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy	Rheumatoid Arthritis	Drug: tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	71		Belgium
1326	JPRN-UMIN000008572	2012/07/31	31/07/2012	The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients	The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients - K-NET study: The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients	Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX)	Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks. Etanercept group patient receive weekly subcutaneous injection of etanercept 50mg for 52 weeks.	Department of Rheumatology and infectious disease, Kitasato university school of medicine	1)Kitasato institute medical center hospital2)Kitasato institute hospital3)Ishikawa internal medicine clinic	Complete: follow-up complete	20years-old	70years-old	Male and Female	80	Not applicable	Japan
1327	EUCTR2011-006018-15-BE (EUCTR)	28/07/2012	02/07/2012	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate	A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Product Name: ASP015K Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development, Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Hungary;Czech Republic;Mexico;Poland;Belgium;Ukraine;Bulgaria;Colombia
1328	EUCTR2011-005634-19-ES (EUCTR)	27/07/2012	24/04/2012	A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany
1329	EUCTR2011-004529-28-CZ (EUCTR)	25/07/2012	03/04/2012	A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis	A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available	Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Czech Republic;Argentina;Poland;Malaysia;Bulgaria;Chile;Russian Federation;Korea, Republic of
1330	EUCTR2011-002067-20-GB (EUCTR)	23/07/2012	13/03/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United States;Portugal;Greece;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany
1331	EUCTR2011-005648-93-EE (EUCTR)	19/07/2012	16/04/2012	A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	400		Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany
1332	EUCTR2012-000439-17-GB (EUCTR)	17/07/2012	16/04/2012	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis	active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457	Merck, Sharpe & Dohme Corp., a subsidiary of Merck & Co. Inc (hereafter referred to as Merck)	NULL	Not Recruiting			Female: yes Male: yes	342	Phase 2	United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1333	EUCTR2010-019262-86-AT (EUCTR)	12/07/2012	06/06/2012	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - SARIL-RA-EXTEND	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Other descriptive name: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1334	EUCTR2010-022243-38-LT (EUCTR)	11/07/2012	29/05/2012	A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	840		United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand
1335	EUCTR2010-022242-24-LT (EUCTR)	11/07/2012	29/05/2012	A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite DMARD Therapy	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;South Africa;Bulgaria;Japan;Korea, Republic of
1336	JPRN-UMIN000010902	2012/07/11	07/06/2013	A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty	A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty - A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty	Osteoarthritis of knee, rheumatoid arthritis, avascular necrosis	An epidural anesthesia containing 2mg/ml ropivacaine 100ml and 10mg/ml morphine 0.8ml for pain after total knee arthroplasty A periarticular multimodal drug injection including 7.5mg/ml ropivacaine, 10mg/ml morphine 0.8ml, bosmin 0.3mg, methylprednisolone 40mg, and ketoprofen 50mg for pain after total knee arthroplasty	Nekoyama miyao hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	100	Not selected	Japan
1337	EUCTR2011-005376-42-LV (EUCTR)	06/07/2012	13/03/2012	A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis	A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0114-0006B	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	60		Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia
1338	EUCTR2011-002067-20-PT (EUCTR)	06/07/2012	21/03/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892	Phase 4	Portugal;United States;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1339	JPRN-UMIN000033222	2012/07/01	02/07/2018	Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases	Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases - Prophylactic Iodine-supported Primary TKA	Osteoarthritis, Rheumatoid arthritis of knee joint	prophylactic iodine-suported primaru TKA	Fukui General Hospital	NULL	Complete: follow-up complete	50years-old	90years-old	Male and Female	30	Not selected	Japan
1340	JPRN-UMIN000008404	2012/07/01	12/07/2012	Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria.	Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria. - Extension of Tocilizumab Dose Intervals in Patients with Rheumatoid Arthritis using IL-6 Serum Level Criteria.	rheumatoid arthritis	Extension of Tocilizumab Dose Intervals	Japan Labour Health and Welfare Organization,Yokohama Rosai Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
1341	NCT01578850 (ClinicalTrials.gov)	July 2012	12/4/2012	Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening	A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)	Rheumatoid Arthritis	Drug: Etanercept;Drug: placebo	Pfizer	NULL	Completed	18 Years	70 Years	All	491	Phase 4	Brazil;China;Colombia;Czech Republic;Egypt;Hungary;Jordan;Lebanon;Malaysia;Mexico;Philippines;Qatar;Romania;Russian Federation;South Africa;Taiwan;Thailand;Ukraine;United Arab Emirates;Saudi Arabia
1342	EUCTR2010-018485-24-HU (EUCTR)	29/06/2012	02/05/2012	To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis	A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA	Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	216		Czech Republic;Hungary;Spain;Latvia;Germany
1343	EUCTR2011-002067-20-BG (EUCTR)	28/06/2012	11/05/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892	Phase 4	United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1344	EUCTR2011-005260-20-GB (EUCTR)	28/06/2012	10/05/2012	RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.	Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER	Adult Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	Roche Products Limited	NULL	Not Recruiting			Female: yes Male: yes	618	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1345	EUCTR2011-002067-20-AT (EUCTR)	26/06/2012	27/03/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892		United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1346	EUCTR2011-002067-20-ES (EUCTR)	26/06/2012	10/05/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892		United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1347	EUCTR2011-005204-15-AT (EUCTR)	20/06/2012	15/05/2012	Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?	Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop	biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Simponi INN or Proposed INN: GOLIMUMAB Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT	Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 4	Austria
1348	EUCTR2011-002067-20-CZ (EUCTR)	19/06/2012	25/04/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892	Phase 4	United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany
1349	EUCTR2011-005376-42-ES (EUCTR)	18/06/2012	29/03/2012	A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis	A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0114-0006B	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;Hungary;Poland;Spain;Russian Federation;Bulgaria;Latvia
1350	EUCTR2010-018485-24-LV (EUCTR)	15/06/2012	14/05/2012	To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis	A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA	Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 2	Hungary;Czech Republic;Spain;Germany;Latvia
1351	EUCTR2012-000439-17-DK (EUCTR)	15/06/2012	15/06/2012	A Study to Evaluate Safety, Tolerability and Effecacy of MK-8457 plus Methotrexate in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis	active rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 Product Name: MK-8457 Product Code: MK-8457	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.	,NULL	Not Recruiting			Female: yes Male: yes	342	Phase 2	United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Moldova, Republic of;Japan
1352	EUCTR2011-005634-19-EE (EUCTR)	13/06/2012	16/04/2012	A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.	A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany
1353	EUCTR2011-001122-18-HU (EUCTR)	13/06/2012	02/05/2012	A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Code: CNTO 1959 Other descriptive name: CNTO 1959 IgG Product Name: Ustekinumab Product Code: CNTO1275 Other descriptive name: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria
1354	EUCTR2011-002067-20-DE (EUCTR)	13/06/2012	16/02/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892	Phase 4	Ireland;Austria;Italy;United States;Portugal;Greece;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1355	EUCTR2011-001729-25-NL (EUCTR)	11/06/2012	05/03/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 15.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800		United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1356	EUCTR2011-005448-87-CZ (EUCTR)	11/06/2012	12/04/2012	A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)	A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	320		United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Hungary;Czech Republic;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China
1357	EUCTR2009-017998-37-BE (EUCTR)	08/06/2012	11/04/2012	Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.	Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.	Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease. MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL Product Name: 99mTc-S-HYNIC Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL	Ghent University Hospital	NULL	Not Recruiting			Female: yes Male: yes	36	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Belgium
1358	EUCTR2011-005021-48-NL (EUCTR)	07/06/2012	05/06/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
1359	EUCTR2011-004419-22-HU (EUCTR)	06/06/2012	21/03/2012	Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate	A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1360	EUCTR2011-004419-22-CZ (EUCTR)	06/06/2012	13/03/2012	Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate	A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1361	EUCTR2011-004419-22-SK (EUCTR)	06/06/2012	12/04/2012	Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate	A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1362	NCT01611688 (ClinicalTrials.gov)	June 4, 2012	1/6/2012	First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis	First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis	Drug: NNC0215-0384;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	All	36	Phase 1	Germany
1363	EUCTR2011-004529-28-BG (EUCTR)	01/06/2012	07/05/2012	A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis	A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Poland;Bulgaria
1364	JPRN-UMIN000008281	2012/06/01	28/06/2012	Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab	Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab - Study of dose-escalation therapy in IFX-treated RA	rheumatoid arthritis	Dose-escalation of MTX or IFX	Department of Internal Medicien and Rheumatology, Juntendo University School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	30	Not selected	Japan
1365	EUCTR2011-001729-25-GB (EUCTR)	01/06/2012	19/04/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Austria;Colombia;Italy;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1366	EUCTR2011-002067-20-IE (EUCTR)	01/06/2012	10/04/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892	Phase 4	United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany
1367	JPRN-UMIN000007806	2012/06/01	01/05/2012	The feasibility study of accelated infliximab infusion during maintenance phase	The feasibility study of accelated infliximab infusion during maintenance phase - The feasibility study of accelated infliximab infusion during maintenance phase	patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)	Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.	Chiba University Hospital	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	54	Phase 2	Japan
1368	NCT01559103 (ClinicalTrials.gov)	May 31, 2012	19/3/2012	Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients	A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)	Rheumatoid Arthritis	Biological: MEDI5117;Biological: MEDI5117 Placebo	Novo Nordisk A/S	NULL	Terminated	20 Years	75 Years	All	39	Phase 1	United States;Germany;United Kingdom
1369	EUCTR2012-000222-21-DE (EUCTR)	31/05/2012	16/03/2012	Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection.	An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis - Preference MTX pre-filled syringe vs pre-filled pen in RA	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Code: 70930.00.00 INN or Proposed INN: Methotrexate disodium Product Name: methotrexate pre-filled pen INN or Proposed INN: Methotrexate disodium	medac Gesellschaft für klinische Spezialpräparate mbH	NULL	Not Recruiting			Female: yes Male: yes			Germany
1370	EUCTR2011-005376-42-HU (EUCTR)	30/05/2012	11/04/2012	A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis	A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0114-0006B	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	60		Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia
1371	EUCTR2011-002067-20-HU (EUCTR)	30/05/2012	20/03/2012	Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.	A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -	Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	892		United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany
1372	EUCTR2011-004720-35-SE (EUCTR)	28/05/2012	22/12/2011	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE	The Karolinska Institute, ClinTRID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Sweden
1373	EUCTR2011-006040-79-DK (EUCTR)	25/05/2012	25/05/2012	A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arth	The efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis.A randomized, double-blinded, placebo-controlled trial. - DanACT Early	Adult Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra®	Aarhus University Hospital, Department of Rheumatology U	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Denmark
1374	EUCTR2011-005021-48-CZ (EUCTR)	23/05/2012	15/02/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
1375	EUCTR2011-001729-25-IT (EUCTR)	23/05/2012	19/03/2012	Study designed to demonstrate the efficacy and safety of certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis.	Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan INN or Proposed INN: METHOTREXATE	UCB PHARMA SA/NV.	NULL	Not Recruiting			Female: yes Male: yes	800		United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1376	EUCTR2011-004419-22-DE (EUCTR)	23/05/2012	01/03/2012	Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate	A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1377	EUCTR2011-006070-73-BG (EUCTR)	22/05/2012	07/05/2012	Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis	A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	130		United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;South Africa;Bulgaria;Germany
1378	EUCTR2011-001729-25-SE (EUCTR)	22/05/2012	22/02/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1379	EUCTR2011-006070-73-CZ (EUCTR)	16/05/2012	29/02/2012	Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis	A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib 50 mg blue film-coated tablet Product Code: R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	130		United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany
1380	EUCTR2011-005021-48-ES (EUCTR)	14/05/2012	21/02/2012	A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO	Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg Concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
1381	EUCTR2011-004529-28-PL (EUCTR)	14/05/2012	28/03/2012	A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis	A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Poland;Bulgaria
1382	EUCTR2011-005448-87-HU (EUCTR)	14/05/2012	21/03/2012	A STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)	A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	320		United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China
1383	EUCTR2012-000139-21-AT (EUCTR)	14/05/2012	23/04/2012	Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB	Medizinische Universität Wien, Universitätsklinik für Innere Medizin III	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
1384	EUCTR2012-000439-17-LT (EUCTR)	11/05/2012	15/03/2012	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis	active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: None Other descriptive name: MK-8457 Product Name: MK-8457 Product Code: MK-8457 INN or Proposed INN: None Other descriptive name: MK-8457	MERCK SHARP & DOHME CORP.	NULL	Not Recruiting			Female: yes Male: yes	342	Phase 2	United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of
1385	EUCTR2011-005008-14-HU (EUCTR)	10/05/2012	28/02/2012	Not applicable	Randomized, Double blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis who have an Inadequate Response to Methotrexate Alone	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG0634 Product Name: GLPG0634 Product Name: GLPG0634 Product Name: GLPG0634	Galapagos SASU	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;European Union;Ukraine;Russian Federation;Moldova, Republic of
1386	EUCTR2011-005021-48-BG (EUCTR)	09/05/2012	20/04/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
1387	EUCTR2011-005021-48-HU (EUCTR)	04/05/2012	15/02/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
1388	EUCTR2011-006125-14-HU (EUCTR)	04/05/2012	08/03/2012	A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE	A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: RoActemra Product Code: RO4877533	Roche (Magyarország) Kft.	NULL	Not Recruiting			Female: yes Male: yes	241		Hungary
1389	EUCTR2011-004419-22-EE (EUCTR)	02/05/2012	21/03/2012	Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate	A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany
1390	JPRN-UMIN000014484	2012/05/01	01/12/2014	Saitama Actemra study for QOL in patients with Rheumatoid arthritis	Saitama Actemra study for QOL in patients with Rheumatoid arthritis - SAQRA study	rheumatoid arthritis	Treatment with Tocilizumab	Juntendo University, Juntendo Koshigaya Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	40	Not selected	Japan
1391	JPRN-UMIN000007786	2012/05/01	19/04/2012	"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis "	"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis " - Effect examination of infliximab to an anti-TNF invalid example	Rheumatoid Arthritis	infliximab plus methotrexate	Saitama Medical Center. Saitama Medical University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	40	Not applicable	Japan
1392	NCT01548001 (ClinicalTrials.gov)	May 2012	5/3/2012	Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis	A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Iguratimod;Drug: Methotrexate	Jiangsu Simcere Pharmaceutical Co., Ltd.	NULL	Active, not recruiting	18 Years	65 Years	Both	910	Phase 4	China
1393	NCT01617005 (ClinicalTrials.gov)	May 2012	8/6/2012	A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)	Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	50	N/A	Montenegro
1394	NCT01579006 (ClinicalTrials.gov)	May 2012	16/4/2012	Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis	A Multi National, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (Actemra)	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	Clalit Health Services	Completed	18 Years	N/A	All	184	N/A	Israel
1395	JPRN-UMIN000009535	2012/04/25	12/12/2012	Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate	Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate - SCRUM study	rheumatoid arthritis	We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation . MTX increase group was increased to 16mg, it will continue to increase as much as possible. We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation . MTX increase group was increased to 16mg, it will continue to increase as much as possible. We observe the patients if there is no positive joint power Doppler signal.	Osaka City University Medical School	NULL	Complete: follow-up complete	20years-old	100years-old	Male and Female	120	Not selected	Japan
1396	JPRN-UMIN000018017	2012/04/23	22/06/2015	Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy	Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy - Analysis for the reactivation of hepatitis B virus in patients treated with anti-tumor necrosis factor-alpha therapy	rheumatoid arthritis or psoriasis patients with past hepatitis B virus infection	The effect of preventive lamivudine, adefovir or entecavir on de novo HBV hepatitis.	Department of general internal medicine, Kyushu-University hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	70	Not selected	Japan
1397	EUCTR2011-004529-28-HU (EUCTR)	18/04/2012	01/03/2012	A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis	A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of
1398	EUCTR2011-001729-25-DE (EUCTR)	11/04/2012	10/01/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800		United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1399	JPRN-UMIN000011087	2012/04/11	01/07/2013	Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates	Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates - Efficacy of monthly minodronate for osteoporosis in RA	Osteoporosis	Minodronic acid (50mg/month or 1mg/day)	Osaka University Graduate School of Medicine	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not applicable	Japan
1400	EUCTR2011-005021-48-PL (EUCTR)	10/04/2012	14/03/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of
1401	EUCTR2011-002392-41-BG (EUCTR)	09/04/2012	07/02/2012	A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.	A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria
1402	EUCTR2011-001729-25-CZ (EUCTR)	03/04/2012	03/02/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800		United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1403	JPRN-UMIN000007380	2012/04/01	01/05/2012	Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis	Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis - Comparison of tocilizumab and high-dose methotrexate on rheumatoid arthritis	rheumatoid arthritis	tocilizumab + methotrexate (10mg/week) high-dose methotrexate (stepwisely increased to 16mg/week)	Kinki University Faculty of Medicine, Division of Hematology and Rheumatology	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	40	Not selected	Japan
1404	JPRN-UMIN000007432	2012/04/01	02/03/2012	Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody.	Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. - PRISM Study	rheumatoid arthritis	Infliximab and Methotrexate. Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks.	Keio University	NULL	Complete: follow-up continuing	20years-old	75years-old	Male and Female	100	Not selected	Japan
1405	NCT01579890 (ClinicalTrials.gov)	April 2012	16/4/2012	Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis	A Non-blinded, Non-placebo Controlled, Compassionate Use, Open Treatment, Open-ended Program of the Safety of Pennsaid Topical Lotion (Diclofenac) in the Treatment of Osteo or Rheumatoid Arthritis	Osteoarthritis of the Hand	Drug: Diclofenac	Mallinckrodt	Nuvo Research Inc.	Approved for marketing	N/A	N/A	Both		N/A	NULL
1406	EUCTR2011-004171-36-ES (EUCTR)	30/03/2012	30/01/2012	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Not Recruiting			Female: yes Male: yes	616		Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of
1407	EUCTR2011-002392-41-HU (EUCTR)	28/03/2012	16/12/2011	A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.	A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria
1408	EUCTR2010-021184-32-EE (EUCTR)	23/03/2012	08/03/2012	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1409	EUCTR2011-001729-25-HU (EUCTR)	22/03/2012	26/01/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800		United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1410	EUCTR2011-001729-25-ES (EUCTR)	16/03/2012	27/01/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800		United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1411	EUCTR2011-002275-41-CZ (EUCTR)	15/03/2012	28/12/2011	A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.	A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.	Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60		Czech Republic;Belgium
1412	EUCTR2011-004468-31-LT (EUCTR)	14/03/2012	05/01/2012	Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	617		Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1413	EUCTR2009-011791-30-HU (EUCTR)	14/03/2012	19/01/2012	A multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis	A randomised, double-blind, placebo-controlled, multiple dose trial of NNC0151-0000-0000 in subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NNC151-0000 Product Code: NNC0151-0000-0000 Other descriptive name: Anti-C5aR	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	48		Czech Republic;Hungary;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom
1414	EUCTR2011-003953-25-DE (EUCTR)	13/03/2012	04/01/2012	A Study of Two Different Adalimumab Formulations in Adults with Rheumatoid Arthritis.	A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.	Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab Product Code: L04 AB04 INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60		Canada;Australia;Germany
1415	EUCTR2011-001729-25-IE (EUCTR)	09/03/2012	12/01/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1416	EUCTR2011-001729-25-AT (EUCTR)	08/03/2012	08/02/2012	Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.	A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -	Early active rheumatoid arthritis MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800		United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
1417	JPRN-UMIN000017230	2012/03/01	22/04/2015	Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)	Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies) - Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)	Rheumatoid arthritis	Biologic treatment (tocilizumab)	Kyushu University	NULL	Recruiting	20years-old	Not applicable	Male and Female	60	Not selected	Japan
1418	NCT01565408 (ClinicalTrials.gov)	March 2012	21/3/2012	Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis	Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis	Drug: NNC0114-0006;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	All	32	Phase 1	Germany;Russian Federation
1419	NCT01670045 (ClinicalTrials.gov)	March 2012	17/8/2012	A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis	A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	43	N/A	Indonesia;Greece
1420	EUCTR2011-002024-40-ES (EUCTR)	16/02/2012	14/10/2011	Proof-of-Concept Study with BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CCR1 Antagonist Product Code: BMS-817399	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	172	Phase 2	United States;Mexico;Argentina;Spain;South Africa;Russian Federation;Korea, Republic of
1421	EUCTR2011-004171-36-CZ (EUCTR)	15/02/2012	30/11/2011	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
1422	EUCTR2011-004468-31-ES (EUCTR)	10/02/2012	07/12/2011	Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1423	EUCTR2011-004468-31-PL (EUCTR)	07/02/2012	10/02/2012	Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	617		Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1424	EUCTR2011-004468-31-LV (EUCTR)	06/02/2012	30/12/2011	Long-term safety and effectivenss CT-P13 together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	617		Portugal;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
1425	EUCTR2011-000311-34-IT (EUCTR)	03/02/2012	06/12/2011	GO-AHEAD	A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis (Phase 3b, Protocol No. P07642, also known as MK-8259-006-00). - GO-AHEAD	Active Axial Spondyloarthritis (SpA) MedDRA version: 14.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	SCHERING PLOUGH RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATION	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Greece;Canada;Finland;Spain;Turkey;Russian Federation;Germany;United Kingdom;Italy
1426	EUCTR2011-004468-31-IT (EUCTR)	02/02/2012	02/03/2012	Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13-3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Other descriptive name: NA	CELLTRION, INC.	NULL	Not Recruiting			Female: yes Male: yes	617		Korea, Republic of;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Peru;Latvia;Bosnia and Herzegovina
1427	JPRN-UMIN000007205	2012/02/01	02/02/2012	The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis	The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis - The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis	Rheumatoid arthritis	1) Tacrolimus Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained. The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on. However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects.	Juntendo University	NULL	Pending	65years-old	Not applicable	Male and Female	30	Not selected	Japan
1428	JPRN-UMIN000007019	2012/02/01	01/02/2012	Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease	Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease - Treatment of AOSD by tocilizumab mono-therapy	Rheumatoid arthritis	tocilizumab monotherapy	Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity	NULL	Complete: follow-up complete	16years-old	70years-old	Male and Female	40	Not selected	Japan
1429	JPRN-UMIN000006702	2012/02/01	11/11/2011	A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis	A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis - An intensive treatment strategy in patients with active early RA	rheumatoid arthritis	Intensive treatment group Period: 24 weeks In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72. Conventional treatment group Period: 24 weeks In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.	Tokyo Medical and Dental University	Department of Pharmacovigilance	Complete: follow-up continuing	20years-old	70years-old	Male and Female	290	Not applicable	Japan
1430	NCT01562327 (ClinicalTrials.gov)	February 2012	21/3/2012	A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis	A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	50	N/A	Argentina
1431	NCT01646385 (ClinicalTrials.gov)	February 2012	12/4/2012	Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry	Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data	Rheumatoid Arthritis	Drug: etanercept;Drug: non-biologic anti-rheumatic drugs	Pfizer	NULL	Completed	18 Years	N/A	All	6393	N/A	NULL
1432	EUCTR2011-002275-41-BE (EUCTR)	31/01/2012	06/01/2012	A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.	A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.	Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60		Czech Republic;Belgium
1433	EUCTR2011-004468-31-AT (EUCTR)	26/01/2012	30/11/2011	Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Jordan;Poland
1434	EUCTR2010-023782-22-SK (EUCTR)	25/01/2012	07/10/2011	A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG	A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG	Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-04171327 INN or Proposed INN: Not available Product Code: PF-04171327 INN or Proposed INN: Not available Product Code: PF-04171327 INN or Proposed INN: Not available Trade Name: Decortin INN or Proposed INN: PREDNISONE	Pfizer Inc.235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	315	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of
1435	EUCTR2011-002849-36-LV (EUCTR)	12/01/2012	22/11/2011	A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid Arthritis	A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-39758979-AAC - enteric coated tablet - 10 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned Product Name: JNJ-39758979-AAC - enteric coated tablet - 30 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned Product Name: JNJ-39758979-AAC - enteric coated tablet - 100 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	325	Phase 2	United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Poland;Malaysia;Singapore;Romania;Latvia;Japan
1436	EUCTR2011-004468-31-GB (EUCTR)	06/01/2012	25/11/2011	Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	617	Phase 3	Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1437	JPRN-UMIN000012613	2012/01/01	20/12/2013	Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients.	Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients. - Reduction of etanercept after remission in RA patients.	rheumatoid arthritis	etanercept50mg/wk or25mg twice/wk reduction of etanercept to 25mg/wk arfter 3 months from remission	Dept. of orthopedic surgery, Osaka Medical College	NULL	Complete: follow-up complete	20years-old	70years-old	Male and Female	30	Not selected	Japan
1438	NCT02922192 (ClinicalTrials.gov)	January 1, 2012	28/9/2016	Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis	Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis	Rheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing Spondylitis	Drug: TNF-a antagonists, non-TNFs, DMARD non-biologics	Biologics & Biosimilars Collective Intelligence Consortium	HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Kaiser Permanente;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta Pharmaceuticals, Inc.;Pfizer;University of Pittsburgh	Completed	18 Years	N/A	All	90360		NULL
1439	EUCTR2011-004468-31-SK (EUCTR)	30/12/2011	04/01/2012	Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis	An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes			Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina
1440	EUCTR2010-023782-22-BG (EUCTR)	21/12/2011	21/05/2012	A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG	A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG	Rheumatoid Arthritis MedDRA version: 15.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE	Pfizer Inc.235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;Bulgaria;South Africa;Germany;Korea, Republic of
1441	EUCTR2010-023782-22-DE (EUCTR)	13/12/2011	16/09/2011	A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG	A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG	Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-04171327 INN or Proposed INN: na Product Code: PF-04171327 INN or Proposed INN: na Product Code: PF-04171327 INN or Proposed INN: na Trade Name: Decortin INN or Proposed INN: PREDNISONE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of
1442	EUCTR2009-016266-90-PT (EUCTR)	09/12/2011	29/01/2010	Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	1740		Belarus;United States;Portugal;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1443	EUCTR2011-000436-28-PL (EUCTR)	07/12/2011	20/06/2011	A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.	A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation
1444	EUCTR2010-020065-24-GR (EUCTR)	05/12/2011	04/11/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Greece;Ecuador;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
1445	NCT01326962 (ClinicalTrials.gov)	November 30, 2011	7/3/2011	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF	Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	28	Phase 3	Saudi Arabia
1446	EUCTR2011-001220-38-DE (EUCTR)	30/11/2011	21/07/2011	A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis	A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	350		United States;Belgium;Russian Federation;Germany;United Kingdom
1447	EUCTR2011-005036-26-GB (EUCTR)	29/11/2011	31/10/2011	A study to investigate what effects FX125L (taken by mouth) has on adults with chronic inflammatory diseases	An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease	AsthmaChronic obstructive pulmonary diseaseRheumatoid arthritisPsoriasis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Classification code 10003553;Term: Asthma;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: FX125L	Funxional Therapeutics Ltd	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	United Kingdom
1448	EUCTR2011-000275-13-BE (EUCTR)	29/11/2011	20/10/2011	Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs	A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	630		Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan
1449	EUCTR2010-023956-99-CZ (EUCTR)	29/11/2011	17/06/2011	Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 (v1.0, dated 09-Oct-2014)	RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	677	Phase 2	Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of;United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil
1450	EUCTR2010-023782-22-HU (EUCTR)	22/11/2011	27/09/2011	A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG	A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG	Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE	Pfizer Inc.235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of
1451	EUCTR2011-000102-21-BG (EUCTR)	09/11/2011	01/09/2011	Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents	A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1	Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	548		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1452	EUCTR2010-024516-34-BG (EUCTR)	09/11/2011	07/09/2011	Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate	A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	215		United States;Hungary;Slovakia;Canada;Bulgaria;Italy
1453	JPRN-UMIN000006653	2011/11/01	04/11/2011	Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US-	Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US- - TM Stem Registry Study -Multicenter clinical research in Japan and US	Patients who have been diagnosed Osteoarthritis, Rheumatoid Arthritis and Avascular Necrosis, etc.	Trabecular Metal Primary Hip Prosthesis by THA	Shonan Kamakura Joint Reconstruction Center	NULL	Complete: follow-up continuing	18years-old	Not applicable	Male and Female	100	Not applicable	Japan,North America
1454	NCT01468077 (ClinicalTrials.gov)	November 2011	7/11/2011	A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment	Multicenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 Hour	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	47	Phase 2	Denmark;Iceland
1455	NCT01251120 (ClinicalTrials.gov)	November 2011	30/11/2010	A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis	A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: DMARD	Hoffmann-La Roche	NULL	Terminated	18 Years	N/A	All	2	Phase 4	Finland
1456	NCT01469013 (ClinicalTrials.gov)	November 2011	8/11/2011	Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy	Arthritis, Rheumatoid	Drug: Placebo;Drug: Baricitinib;Drug: Methotrexate	Eli Lilly and Company	NULL	Completed	20 Years	75 Years	All	145	Phase 2	Japan
1457	NCT01592292 (ClinicalTrials.gov)	November 2011	11/4/2012	An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy	A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent	Rheumatoid Arthritis	Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab	Hoffmann-La Roche	NULL	Completed	20 Years	N/A	All	90	N/A	Korea, Republic of
1458	NCT01408602 (ClinicalTrials.gov)	November 2011	2/8/2011	A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis Patients	A 24-week, Phase 2, Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 2 Doses of MRC375 in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: MRC375;Drug: Matching Placebo;Drug: MRC375 150mg	Molecular Research Center, Inc.	Camargo Pharmaceutical Services;Clin Data Services;Harrison Clinical Research;BARC Global Central Laboratory;Bilcare Global Clinical Supplies	Active, not recruiting	18 Years	N/A	Both	300	Phase 2	United States
1459	EUCTR2010-020992-21-SK (EUCTR)	26/10/2011	06/12/2011	Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis	A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable	AB Science	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany
1460	EUCTR2009-016266-90-BE (EUCTR)	25/10/2011	22/08/2011	Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	1594	Phase 2;Phase 3	Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Romania;Germany;New Zealand
1461	EUCTR2011-000102-21-DE (EUCTR)	20/10/2011	09/08/2011	Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents	A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NARTURE-1	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	548		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1462	EUCTR2010-020992-21-ES (EUCTR)	17/10/2011	28/05/2012	Comparación de la eficacia de masitinib frente a metotrexato en el tratamiento de la artritis reumatoide	Estudio prospectivo, Fase IIb/III, multicéntrico, randomizado, doble ciego, controlado, de 3 grupos paralelos y 24 semanas de duración con posible extensión, para comparar la eficacia y seguridad de masitinib, a la dosis de 3 y 4,5 mg/kg/día, con metotrexato, con randomización 1:1:1, en el tratamiento de pacientes con artritis reumatoide activa y con una respuesta inadecuada a 1. metotrexato, a 2. cualquier FAME incluido al menos un fármaco biológico si previamente resultó ineficaz en pacientes tratados con metotrexato o a 3. metotrexato en combinación con cualquier FAME incluidos fármacos biológicos - AB1010 en tratamiento de pacientes con artritis reumatoide activa.	Atritis Reumatoide MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: no aplica Trade Name: Methotrexate Product Name: Methotrexate Product Code: no aplica INN or Proposed INN: METHOTREXATE Other descriptive name: no aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica	AB Science	NULL	Not Recruiting			Female: yes Male: yes	140		Slovakia;Greece;Thailand;Spain;Turkey;Germany;India;United States;Czech Republic
1463	EUCTR2010-020992-21-CZ (EUCTR)	12/10/2011	18/07/2011	Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis	A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable	AB Science	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2	United States;Czech Republic;Slovakia;Greece;Spain;Thailand;Turkey;Germany;India
1464	EUCTR2010-019912-18-BG (EUCTR)	03/10/2011	25/08/2011	A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
1465	NCT01359943 (ClinicalTrials.gov)	October 2011	19/5/2011	Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate	A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate	Rheumatoid Arthritis	Biological: secukinumab (AIN457);Drug: placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	221	Phase 2	United States;Bulgaria;Canada;Hungary;Italy;Poland;Puerto Rico;Slovakia
1466	NCT01641952 (ClinicalTrials.gov)	October 2011	13/7/2012	An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent	Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	505	N/A	Romania
1467	EUCTR2010-024516-34-SK (EUCTR)	29/09/2011	13/04/2012	Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate	A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	215		United States;Hungary;Slovakia;Canada;Bulgaria;Italy
1468	NCT04169100 (ClinicalTrials.gov)	September 28, 2011	14/11/2019	Novel Form of Acquired Long QT Syndrome	Novel Form of Acquired Long QT Syndrome	Long QT Syndrome;Connective Tissue Diseases;Rheumatoid Arthritis	Drug: Prednisone	Narrows Institute for Biomedical Research	VA New York Harbor Healthcare System	Recruiting	18 Years	89 Years	All	25	Phase 4	United States
1469	EUCTR2010-020065-24-BE (EUCTR)	26/09/2011	16/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	United States;Serbia;Philippines;Greece;Ecuador;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany
1470	EUCTR2010-023956-99-DE (EUCTR)	22/09/2011	01/06/2011	Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12	RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	677	Phase 2	United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
1471	EUCTR2011-000102-21-SK (EUCTR)	22/09/2011	28/06/2011	Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents	A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	548		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
1472	EUCTR2010-023782-22-CZ (EUCTR)	21/09/2011	01/08/2011	A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG	A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG	Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of
1473	EUCTR2011-001220-38-BE (EUCTR)	19/09/2011	30/08/2011	A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis	A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Belgium;Russian Federation;Germany;United Kingdom
1474	EUCTR2010-023692-26-SK (EUCTR)	09/09/2011	13/09/2011	Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)	(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
1475	EUCTR2010-023587-40-NL (EUCTR)	06/09/2011	11/05/2011	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700		Germany;Netherlands;Italy;Sweden;Greece;Finland;Spain
1476	EUCTR2010-020065-24-DE (EUCTR)	06/09/2011	30/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
1477	NCT01350804 (ClinicalTrials.gov)	September 2011	9/5/2011	Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1)	A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)	Rheumatoid Arthritis	Biological: AIN457;Biological: Placebo;Biological: Abatacept	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	551	Phase 3	United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Romania;Russian Federation;Slovakia;Spain
1478	NCT01446978 (ClinicalTrials.gov)	September 2011	3/10/2011	Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs	Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate	Vaccine Response Impaired	Biological: hepatitis A vaccine	Sormland County Council, Sweden	NULL	Active, not recruiting	18 Years	N/A	Both	150	Phase 2	Sweden
1479	NCT01245439 (ClinicalTrials.gov)	September 2011	17/11/2010	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis	Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	65	Phase 3	Turkey
1480	EUCTR2010-019912-18-HU (EUCTR)	31/08/2011	08/06/2011	A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa	Adult Rheumatoid Arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
1481	EUCTR2010-020065-24-NL (EUCTR)	31/08/2011	06/07/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
1482	EUCTR2010-024516-34-HU (EUCTR)	31/08/2011	29/06/2011	Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate	A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	215		United States;Hungary;Canada;Bulgaria;Italy
1483	EUCTR2010-020745-27-HU (EUCTR)	31/08/2011	11/07/2011	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3)	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1484	NCT01377012 (ClinicalTrials.gov)	August 30, 2011	17/6/2011	Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFa Agents	A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)	Rheumatoid Arthritis	Biological: Secukinumab (AIN457);Biological: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	637	Phase 3	United States;Argentina;Belgium;Canada;Colombia;Guatemala;Hungary;India;Italy;Japan;Mexico;Panama;Puerto Rico;Thailand;Turkey;United Kingdom;Peru;Romania
1485	EUCTR2010-020065-24-ES (EUCTR)	25/08/2011	01/07/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Anticuerpo monoclonal anti-humano recombinante humanizado, receptor de IL-6R. Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
1486	EUCTR2011-000385-35-IT (EUCTR)	19/08/2011	27/02/2012	MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY	MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY - CZP-SPEED	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: CIMZIA INN or Proposed INN: CERTOLUZIMAB PEGOL Other descriptive name: NA	UCB PHARMA	NULL	Not Recruiting			Female: yes Male: yes			Italy
1487	EUCTR2011-000102-21-CZ (EUCTR)	19/08/2011	27/05/2011	Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents	A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	548		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1488	EUCTR2010-022378-15-GB (EUCTR)	18/08/2011	10/02/2011	A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.	VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (IMMU-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody	Nycomed GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1489	EUCTR2011-002363-15-IS (EUCTR)	17/08/2011	22/06/2011	A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.	Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST	Adult Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra®	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	56		Denmark;Iceland
1490	EUCTR2010-023956-99-HU (EUCTR)	17/08/2011	18/05/2011	Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12	RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	677	Phase 2	United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
1491	EUCTR2011-000102-21-ES (EUCTR)	17/08/2011	04/07/2011	Seguridad y Eficacia de secukinumab comparado con placebo y abatacept in pacientes con artritis reumatoide activa que no respodieron a agentes anti- TNFalfa	Estudio aleatorizado, doble ciego, controlado con placebo y con control activo de secukinumab para demostrar la eficacia en 24 semanas y evaluar la seguridad, tolerabilidad y eficacia a largo plazo durante 1 año en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada a anti-TNFalfa	ARTRITIS REUMATOIDE MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: secukinumab Other descriptive name: NO APLICA Trade Name: ORENCIA 250 mg polvo para concentrado para sol. para perfusión INN or Proposed INN: ABATACEPT Other descriptive name: ABATACEPT	Novartis Farmacéutica S.A.	NULL	Not Recruiting			Female: yes Male: yes	548		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
1492	EUCTR2011-002363-15-DK (EUCTR)	16/08/2011	27/07/2011	A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.	Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST	Adult Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	56		Denmark;Iceland
1493	EUCTR2010-020065-24-GB (EUCTR)	15/08/2011	08/04/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
1494	EUCTR2010-021184-32-IT (EUCTR)	03/08/2011	02/02/2011	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany
1495	EUCTR2011-000436-28-HU (EUCTR)	02/08/2011	10/08/2011	A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.	A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE	Zalicus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria
1496	NCT01426789 (ClinicalTrials.gov)	August 2011	12/8/2011	A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients	A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension	Rheumatoid Arthritis	Drug: Placebo;Drug: Secukinumab	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	100	Phase 2	United States;Belgium;Germany;Russian Federation;United Kingdom
1497	JPRN-UMIN000013750	2011/07/31	21/04/2014	Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis	Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis - Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis	Rheumatoid arthritis, Periodontitis	IL-6 receptor inhibition group: Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later. TNF inhibition group: Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.	Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	80	Not selected	Japan
1498	EUCTR2011-000275-13-HU (EUCTR)	29/07/2011	10/06/2011	Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs	A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	630		Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan
1499	EUCTR2010-023956-99-NL (EUCTR)	28/07/2011	30/05/2011	Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Protocol Amendment 03 (v1.0, dated 08-Mar-2011)	RHEUMATOID ARTHRITIS,NOS MedDRA version: 13.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: BMS-945429 Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	677	Phase 2	United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of
1500	EUCTR2011-001863-39-AT (EUCTR)	28/07/2011	15/06/2011	A study of saftey and efficacy of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab Monotherapy in patients with mild to moderate rheumatoid arthritis, who have not adequately responded to their current treatment with MTX.	A multi-center study of the safety and effect on disease activity of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab monotheraphy in patients with mild to moderate rheumatoid arthritis, with inadequate response to MTX (defined as DAS 28 = 4,5 and > 2,6) - OPTIMISE	Mild to moderate rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexat Lederle 2.5mg tablets Product Name: Methotrexat Product Code: RO0029893 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	Roche Austria GmbH	NULL	Not Recruiting			Female: yes Male: yes			Austria
1501	EUCTR2010-020065-24-AT (EUCTR)	28/07/2011	17/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
1502	EUCTR2010-020065-24-CZ (EUCTR)	26/07/2011	27/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
1503	EUCTR2010-022206-40-PL (EUCTR)	26/07/2011	11/04/2011	A Rheumatoid Arthritis Study in Patients (FLEX-O)	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 3	United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
1504	EUCTR2010-020065-24-LT (EUCTR)	25/07/2011	25/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080		Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
1505	EUCTR2010-024516-34-IT (EUCTR)	25/07/2011	29/12/2011	Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate	A randomized, double-blind, placebo-controlled study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457F Other descriptive name: Secukinumab	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	215		United States;Hungary;Canada;Bulgaria;Italy
1506	EUCTR2010-023956-99-BE (EUCTR)	20/07/2011	24/05/2011	Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12	RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	677	Phase 2	United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of
1507	EUCTR2011-000275-13-GB (EUCTR)	20/07/2011	18/07/2011	Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs	A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	630		Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan
1508	EUCTR2010-023956-99-ES (EUCTR)	20/07/2011	03/11/2011	Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - Site Specific (v1.0, dated 11-Jan-2011);Protocol Amendment 03 (v1.0, dated 08-Mar-2011) -	RHEUMATOID ARTHRITIS,NOS MedDRA version: 14.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: BMS-945429 Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	677	Phase 2	Hungary;Germany;Netherlands;France;Italy;South Africa;Brazil;Russian Federation;Czech Republic;Canada;Peru;Taiwan;Argentina;Belgium;Mexico;Korea, Republic of;Spain;Japan;United States
1509	EUCTR2011-000102-21-HU (EUCTR)	14/07/2011	08/06/2011	Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents	A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1	Rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: ABATACEPT	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	548		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany
1510	EUCTR2011-001220-38-GB (EUCTR)	12/07/2011	17/05/2011	A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis	A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Belgium;Russian Federation;Germany;United Kingdom
1511	JPRN-jRCTs032180273	11/07/2011	14/03/2019	Wear of OXINIUM on XLPE: Multicenter RCT Study	Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 28mmOX multicenter study	Hip osteoarthritis, Rheumatoid arthritis Hip osteoarthritis, Rheumatoid arthritis	Arm A: Oxidized zirconium alloy (OXINIUM) femoral head Arm B: Standard cobalt chromium alloy head Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE)	Akiyama Haruhiko	NULL	Not Recruiting	>= 20age old	<= 75age old	Both	1308	Phase 4	Japan
1512	EUCTR2010-023956-99-IT (EUCTR)	11/07/2011	01/03/2012	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate	RHEUMATOID ARTHRITIS,NOS MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Anti-Interleukin-6 Monoclonal Product Code: BMS-945429 INN or Proposed INN: NA Other descriptive name: anti IL 6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: NA Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE	BRISTOL-M.SQUIBB	NULL	Not Recruiting			Female: yes Male: yes	677	Phase 2	United States;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of
1513	EUCTR2009-016266-90-AT (EUCTR)	06/07/2011	31/05/2011	Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	1594		Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1514	JPRN-JapicCTI-111628	01/7/2011		Phase IIB Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects Who Are Not Responding to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.	Rheumatoid Arthritis	Intervention name : Clazakizumab Dosage And administration of the intervention : Injection, 25 mg, 100 mg, 200 mg Control intervention name : Methotrexate,Adalimumab Dosage And administration of the control intervention : Methotrexate:Oral,7.5 mg, Adalimumab:Injection,40mg	Bristol-Myers K.K.	NULL		18		BOTH	406	Phase 2	NULL
1515	EUCTR2010-021283-14-HU (EUCTR)	29/06/2011	27/04/2011	A randomised, double blind, placebo-controlled trial with multiple doses of Anti-IL-20 in subjects with rheumatoid arthritis	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	66		Portugal;Hungary;United Kingdom;Spain;Italy
1516	EUCTR2011-000275-13-IT (EUCTR)	28/06/2011	23/02/2012	Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs.	A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: Secukinumab	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	630		Panama;United States;Thailand;Guatemala;Turkey;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan
1517	EUCTR2011-000102-21-IT (EUCTR)	28/06/2011	09/01/2012	Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti- TNFa agents	A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457F INN or Proposed INN: Secukinumab Trade Name: ORENCIA*IV 2FL 250MG+2SIR INN or Proposed INN: ABATACEPT	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	548		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
1518	EUCTR2010-019262-86-ES (EUCTR)	22/06/2011	21/04/2010	Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)	Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)	Artritis Reumatoide_______________________Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Netherlands;Germany;Norway;Sweden
1519	EUCTR2010-022208-36-GR (EUCTR)	21/06/2011	16/05/2011	An Open Label Study for Patients With Rheumatoid Arthritis	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1505	Phase 3	United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;Malaysia;Australia;Peru;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;New Zealand;Japan
1520	EUCTR2010-019262-86-IT (EUCTR)	17/06/2011	06/09/2011	Long term evaluation of SAR153191 (REGN88) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: SAR153191	SANOFI-AVENTIS S.P.A	NULL	Not Recruiting			Female: yes Male: yes	1696	Phase 3	Portugal;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Australia;Peru;South Africa;Netherlands;Finland;Korea, Democratic People's Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Norway;Germany;New Zealand;Sweden
1521	EUCTR2011-000107-40-GB (EUCTR)	16/06/2011	10/03/2011	A 12 weeks study to evaluate effect of revamilst in addition tomethotrexate in rheumatiod arthritis patients.	A Phase IIb, 12 week Randomized, Double-Blind, Parallel Group, Placebo-Controlled study to evaluate Efficacy, Safety and Tolerability of 2, 4 and 6 mg of Revamilast in patients with Active Rheumatoid Arthritis who have had an inadequate response to Methotrexate.	Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Revamilast Product Code: GRC 4039 INN or Proposed INN: Revamilast Product Name: Revamilast Product Code: GRC 4039 INN or Proposed INN: Revamilast Product Name: Revamilast Product Code: GRC 4039 INN or Proposed INN: Revamilast	Glenmark Pharmaceuticals SA	NULL	Not Recruiting			Female: yes Male: yes	406	Phase 2	Philippines;Poland;Sri Lanka;United Kingdom;India
1522	EUCTR2010-020065-24-HU (EUCTR)	15/06/2011	02/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
1523	EUCTR2010-023587-40-DE (EUCTR)	14/06/2011	02/03/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700		United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
1524	EUCTR2008-001523-57-NO (EUCTR)	10/06/2011	23/09/2008	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Denmark;Germany;Norway;France;Hungary;Spain;Italy;United Kingdom
1525	EUCTR2010-022208-36-DE (EUCTR)	08/06/2011	03/12/2010	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1505	Phase 3	Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1526	EUCTR2010-021184-32-BE (EUCTR)	08/06/2011	14/04/2011	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti- TNF therapies	Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the US Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1527	EUCTR2010-020065-24-LV (EUCTR)	08/06/2011	11/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
1528	EUCTR2010-022207-22-DE (EUCTR)	08/06/2011	03/12/2010	A Study in Patients With Rheumatoid Arthritis (FLEX-V)	A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors (FLEX-V)	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: not available Other descriptive name: not available Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: not available Other descriptive name: not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	555	Phase 3	United States;Taiwan;Greece;Spain;Russian Federation;Colombia;Italy;Mexico;Argentina;Poland;Brazil;Malaysia;Australia;Germany;New Zealand;Japan;Korea, Republic of
1529	EUCTR2010-022504-42-GB (EUCTR)	07/06/2011	16/11/2010	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY3009104 Product Code: LY3009104 INN or Proposed INN: Not available Other descriptive name: JAK1 / JAK2 Inhibtor Product Name: LY3009104 Product Code: LY3009104 INN or Proposed INN: Not available Other descriptive name: JAK1 / JAK2 Inhibtor	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Hungary;United Kingdom
1530	EUCTR2011-000215-79-FR (EUCTR)	07/06/2011	24/02/2011	Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA	Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA	Polyarthrite rhumatoïde	Trade Name: Roactemra Other descriptive name: TOCILIZUMAB	CHU de Clermont Ferrand	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France
1531	EUCTR2007-000012-90-NL (EUCTR)	01/06/2011	18/10/2010	The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial	The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial	The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure. MedDRA version: 9.1;Level: LLT;Classification code 10041591;Term: Spinal osteoarthritis MedDRA version: 9.1;Classification code 10003268;Term: Arthritis rheumatoid	Trade Name: Celebrex Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses	University of Dundee	NULL	Not Recruiting			Female: yes Male: yes			Denmark;Netherlands;United Kingdom
1532	JPRN-UMIN000005590	2011/06/01	12/05/2011	Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis	Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis - Maintenance of remission by tocilizumab mono-therapy	Rheumatoid arthritis	Cessation of MTX (tocilizumab monotherapy) Continue MTX with tocilizumab	Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	40	Not selected	Japan
1533	JPRN-UMIN000005773	2011/06/01	14/06/2011	Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis	Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis - Quantification of knee cartilage in rheumatoid arthritis by MRI analysis	rheumatoid arthritis	ETN+MTX MTX	22nd Century Medical & Research Center, the University of Tokyo	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	20	Not selected	Japan
1534	NCT01355354 (ClinicalTrials.gov)	June 2011	17/5/2011	Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects	An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily	Healthy Volunteers;Rheumatoid Arthritis	Drug: Digoxin;Drug: Fostamatinib	AstraZeneca	NULL	Completed	18 Years	45 Years	Both	21	Phase 1	United Kingdom
1535	NCT01373151 (ClinicalTrials.gov)	June 2011	13/6/2011	Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate	A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.	Rheumatoid Arthritis	Drug: BMS-945429 Placebo;Biological: BMS-945429;Drug: Methotrexate;Drug: Methotrexate Placebo;Drug: Adalimumab Placebo;Drug: Adalimumab	CSL Behring	NULL	Completed	18 Years	N/A	All	418	Phase 2	United States;Argentina;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Czech Republic;Peru
1536	EUCTR2010-022378-15-DE (EUCTR)	25/05/2011	09/02/2011	A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.	VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody	Nycomed GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1537	EUCTR2010-022378-15-ES (EUCTR)	19/05/2011	21/02/2011	A clinical study to explore the therapeutic effects of different doses ofthe new drug veltuzumab, a drug of biologic origin, and placebo, inpatients with rheumatoid arthritis.	VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody	Nycomed GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1538	EUCTR2010-018485-24-DE (EUCTR)	18/05/2011	28/01/2011	To investigate the efficacy and safety of SC BT061 in patients with activerheumatoid arthritis	A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA	Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	176		Hungary;Czech Republic;Spain;Latvia;Germany
1539	EUCTR2010-021283-14-PT (EUCTR)	13/05/2011	07/12/2010	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom
1540	JPRN-UMIN000024507	2011/05/12	21/10/2016	Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis	Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis - Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis	rheumatoid arthritis	In these patients, who had received SASP/MTX combination therapy for at least 12 weeks, SASP was discontinued, and the patients received MTX monotherapy for the next 24 weeks.	Japan Community Healthcare Organization	NULL	Complete: follow-up complete	20years-old	100years-old	Male and Female	10	Not selected	Japan
1541	EUCTR2009-015019-42-DE (EUCTR)	10/05/2011	20/08/2010	Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)	A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS	Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	170		United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands
1542	EUCTR2009-013758-33-NL (EUCTR)	10/05/2011	16/09/2010	MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	36		Denmark;Netherlands;Sweden
1543	EUCTR2010-023587-40-GR (EUCTR)	10/05/2011	16/05/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700		United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
1544	EUCTR2010-020839-39-BE (EUCTR)	10/05/2011	25/11/2010	Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapy	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB	UCB Biosciences, Inc. A Member of the UCB Group of Companies	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	United States;Belgium;United Kingdom
1545	EUCTR2010-022224-77-BE (EUCTR)	10/05/2011	14/01/2011	Open-label study to assess the safety and efficacy of CDP6038 inpatients who completed RA0056	A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CDP6038 Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype	UCB Biosciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Belgium;United Kingdom
1546	EUCTR2010-019871-31-CZ (EUCTR)	10/05/2011	01/03/2011	Etoricoxib and placebo in patients with rheumatoid arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid ArthritisRandomizovaná dvojite zaslepená placebem kontrolovaná multicentrická studie fáze III složená ze dvou cástí hodnotící relativní úcinnost a toleranci dvou dávek MK-0663/Etoricoxibu u pacientu s revmatoidní artritidou	Rheumatoid Arthritis (RA) MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1250	Phase 3	United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1547	EUCTR2010-023587-40-SE (EUCTR)	04/05/2011	14/03/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor	A randomized, open-label, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	96		United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
1548	EUCTR2009-016266-90-ES (EUCTR)	03/05/2011	16/12/2009	Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Artritis Reumatoide_____________________________________Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1740	Phase 2	Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands
1549	EUCTR2010-019871-31-SK (EUCTR)	02/05/2011	28/02/2011	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term:	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
1550	EUCTR2010-020065-24-IT (EUCTR)	29/04/2011	20/03/2012	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel(etanercept) in Patients With Rheumatoid Arthritis and Increased Riskfor Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptorblockade with tocilizumab (TCZ) in comparison with etanercept (ETA) onthe rate of cardiovascular events in patients with moderate to severerheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: TOCILIZUMAB Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Philippines;Greece;Ecuador;Spain;Chile;Russian Federation;Israel;Italy;India;Malaysia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany
1551	EUCTR2010-023587-40-DK (EUCTR)	28/04/2011	12/04/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	United States;European Union;Greece;Finland;Spain;Denmark;Russian Federation;Netherlands;Germany;Italy;Sweden
1552	EUCTR2010-022224-77-GB (EUCTR)	27/04/2011	21/12/2010	Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056	A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CDP6038 Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype	UCB Biosciences Inc	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	United States;Belgium;United Kingdom
1553	EUCTR2010-019262-86-DE (EUCTR)	26/04/2011	20/08/2010	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2025	Phase 3	Philippines;Taiwan;Estonia;United States;Portugal;Belarus;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1554	EUCTR2010-019514-24-CZ (EUCTR)	21/04/2011	06/12/2010	Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)	A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO	Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX Goldshield Tablets INN or Proposed INN: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	380		United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany
1555	EUCTR2010-019912-18-GR (EUCTR)	18/04/2011	01/04/2011	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis	Rheumatoid arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: tocilizumab 162mg/0.9ml SC PFS SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;Greece;Spain;Bulgaria
1556	EUCTR2010-023587-40-FI (EUCTR)	15/04/2011	24/02/2011	A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	96		Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
1557	EUCTR2010-023587-40-ES (EUCTR)	13/04/2011	17/02/2011	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.	Adult Rheumatoid Arthritis (RA)Artritis reumatoide del adulto (AR) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	Greece;Finland;Spain;Denmark;Netherlands;Germany;Italy;Sweden
1558	EUCTR2010-018485-24-ES (EUCTR)	12/04/2011	04/11/2010	A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA	A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA	Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 2	Hungary;Czech Republic;Spain;Latvia;Germany
1559	EUCTR2010-021020-94-HU (EUCTR)	08/04/2011	05/10/2010	A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a	A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a	active rheumatoid arthritis MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SAR153191 Product Code: SAR153191 Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Czech Republic;Germany;Spain;Italy
1560	EUCTR2010-022378-15-HU (EUCTR)	08/04/2011	21/02/2011	VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET	VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody	Nycomed GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Czech Republic;Hungary;Spain;Germany;United Kingdom
1561	EUCTR2010-023692-26-GB (EUCTR)	07/04/2011	18/11/2010	Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)	(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Germany
1562	EUCTR2008-007346-63-GB (EUCTR)	05/04/2011	11/10/2010	Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP	Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP	Rheumatoid Arthritis	Product Name: bIAP Product Code: EC 3.1.3.1 INN or Proposed INN: bovine intesastinal alkaline phosphatase (bIAP) Other descriptive name: bIAP	Alloksys Life Sciences B.V.	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	United Kingdom
1563	EUCTR2010-019514-24-DE (EUCTR)	04/04/2011	08/11/2010	Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)	A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO	Rheumatoid Arthritis. MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	380		United States;Czech Republic;Puerto Rico;Canada;Argentina;Spain;Austria;Germany
1564	EUCTR2009-015019-42-BE (EUCTR)	04/04/2011	06/09/2010	Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)	A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS	Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany
1565	JPRN-UMIN000005362	2011/04/01	01/04/2011	Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).	Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). - Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs.	Patients with rheumatoid arthritis with anemia taking NSAIDs	Treatment with mesalazine	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine	NULL	Complete: follow-up complete	20years-old	70years-old	Male and Female	13	Not selected	Japan
1566	EUCTR2010-022206-40-LT (EUCTR)	01/04/2011	28/12/2010	A Rheumatoid Arthritis Study in Patients(FLEX-O)	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: not available Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 3	United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Australia;Peru;South Africa;Bulgaria;Japan;New Zealand
1567	EUCTR2010-022205-17-LT (EUCTR)	01/04/2011	28/12/2010	A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate(FLEX-M)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M)	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available Other descriptive name: Not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	990	Phase 3	United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
1568	EUCTR2010-022208-36-LT (EUCTR)	01/04/2011	28/12/2010	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1505	Phase 3	Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1569	NCT01336218 (ClinicalTrials.gov)	April 2011	14/4/2011	Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.	An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin	Rheumatoid Arthritis;Healthy Volunteers	Drug: fostamatinib;Drug: rifampicin	AstraZeneca	NULL	Completed	18 Years	55 Years	Both	15	Phase 1	United States
1570	EUCTR2010-023880-17-GB (EUCTR)	31/03/2011	25/02/2011	SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drug	SWITCH: Randomised-controlled trial of switching to alternative tumour-necrosis factor (TNF)-blocking drugs or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-blocking drug. - SWITCH	Rheumatoid arthritis in patients who have failed to respond to an initial TNF-blocking drug MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Mabthera Product Name: Rituximab Product Code: n/a INN or Proposed INN: Rituximab Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of the world) Trade Name: Orencia Product Name: Abatacept Product Code: n/a INN or Proposed INN: abatacept Other descriptive name: Orencia Trade Name: Remicade Product Name: Infliximab Product Code: n/a INN or Proposed INN: infliximab Other descriptive name: n/a Trade Name: Enbrel Product Name: Etanercept Product Code: n/a INN or Proposed INN: etanercept Other descriptive name: n/a	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	477	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1571	EUCTR2010-022206-40-BG (EUCTR)	30/03/2011	24/02/2011	A Rheumatoid Arthritis Study in Patients (FLEX-O)	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 3	United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
1572	EUCTR2010-022205-17-BG (EUCTR)	29/03/2011	24/02/2011	A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M)	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399 Trade Name: Boostrix® Product Name: Boostrix® Product Code: - Other descriptive name: DIPHTHERIA TOXOID Other descriptive name: TETANUS TOXOID Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE Other descriptive name: PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED ON ALUMINIUM HYDROXIDE Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE Trade Name: PNEUMOVAX® 23 Product Name: PNEUMOVAX® 23 Product Code: - Other descriptive name: pneumococcal serotypes	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	990	Phase 3	United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
1573	EUCTR2010-021558-21-GB (EUCTR)	28/03/2011	08/10/2010	A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616 Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Hungary;Slovakia;Czech Republic;Germany;United Kingdom;Ukraine
1574	EUCTR2010-021577-37-BG (EUCTR)	24/03/2011	04/02/2011	A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Anti Lymphotoxin Alpha Product Code: MLTA3698A Other descriptive name: Anti lymphotoxin alpha Trade Name: Humira INN or Proposed INN: ADALIMUMAB	GENENTECH, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Hungary;Mexico;Spain;Peru;Chile;Bulgaria;Germany
1575	EUCTR2010-022208-36-BG (EUCTR)	24/03/2011	24/02/2011	An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P)	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P)	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available Other descriptive name: Not available Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: Not available Other descriptive name: Not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1505	Phase 3	United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
1576	EUCTR2010-023910-30-GB (EUCTR)	23/03/2011	28/02/2011	A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA)	A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA)	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Enbrel 50mg pre-filled pen Product Name: Etanercept (Enbrel) Product Code: EU/1/99/126/020 INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Enbrel 50mg pre-filled syringe Product Name: Etanercept (Enbrel) Product Code: EU/1/99/126/017 INN or Proposed INN: Etanercept	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	United Kingdom
1577	EUCTR2010-021558-21-SK (EUCTR)	23/03/2011	26/10/2010	A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616 Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Germany;United Kingdom;Slovakia;Ukraine
1578	EUCTR2010-022207-22-ES (EUCTR)	21/03/2011	29/12/2010	A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfa	A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfa	Rheumatoid Arthritis Artritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	555	Phase 3	Greece;Poland;Spain;Germany;Italy
1579	EUCTR2010-022208-36-ES (EUCTR)	21/03/2011	29/12/2010	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR)	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR)	Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1505	Phase 3	Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1580	EUCTR2010-023692-26-BG (EUCTR)	17/03/2011	24/02/2011	Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)	(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	370	Phase 2	Netherlands;United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;South Africa;Germany
1581	EUCTR2010-021577-37-DE (EUCTR)	17/03/2011	29/10/2010	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: N/A Product Code: MLTA3698A Trade Name: Humira INN or Proposed INN: ADALIMUMAB	GENENTECH, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Spain;Bulgaria;Germany
1582	EUCTR2010-022378-15-CZ (EUCTR)	16/03/2011	21/02/2011	A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.	VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (IMMU-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody	Nycomed GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
1583	EUCTR2010-022207-22-GR (EUCTR)	15/03/2011	20/01/2011	A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors	A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	555	Phase 3	Greece;Poland;Spain;Germany;Italy
1584	EUCTR2010-023587-40-IT (EUCTR)	10/03/2011	27/04/2011	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - ND	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - ND	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra INN or Proposed INN: tocilizumab Trade Name: Humira INN or Proposed INN: Adalimumab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700		Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
1585	EUCTR2010-021020-94-DE (EUCTR)	10/03/2011	15/09/2010	A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a	A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a	active rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Code: SAR153191 Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Czech Republic;Germany;Spain;Italy
1586	EUCTR2010-022865-81-CZ (EUCTR)	02/03/2011	22/12/2010	Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis	A phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis - ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 Other descriptive name: ALX-0061 Nanobody	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 1/2	Hungary;Czech Republic
1587	NCT01313520 (ClinicalTrials.gov)	March 1, 2011	25/2/2011	A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)	A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136)	Arthritis, Rheumatoid	Drug: Infliximab;Drug: Placebo	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	61	Phase 2	Moldova, Republic of;Romania
1588	NCT01301703 (ClinicalTrials.gov)	March 2011	21/2/2011	Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis	The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)	Tel-Aviv Sourasky Medical Center	NULL	Not yet recruiting	18 Years	64 Years	Both	100	Phase 4	Israel
1589	NCT01353859 (ClinicalTrials.gov)	March 2011	13/5/2011	A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs	An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	39	Phase 3	Indonesia;Greece
1590	EUCTR2010-020839-39-GB (EUCTR)	25/02/2011	12/10/2010	Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olikizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB	UCB Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	220		United Kingdom;United States
1591	EUCTR2010-020890-18-CZ (EUCTR)	25/02/2011	02/11/2010	AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS	AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: tasocitinib citrate Trade Name: Methotrexate Sodium Tablets 2.5 mg INN or Proposed INN: Methotrexate Sodium	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Czech Republic
1592	EUCTR2010-022207-22-IT (EUCTR)	24/02/2011	03/02/2011	A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors - ND	A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors - ND	Rheumatoid Arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	555	Phase 3	Greece;Poland;Spain;Germany;Italy
1593	EUCTR2010-022206-40-HU (EUCTR)	23/02/2011	26/11/2010	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 3	Hungary;Poland;Lithuania;Bulgaria
1594	EUCTR2010-022205-17-HU (EUCTR)	18/02/2011	15/12/2010	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	990	Phase 3	Hungary;Poland;Lithuania;Bulgaria
1595	EUCTR2010-020744-35-IT (EUCTR)	18/02/2011	22/12/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002 - OSKIRA-2	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002 - OSKIRA-2	Patients with active Rheumatoid Arthritis despite current treatment with a DMARD. MedDRA version: 9.1;Level: PT;Classification code 10039073	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib	ASTRAZENECA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;United Kingdom;Italy
1596	EUCTR2010-020745-27-IT (EUCTR)	18/02/2011	22/12/2010	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist. D4300C00003 - OSKIRA-3	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist. D4300C00003 - OSKIRA-3	Patients with active Rheumatoid Arthritis (RA), despite treatment with methotrexate, who have had an inadequate response to a single TNF-alfa antagonist. MedDRA version: 9.1;Level: PT;Classification code 10039073	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib	ASTRAZENECA	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	France;Portugal;Hungary;Czech Republic;Spain;Germany;United Kingdom;Italy
1597	EUCTR2010-022208-36-HU (EUCTR)	18/02/2011	26/11/2010	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1505	Phase 3	Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1598	EUCTR2010-020890-18-HU (EUCTR)	18/02/2011	16/11/2010	Tofacitinib MRI in Early Rheumatoid Arthritis	AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF Tofacitinib (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: tasocitinib citrate Trade Name: Methotrexate Sodium Tablets 2.5 mg INN or Proposed INN: Methotrexate Sodium	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Czech Republic;Hungary
1599	EUCTR2010-020744-35-DE (EUCTR)	17/02/2011	21/07/2010	Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Disease Modifying Anti-rheumatic Drug (DMARD) But NotResponding. (OSKIRA - 2)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Serbia;United States;Spain;Ukraine;Lithuania;Israel;Italy;United Kingdom;India;Czech Republic;Canada;Romania;South Africa;Latvia;Germany
1600	EUCTR2010-020745-27-DE (EUCTR)	17/02/2011	21/07/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3)	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1601	EUCTR2010-020892-22-DE (EUCTR)	17/02/2011	21/07/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1602	EUCTR2010-023692-26-CZ (EUCTR)	16/02/2011	22/12/2010	Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)	(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
1603	EUCTR2009-012615-18-FR (EUCTR)	16/02/2011	05/11/2010	Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION	Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION	Rheumatoid arthritis (RA) MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Trade Name: UVEDOSE INN or Proposed INN: COLECALCIFEROL	CHU de Clermont-Ferrand	NULL	Not Recruiting			Female: yes Male: yes			France
1604	EUCTR2010-020743-12-DE (EUCTR)	15/02/2011	21/07/2010	Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Estonia;Slovakia;Ukraine;Chile;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany
1605	EUCTR2010-021558-21-DE (EUCTR)	15/02/2011	19/10/2010	A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Hungary;Slovakia;Germany;United Kingdom
1606	EUCTR2010-022865-81-HU (EUCTR)	11/02/2011	15/02/2011	Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis	A phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis - ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 Other descriptive name: ALX-0061 Nanobody	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 1/2	Czech Republic;Hungary
1607	EUCTR2010-020892-22-IT (EUCTR)	08/02/2011	22/12/2010	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-X	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-X	Patients with active Rheumatoid Arthritis (RA) who have participated in a qualifying study. MedDRA version: 9.1;Level: PT;Classification code 10039073	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib	ASTRAZENECA	NULL	Not Recruiting			Female: yes Male: yes	2000		Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;United Kingdom;Italy
1608	EUCTR2010-021558-21-HU (EUCTR)	08/02/2011	07/10/2010	A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616 Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Hungary;Slovakia;Czech Republic;Germany;United Kingdom
1609	EUCTR2010-020499-50-GB (EUCTR)	07/02/2011	31/12/2010	Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.	Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.	rheumatoid arthritis MedDRA version: 13;Level: PT;Classification code 10039073;Term: rheumatoid arthritis	Trade Name: MabThera Product Name: rituximab	South Tees Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	46	Phase 4	United Kingdom
1610	EUCTR2010-022504-42-HU (EUCTR)	04/02/2011	23/11/2010	A study to evaluate the efficacy of different doses of LY3009104 therapy compared to placebo in patients with Rheumatoid Arthritis who are on ongoing methotrexate background therapy.	A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY3009104 Product Code: LY3009104 INN or Proposed INN: Not available Other descriptive name: JAK1 / JAK2 Inhibitor Product Name: LY3009104 Product Code: LY3009104 INN or Proposed INN: Not available Other descriptive name: JAK1 / JAK2 Inhibtor	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Czech Republic;Hungary;Mexico;Argentina;Poland;Ukraine;Croatia;Romania;Peru;United Kingdom;India
1611	EUCTR2010-023692-26-HU (EUCTR)	04/02/2011	08/02/2011	Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)	(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4	Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
1612	EUCTR2010-019262-86-NL (EUCTR)	02/02/2011	24/06/2010	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile
1613	EUCTR2010-021283-14-IT (EUCTR)	01/02/2011	23/12/2010	A randomised, double blind, placebo-controlled, multiple dose trial of NNC109-0012 (Anti-IL-20) in subjects with rheumatoid arthritis - NN8226-3875	A randomised, double blind, placebo-controlled, multiple dose trial of NNC109-0012 (Anti-IL-20) in subjects with rheumatoid arthritis - NN8226-3875	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073	Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012	NOVO NORDISK	NULL	Not Recruiting			Female: yes Male: yes	66		Hungary;Portugal;United Kingdom;Spain;Italy
1614	JPRN-UMIN000008164	2011/02/01	13/06/2012	Restart for sustaining remission of rheumatoid arthritis in use of etanercept	Restart for sustaining remission of rheumatoid arthritis in use of etanercept - RESUME	Rheumatoid Arthritis	After the administration of etanercept (50mg/week), the dosage of etanercept will be discontinued when the low disease activity (DAS28-ESR<3.2) is achieved. If patients recur from low disease activity, same dose of etanercept will be administered again by the observation of every two months. This strategy will be maintained for two years. We must control the disease activity below the low disease activity using combined medicine except glucocorticoid if patients could not reach low disease activity after the administration of etanercept in three months. It will be considered to be a dropout if patients cannot reach low disease activity within six months.	Osaka City University Medical School	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Phase 4	Japan
1615	NCT01282255 (ClinicalTrials.gov)	February 2011	21/1/2011	Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis	A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis	Drug: NNC109-0012;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	All	67	Phase 2	Czech Republic;Germany;Italy;Poland;Portugal;Romania;Spain;United Kingdom
1616	NCT01254331 (ClinicalTrials.gov)	February 2011	3/12/2010	An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment	Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	51	Phase 3	Tunisia
1617	EUCTR2010-019926-15-CZ (EUCTR)	27/01/2011	01/12/2010	A Phase 2 placebo-controlled study to compare the effectiveness and safety of two doses of apremilast (CC-10004) in subjects with active rheumatoid arthritis, who have not responded to methotrexate treatment	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO COMPARE THE EFFICACY AND SAFETY OF TWO DOSES OF APREMILAST (CC-10004) IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis, a chronic systemic autoimmune inflammatory disease characterized by persisten synovial inflammations. MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: Apremilast	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	United States;Czech Republic
1618	EUCTR2010-021577-37-ES (EUCTR)	27/01/2011	23/11/2010	ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	Artritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: N/A Product Code: MLTA3698A Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	GENENTECH, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Germany;Bulgaria;Spain
1619	EUCTR2010-019514-24-AT (EUCTR)	27/01/2011	21/12/2010	Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)	A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO	Rheumatoid Arthritis. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	380		United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Austria;Germany
1620	EUCTR2010-019514-24-ES (EUCTR)	27/01/2011	30/11/2010	Estudio multicéntrico, doble ciego, aleatorizado, de brazos paralelos para determinar la respuesta a la dosis de metotrexato (MTX) en combinación con adalimumab en sujetos con artritis reumatoide temprana (CONCERTO). A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO	Estudio multicéntrico, doble ciego, aleatorizado, de brazos paralelos para determinar la respuesta a la dosis de metotrexato (MTX) en combinación con adalimumab en sujetos con artritis reumatoide temprana (CONCERTO). A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO	Rheumatoid Arthritis. Artritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB Trade Name: MTX HEXAL Tablets INN or Proposed INN: METOTREXATO Other descriptive name: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	380		Czech Republic;Spain;Austria;Germany
1621	EUCTR2010-019514-24-BE (EUCTR)	25/01/2011	25/11/2010	Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)	A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO	Rheumatoid Arthritis. MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 3	United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany
1622	EUCTR2010-019912-18-ES (EUCTR)	17/01/2011	19/01/2011	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	Rheumatoid arthritis (RA)Artritis Reumatoide (AR) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml SC PFS SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Hungary;Greece;Spain;Bulgaria
1623	EUCTR2010-021283-14-GB (EUCTR)	14/01/2011	08/10/2010	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	66		Portugal;Hungary;Spain;Italy;United Kingdom
1624	EUCTR2010-020892-22-BG (EUCTR)	13/01/2011	09/11/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1625	EUCTR2010-019871-31-BE (EUCTR)	11/01/2011	31/08/2010	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term:	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
1626	EUCTR2010-020743-12-PL (EUCTR)	11/01/2011	01/10/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany
1627	EUCTR2010-022208-36-IT (EUCTR)	10/01/2011	08/02/2011	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis(RA) - ND	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis(RA) - ND	Rheumatoid Arthritis. MedDRA version: 9.1;Level: PT;Classification code 10039073	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1505	Phase 3	Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
1628	EUCTR2010-021283-14-ES (EUCTR)	07/01/2011	05/11/2010	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis.Ensayo de dosis múltiples, aleatorizado, doble ciego y controlado con placebo de anti IL 20 (109 0012) en pacientes con artritis reumatoide.	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis.Ensayo de dosis múltiples, aleatorizado, doble ciego y controlado con placebo de anti IL 20 (109 0012) en pacientes con artritis reumatoide.	Rheumatoid arthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	66		Hungary;Portugal;United Kingdom;Spain;Italy
1629	EUCTR2010-022049-88-DE (EUCTR)	05/01/2011	11/11/2010	Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI	Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI	Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra 20 mg/ml Concentrate for solution for infusion Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: Tocilizumab Trade Name: Mabthera 500 mg Concentrate for solution for infusion Product Name: Rituximab Product Code: RO045-2294 INN or Proposed INN: RITUXIMAB	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes			Germany
1630	NCT01351805 (ClinicalTrials.gov)	January 2011	4/5/2011	Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain	Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain	Autoimmune Diseases;Systemic Inflammatory Process;Knee Pain Chronic;Osteoarthritis;Rheumatoid Arthritis	Drug: Fish Oil;Dietary Supplement: Vitamin D;Other: placebo pill	Brigham and Women's Hospital	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Active, not recruiting	50 Years	N/A	All	25876	N/A	United States
1631	NCT01223911 (ClinicalTrials.gov)	January 2011	14/10/2010	A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis	A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis	Drug: NNC 0151-0000-0000;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	All	34	Phase 2	Czech Republic;Denmark;Hungary;Poland;Romania;United Kingdom
1632	NCT01207453 (ClinicalTrials.gov)	January 2011	21/9/2010	Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis	Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Milnacipran;Drug: Placebo	Brigham and Women's Hospital	Forest Laboratories;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Completed	24 Years	N/A	All	49	Phase 4	United States
1633	NCT01274182 (ClinicalTrials.gov)	January 2011	10/1/2011	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.	Rheumatoid Arthritis	Biological: GP2013;Biological: MabThera;Biological: Rituxan	Sandoz	Novartis Pharmaceuticals	Completed	18 Years	N/A	All	312	Phase 1/Phase 2	United States;Argentina;Austria;Belgium;Brazil;Estonia;France;Germany;Hungary;India;Italy;Romania;Spain;Turkey
1634	NCT01411215 (ClinicalTrials.gov)	January 2011	13/5/2011	A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department	A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department	Rheumatoid Arthritis;Ankylosing Spondylitis	Drug: Enbrel	Pfizer	NULL	Terminated	18 Years	N/A	All	160	N/A	China
1635	EUCTR2010-021558-21-CZ (EUCTR)	23/12/2010	21/10/2010	A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: AK106-001616 Product Code: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen Product Name: AK106-001616 Product Code: AK106-001616	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Slovakia;Ukraine;Germany;United Kingdom
1636	EUCTR2010-019134-27-BG (EUCTR)	23/12/2010	18/10/2010	A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY	A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY	Rhuematoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Trade Name: Methotrexate 10 mg tablets Product Name: Methotrextate INN or Proposed INN: Methotrexate Trade Name: Folimet Product Name: Folic Acid INN or Proposed INN: Folic Acid	Chelsea Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United States;Czech Republic;Mexico;Argentina;Poland;Bulgaria
1637	EUCTR2010-021020-94-ES (EUCTR)	21/12/2010	21/10/2010	Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-?	Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-?	artritis reumatoide activa MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191 Trade Name: SIMPONI 50 mg solución inyectable en pluma precargada INN or Proposed INN: GOLIMUMAB Other descriptive name: GOLIMUMAB	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Czech Republic;Germany;Spain;Italy
1638	NCT02675803 (ClinicalTrials.gov)	December 20, 2010	9/7/2015	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis Patients	A Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VAY736 in Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Biological: VAY736;Biological: VAY736 placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	65 Years	All	65	Phase 1	Germany
1639	EUCTR2010-021020-94-CZ (EUCTR)	17/12/2010	05/10/2010	A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a	A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a	active rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Code: SAR153191 Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Germany;Czech Republic;Spain;Italy
1640	EUCTR2010-020744-35-PT (EUCTR)	17/12/2010	16/09/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom
1641	EUCTR2010-020745-27-PT (EUCTR)	17/12/2010	16/09/2010	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	France;Portugal;Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom
1642	EUCTR2010-020892-22-PT (EUCTR)	17/12/2010	17/09/2010	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		Portugal;Estonia;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands
1643	EUCTR2010-021577-37-HU (EUCTR)	16/12/2010	27/10/2010	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: N/A Product Code: MLTA3698A Trade Name: Humira INN or Proposed INN: ADALIMUMAB	GENENTECH, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Spain;Bulgaria;Germany
1644	EUCTR2010-021283-14-CZ (EUCTR)	15/12/2010	27/09/2010	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	66		Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom
1645	EUCTR2010-020743-12-FR (EUCTR)	14/12/2010	05/10/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom
1646	EUCTR2010-020745-27-FR (EUCTR)	14/12/2010	05/10/2010	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;France;Hungary;Czech Republic;Spain;Belgium;Germany;Italy;United Kingdom
1647	EUCTR2010-022206-40-SK (EUCTR)	13/12/2010	27/04/2016	A Rheumatoid Arthritis Study in Patients (FLEX-O)	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 3	United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
1648	EUCTR2010-020745-27-ES (EUCTR)	13/12/2010	30/09/2010	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonistEstudio en fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas de fostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficiente a un antagonista del TNF-alfa - OSKIRA - 3	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonistEstudio en fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas de fostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficiente a un antagonista del TNF-alfa - OSKIRA - 3	Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	France;Portugal;Hungary;Czech Republic;Belgium;Spain;Germany;Italy;United Kingdom
1649	EUCTR2010-020744-35-ES (EUCTR)	13/12/2010	23/09/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2	Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom
1650	EUCTR2010-020892-22-ES (EUCTR)	13/12/2010	05/10/2010	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid ArthritisEstudio de extensión a largo plazo para evaluar la seguridad y la eficacia de fostamatinib disódico (FosD) en el tratamiento de la artritisreumatoide - OSKIRA - X	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid ArthritisEstudio de extensión a largo plazo para evaluar la seguridad y la eficacia de fostamatinib disódico (FosD) en el tratamiento de la artritisreumatoide - OSKIRA - X	Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Netherlands;Latvia;Germany;Italy;United Kingdom
1651	EUCTR2009-015898-12-NL (EUCTR)	10/12/2010	10/06/2010	Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Patients with active rheumatoid arthritis and an inadequate response to Methotrexate MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: GLPG0259 Product Code: GLPG0259 Product Name: GLPG0259 Product Code: GLPG0259 Product Name: GLPG0259 Product Code: GLPG0259 Product Name: GLPG0259 Product Code: GLPG0259	Galápagos NV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Netherlands;Belgium
1652	EUCTR2009-016266-90-RO (EUCTR)	03/12/2010	26/07/2010	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1740	Phase 2;Phase 3	Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands
1653	EUCTR2010-019262-86-LT (EUCTR)	01/12/2010	26/10/2010	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1654	EUCTR2010-019871-31-GB (EUCTR)	01/12/2010	08/10/2010	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.	,NULL	Not Recruiting			Female: yes Male: yes	1800	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
1655	NCT01142726 (ClinicalTrials.gov)	December 2010	3/6/2010	Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA	Rheumatoid Arthritis	Drug: Abatacept;Drug: Methotrexate;Drug: Abatacept placebo;Drug: Methotrexate placebo	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	511	Phase 3	United States;Australia;Belgium;Canada;Denmark;Finland;France;Germany;Italy;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Sweden;Norway
1656	EUCTR2010-018646-31-LT (EUCTR)	30/11/2010	06/08/2010	CT-P13 Compared With Remicade When Co-Administered With Methotrexate	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Colombia;Bulgaria;Chile;Indonesia;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Russian Federation;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan
1657	EUCTR2010-021184-32-DE (EUCTR)	30/11/2010	30/08/2010	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1658	EUCTR2010-018375-22-BG (EUCTR)	25/11/2010	23/09/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand
1659	EUCTR2010-020892-22-BE (EUCTR)	23/11/2010	01/07/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1660	EUCTR2010-020743-12-BE (EUCTR)	23/11/2010	07/07/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom
1661	EUCTR2010-020745-27-BE (EUCTR)	23/11/2010	01/07/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3)	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1662	EUCTR2009-011791-30-CZ (EUCTR)	18/11/2010	02/08/2010	A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis	A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: NNC151-0000 Product Code: NNC0151-0000-0000 Other descriptive name: Anti-C5aR	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	48		Hungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom
1663	EUCTR2009-015019-42-FI (EUCTR)	17/11/2010	27/09/2010	Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)	A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS	Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	170		United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands
1664	EUCTR2010-021184-32-AT (EUCTR)	11/11/2010	19/10/2010	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	288	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1665	EUCTR2009-012041-35-BG (EUCTR)	10/11/2010	18/08/2010	A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy	A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy - TNF-K-003	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TNF-Kinoid Product Code: TNF-K	Neovacs SA	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria
1666	EUCTR2010-020743-12-BG (EUCTR)	10/11/2010	09/11/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Peru;Bulgaria;Germany
1667	EUCTR2010-018646-31-ES (EUCTR)	05/11/2010	12/08/2010	Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Artritis reumatoide.Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
1668	EUCTR2010-018674-20-DE (EUCTR)	05/11/2010	17/08/2010	Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination With Methotrexate in Adults With Very Early Rheumatoid Arthritis (RA)	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised protocol 01 incorporating protocol amendment 01	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden
1669	EUCTR2010-018674-20-DK (EUCTR)	05/11/2010	21/09/2010	Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised protocol 01 incorporating protocol amendment 01	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Denmark;Australia;South Africa;Germany;Korea, Republic of;Sweden
1670	EUCTR2010-019871-31-AT (EUCTR)	03/11/2010	01/09/2010	Etoricoxib and placebo in patients with rheumatoid arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1671	EUCTR2009-015019-42-LT (EUCTR)	02/11/2010	17/09/2010	Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)	A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS	Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	170		Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
1672	EUCTR2010-019871-31-LT (EUCTR)	02/11/2010	17/09/2010	Etoricoxib and placebo in patients with rheumatoid arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1250	Phase 3	United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1673	EUCTR2009-016266-90-NL (EUCTR)	01/11/2010	16/04/2010	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SAR153191 Product Code: SAR153191 Product Name: SAR153191 Product Code: SAR153191 Product Name: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1740	Phase 2;Phase 3	Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Netherlands;Germany
1674	JPRN-UMIN000004412	2010/11/01	20/10/2010	Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid	Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid - CARAT study	rheumatoid arthritis	tocilizumab	General Internal Medicine, Tenri Hospital	NULL	Recruiting	16years-old	80years-old	Male and Female	25	Not applicable	Japan
1675	JPRN-UMIN000008756	2010/11/01	30/08/2012	Abatacept-based approach to cure of RA	Abatacept-based approach to cure of RA - ACURE study	Rheumatoid Arthritis	Abatacept treatmentat month 12 MTX treatment at month 12	University of Occupational and Environmental Health, Japan	NULL	Recruiting	15years-old	Not applicable	Female	40	Not selected	Japan
1676	NCT01225991 (ClinicalTrials.gov)	November 2010	20/10/2010	Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis	An Open-label Trial of Milnacipran for the Treatment of Pain in Rheumatoid Arthritis (RA) in Older Adults	Rheumatoid Arthritis	Drug: Milnacipran	University of California, Los Angeles	Forest Laboratories	Completed	50 Years	N/A	All	18	Phase 4	United States
1677	NCT01255761 (ClinicalTrials.gov)	November 2010	6/12/2010	A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects	Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia	Rheumatoid Arthritis	Biological: Certolizumab Pegol (CZP)	UCB Pharma	NULL	Completed	18 Years	N/A	All	736	Phase 4	United States
1678	NCT01287858 (ClinicalTrials.gov)	November 2010	12/1/2011	Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects	A Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy Subjects	Rheumatoid Arthritis	Drug: AC430	Daiichi Sankyo Inc.	NULL	Completed	18 Years	45 Years	Both	88	Phase 1	United States
1679	NCT01618019 (ClinicalTrials.gov)	November 2010	8/6/2012	N-3 PUFA and Rheumatoid Arthritis in Korea	Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Dietary Supplement: Omega-3 fatty acid;Dietary Supplement: Placebo	Hanyang University	NULL	Completed	18 Years	80 Years	All	109	N/A	Korea, Republic of
1680	NCT01225393 (ClinicalTrials.gov)	November 2010	18/10/2010	A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis	A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placebo	Genentech, Inc.	NULL	Completed	18 Years	75 Years	Both	211	Phase 2	Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States
1681	NCT01217814 (ClinicalTrials.gov)	November 2010	7/10/2010	Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-a Blockers	A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-a Antagonists	Rheumatoid Arthritis	Drug: Sarilumab;Drug: Placebo;Drug: Golimumab;Drug: methotrexate (MTX);Drug: Folic/folinic acid	Sanofi	Regeneron Pharmaceuticals	Terminated	18 Years	75 Years	All	16	Phase 2	United States;Colombia;Czechia;Italy;Mexico;Spain;Brazil;Canada;Czech Republic;Germany;Hungary;Norway
1682	NCT01245790 (ClinicalTrials.gov)	November 2010	19/11/2010	A Study of Fostamatinib in Subjects With Impaired Kidney Function	An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg	Rheumatoid Arthritis;Renal Impairment	Drug: fostamatinib	AstraZeneca	NULL	Completed	18 Years	N/A	Both	24	Phase 1	United States
1683	NCT01242488 (ClinicalTrials.gov)	November 2010	15/11/2010	Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy	Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy	Rheumatoid Arthritis	Biological: CDP6038;Biological: Tocilizumab (Actemra or RoActemra);Other: Placebo sc;Other: Placebo iv	UCB Pharma	NULL	Completed	18 Years	N/A	Both	221	Phase 2	United States;Belgium;United Kingdom
1684	EUCTR2008-006924-68-AT (EUCTR)	28/10/2010	12/01/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy
1685	EUCTR2010-021184-32-FR (EUCTR)	28/10/2010	13/09/2010	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti- TNF therapies	A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or two anti- TNF therapies	Refractory rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	France;Hungary;Estonia;Poland;Belgium;Spain;Austria;Bulgaria;Germany;United Kingdom;Italy
1686	EUCTR2010-020744-35-GB (EUCTR)	26/10/2010	05/07/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
1687	NCT01362062 (ClinicalTrials.gov)	October 26, 2010	26/5/2011	Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy	A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	110	N/A	India
1688	EUCTR2010-020743-12-GB (EUCTR)	26/10/2010	05/07/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom
1689	EUCTR2010-020745-27-GB (EUCTR)	26/10/2010	05/07/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3)	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	France;Portugal;United States;Spain;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1690	EUCTR2010-020892-22-GB (EUCTR)	26/10/2010	05/07/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1691	EUCTR2010-019871-31-DE (EUCTR)	25/10/2010	09/12/2010	Etoricoxib and placebo in patients with rheumatoid arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1250	Phase 3	United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1692	EUCTR2010-020892-22-LV (EUCTR)	22/10/2010	13/08/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		United States;Portugal;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Peru;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany
1693	EUCTR2010-020744-35-LV (EUCTR)	22/10/2010	13/08/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;Czech Republic;Canada;Romania;South Africa;Latvia;Germany
1694	EUCTR2010-018674-20-IT (EUCTR)	21/10/2010	17/12/2010	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA - ND	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA - ND	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073	Product Name: Abatacept Product Code: BMS188667 Trade Name: METHOTREXATE HOSPIRA 2.5 mg tablety INN or Proposed INN: Methotrexate	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	France;Finland;Denmark;Germany;Italy;Sweden
1695	EUCTR2010-018485-24-CZ (EUCTR)	20/10/2010	24/08/2010	To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis	A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA	Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	128		Hungary;Czech Republic;Spain;Latvia;Germany
1696	EUCTR2010-019134-27-CZ (EUCTR)	19/10/2010	28/06/2010	A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY	A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY	Rhuematoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Trade Name: Methotrexate Product Name: Methotrextate INN or Proposed INN: Methotrexate Trade Name: Folic Acid Product Name: Folic Acid INN or Proposed INN: Folic Acid	Chelsea Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	Czech Republic;Bulgaria
1697	EUCTR2010-019871-31-FI (EUCTR)	18/10/2010	30/08/2010	Etoricoxib and placebo in patients with rheumatoid arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
1698	EUCTR2010-021020-94-IT (EUCTR)	15/10/2010	28/09/2010	A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-alpha) antagonists. - ND	A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-alpha) antagonists. - ND	active rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073	Product Code: SAR153191 Trade Name: SIMPONI INN or Proposed INN: GOLIMUMAB	Sanofi-aventis Recherche & D?veloppement	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Czech Republic;Germany;Spain;Italy
1699	EUCTR2010-020892-22-HU (EUCTR)	15/10/2010	11/08/2010	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;Italy;United Kingdom
1700	EUCTR2007-006129-29-PL (EUCTR)	14/10/2010	21/04/2010	A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis	A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study	Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MOR103 Product Code: MOR103 Other descriptive name: Human Recombinant IgG1, lambda	MorphoSys AG	NULL	Not Recruiting			Female: yes Male: yes	89		Germany;Ukraine;Netherlands;Belarus;Bulgaria;Poland
1701	EUCTR2010-019964-36-DE (EUCTR)	14/10/2010	09/06/2010	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CCX354-C Product Code: CCX354-C Other descriptive name: CCX354 Product Name: CCX354-C Product Code: CCX354-C Other descriptive name: CCX354	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Czech Republic;Hungary;Belgium;Germany
1702	EUCTR2008-001523-57-DE (EUCTR)	14/10/2010	10/06/2010	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - IM101179	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - IM101179	Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Hungary;United Kingdom;Germany;Denmark;France;Norway;Spain;Italy
1703	EUCTR2010-020743-12-HU (EUCTR)	14/10/2010	11/08/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	France;Estonia;Hungary;Poland;Bulgaria;Germany;United Kingdom
1704	EUCTR2010-018674-20-FI (EUCTR)	13/10/2010	23/08/2010	Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating amendment 01.	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden
1705	EUCTR2010-020738-24-GB (EUCTR)	12/10/2010	17/08/2010	To see whether for patients with established rheumatoid arthritis that have already achieved a good response to Tumour Necrosis Factor Inhibitor (TNF inhibitor) treatment, whether the treatment be tapered to a minimum dose without affecting the control of disease activity.	Optimising Treatment With Tumour Necrosis Factor Inhibitors In Rheumatoid Arthritis: Is Dose Tapering Practical In Good Responders? A Proof Of Principle” And Exploratory Trial. (OPTTIRA) - OPTTIRA	Patients with established Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel pre-filled pen Product Name: Etanercept INN or Proposed INN: etanercept Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab Trade Name: Enbrel pre-filled syringe Product Name: Etanercept INN or Proposed INN: etanercept	King's College London	NULL	Not Recruiting			Female: yes Male: yes	99	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1706	EUCTR2010-018375-22-LT (EUCTR)	11/10/2010	16/08/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand
1707	EUCTR2010-018646-31-SK (EUCTR)	11/10/2010	23/06/2010	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
1708	EUCTR2010-018646-31-LV (EUCTR)	11/10/2010	29/06/2010		A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	633	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
1709	EUCTR2010-020892-22-CZ (EUCTR)	11/10/2010	30/08/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1710	EUCTR2010-020744-35-LT (EUCTR)	11/10/2010	18/08/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
1711	EUCTR2010-020743-12-SK (EUCTR)	11/10/2010	05/08/2010	Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany
1712	EUCTR2010-020892-22-SK (EUCTR)	11/10/2010	05/08/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1713	EUCTR2010-020744-35-CZ (EUCTR)	11/10/2010	30/08/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
1714	EUCTR2010-020892-22-LT (EUCTR)	11/10/2010	18/08/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1715	EUCTR2010-020745-27-CZ (EUCTR)	11/10/2010	30/08/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3)	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonist - OSKIRA - 3	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany
1716	EUCTR2010-018646-31-BG (EUCTR)	07/10/2010	07/09/2010	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
1717	EUCTR2010-018375-22-DE (EUCTR)	05/10/2010	14/07/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1200		United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand
1718	EUCTR2009-015019-42-AT (EUCTR)	05/10/2010	01/09/2010	Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)	A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS	Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	170		Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany
1719	EUCTR2009-016119-38-BG (EUCTR)	05/10/2010	18/08/2010	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	220		United Kingdom;Bulgaria;Latvia;Poland
1720	EUCTR2009-015845-21-GR (EUCTR)	04/10/2010	04/10/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
1721	EUCTR2010-018646-31-PT (EUCTR)	01/10/2010	23/07/2010	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
1722	EUCTR2006-005035-19-HU (EUCTR)	01/10/2010	19/09/2007	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TASOCITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TASOCITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Product Code: CP-690,550 Product Name: CP-690,550 Product Code: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 2;Phase 3	Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden
1723	EUCTR2009-015845-21-PT (EUCTR)	01/10/2010	22/07/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;Portugal;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
1724	NCT01149057 (ClinicalTrials.gov)	October 2010	22/6/2010	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS	An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	Clalit Health Services	Completed	18 Years	N/A	All	145	Phase 4	Israel
1725	NCT02528292 (ClinicalTrials.gov)	October 2010	5/8/2011	Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid Arthritis	Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy	Rheumatoid Arthritis	Procedure: Synovial biopsy;Drug: Anti-TNF therapy	Barts & The London NHS Trust	NULL	Active, not recruiting	18 Years	N/A	Both	24	Phase 4	United Kingdom
1726	EUCTR2010-018646-31-AT (EUCTR)	29/09/2010	03/08/2010		A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
1727	EUCTR2010-019694-15-BE (EUCTR)	28/09/2010	28/07/2010	Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone	Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone	Rheumatoid Arthritis in adult MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Medrol 4 mg tablets Other descriptive name: METHYLPREDNISOLONE Trade Name: Medrol A 16 mg tablets Other descriptive name: METHYLPREDNISOLONE	N.V. Roche S.A.	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Belgium
1728	EUCTR2010-019262-86-GR (EUCTR)	28/09/2010	23/09/2010	A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)	A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: N/A Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Netherlands;Germany;Norway;Sweden
1729	EUCTR2010-020892-22-EE (EUCTR)	27/09/2010	16/08/2010	Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
1730	EUCTR2010-020743-12-EE (EUCTR)	24/09/2010	16/08/2010	Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to Methotrexate - OSKIRA - 1	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	Astra Zeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Peru;Bulgaria;Germany
1731	EUCTR2010-018674-20-BE (EUCTR)	23/09/2010	19/08/2010	Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination with Methotrexate in Adults with very early Rheumatoid Arthritis (RA)	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating protocol amendment 01	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden
1732	EUCTR2009-011791-30-DK (EUCTR)	22/09/2010	12/11/2009	A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis	A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: NNC151-0000 Product Code: NNC0151-0000-0000 Other descriptive name: Anti-C5aR	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	48		Hungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom
1733	JPRN-UMIN000011789	2010/09/21	20/09/2013	Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis	Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis - Intravenous abatacept at an increased dose in RA patients	Rheumatoid arthritis	Administration of increased dose of abatacept to patients with rheumatoid arthritis previously treated with abatacept.	National Health Organization Nagoya Medical Center	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	20	Not applicable	Japan
1734	EUCTR2009-015898-12-BE (EUCTR)	20/09/2010	14/06/2010	Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Patients with active rheumatoid arthritis and an inadequate response to Methotrexate MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GLPG0259 Product Code: GLPG0259 Product Name: GLPG0259 Product Code: GLPG0259 Product Name: GLPG0259 Product Code: GLPG0259 Product Name: GLPG0259 Product Code: GLPG0259	Galápagos NV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Netherlands;Belgium
1735	EUCTR2010-018674-20-SE (EUCTR)	16/09/2010	20/08/2010	Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating amendment 01	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	France;United States;Mexico;Canada;Finland;Denmark;Australia;Russian Federation;Germany;Italy;Korea, Republic of;Sweden
1736	EUCTR2010-019935-37-FI (EUCTR)	15/09/2010	02/07/2010	A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis	A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term:	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Other descriptive name: TOCILIZUMAB	Roche Oy	NULL	Not Recruiting			Female: yes Male: yes	160		Finland
1737	EUCTR2010-018646-31-IT (EUCTR)	14/09/2010	26/07/2010		A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis - ND	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade INN or Proposed INN: Infliximab	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
1738	EUCTR2010-018375-22-GB (EUCTR)	14/09/2010	29/06/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand
1739	EUCTR2010-018674-20-FR (EUCTR)	10/09/2010	16/08/2010	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.	A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety INN or Proposed INN: METHOTREXATE Other descriptive name: MTX	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	France;Finland;Belgium;Denmark;Germany;Italy;Sweden
1740	EUCTR2010-018646-31-GB (EUCTR)	09/09/2010	22/07/2010		A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	633	Phase 3	Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania
1741	EUCTR2009-013758-33-DK (EUCTR)	09/09/2010	09/06/2010	MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	36		Denmark;Netherlands;Sweden
1742	EUCTR2010-019964-36-CZ (EUCTR)	08/09/2010	09/06/2010	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CCX354-C Product Code: CCX354-C Other descriptive name: CCX354	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Hungary;Czech Republic;Belgium;Germany
1743	EUCTR2009-016266-90-LT (EUCTR)	06/09/2010	25/01/2010	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: not applicable Product Code: SAR153191 Product Name: not applicable Product Code: SAR153191 Product Name: not applicable Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1740		Portugal;Estonia;Hungary;Czech Republic;Greece;Finland;Spain;Romania;Lithuania;Austria;Netherlands;Germany
1744	NCT01208506 (ClinicalTrials.gov)	September 2010	23/9/2010	First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis	First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis;Healthy	Drug: NNC0114-0000-0005;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	All	64	Phase 1	Germany
1745	NCT01197521 (ClinicalTrials.gov)	September 2010	8/9/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.	(OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: fostamatinib;Drug: placebo, fostamatinib	AstraZeneca	NULL	Completed	18 Years	N/A	All	923	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Chile;Estonia;France;Hungary;India;Mexico;Peru;Poland;Slovakia;Ukraine;United Kingdom;Germany;Russian Federation
1746	NCT01154647 (ClinicalTrials.gov)	September 2010	28/6/2010	Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes	Unraveling Impaired Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes: a Series of Experiments Targeting Brain Neurotransmission	Fatigue Syndrome, Chronic;Fibromyalgia;Arthritis, Rheumatoid	Drug: citalopram;Drug: 1 ml 0.9 % NaCl	Vrije Universiteit Brussel	Research Foundation Flanders;Universiteit Antwerpen;University Hospital, Antwerp;Artesis University College, Antwerp	Not yet recruiting	18 Years	65 Years	Female	70	N/A	Belgium
1747	NCT01197534 (ClinicalTrials.gov)	September 2010	8/9/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.	(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs	Rheumatoid Arthritis	Drug: fostamatinib;Drug: placebo, fostamatinib	AstraZeneca	NULL	Completed	18 Years	N/A	All	913	Phase 3	United States;Canada;Czech Republic;Germany;India;Israel;Italy;Latvia;Lithuania;Portugal;Romania;Serbia;South Africa;Spain;Ukraine;United Kingdom
1748	EUCTR2010-019964-36-BE (EUCTR)	26/08/2010	20/05/2010	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CCX354-C Product Code: CCX354-C Other descriptive name: CCX354	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Czech Republic;Hungary;Belgium;Germany
1749	EUCTR2009-016119-38-LV (EUCTR)	13/08/2010	28/05/2010	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	220		United Kingdom;Bulgaria;Latvia;Poland
1750	EUCTR2010-018375-22-ES (EUCTR)	03/08/2010	04/06/2010	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	Rheumatoid arthritisArtritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml jeringa SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
1751	NCT01195272 (ClinicalTrials.gov)	August 2010	2/9/2010	A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.	A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	21	Phase 4	United Kingdom
1752	EUCTR2010-018375-22-IT (EUCTR)	29/07/2010	05/07/2010	A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND	A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Trade Name: RoActemra INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1200		Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
1753	EUCTR2010-019261-28-DE (EUCTR)	26/07/2010	16/06/2010	A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis	A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: NNC 0142-0000-0002 Product Code: NNC 142-0002	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	160		Germany
1754	EUCTR2009-015845-21-DE (EUCTR)	22/07/2010	18/03/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Finland;Czech Republic;United Kingdom;Germany;Belgium;Spain;Greece;Sweden
1755	EUCTR2010-019262-86-HU (EUCTR)	21/07/2010	27/05/2010	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2025	Phase 3	United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;New Zealand
1756	EUCTR2009-016987-34-HU (EUCTR)	21/07/2010	26/02/2010	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Moderate to severe active Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Czech Republic;Hungary;Poland;Spain;Bulgaria;Germany;Sweden
1757	EUCTR2009-015845-21-CZ (EUCTR)	16/07/2010	26/03/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
1758	EUCTR2009-012759-12-CZ (EUCTR)	16/07/2010	22/02/2010	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Denmark;Germany;Sweden
1759	EUCTR2009-016987-34-BG (EUCTR)	15/07/2010	09/07/2010	Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Moderate to severe active Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Not applicable Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1760	EUCTR2010-019964-36-HU (EUCTR)	14/07/2010	07/06/2010	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CCX354-C Product Code: CCX354-C Other descriptive name: CCX354	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Hungary;Czech Republic;Belgium
1761	EUCTR2009-016266-90-GR (EUCTR)	13/07/2010	01/07/2010	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1740		Portugal;Estonia;Hungary;Czech Republic;Greece;Finland;Spain;Romania;Lithuania;Austria;Netherlands;Germany
1762	EUCTR2009-010516-15-GR (EUCTR)	13/07/2010	21/04/2010	Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid arthritis (seropositive) MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis	Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Greece;Poland;Spain
1763	EUCTR2009-017438-32-PL (EUCTR)	06/07/2010	26/04/2010	A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis	A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis	active rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Germany;Poland
1764	EUCTR2009-015845-21-SE (EUCTR)	06/07/2010	10/05/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
1765	EUCTR2009-012041-35-BE (EUCTR)	02/07/2010	30/09/2009	A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy	A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy - TNF-K-003	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet Other descriptive name: N.A.	Neovacs SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	48	Phase 2	France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria
1766	JPRN-UMIN000003880	2010/07/01	07/07/2010	Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area	Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area - KABUKI study	Rheumatoid arthritis	DAS28>3.2 at 24 weeks Switching to another biologics DAS28>3.2 at 24 weeks Dose up of MTX or addition of other DMARDs DAS28<=3.2 at 24 weeks 40 mg of Adalimumab every two week DAS28<=3.2 at 24 weeks 40 mg of Adalimumab every four week	Osaka City University Medical School	Higashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu Hospital	Recruiting	20years-old	Not applicable	Male and Female	100	Not applicable	Japan
1767	EUCTR2010-019262-86-FI (EUCTR)	01/07/2010	19/05/2010	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden
1768	JPRN-UMIN000003807	2010/07/01	01/07/2010	A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis	A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis - JaSTAR Study	Rheumatoid Arthritis	Combination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate) Combination therapy of TNF-bloking biologics and methotrexate	Japan Association of Rheumatologists in Private Practice	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	160	Not applicable	Japan
1769	EUCTR2009-016119-38-CZ (EUCTR)	01/07/2010	02/07/2010	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	220		Czech Republic;Poland;Bulgaria;Latvia;United Kingdom
1770	EUCTR2009-016266-90-DE (EUCTR)	24/06/2010	12/01/2010	Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	1594		Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1771	EUCTR2009-012055-19-FR (EUCTR)	24/06/2010	26/04/2010	A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis	A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK315234 Injection 100mg/mL Product Code: GSK315234	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	France;Belgium;Ireland;United Kingdom
1772	EUCTR2009-012055-19-GB (EUCTR)	24/06/2010	15/03/2010	A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis	A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK315234 Injection 100mg/mL Product Code: GSK315234	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45		United Kingdom;Belgium;France;Ireland
1773	EUCTR2009-016119-38-PL (EUCTR)	23/06/2010	30/04/2010	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	220		United Kingdom;Bulgaria;Latvia;Poland
1774	EUCTR2010-019262-86-EE (EUCTR)	18/06/2010	21/05/2010	Long term evaluation of sarilumab in rheumatoid arthritis patients	A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	2000	Phase 3	Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden;United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru
1775	EUCTR2009-013758-33-SE (EUCTR)	17/06/2010	22/03/2010	MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	36		Denmark;Netherlands;Sweden
1776	EUCTR2009-012055-19-IE (EUCTR)	16/06/2010	12/02/2010	A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis	A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK315234 Injection 100mg/mL Product Code: GSK315234	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45		United Kingdom;Belgium;France;Ireland
1777	EUCTR2009-015845-21-FI (EUCTR)	16/06/2010	30/04/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
1778	EUCTR2009-012759-12-GR (EUCTR)	15/06/2010	13/11/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
1779	EUCTR2009-010582-23-GR (EUCTR)	15/06/2010	30/12/2009	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?)	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal Product Name: Golimumab prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1780	EUCTR2008-001523-57-HU (EUCTR)	14/06/2010	27/04/2010	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy
1781	EUCTR2009-015845-21-BE (EUCTR)	08/06/2010	04/05/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
1782	EUCTR2009-014296-40-IT (EUCTR)	08/06/2010	08/02/2010	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS - ND	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS - ND	Rheumatoid arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073	Product Code: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria
1783	EUCTR2010-019873-13-BE (EUCTR)	07/06/2010	14/04/2010	Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA	Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA	early rheumatoid arthritis MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Trade Name: RoActemra Product Name: Tocilizumab	UCL Cliniques Universitaires Saint Luc	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Belgium
1784	EUCTR2008-005708-18-GB (EUCTR)	04/06/2010	14/04/2010	Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess	Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess	Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndrome	Trade Name: Glucophage (metformin) Product Name: Metformin	Queen Mary University of London	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
1785	EUCTR2008-007185-33-NL (EUCTR)	20/05/2010	28/09/2009	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ATN-103 Product Code: ATN-103	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 1;Phase 2	Hungary;Belgium;Germany;Netherlands;United Kingdom
1786	EUCTR2009-016119-38-GB (EUCTR)	19/05/2010	17/03/2010	Safety and Efficacy of AMG 827 in Subjects With RA	A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	220		Czech Republic;United Kingdom;Bulgaria;Latvia;Poland;Australia
1787	EUCTR2009-017163-42-SE (EUCTR)	18/05/2010	23/03/2010	Pain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADE	Pain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADE	Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Humira.	Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Karolinska Institute	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Sweden
1788	EUCTR2009-014735-20-BG (EUCTR)	18/05/2010	23/02/2010	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: CAM-3001 Product Code: CAM-3001 Other descriptive name: anti-GM-CSF receptor alpha	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Czech Republic;Hungary;Estonia;Poland;Lithuania;Bulgaria;Latvia
1789	EUCTR2009-016987-34-PL (EUCTR)	17/05/2010	19/03/2010	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Moderate to severe active Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Czech Republic;Hungary;Spain;Poland;Bulgaria;Germany;Sweden
1790	EUCTR2009-015845-21-GB (EUCTR)	13/05/2010	17/03/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
1791	EUCTR2009-015950-39-DE (EUCTR)	12/05/2010	28/12/2009	Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritis	Addition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA	Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera® Product Name: Rituximab INN or Proposed INN: RITUXIMAB	Johann Wolfgang Goethe-Universität Frankfurt/M.	NULL	Not Recruiting			Female: yes Male: yes			Germany
1792	EUCTR2009-015845-21-ES (EUCTR)	12/05/2010	12/01/2012	A comparison of tocilizumab and adalimumab in patients withrheumatoid arthritis looking at improvement in joint pain, joint swellingand general disease activity.	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	United States;Portugal;Greece;Finland;Spain;Turkey;United Kingdom;Switzerland;Czech Republic;Mexico;Belgium;Brazil;Australia;Germany;Sweden
1793	EUCTR2009-015740-42-DE (EUCTR)	12/05/2010	12/01/2010	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: A	Universitätsklinkum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 3	Germany
1794	EUCTR2010-018331-18-GB (EUCTR)	12/05/2010	18/03/2010	A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
1795	EUCTR2009-010516-15-ES (EUCTR)	11/05/2010	29/07/2009	Ensayo aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de SBI-087 en sujetos seropositivos con artritis reumatoide activa en tratamiento de fondo estable con metotrexatoRandomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Ensayo aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de SBI-087 en sujetos seropositivos con artritis reumatoide activa en tratamiento de fondo estable con metotrexatoRandomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid arthritis (seropositive)Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis	Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Greece;Poland;Spain
1796	EUCTR2007-000896-41-AT (EUCTR)	06/05/2010	13/05/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
1797	EUCTR2009-016987-34-SK (EUCTR)	05/05/2010	28/04/2010	Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Moderate to severe active Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Not applicable Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1798	EUCTR2009-012566-32-BG (EUCTR)	05/05/2010	27/04/2010	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1799	EUCTR2009-016987-34-DE (EUCTR)	03/05/2010	17/02/2010	Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Moderate to severe active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Not applicable Product Code: CP-690,550 INN or Proposed INN: Tofacitinib Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Philippines;Taiwan;Slovakia;Thailand;Costa Rica;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Denmark;Australia;Peru;Korea, Republic of;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1800	JPRN-UMIN000003615	2010/05/01	14/05/2010	Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA	Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA - JANET(Japan Nonbiologic DMARDs effectiveness Trial)	RA(Rheumatoid Arthritis)	Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 months	St Luke's International Hospital	NULL	Recruiting	20years-old	80years-old	Male and Female	20	Not selected	Japan
1801	NCT01119859 (ClinicalTrials.gov)	May 2010	1/4/2010	A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis	A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Adalimumab;Drug: Placebo to tocilizumab;Drug: Placebo to adalimumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	326	Phase 4	United States;Australia;Belgium;Brazil;Czech Republic;Finland;Germany;Greece;Mexico;Portugal;Spain;Sweden;Switzerland;Turkey;United Kingdom;Norway
1802	EUCTR2008-002623-85-SE (EUCTR)	28/04/2010	04/03/2010	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company, Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1803	EUCTR2009-017379-90-IT (EUCTR)	27/04/2010	31/03/2010	Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND	Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND	RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	INN or Proposed INN: ETANERCEPT	AZIENDA OSPEDALIERA SENESE	NULL	Not Recruiting			Female: yes Male: yes			Italy
1804	EUCTR2009-017438-32-BE (EUCTR)	27/04/2010	24/02/2010	A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis	A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis	active rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: N/A Product Code: VX-509 Product Name: N/A Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Poland;Belgium;Germany
1805	EUCTR2009-014735-20-CZ (EUCTR)	23/04/2010	12/11/2009	A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Other descriptive name: anti-GM-CSF receptor alpha	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Hungary;Estonia;Czech Republic;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan
1806	EUCTR2009-016987-34-CZ (EUCTR)	23/04/2010	04/03/2010	Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Moderate to severe active Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Not applicable Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1807	EUCTR2009-016987-34-ES (EUCTR)	19/04/2010	12/02/2010	Estudio de fase 3 aleatorizado y doble ciego de la eficacia y la seguridad de 2 dosis de CP-690,550 en comparación con metotrexato en pacientes con artritis reumatoide no tratados previamente con metotrexato PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Estudio de fase 3 aleatorizado y doble ciego de la eficacia y la seguridad de 2 dosis de CP-690,550 en comparación con metotrexato en pacientes con artritis reumatoide no tratados previamente con metotrexato PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Artritis Reumatoide activa moderada a grave Moderate to severe active Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Metotrexato Sodico INN or Proposed INN: METOTREXATO SODICO	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Czech Republic;Hungary;Slovakia;Poland;Belgium;Spain;Bulgaria;Germany;Sweden
1808	EUCTR2009-017438-32-HU (EUCTR)	16/04/2010	24/02/2010	A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis	A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis	active rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Germany;Poland
1809	EUCTR2009-011791-30-GB (EUCTR)	14/04/2010	14/10/2009	A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis	A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: NNC151-0000 Product Code: NNC0151-0000-0000 Other descriptive name: Anti-C5aR	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom
1810	EUCTR2009-012118-27-BE (EUCTR)	13/04/2010	23/02/2010	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy - N/A	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy - N/A	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168-AEK - Over Encapsulated Tablet - 50 mg Product Code: JNJ-38518168 INN or Proposed INN: N/A	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	95	Phase 2	Czech Republic;Spain;Belgium;Netherlands;United Kingdom
1811	EUCTR2009-015835-34-IT (EUCTR)	09/04/2010	29/03/2010	VITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - ND	VITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - ND	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid	Trade Name: DIBASE*IM OS 2F 1ML 300000UI/M INN or Proposed INN: Colecalciferol	AZIENDA OSPEDALIERA ORDINE MAURIZIANO	NULL	Not Recruiting			Female: yes Male: no		Phase 3	Italy
1812	EUCTR2009-014296-40-AT (EUCTR)	07/04/2010	29/12/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tasocitinib (proposed INN) Product Code: CP-690,550	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria
1813	EUCTR2009-012055-19-BE (EUCTR)	06/04/2010	02/03/2010	A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis	A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK315234 Injection 100mg/mL Product Code: GSK315234	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45		United Kingdom;Belgium;France;Ireland
1814	EUCTR2009-016266-90-CZ (EUCTR)	06/04/2010	22/12/2009	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1740		Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands
1815	EUCTR2009-011137-26-PL (EUCTR)	01/04/2010	25/01/2010		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland
1816	EUCTR2009-016987-34-BE (EUCTR)	01/04/2010	11/02/2010	Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Moderate to severe active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Not applicable Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1817	NCT01313858 (ClinicalTrials.gov)	April 2010	10/3/2011	A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)	Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis	Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing	Drug: Simponi®;Drug: Methotrexate	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	1613	N/A	Germany
1818	NCT01151644 (ClinicalTrials.gov)	April 2010	25/6/2010	Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases	Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases	Rheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DM	Biological: Anti-pandemic H1N1 influenza vaccine	University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo	Active, not recruiting	N/A	N/A	Both	5000	Phase 4	Brazil
1819	NCT01067430 (ClinicalTrials.gov)	April 2010	10/2/2010	Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)	Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: Etoricoxib;Drug: Diclofenac	Northumbria Healthcare NHS Foundation Trust	NULL	Withdrawn	18 Years	N/A	All	0	Phase 4	United Kingdom
1820	EUCTR2009-012566-32-HU (EUCTR)	31/03/2010	20/11/2009	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Hungary;Poland;Bulgaria;Latvia;United Kingdom
1821	EUCTR2007-006657-63-HU (EUCTR)	26/03/2010	15/02/2010	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel 25 mg powder and solvent for solution for injection Product Name: Enbrel Trade Name: Enbrel 50 mg powder and solvent for solution for injection Product Name: Enbrel	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	186	Phase 4	Hungary;Finland;Denmark;Iceland;Sweden
1822	EUCTR2009-015636-15-HU (EUCTR)	25/03/2010	08/02/2010	Rheumatoid arthritis	An Open-label Extension Study to Assess the Long-term Safety and Tolerability of ATN-103 in Subjects With Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ATN-103 Product Code: ATN-103	Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company	NULL	Not Recruiting			Female: yes Male: yes	260		Hungary;Russian Federation;Germany;Canada;Switzerland;Belgium;Japan;United States;South Africa
1823	EUCTR2009-014735-20-PL (EUCTR)	23/03/2010	21/12/2009	A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Other descriptive name: anti-GM-CSF receptor alpha	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan
1824	EUCTR2009-016266-90-FI (EUCTR)	23/03/2010	29/12/2009	Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sar	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	1594		Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1825	EUCTR2009-011137-26-GR (EUCTR)	22/03/2010	20/10/2009		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1826	EUCTR2009-012759-12-HU (EUCTR)	17/03/2010	25/01/2010	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
1827	EUCTR2007-006657-63-IS (EUCTR)	10/03/2010	18/02/2010	Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT	Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Finland;Iceland;Denmark;Norway;Sweden
1828	EUCTR2009-010582-23-IT (EUCTR)	10/03/2010	08/01/2010	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA) - ND	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA) - ND	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: golimumab Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: golimumab	CENTOCOR	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1829	EUCTR2009-015653-20-NL (EUCTR)	08/03/2010	10/03/2010	Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicable	Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicable	rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: etanercept Product Name: Etanercept INN or Proposed INN: METHOTREXATE Other descriptive name: methotrexate		NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
1830	EUCTR2009-016266-90-HU (EUCTR)	03/03/2010	30/12/2009	Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	1594		Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand
1831	EUCTR2009-010516-15-PL (EUCTR)	03/03/2010	21/08/2009	Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid arthritis (seropositive) MedDRA version: 13.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087	Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Greece;Spain;Poland
1832	EUCTR2009-016266-90-EE (EUCTR)	02/03/2010	05/01/2010	Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients	A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sar	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	1594		Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Romania;Germany;New Zealand
1833	EUCTR2009-011137-26-PT (EUCTR)	01/03/2010	09/12/2009	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1834	NCT01061736 (ClinicalTrials.gov)	March 2010	2/2/2010	Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients	A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy	Rheumatoid Arthritis	Drug: Sarilumab;Drug: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic Acid	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	75 Years	All	1675	Phase 2/Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;Chile;Colombia;Czechia;Egypt;Estonia;Finland;Germany;Greece;Hungary;India;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Philippines;Poland;Portugal;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;Ukraine;Czech Republic
1835	NCT02010216 (ClinicalTrials.gov)	March 2010	4/12/2013	A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)	Non-Randomized Phase IV Trial on Efficacy and Safety of Actemra in the Treatment of Adult Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	23	Phase 4	Kazakhstan
1836	NCT01034397 (ClinicalTrials.gov)	March 2010	16/12/2009	A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs	A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	54	Phase 4	Portugal
1837	NCT01063062 (ClinicalTrials.gov)	February 28, 2010	3/2/2010	A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)	A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	107	Phase 3	Egypt
1838	EUCTR2009-011137-26-CZ (EUCTR)	26/02/2010	13/10/2009		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1839	EUCTR2009-011137-26-AT (EUCTR)	25/02/2010	04/09/2009		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1840	EUCTR2006-005330-20-CZ (EUCTR)	19/02/2010	19/04/2007	anti TNF-IR phase III	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	Rheumatoid arthritis MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	France;Hungary;Czech Republic;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
1841	EUCTR2009-014735-20-LT (EUCTR)	18/02/2010	25/11/2009	A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Other descriptive name: anti-GM-CSF receptor alpha	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan
1842	EUCTR2009-011137-26-IT (EUCTR)	15/02/2010	02/10/2009		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-na?ve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO -MORE	Active Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073	Product Name: Golimumab Product Code: SCH900259 Product Name: Golimumab Product Code: SCH 900259	Shering Plough Research Institute, A division of Schering Plough Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1843	EUCTR2009-010582-23-BE (EUCTR)	10/02/2010	23/09/2009	Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen or prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1844	EUCTR2009-014296-40-BE (EUCTR)	10/02/2010	08/10/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Code: CP-690,550	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	United States;Tanzania, United Republic of;Taiwan;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Brazil;Australia;Germany;Korea, Republic of;Sweden
1845	EUCTR2007-006129-29-NL (EUCTR)	10/02/2010	18/08/2009	A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis	A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study	Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MOR103 Product Code: MOR103 Other descriptive name: Human Recombinant IgG1, lambda	MorphoSys AG	NULL	Not Recruiting			Female: yes Male: yes	89		Germany;Ukraine;Belarus;Netherlands;Bulgaria;Poland
1846	EUCTR2009-016987-34-SE (EUCTR)	09/02/2010	23/12/2009	.	PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Moderate to severe active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Methotrexate Sodium INN or Proposed INN: METHOTREXATE SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Philippines;Taiwan;Slovakia;Thailand;Costa Rica;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;Peru;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden
1847	EUCTR2007-000830-38-PL (EUCTR)	08/02/2010	05/01/2010	A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.	A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Cimzia® Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	France;Poland;Austria;Germany;Italy
1848	EUCTR2009-012566-32-CZ (EUCTR)	05/02/2010	01/10/2009	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1849	EUCTR2008-007185-33-BE (EUCTR)	01/02/2010	10/09/2009	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ATN-103 Product Code: ATN-103	Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 1/2	Hungary;United Kingdom;Germany;Netherlands;Belgium
1850	NCT01038674 (ClinicalTrials.gov)	February 2010	22/12/2009	Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis	A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis	Drug: anti-IL-20;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	All	16	Phase 1	Belgium;Poland
1851	EUCTR2009-012759-12-IE (EUCTR)	26/01/2010	05/11/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
1852	EUCTR2009-014735-20-HU (EUCTR)	25/01/2010	02/11/2009	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CAM-3001 Product Code: CAM-3001 Other descriptive name: anti-GM-CSF receptor alpha	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	216	Phase 2	Czech Republic;Estonia;Hungary;Poland;Lithuania;Bulgaria
1853	EUCTR2007-006129-29-BG (EUCTR)	21/01/2010	26/10/2009	A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis	A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study	Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MOR103 Product Code: MOR103 Other descriptive name: Human Recombinant IgG1, lambda	MorphoSys AG	NULL	Not Recruiting			Female: yes Male: yes	89		Belarus;Poland;Ukraine;Bulgaria;Netherlands;Germany
1854	EUCTR2008-006064-11-HU (EUCTR)	20/01/2010	27/10/2009	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	564		Hungary;Lithuania
1855	EUCTR2009-011137-26-BE (EUCTR)	18/01/2010	19/10/2009	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150	Phase 3	Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1856	EUCTR2009-012759-12-SE (EUCTR)	12/01/2010	17/11/2009	A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
1857	EUCTR2008-007185-33-DE (EUCTR)	12/01/2010	02/09/2009	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ATN-103 Product Code: ATN-103	Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 1/2	Hungary;United Kingdom;Germany;Netherlands;Belgium
1858	EUCTR2009-012759-12-PT (EUCTR)	12/01/2010	21/10/2009	A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
1859	EUCTR2009-014296-40-FR (EUCTR)	11/01/2010	19/11/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
1860	EUCTR2009-014296-40-IE (EUCTR)	06/01/2010	06/10/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	United Kingdom;Germany;Belgium;France;Spain;Ireland;Italy;Austria
1861	EUCTR2006-005035-19-IE (EUCTR)	06/01/2010	07/10/2009	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4500	Phase 2;Phase 3	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
1862	EUCTR2009-014296-40-GB (EUCTR)	05/01/2010	20/10/2010	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	Germany;United Kingdom;Belgium;France;Ireland;Spain;Italy;Austria
1863	EUCTR2009-010582-23-DE (EUCTR)	04/01/2010	22/09/2009	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1864	NCT02731560 (ClinicalTrials.gov)	January 2010	6/3/2016	Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)	Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Rituximab	Prof. Abid Z. Farooqi	Aga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, Rawalpindi	Completed	18 Years	80 Years	Both	74	Phase 4	NULL
1865	NCT01071798 (ClinicalTrials.gov)	January 2010	18/2/2010	An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis	A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1653	N/A	Germany;United States
1866	NCT01089023 (ClinicalTrials.gov)	January 2010	8/3/2010	A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	95	Phase 4	Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates
1867	NCT01039688 (ClinicalTrials.gov)	January 2010	23/12/2009	Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX	Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: CP-690,550;Drug: Disease-modifying antirheumatic drug	Pfizer	NULL	Completed	18 Years	99 Years	All	956	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Costa Rica;Czechia;Dominican Republic;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Thailand;Ukraine;Czech Republic
1868	EUCTR2009-011268-13-GB (EUCTR)	31/12/2009	15/03/2010	Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study	Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera Product Name: Rituximab Trade Name: Enbrel Product Name: Etanercept Trade Name: Humira Product Name: Adalimumab	NHS Greater Glasgow and Clyde	University of Glasgow	Not Recruiting			Female: yes Male: yes			United Kingdom
1869	EUCTR2009-010582-23-GB (EUCTR)	31/12/2009	28/06/2010	Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab prefilled pen or prefilled syringe Product Code: CNTO 148 INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Greece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden
1870	EUCTR2008-006064-11-LT (EUCTR)	30/12/2009	19/10/2009	An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroids	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	564		United States;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;Australia;New Zealand;Korea, Republic of
1871	EUCTR2009-014735-20-EE (EUCTR)	29/12/2009	27/10/2009	A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Other descriptive name: anti-GM-CSF receptor alpha	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Hungary;Czech Republic;Estonia;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan
1872	EUCTR2009-014735-20-LV (EUCTR)	29/12/2009	21/10/2009	A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.	A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Other descriptive name: anti-GM-CSF receptor alpha	MedImmune Ltd	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan
1873	EUCTR2009-012566-32-LV (EUCTR)	29/12/2009	30/10/2009	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1874	EUCTR2009-011137-26-IE (EUCTR)	21/12/2009	15/09/2009	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1875	EUCTR2009-012759-12-FI (EUCTR)	21/12/2009	28/09/2009	A 2 year, global, randomized, phase III clinical trial stuying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with methotrexate and methotrexate only, in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	United States;Portugal;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Peru;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Germany;New Zealand;Sweden
1876	EUCTR2009-012566-32-PL (EUCTR)	17/12/2009	09/11/2009	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland
1877	EUCTR2009-012204-42-BE (EUCTR)	16/12/2009	28/09/2009	A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis	A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK706769 Product Code: GSK706769	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	50		Belgium;Ireland
1878	EUCTR2009-010582-23-SE (EUCTR)	16/12/2009	23/10/2009	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1879	EUCTR2008-002623-85-DE (EUCTR)	16/12/2009	12/06/2009	Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	300		Poland;Romania;Germany;Netherlands;Sweden;Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France
1880	EUCTR2009-011137-26-FR (EUCTR)	15/12/2009	10/09/2009	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1881	EUCTR2009-011137-26-DK (EUCTR)	07/12/2009	02/11/2009		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland
1882	EUCTR2009-012759-12-DK (EUCTR)	07/12/2009	03/11/2009	A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Denmark;Australia;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
1883	EUCTR2008-004894-16-HU (EUCTR)	03/12/2009	17/11/2008	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Czech Republic;Hungary;Poland;Germany
1884	EUCTR2009-011137-26-NL (EUCTR)	02/12/2009	31/08/2009		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1885	EUCTR2009-012566-32-GB (EUCTR)	02/12/2009	02/08/2010	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Rheumatoid arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;Czech Republic;United Kingdom;Bulgaria;Latvia;Poland
1886	EUCTR2009-012759-12-ES (EUCTR)	01/12/2009	23/09/2009	Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Artritis ReumatoideRheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
1887	NCT01044498 (ClinicalTrials.gov)	December 2009	7/1/2010	A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis	An Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Ortho-Novum® 1/35	Hoffmann-La Roche	NULL	Completed	18 Years	44 Years	Female	46	Phase 3	United States
1888	EUCTR2009-016055-22-FI (EUCTR)	27/11/2009	09/10/2009	Immuunipuutteisten matkailijoiden A-hepatiittisuojaus	Immuunipuutteisten matkailijoiden A-hepatiittisuojaus	Terveet vapaaehtoiset ja vapaaehtoiset potilaat, joilla on diagnosoitu nivelreuma. MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Epaxal Product Name: Epaxal	HY, HUS	NULL	Not Recruiting			Female: yes Male: yes			Finland;Sweden
1889	EUCTR2008-007185-33-GB (EUCTR)	26/11/2009	28/07/2010	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ATN-103 Product Code: ATN-103	Wyeth Pharmaceuticals Inc., Acting through its division Wyeth Research, a Pfizer Company	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 1/2	Hungary;Germany;United Kingdom;Netherlands;Belgium
1890	EUCTR2009-012424-87-GB (EUCTR)	26/11/2009	14/10/2009	T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF	T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF	Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.0;Classification code 10037160;Term: Psoriatic arthritis MedDRA version: 12.0;Classification code 10002556;Term: Ankylosing spondylitis	Trade Name: Enbrel INN or Proposed INN: etanercept Trade Name: Humira INN or Proposed INN: adalimumab Trade Name: Enbrel INN or Proposed INN: etanercept Trade Name: Enbrel INN or Proposed INN: Etanercept	Imperial College London South Kensington London	NULL	Not Recruiting			Female: yes Male: yes	55	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1891	EUCTR2009-010582-23-AT (EUCTR)	26/11/2009	12/10/2009	Golimumab in Rheumatoid Arthritis Patients With An Inadequate Response to Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen or Prefilled Syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
1892	EUCTR2009-013223-37-ES (EUCTR)	25/11/2009	17/09/2009	Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS	Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS	ARTRITIS REUMATOIDE MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 Trade Name: DECORTIN (PREDNISONA) 5 MG COMPRIMIDOS INN or Proposed INN: Prednisone Other descriptive name: Decortin®	Pfizer S.A.	NULL	Not Recruiting			Female: yes Male: yes	119	Phase 2	Hungary;Czech Republic;Spain
1893	EUCTR2009-012185-32-IT (EUCTR)	23/11/2009	25/06/2009	Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND	Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND	Moderate to severe active rheumatoid arthritis (RA), who are inadequate responders to DMARDs. MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: Ro487-7533 INN or Proposed INN: RoActemra	ROCHE	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Italy
1894	EUCTR2009-009696-34-DE (EUCTR)	23/11/2009	14/05/2009	A Study in Patients with Rheumatoid Arthritis	A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY2439821 Product Code: LY2439821 INN or Proposed INN: N.A.	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	648	Phase 2	India;Russian Federation;Germany;Peru;Taiwan;Argentina;Romania;Korea, Republic of;Chile;Poland
1895	EUCTR2009-014296-40-ES (EUCTR)	20/11/2009	24/09/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS. Estudio de fase 3 aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato y con una respuesta insuficiente a inhibidores del TNF.	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS. Estudio de fase 3 aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato y con una respuesta insuficiente a inhibidores del TNF.	Rheumatoid arthritisArtritis reumatoide MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer S.A.	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
1896	EUCTR2009-012759-12-DE (EUCTR)	13/11/2009	25/08/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
1897	EUCTR2009-012204-42-IE (EUCTR)	13/11/2009	09/09/2009	A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis	A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK706769 Product Code: GSK706769	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	50		Belgium;Ireland
1898	EUCTR2009-012759-12-FR (EUCTR)	13/11/2009	09/10/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
1899	EUCTR2009-014296-40-DE (EUCTR)	12/11/2009	27/08/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: not applicable Product Code: CP-690,550	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
1900	EUCTR2009-012759-12-IT (EUCTR)	12/11/2009	17/11/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - ND	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - ND	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab Trade Name: RoActemra INN or Proposed INN: Tocilizumab Trade Name: RoActemra INN or Proposed INN: Tocilizumab Trade Name: Methotrexate ``Lederle`` 2.5mg tablets INN or Proposed INN: Methotrexate	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden
1901	EUCTR2008-006924-68-HU (EUCTR)	11/11/2009	02/09/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Portugal;Hungary;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
1902	EUCTR2009-011137-26-SK (EUCTR)	11/11/2009	19/11/2009	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150	Phase 3	Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1903	EUCTR2009-013316-12-NL (EUCTR)	10/11/2009	21/10/2009	A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early	A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra Trade Name: Methotrexate 'Lederle' 2,5mg tablets	Roche Nederland B.V.	NULL	Not Recruiting			Female: yes Male: yes			Netherlands
1904	EUCTR2009-013223-37-CZ (EUCTR)	10/11/2009	17/08/2009	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 INN or Proposed INN: Prednisone Other descriptive name: Decortin®	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	119	Phase 2	Hungary;Czech Republic;Spain
1905	EUCTR2008-002623-85-IE (EUCTR)	06/11/2009	15/09/2009	Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	300		Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France;Poland;Romania;Germany;Netherlands;Sweden
1906	EUCTR2007-003288-36-GB (EUCTR)	04/11/2009	03/10/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
1907	EUCTR2009-014824-40-CZ (EUCTR)	03/11/2009	03/09/2009	An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomitantly taking methotrexate.	An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomitantly taking methotrexate.	Rheumatoid arthritis	Product Code: ART621	Arana Therapeutics Ltd	NULL	Not Recruiting			Female: yes Male: yes	200		Czech Republic
1908	EUCTR2007-006129-29-DE (EUCTR)	03/11/2009	16/06/2009	A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis	A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study	Rheumatoid arthritis MedDRA version: 13.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MOR103 Product Code: MOR103 Other descriptive name: Human Recombinant IgG1, lambda	MorphoSys AG	NULL	Not Recruiting			Female: yes Male: yes	89		Poland;Ukraine;Bulgaria;Netherlands;Germany
1909	JPRN-UMIN000002687	2009/11/01	16/11/2009	ENBREL Clinical Outcome in RA patients for Growing Evidence	ENBREL Clinical Outcome in RA patients for Growing Evidence - ENCOURAGE	rheumatoid arthritis	MTX/MTX+DMARDs group MTX+ETN group ETN continuation group ETN discontinuation group	TAP Corporation	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	330	Not applicable	Japan,Asia(except Japan)
1910	JPRN-UMIN000002744	2009/11/01	10/11/2009	Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation	Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation - Surprise study	rheumatoid arthritis	tocilizumab plus methotrexate tocilizumab	Keio University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	300	Not selected	Japan
1911	NCT00844714 (ClinicalTrials.gov)	November 2009	12/2/2009	Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy	Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy	Endothelial Function;Rheumatoid Arthritis;Inflammation	Drug: Rituxan	University of California, San Francisco	Genentech, Inc.	Completed	18 Years	N/A	All	20	N/A	United States
1912	NCT01007175 (ClinicalTrials.gov)	November 2009	2/11/2009	Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Efficacy Of ATN-103 Administered To Japanese Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate	Rheumatoid Arthritis	Biological: ATN-103 10 mg q4wks;Biological: ATN-103 30 mg q4wks;Biological: ATN-103 80 mg q4wks;Biological: ATN-103 10 mg q8wks;Biological: ATN-103 80 mg q8wks	Ablynx	NULL	Completed	20 Years	75 Years	Both	60	Phase 1/Phase 2	Japan
1913	NCT01009879 (ClinicalTrials.gov)	November 2009	5/11/2009	Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow Emigrants	Human TNFa-Induced Pre-B Cell Bone Marrow Emigrants	Rheumatoid Arthritis	Drug: Etanercept	University of Pittsburgh	Amgen	Withdrawn	18 Years	N/A	Both	0	Phase 4	United States
1914	NCT01006681 (ClinicalTrials.gov)	November 2009	31/10/2009	Vaccination Against Influenza H1N1 in Rheumatic Diseases	Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs	Influenza;Rheumatic Diseases	Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)	Tel-Aviv Sourasky Medical Center	NULL	Not yet recruiting	18 Years	65 Years	Both	400	Phase 2	NULL
1915	NCT01010581 (ClinicalTrials.gov)	November 2009	9/11/2009	SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis	A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: SC12267 (4SC-101);Drug: Placebo;Drug: Methotrexate;Drug: Folic Acid	4SC AG	NULL	Completed	18 Years	N/A	Both	266	Phase 2	Bulgaria;Czech Republic;Poland;Romania
1916	NCT00976599 (ClinicalTrials.gov)	November 2009	11/9/2009	A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis	An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: CP-690,550 + methotrexate;Drug: Placebo + Methotrexate	Pfizer	NULL	Completed	18 Years	N/A	All	29	Phase 2	United States
1917	EUCTR2009-012118-27-NL (EUCTR)	27/10/2009	27/05/2009	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Czech Republic;United Kingdom;Netherlands;Spain
1918	EUCTR2009-011137-26-ES (EUCTR)	23/10/2009	06/08/2009	Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE	Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE	Artritis reumatoide MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1919	EUCTR2009-011137-26-FI (EUCTR)	22/10/2009	25/08/2009		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1920	EUCTR2009-011137-26-GB (EUCTR)	19/10/2009	18/10/2010	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1921	EUCTR2009-012953-39-PL (EUCTR)	19/10/2009	31/07/2009	A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis	A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SC12267 Product Code: SC12267 Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE	4SC AG	NULL	Not Recruiting			Female: yes Male: yes	244	Phase 2	Czech Republic;Bulgaria;Poland
1922	EUCTR2009-011137-26-HU (EUCTR)	19/10/2009	02/09/2009		An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland
1923	EUCTR2009-013223-37-HU (EUCTR)	16/10/2009	02/09/2009	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 INN or Proposed INN: Prednisone Other descriptive name: Decortin®	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	119	Phase 2	Hungary;Spain
1924	EUCTR2008-007185-33-HU (EUCTR)	16/10/2009	09/09/2009	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ATN-103 Product Code: ATN-103	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 1/2	Hungary;United Kingdom;Germany;Netherlands;Belgium
1925	EUCTR2009-012705-19-CZ (EUCTR)	16/10/2009	17/07/2009	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	Rheumatoid Arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:	Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305 Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305	Lexicon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Czech Republic;Bulgaria
1926	EUCTR2009-012759-12-GB (EUCTR)	14/10/2009	17/08/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
1927	EUCTR2009-014394-41-DK (EUCTR)	12/10/2009	23/09/2009	Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)	Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)	Reumatoid artritis MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid	Trade Name: Humira Product Name: Humira Product Code: Adalimummab INN or Proposed INN: ADALIMUMAB Other descriptive name: Adalimumab	Hvidovre Hospital	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Denmark
1928	EUCTR2009-012218-30-PT (EUCTR)	06/10/2009	12/08/2009	A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT	A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT	Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis of dominant hand.	Trade Name: RoActemra	Roche Farmacêutica Química, Lda.	NULL	Not Recruiting			Female: yes Male: yes			Portugal
1929	EUCTR2009-011137-26-DE (EUCTR)	05/10/2009	03/08/2009	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE	Active Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Simponi Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
1930	EUCTR2008-002623-85-GB (EUCTR)	01/10/2009	17/08/2009	Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA). (Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Pharmaceuticals Inc. Philadelphia (A Pfizer Company)	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Qatar;Spain;Ireland;Russian Federation;United Kingdom;Switzerland;Italy;France;Poland;Romania;Germany;Netherlands;Sweden
1931	EUCTR2009-011000-34-DE (EUCTR)	30/09/2009	09/06/2009	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate	Moderate to severe Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: AIN457 Other descriptive name: rhumAb to Il-17A (IgG1-k-class)	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Slovakia;Czech Republic;Germany
1932	EUCTR2009-012705-19-BG (EUCTR)	29/09/2009	06/10/2009	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	Rheumatoid Arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:	Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305 Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305	Lexicon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	104	Phase 2	Hungary;Czech Republic;Bulgaria
1933	EUCTR2009-012118-27-ES (EUCTR)	28/09/2009	03/07/2009	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy SubstudyEstudio de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos de JNJ 38518168 en pacientes con artritis reumatoide activa a pesar del tratamiento con metotrexato con un sub-estudio de biopsia sinovial	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy SubstudyEstudio de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos de JNJ 38518168 en pacientes con artritis reumatoide activa a pesar del tratamiento con metotrexato con un sub-estudio de biopsia sinovial	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.JNJ-38518168 se está desarrollando para el tratamiento de la Artritis Reumatoide MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Czech Republic;United Kingdom;Netherlands;Spain
1934	EUCTR2006-005035-19-FI (EUCTR)	21/09/2009	15/06/2009	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4500	Phase 2;Phase 3	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
1935	EUCTR2006-006373-25-FI (EUCTR)	21/09/2009	16/06/2009		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
1936	EUCTR2009-012759-12-AT (EUCTR)	14/09/2009	21/08/2009	A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	United States;Portugal;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Peru;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Germany;New Zealand;Sweden
1937	EUCTR2009-012953-39-BG (EUCTR)	11/09/2009	18/09/2009	A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis	A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SC12267 Product Code: SC12267 INN or Proposed INN: Vidofludimus Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE	4SC AG	NULL	Not Recruiting			Female: yes Male: yes	244	Phase 2	Czech Republic;Bulgaria;Poland
1938	EUCTR2008-001847-20-DE (EUCTR)	08/09/2009	03/06/2009	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Germany;Latvia;Netherlands;Norway;Sweden
1939	EUCTR2009-012118-27-GB (EUCTR)	04/09/2009	18/06/2009	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	95	Phase 2	Czech Republic;United Kingdom;Netherlands;Spain
1940	EUCTR2009-012118-27-CZ (EUCTR)	04/09/2009	25/06/2009	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United Kingdom;Czech Republic;Netherlands;Spain
1941	EUCTR2006-005035-19-GB (EUCTR)	03/09/2009	27/04/2009	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4500	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
1942	EUCTR2006-006373-25-GB (EUCTR)	03/09/2009	16/11/2010	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
1943	EUCTR2009-011000-34-SK (EUCTR)	02/09/2009	09/09/2009	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201	Moderate to severe Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class)	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Czech Republic;Germany;Slovakia
1944	EUCTR2009-012953-39-CZ (EUCTR)	02/09/2009	03/07/2009	A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis	A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SC12267 Product Code: SC12267 Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE	4SC AG	NULL	Not Recruiting			Female: yes Male: yes	244	Phase 2	Czech Republic;Bulgaria;Poland
1945	NCT00975130 (ClinicalTrials.gov)	September 2009	20/8/2009	Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)	An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)	Arthritis, Rheumatoid	Biological: SC golimumab;Biological: IV golimumab	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	3366	Phase 3	Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;Denmark;Ecuador;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Korea, Republic of;Mexico;Monaco;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom
1946	NCT01075477 (ClinicalTrials.gov)	September 2009	24/2/2010	An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)	Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines	Rheumatoid Arthritis	Drug: rituximab [Mabthera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	151	N/A	Finland;United States
1947	NCT00984815 (ClinicalTrials.gov)	September 2009	23/9/2009	Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment	Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment	Osteoarthritis;Rheumatoid Arthritis;Chronic Low Back Pain;Chronic Regional Pain Syndrome;Chronic Soft Tissue Pain	Drug: HZT-501	Horizon Pharma Ireland, Ltd., Dublin Ireland	NULL	Completed	40 Years	80 Years	All	86	Phase 3	United States
1948	EUCTR2009-010813-57-DE (EUCTR)	28/08/2009	24/06/2009	A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate.	A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: recombinant human Mab of IgG4 subtype Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: recombinant human Mab of IgG4 subtype	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	72		Germany
1949	EUCTR2009-011000-34-HU (EUCTR)	27/08/2009	20/07/2009	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201	Moderate to severe Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class)	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Slovakia;Czech Republic;Germany
1950	EUCTR2008-006936-37-BE (EUCTR)	24/08/2009	08/04/2009	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid Arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ILV-094 Product Code: ILV-094 Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1	Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Hungary;Belgium;Netherlands;Germany
1951	EUCTR2009-011000-34-CZ (EUCTR)	18/08/2009	15/06/2009	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201	Moderate to severe Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class)	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Slovakia;Germany;Czech Republic
1952	EUCTR2009-011206-42-CZ (EUCTR)	18/08/2009	05/06/2009	A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics	A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics	Active Rheumatoid Arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: INCB028050 phosphate Product Code: INCB028050 Other descriptive name: INCB028050 phosphate salt Product Name: INCB028050 phosphate Product Code: INCB028050 Other descriptive name: INCB028050 phosphate salt Product Name: INCB028050 phosphate Product Code: INCB028050 Other descriptive name: INCB028050 phosphate salt	Incyte Corporation	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Czech Republic
1953	EUCTR2008-002623-85-FR (EUCTR)	18/08/2009	04/06/2009	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium tablets 2.5mg Product Name: Methotrexate INN or Proposed INN: methotrexate	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1954	EUCTR2009-012705-19-HU (EUCTR)	17/08/2009	16/07/2009	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	Rheumatoid Arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:	Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305 Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305	Lexicon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	104	Phase 2	Hungary;Czech Republic;Bulgaria
1955	EUCTR2009-010516-15-HU (EUCTR)	14/08/2009	14/07/2009	Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid arthritis (seropositive) MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis	Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Greece;Poland;Spain
1956	EUCTR2009-011000-34-BE (EUCTR)	14/08/2009	22/07/2009	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201	A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201	Moderate to severe Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class)	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Czech Republic;Slovakia;Belgium;Germany
1957	EUCTR2008-008338-35-FI (EUCTR)	13/08/2009	14/05/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain
1958	EUCTR2006-005035-19-DK (EUCTR)	11/08/2009	23/06/2009	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate( Phase III formulation) Product Code: CP-690,550-10 Product Name: Tofacitinib citrate (Proposed commercial formulation debossed) Product Code: CP-690,550-10	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4500	Phase 2;Phase 3	Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
1959	EUCTR2008-006936-37-DE (EUCTR)	03/08/2009	16/04/2009	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid Arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ILV-094 Product Code: ILV-094 Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1	Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer company	NULL	Not Recruiting			Female: yes Male: yes	180		Hungary;Germany;Netherlands;Belgium
1960	JPRN-UMIN000002340	2009/08/01	20/08/2009	Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)	Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) - cHAMLET	Rheumatoid Arthritis	Treatment with higher dosages of infliximab (3-10 mg/Kg) Every 2 months Follow-up to 54 weeks Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol Follow-up to 54 weeks	Department of Rheumatosurgery, Osaka City University Medical School	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	60	Phase 4	Japan
1961	NCT01224041 (ClinicalTrials.gov)	August 2009	18/10/2010	Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate	Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study	Rheumatoid Arthritis	Drug: Tacrolimus	Astellas Pharma Inc	Astellas Pharma Korea, Inc.	Completed	18 Years	75 Years	Both	78	Phase 4	Korea, Republic of
1962	EUCTR2007-006603-20-HU (EUCTR)	29/07/2009	14/05/2009	A Phase 2, 2-Part, Multicenter, Randomized, Double-blind,Parallel-group, Placebo-controlled, Proof-of-concept, dose-findingStudy Evaluating the Efficacy and Safety of CNTO 136Administered Subcutaneously in Subjects with Active RheumatoidArthritis Despite Methotrexate Therapy - Not available	A Phase 2, 2-Part, Multicenter, Randomized, Double-blind,Parallel-group, Placebo-controlled, Proof-of-concept, dose-findingStudy Evaluating the Efficacy and Safety of CNTO 136Administered Subcutaneously in Subjects with Active RheumatoidArthritis Despite Methotrexate Therapy - Not available	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CNTO136 Product Code: CNTO136 INN or Proposed INN: not available Other descriptive name: CNTO 136 IgG	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	Hungary
1963	EUCTR2008-006075-75-CZ (EUCTR)	29/07/2009	28/07/2009	A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	Hungary;United Kingdom;Germany;Czech Republic
1964	EUCTR2008-006936-37-NL (EUCTR)	27/07/2009	29/04/2009	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid Arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ILV-094 Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1	Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	120		Hungary;Germany;Netherlands;Belgium
1965	EUCTR2008-002623-85-NL (EUCTR)	27/07/2009	01/05/2009	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel 25mg PFS Product Name: Enbrel (Etanercept) Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel 50mg PFS Product Name: Enbrel (Etanercept) Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	300		France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1966	EUCTR2008-002623-85-ES (EUCTR)	27/07/2009	19/02/2010	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato.	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato.	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1967	EUCTR2008-005525-11-GR (EUCTR)	20/07/2009	17/11/2009	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
1968	EUCTR2008-008338-35-DE (EUCTR)	14/07/2009	04/05/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Finland;United Kingdom;Czech Republic;Germany;Denmark;Bulgaria;Spain
1969	EUCTR2008-002623-85-IT (EUCTR)	14/07/2009	30/06/2009	A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate - PRIZE	A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate - PRIZE	Moderate to severe early Rheumatoid Arthritis (RA). MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ENBREL*SC 4SIR 25MG 0,5ML+8TAM INN or Proposed INN: Etanercept Trade Name: ENBREL*SC 4SIR 50MG 1ML+8TAMP INN or Proposed INN: Etanercept Trade Name: METHOTREXATE*25CPR 2,5MG INN or Proposed INN: Methotrexate	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	300		France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
1970	EUCTR2008-004875-23-HU (EUCTR)	08/07/2009	11/05/2009	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	198		Hungary;Germany;Belgium;France;Austria;Poland
1971	NCT00928512 (ClinicalTrials.gov)	July 2009	25/6/2009	Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)	A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate	Rheumatoid Arthritis	Drug: Secukinmab;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	237	Phase 2	United States;Belgium;Czech Republic;Germany;Hungary;Japan;Korea, Republic of;Poland;Russian Federation;Slovakia;Taiwan;Puerto Rico
1972	EUCTR2009-012141-34-GB (EUCTR)	29/06/2009	15/05/2009	Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Total Hip Replacement. - (TRANX-H)	Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Total Hip Replacement. - (TRANX-H)	Blood loss in total hip replacement in patient with ostoearthritis and rheumatoid arthritis.	Trade Name: Cyklokapron® Product Name: Cyklokapron® Product Code: NA	University Hospital of North Tees and Hartlepool	NULL	Not Recruiting			Female: yes Male: yes	150		United Kingdom
1973	EUCTR2008-004875-23-AT (EUCTR)	26/06/2009	30/04/2009	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: NA Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	236		Hungary;Germany;Belgium;France;Poland;Austria
1974	EUCTR2008-008337-11-GR (EUCTR)	25/06/2009	20/10/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1975	EUCTR2007-000828-40-PL (EUCTR)	24/06/2009	12/05/2009	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis.	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Germany;France;Italy;Austria;Poland
1976	EUCTR2008-006917-25-PL (EUCTR)	24/06/2009	10/03/2009	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).	Patients with active rheumatoid arthritis who are on a stable dose of methotrexate	Product Name: Tranilast INN or Proposed INN: Tranilast Product Name: Tranilast INN or Proposed INN: Tranilast	Nuon Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United Kingdom;Czech Republic;Germany;Bulgaria;Poland
1977	EUCTR2008-007788-17-DE (EUCTR)	24/06/2009	08/04/2009	PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Product Code: CP-690,550	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	611	Phase 3	Czech Republic;Bulgaria;Germany
1978	EUCTR2008-008337-11-SK (EUCTR)	22/06/2009	09/09/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	795	Phase 3	Slovakia;Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
1979	EUCTR2008-008337-11-ES (EUCTR)	19/06/2009	27/03/2009	Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Artritis reumatoide RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer, S.A.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1980	EUCTR2008-008338-35-ES (EUCTR)	19/06/2009	27/03/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato	CP 690,550 está estudiándose como fármaco antirreumático modificador de la enfermedad (FARME) en el tratamiento de la artritis reumatoide activa moderada o grave en adultosCP-690,550 ins being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	Pfizer, S.A	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
1981	EUCTR2008-008337-11-DK (EUCTR)	18/06/2009	15/05/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1982	EUCTR2008-008337-11-FI (EUCTR)	17/06/2009	24/04/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	795	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1983	EUCTR2008-002381-55-ES (EUCTR)	16/06/2009	01/08/2008	Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.	Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.	Pacientes con artritis reumatoide (AR) activa refractarios a uno o más fármacos antiTNF (definido por un DAS28>3,2). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ROCHE FARMA, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain
1984	EUCTR2008-008338-35-BG (EUCTR)	16/06/2009	22/05/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Code: CP-690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain
1985	EUCTR2008-007023-26-BG (EUCTR)	16/06/2009	22/05/2009	PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Poland;Bulgaria
1986	EUCTR2008-008337-11-DE (EUCTR)	16/06/2009	07/04/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	795	Phase 3	Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
1987	EUCTR2008-008338-35-GB (EUCTR)	11/06/2009	09/04/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Finland;Germany;Czech Republic;United Kingdom;Denmark;Bulgaria;Spain
1988	EUCTR2008-008337-11-GB (EUCTR)	10/06/2009	09/04/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;Germany;United Kingdom;Denmark;Spain;Greece;Poland;Sweden
1989	EUCTR2008-008337-11-PL (EUCTR)	09/06/2009	30/04/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	795	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
1990	EUCTR2008-006917-25-BG (EUCTR)	09/06/2009	10/06/2009	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).	Patients with active rheumatoid arthritis who are on a stable dose of methotrexate	Product Name: Tranilast INN or Proposed INN: Tranilast Product Name: Tranilast INN or Proposed INN: Tranilast Product Name: methotrexate INN or Proposed INN: METHOTREXATE	Nuon Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United Kingdom;Czech Republic;Germany;Bulgaria;Poland
1991	EUCTR2008-007023-26-PL (EUCTR)	03/06/2009	05/06/2009	PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Bulgaria;Poland
1992	EUCTR2008-008338-35-DK (EUCTR)	03/06/2009	29/04/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
1993	EUCTR2008-001105-42-PL (EUCTR)	03/06/2009	17/04/2009	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: LY2127399 INN or Proposed INN: N/A Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Germany;Belgium;France;Austria;Poland
1994	EUCTR2008-006924-68-GR (EUCTR)	03/06/2009	19/11/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
1995	JPRN-UMIN000002175	2009/06/01	10/07/2009	Comparison of the clinical responses by the dosage of once or triple a week of MTX in patients with rheumatoid Arthritis	Comparison of the clinical responses by the dosage of once or triple a week of MTX in patients with rheumatoid Arthritis - POEM study	Rheumatoid Arthritis	MTX, once a week MTX, triple a week	POEM study group	NULL	Complete: follow-up continuing	16years-old	80years-old	Male and Female	60	Not applicable	Japan
1996	EUCTR2008-007788-17-BG (EUCTR)	01/06/2009	22/05/2009		PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS -	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Product Code: CP-690,550	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	611	Phase 3	Germany;Czech Republic;Bulgaria
1997	NCT00947492 (ClinicalTrials.gov)	June 2009	27/7/2009	Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs	Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).	Rheumatoid Arthritis	Biological: Venous blood sample	Assistance Publique Hopitaux De Marseille	NULL	Active, not recruiting	18 Years	N/A	Both	60	N/A	France
1998	EUCTR2008-008337-11-SE (EUCTR)	27/05/2009	23/03/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
1999	EUCTR2008-004875-23-DE (EUCTR)	26/05/2009	09/03/2009	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: NA Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	236		Hungary;Germany;Belgium;France;Austria;Poland
2000	EUCTR2008-008338-35-SK (EUCTR)	25/05/2009	09/09/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
2001	EUCTR2008-006917-25-CZ (EUCTR)	22/05/2009	11/03/2009	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).	Patients with active rheumatoid arthritis who are on a stable dose of methotrexate	Product Name: Tranilast INN or Proposed INN: Tranilast Product Name: Tranilast INN or Proposed INN: Tranilast	Nuon Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	Czech Republic;Poland;Bulgaria;Germany;United Kingdom
2002	EUCTR2008-008338-35-CZ (EUCTR)	20/05/2009	18/03/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
2003	EUCTR2008-007788-17-CZ (EUCTR)	20/05/2009	18/03/2009		PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS -	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Product Code: CP-690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	611	Phase 3	Germany;Czech Republic;Bulgaria
2004	EUCTR2008-006924-68-PT (EUCTR)	18/05/2009	17/03/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		France;Portugal;Hungary;Czech Republic;Spain;Netherlands;United Kingdom;Italy
2005	EUCTR2008-004875-23-BE (EUCTR)	18/05/2009	07/01/2009	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	236		France;Hungary;Poland;Belgium;Austria;Germany
2006	EUCTR2008-007023-26-CZ (EUCTR)	18/05/2009	10/03/2009	PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Bulgaria;Poland
2007	EUCTR2009-011105-17-IT (EUCTR)	17/05/2009	27/03/2009	A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue	A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: Ro 487-7533 INN or Proposed INN: RoActemra	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Italy
2008	EUCTR2007-006657-63-FI (EUCTR)	08/05/2009	27/01/2009	Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT	Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Finland;Iceland;Denmark;Norway;Sweden
2009	EUCTR2009-011520-53-SK (EUCTR)	04/05/2009	17/03/2009	Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment	Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment	moderate to severe active rheumatoid arthritis	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	Roche Slovensko s.r.o.	NULL	Not Recruiting			Female: yes Male: yes			Slovakia
2010	NCT00891020 (ClinicalTrials.gov)	May 2009	29/4/2009	A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)	Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choice	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	886	Phase 3	United States;Puerto Rico;United Kingdom
2011	EUCTR2008-007023-26-GR (EUCTR)	29/04/2009	03/04/2009	PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Greece;Poland;Bulgaria
2012	EUCTR2007-001625-10-GR (EUCTR)	29/04/2009	06/03/2009	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2013	EUCTR2008-006924-68-CZ (EUCTR)	28/04/2009	12/02/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
2014	EUCTR2008-006917-25-DE (EUCTR)	24/04/2009	22/01/2009	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).	Patients with active rheumatoid arthritis who are on a stable dose of methotrexate	Trade Name: Ribazen Product Name: Tranilast INN or Proposed INN: Tranilast Trade Name: Ribazen Product Name: Tranilast INN or Proposed INN: Tranilast Product Name: methotrexate INN or Proposed INN: METHOTREXATE	Nuon Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	United Kingdom;Czech Republic;Germany;Bulgaria;Poland
2015	EUCTR2008-008309-23-FR (EUCTR)	24/04/2009	31/03/2009	Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO	Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO	Polyarthrite rhumatoïde active modérée à sévère de moins de 10 ans d'ancienneté, avec réponse inadéquate au méthotrexate (MTX) et/ou à un autre DMARD et/ou à au moins un anti-TNF MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Code: RO487-7533/F01-F05 INN or Proposed INN: tolicizumab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	118	Phase 4	France
2016	EUCTR2008-005525-11-DE (EUCTR)	24/04/2009	09/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81		United Kingdom;Germany;Netherlands;France;Spain
2017	EUCTR2008-006075-75-DE (EUCTR)	22/04/2009	17/02/2009	A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	Hungary;Czech Republic;United Kingdom;Germany
2018	EUCTR2008-005427-28-NL (EUCTR)	22/04/2009	09/12/2008	A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic	A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	1048	Phase 3	Germany;Netherlands;France;Spain;Italy
2019	EUCTR2008-006917-25-GB (EUCTR)	22/04/2009	09/04/2009	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). - Tranilast plus Methotrexate vs MTX Alone in Patients with Active RA	A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). - Tranilast plus Methotrexate vs MTX Alone in Patients with Active RA	Patients with active rheumatoid arthritis who are on a stable dose of methotrexate	Product Name: Tranilast INN or Proposed INN: Tranilast Product Name: Tranilast INN or Proposed INN: Tranilast Product Name: methotrexate	Nuon Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	Czech Republic;Germany;United Kingdom;Bulgaria;Poland
2020	EUCTR2008-004875-23-PL (EUCTR)	22/04/2009	25/02/2009	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: NA Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	236		Hungary;Germany;Belgium;France;Austria;Poland
2021	EUCTR2007-006657-63-DK (EUCTR)	16/04/2009	20/02/2009	Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT	Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Finland;Denmark;Iceland;Norway;Sweden
2022	EUCTR2008-004894-16-CZ (EUCTR)	14/04/2009	26/11/2008	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Hungary;Germany;Czech Republic;Poland
2023	NCT01081717 (ClinicalTrials.gov)	April 14, 2009	4/3/2010	Golimumab Safety and Surveillance Program Using the Ingenix NHI Database	A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments	Rheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing Spondylitis	Drug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general population	Janssen Biotech, Inc.	NULL	Completed	N/A	99 Years	All	1064		United States
2024	EUCTR2008-006075-75-GB (EUCTR)	14/04/2009	28/04/2009	A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	Hungary;Czech Republic;Germany;United Kingdom
2025	EUCTR2009-011044-20-GB (EUCTR)	08/04/2009	14/04/2009	A Single-Centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600mg and 150mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers	A Single-Centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600mg and 150mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers	rheumatoid arthritis MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Code: AZD5672 Trade Name: Avelox® Product Name: Avelox- Moxifloxacin	AstraZeneca AB	NULL	Not Recruiting			Female: no Male: yes	64		United Kingdom
2026	EUCTR2008-006924-68-FR (EUCTR)	06/04/2009	19/03/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Code: RO4877533/F04-F05 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Portugal;France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
2027	EUCTR2008-006924-68-IT (EUCTR)	03/04/2009	23/03/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - extension to study MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - extension to study MA21573	Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF therapies. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: TOCILIZUMAB	F. Hoffmann-La Roche	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
2028	EUCTR2008-005427-28-ES (EUCTR)	03/04/2009	26/01/2009	Estudio fase IIIb, multicéntrico, con un período doble ciego controlado con placebo y aleatorizado de 12 semanas, seguido de una fase de extensión abierta para evaluar la seguridad y la eficacia de certolizumab pegol administrado a pacientes con artritis reumatoide activa. (A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis). - Realistic	Estudio fase IIIb, multicéntrico, con un período doble ciego controlado con placebo y aleatorizado de 12 semanas, seguido de una fase de extensión abierta para evaluar la seguridad y la eficacia de certolizumab pegol administrado a pacientes con artritis reumatoide activa. (A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis). - Realistic	Artritis reumatoide (Rheumatoid arthritis) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	1048	Phase 3	Germany;Netherlands;France;Spain;Italy
2029	EUCTR2008-006924-68-NL (EUCTR)	02/04/2009	09/02/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
2030	EUCTR2008-005427-28-FR (EUCTR)	02/04/2009	19/03/2009	A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic	A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	1048	Phase 3	France;Spain;Germany;Netherlands;Italy
2031	JPRN-UMIN000004271	2009/04/01	27/09/2010	Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxib	Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxib - The usefulness of switching to celecoxib in patients with NSAIDs-induced gastrointestinal mucosal injury	Rheumatoid arthritis (RA)NSAIDs-induced gastrointestinal mucosal injury	Japanese rheumatic patients who have been treated with NSAIDs for twelve or more weeks are switched to CEL (400mg/day). Upper GI endoscopy is conducted before and after administration of CEL. Patients with ulcers at the enrollment are switched to CEL (400mg/day) with famotidine (20mg/day) after healing of their pre-existing ulcers following treatment.	Hoshigaoka Koseinenkin Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not applicable	Japan
2032	NCT00931086 (ClinicalTrials.gov)	April 2009	30/6/2009	Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99	An Expanded Access Trial of Belimumab Antibody (Monoclonal Anti-BLyS Antibody) in Patients With Rheumatoid Arthritis (RA) Who Were Previously Treated Under HGS Protocol LBRA99	Rheumatoid Arthritis	Drug: belimumab	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	No longer available	18 Years	N/A	Both		Phase 4	United States
2033	NCT01075711 (ClinicalTrials.gov)	April 2009	24/2/2010	Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone)	Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet	Arthritis, Rheumatoid	Drug: Prednisone	Merck KGaA	Merck Serono GmbH, Germany	Completed	18 Years	N/A	Both	2728	N/A	Germany
2034	EUCTR2008-004875-23-FR (EUCTR)	31/03/2009	16/04/2009	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 2	France;Hungary;Poland;Belgium;Austria;Germany
2035	EUCTR2008-005525-11-NL (EUCTR)	31/03/2009	12/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81		France;Spain;Germany;Netherlands;United Kingdom
2036	EUCTR2008-006930-92-CZ (EUCTR)	31/03/2009	06/01/2009	A multi-centre randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of ART621 following multiple dose administration for 3 months in patients with rheumatoid arthritis concomitantly taking methotrexate	A multi-centre randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of ART621 following multiple dose administration for 3 months in patients with rheumatoid arthritis concomitantly taking methotrexate	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ART621	Arana Therapeutics Ltd	NULL	Not Recruiting			Female: yes Male: yes	200		Czech Republic
2037	EUCTR2008-003011-12-GB (EUCTR)	30/03/2009	27/04/2009	Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA	Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA	Rheumatoid Arthritis	Trade Name: RoActemra®EV Product Code: PRD82321 Product Name: Tocilizumab Product Code: RO4877533	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
2038	EUCTR2008-000587-17-DE (EUCTR)	26/03/2009	17/12/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2039	EUCTR2007-006657-63-SE (EUCTR)	25/03/2009	06/02/2009	Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT	Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Finland;Denmark;Norway;Iceland;Sweden
2040	EUCTR2008-006936-37-HU (EUCTR)	25/03/2009	02/03/2009	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid Arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ILV-094 Product Code: ILV-094 Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1	Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	180		Hungary;Germany;Netherlands;Belgium
2041	EUCTR2008-006075-75-HU (EUCTR)	24/03/2009	18/02/2009	A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis	A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AK106-001616 Trade Name: Naprosyn 500 mg Product Name: Naprosyn 500 mg INN or Proposed INN: naproxen	Asahi Kasei Pharma Corporation	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	Hungary;Czech Republic;United Kingdom;Germany
2042	EUCTR2008-000744-13-BG (EUCTR)	19/03/2009	26/01/2009	Long Term Follow On Safety Study of Fostamatinib in Patients Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study	An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	800		France;United States;Mexico;Belgium;Poland;Romania;Peru;Bulgaria;Germany;Colombia;Italy
2043	EUCTR2007-005288-86-FR (EUCTR)	18/03/2009	30/07/2008	A Phase IIIb, open-label, run-in and double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with stable-dose methotrexate in patients with active rheumatoid arthritis	A Phase IIIb, open-label, run-in and double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with stable-dose methotrexate in patients with active rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: Anti-TNF humanized antibody Fab' fragment - PEG conjugate	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	335	Phase 3	France
2044	EUCTR2008-004754-33-CZ (EUCTR)	17/03/2009	18/03/2009	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: BG00012 Other descriptive name: Dimeythl Fumarate	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Czech Republic;Poland
2045	EUCTR2008-000587-17-IT (EUCTR)	12/03/2009	20/03/2009	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND	Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti-TNF therapies MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 INN or Proposed INN: tocilizumab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2046	EUCTR2008-006924-68-GB (EUCTR)	06/03/2009	29/04/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Italy;United Kingdom
2047	NCT00810199 (ClinicalTrials.gov)	March 2009	16/12/2008	A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment	Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate;Drug: placebo	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	556	Phase 3	United States;Brazil;Croatia;Denmark;Estonia;France;Germany;Greece;Israel;Italy;Latvia;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Sweden;Thailand;United Kingdom;Monaco
2048	NCT00883753 (ClinicalTrials.gov)	March 2009	17/4/2009	An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy	An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	934	Phase 3	Australia;Canada;Czech Republic;France;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;United Kingdom;Austria;Turkey
2049	EUCTR2008-005427-28-DE (EUCTR)	27/02/2009	10/12/2008	A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic	A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	1048	Phase 3	Germany;Netherlands;France;Spain;Italy
2050	EUCTR2008-000587-17-HU (EUCTR)	27/02/2009	28/11/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2051	EUCTR2008-004754-33-PL (EUCTR)	25/02/2009	24/11/2008	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: BG00012 Other descriptive name: Dimeythl Fumarate	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Czech Republic;Poland
2052	EUCTR2008-006443-39-ES (EUCTR)	23/02/2009	09/12/2008	Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos.	Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos.	Pacientes adultos con artritis reumatoide (AR) activa moderada o grave que son respondedores inadecuados a los tratamientos con FAMEs no biológicos o con anti-TNFs. MedDRA version: 9;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO04877533 INN or Proposed INN: Tocilizumab Other descriptive name: RoActemra	Roche Farma, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain
2053	EUCTR2008-005320-81-ES (EUCTR)	18/02/2009	20/01/2009	Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2	Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2	Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class	Novartis Farmacéutica S.A.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Belgium;Spain;Austria;Germany
2054	EUCTR2007-001625-10-GB (EUCTR)	17/02/2009	02/05/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes	France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
2055	EUCTR2008-001847-20-GR (EUCTR)	17/02/2009	06/03/2009	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Rheumatoid Arthritis	Trade Name: RoActemra® Product Code: L04AC07 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2056	EUCTR2008-005320-81-BE (EUCTR)	16/02/2009	20/02/2009	A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2	A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class	Novartis Pharma Services AG	Novartis Pharma Belgium	Not Recruiting			Female: yes Male: yes			Spain;Belgium;Austria;Germany
2057	EUCTR2008-006924-68-ES (EUCTR)	13/02/2009	19/01/2009	Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573	Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573	Artritis reumatoide/Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
2058	EUCTR2008-004894-16-DE (EUCTR)	12/02/2009	11/11/2008	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Hungary;Czech Republic;Germany;Poland
2059	EUCTR2008-001523-57-ES (EUCTR)	09/02/2009	22/10/2008	Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Sujetos adultos con artritis reumatoide activa, de acuerdo con los criterios de la asociación de reumatismo Americana para la clasificación de la AR y con respuesta al metotrexate inadecuada.Adult subjects with Active Rheumatoid Arthritis, in accordance with the American Rheumatology Association criteria for the classification of AR with inadequate response to Metotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
2060	EUCTR2008-005525-11-FR (EUCTR)	06/02/2009	13/03/2009	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Code: RO452294/V02 INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533/F01 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
2061	EUCTR2008-005320-81-DE (EUCTR)	06/02/2009	17/11/2008	A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2	A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to interleukin-1beta of the IgG1-Kappa-class	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	213		Germany;Spain;Austria
2062	EUCTR2008-001847-20-SE (EUCTR)	02/02/2009	23/10/2008	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
2063	EUCTR2008-005525-11-ES (EUCTR)	29/01/2009	09/12/2008	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Artritis reumatoideRheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
2064	EUCTR2008-004754-33-SK (EUCTR)	29/01/2009	14/11/2008	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: BG00012 Other descriptive name: Dimeythl Fumarate	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Czech Republic;Slovakia;Poland
2065	EUCTR2008-000744-13-IT (EUCTR)	28/01/2009	09/01/2009	An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study - ND	An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study - ND	Reumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fosfamatinib Disodium Product Name: R935788 INN or Proposed INN: Fosfamatinib Disodium	RIGEL PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	800		France;Bulgaria;Germany;Italy
2066	EUCTR2008-005427-28-IT (EUCTR)	28/01/2009	11/03/2009	A phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled,randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis - Realistic	A phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled,randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis - Realistic	rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	1048	Phase 3	Germany;Netherlands;France;Spain;Italy
2067	EUCTR2008-001847-20-IT (EUCTR)	18/01/2009	18/12/2008	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND	Adult patients with active moderate to severe (DAS28 > 4.4) rheumatoid arthritis (RA) who have inadequately responded to prior conventional MTX treatment and have not been treated with any biologic agent before. MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid	Product Name: Tocilizumab Product Code: RO04877533 Trade Name: Methotrexate Lederle 2.5 mg Tablets INN or Proposed INN: Methotrexate Product Name: Tocilizumab Product Code: RO04877533	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;United Kingdom;Italy;Sweden
2068	EUCTR2008-004894-16-PL (EUCTR)	15/01/2009	18/12/2008	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy	Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Hungary;Czech Republic;Germany;Poland
2069	EUCTR2008-000587-17-GR (EUCTR)	13/01/2009	30/01/2009	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti- TNF therapies MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab	F. Hoffmann- La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2070	EUCTR2007-000896-41-GB (EUCTR)	12/01/2009	19/01/2009	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Czech Republic;Hungary;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
2071	EUCTR2007-001377-28-PT (EUCTR)	09/01/2009	25/08/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;Austria
2072	EUCTR2007-006150-25-DE (EUCTR)	09/01/2009	26/05/2008	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate	Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	216		Hungary;Germany;Serbia;Netherlands;Belgium;Mexico;France;Romania;Austria
2073	EUCTR2007-003288-36-ES (EUCTR)	08/01/2009	09/03/2010	Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART	Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART	Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200		Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2074	EUCTR2008-001523-57-DK (EUCTR)	07/01/2009	14/10/2008	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
2075	EUCTR2008-001523-57-GB (EUCTR)	06/01/2009	22/10/2008	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
2076	EUCTR2008-007225-39-BE (EUCTR)	06/01/2009	12/02/2009	A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients.	A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA	early active Rheumatoid Arthritis, previously untreated with DMARDS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Ledertrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE DISODIUM Trade Name: Salazopyrine INN or Proposed INN: SULFASALAZINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE	University Hospitals Leuven	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 4	Belgium
2077	NCT00858780 (ClinicalTrials.gov)	January 2009	6/3/2009	Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)	Rheumatoid Arthritis	Drug: Etanercept;Drug: Placebo	Pfizer	NULL	Completed	18 Years	N/A	All	91	Phase 4	Denmark;Finland;Hungary;Iceland;Norway;Sweden
2078	NCT00838058 (ClinicalTrials.gov)	January 2009	2/2/2009	A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.	An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers	Rheumatoid Arthritis;Healthy Volunteers	Drug: CE-224,535;Drug: CE 224,535	Pfizer	NULL	Completed	18 Years	55 Years	Both	11	Phase 1	United States
2079	EUCTR2008-005525-11-GB (EUCTR)	29/12/2008	16/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Greece;Spain;Netherlands;Germany;United Kingdom
2080	EUCTR2008-001523-57-IT (EUCTR)	23/12/2008	17/03/2009	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - ND	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - ND	active rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid	Trade Name: ORENCIA INN or Proposed INN: ABATACEPT	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy
2081	EUCTR2008-001847-20-LV (EUCTR)	19/12/2008	29/12/2008	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Latvia;Germany;Netherlands;Norway;Sweden
2082	EUCTR2008-001847-20-GB (EUCTR)	19/12/2008	09/09/2008	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate.	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
2083	EUCTR2007-001625-10-IE (EUCTR)	12/12/2008	07/10/2008	AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RADIOGRAPHIC EFFICACY AND SAFETY OF ENBREL™ (ETANERCEPT) ADDED TO METHOTREXATE IN COMPARISON WITH USUAL TREATMENT IN SUBJECTS WITH MODERATE RHEUMATOID ARTHRITIS DISEASE ACTIVITY	AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RADIOGRAPHIC EFFICACY AND SAFETY OF ENBREL™ (ETANERCEPT) ADDED TO METHOTREXATE IN COMPARISON WITH USUAL TREATMENT IN SUBJECTS WITH MODERATE RHEUMATOID ARTHRITIS DISEASE ACTIVITY	RHEUMATOID ARTHRITIS	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Spain;Ireland;Italy;Greece;Poland;Austria
2084	EUCTR2008-001847-20-NL (EUCTR)	10/12/2008	23/10/2008	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAY	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAY	Rheumatoid Arthritis	Product Name: Tocilizumab Product Code: RO04877533 Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2085	EUCTR2008-001847-20-DK (EUCTR)	10/12/2008	21/10/2008	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
2086	EUCTR2008-000744-13-BE (EUCTR)	09/12/2008	08/10/2008	An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study	An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 2	France;Belgium;Bulgaria;Germany;Italy
2087	EUCTR2008-004931-39-PL (EUCTR)	08/12/2008	04/11/2008	A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.	A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.	Active Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ALD518 Product Code: ALD518 Other descriptive name: ALD518 monoclonal antibody (anti IL-6 mAb)	Alder Biopharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	120		Poland
2088	EUCTR2007-003288-36-FR (EUCTR)	08/12/2008	21/10/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
2089	EUCTR2008-002046-27-DE (EUCTR)	08/12/2008	08/07/2008	Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate	Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 1/2	Germany;Belgium;France;Spain
2090	EUCTR2007-000830-38-DE (EUCTR)	05/12/2008	29/09/2008	A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.	A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	France;Poland;Austria;Germany;Italy
2091	EUCTR2007-006150-25-AT (EUCTR)	03/12/2008	07/10/2008	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	216		Hungary;Germany;Netherlands;Belgium;France;Austria
2092	EUCTR2007-006150-25-NL (EUCTR)	01/12/2008	02/06/2008	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	216		Hungary;Germany;Netherlands;Belgium;France;Austria
2093	NCT00767325 (ClinicalTrials.gov)	December 2008	6/10/2008	A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography	Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: Abatacept;Drug: Methotrexate	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	104	Phase 3	Denmark;France;Germany;Hungary;Italy;Norway;Spain;United Kingdom
2094	NCT00805116 (ClinicalTrials.gov)	December 2008	8/12/2008	Marine Oils and Arthritis	Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis	Rheumatoid Arthritis	Dietary Supplement: Whale blubber oil;Dietary Supplement: Cod liver oil	National Institute of Nutrition and Seafood Research, Norway	NULL	Terminated	18 Years	N/A	Both	7	N/A	Norway
2095	NCT00818064 (ClinicalTrials.gov)	December 2008	30/12/2008	Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis	A Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis	Inflammation;Rheumatoid Arthritis;Healthy	Drug: anti-IL-20;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	75 Years	All	32	Phase 1	Netherlands
2096	NCT00810277 (ClinicalTrials.gov)	November 30, 2008	16/12/2008	A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs	An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	14	Phase 3	Finland
2097	EUCTR2008-001847-20-EE (EUCTR)	28/11/2008	13/10/2008	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Rheumatoid Arthritis	Trade Name: RoActemra® Product Code: L04AC07 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2098	EUCTR2007-003288-36-FI (EUCTR)	28/11/2008	30/09/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2099	EUCTR2007-001625-10-IT (EUCTR)	26/11/2008	01/04/2009	An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) added to Methotrexate in Comparison with Usual Treatment in Subjects with Moderate Rheumatoid Arthritis Disease Activity. - EXTRA	An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) added to Methotrexate in Comparison with Usual Treatment in Subjects with Moderate Rheumatoid Arthritis Disease Activity. - EXTRA	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ENBREL INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;United Kingdom;Italy
2100	EUCTR2008-001847-20-FR (EUCTR)	17/11/2008	21/10/2008	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO04877533/F05/F04 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2101	EUCTR2008-001105-42-AT (EUCTR)	11/11/2008	06/08/2008	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: NA Product Code: LY2127399 INN or Proposed INN: N/A Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Germany;Belgium;France;Poland;Austria
2102	EUCTR2007-003288-36-DE (EUCTR)	10/11/2008	03/09/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2103	EUCTR2007-005434-37-GB (EUCTR)	07/11/2008	28/05/2008	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study) Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008), Amendment 08-Site Specific (v1.0, date 11-May-2009) & Amendment 15-Site Specific - UK sites only (v1.0, date 07-OCt-2010). And Pharmacogenetics Blood Sample Protocol Amendment 01 - Site-specific (v1.0, Date 07-Sep-2007). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2104	EUCTR2008-002046-27-BE (EUCTR)	05/11/2008	17/09/2008	Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate	Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 1/2	Germany;Belgium;France;Spain
2105	EUCTR2008-001523-57-FR (EUCTR)	04/11/2008	21/10/2008	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
2106	EUCTR2006-005353-30-GB (EUCTR)	04/11/2008	01/04/2008	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis.	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Spain;Lithuania;Austria;Italy;United Kingdom
2107	EUCTR2007-005434-37-GR (EUCTR)	04/11/2008	06/02/2009	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2108	NCT00771030 (ClinicalTrials.gov)	November 2008	9/10/2008	Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis	A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: AMG 827;Other: Placebo	Amgen	NULL	Completed	18 Years	70 Years	Both	40	Phase 1/Phase 2	Canada;Mexico;United States
2109	NCT00791921 (ClinicalTrials.gov)	November 2008	14/11/2008	Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)	A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.	Rheumatoid Arthritis	Drug: CDP870;Drug: Placebo of CDP870	Otsuka Pharmaceutical Co., Ltd.	UCB Japan Co. Ltd.	Completed	20 Years	74 Years	All	230	Phase 3	Japan
2110	NCT00901550 (ClinicalTrials.gov)	November 2008	13/5/2009	The Chinese University of Hong Kong Early Arthritis Study	The Chinese University of Hong Kong Early Arthritis Study	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Infliximab	Chinese University of Hong Kong	NULL	Completed	18 Years	80 Years	Both	40	N/A	China
2111	NCT00783536 (ClinicalTrials.gov)	November 2008	29/10/2008	A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis	An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept + Methotrexate;Drug: DMARDS	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Withdrawn	18 Years	80 Years	All	0	Phase 4	NULL
2112	NCT00948610 (ClinicalTrials.gov)	November 2008	28/7/2009	Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy	Sleep & Immune Mechanisms in Rheumatoid Arthritis: Remicade Substudy	Rheumatoid Arthritis	Drug: Remicade	University of California, Los Angeles	National Heart, Lung, and Blood Institute (NHLBI)	Completed	18 Years	85 Years	All	20	N/A	United States
2113	NCT00791999 (ClinicalTrials.gov)	November 2008	14/11/2008	Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)	A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.	Rheumatoid Arthritis	Drug: CDP870 400mg;Drug: CDP870 200mg;Drug: CDP870 100mg;Drug: Placebo of CDP870	Otsuka Pharmaceutical Co., Ltd.	UCB Japan Co. Ltd.	Completed	20 Years	74 Years	All	316	Phase 2/Phase 3	Japan
2114	NCT00796705 (ClinicalTrials.gov)	November 2008	20/11/2008	Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)	Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha Inhibition	Rheumatoid Arthritis	Drug: Adalimumab;Drug: Adalimumab placebo;Drug: Etanercept	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Terminated	18 Years	N/A	All	13	Phase 4	United States
2115	EUCTR2007-002950-42-GB (EUCTR)	27/10/2008	20/03/2008	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	GlaxoSmithKline Research & Development	NULL	Not Recruiting			Female: yes Male: yes	248	Phase 3	Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom
2116	EUCTR2008-005320-81-AT (EUCTR)	21/10/2008	22/09/2008	A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2	A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		Germany;Spain;Austria
2117	EUCTR2008-000742-30-HU (EUCTR)	18/10/2008	24/04/2008	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	Rigel Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 2	Hungary;Bulgaria;Poland
2118	EUCTR2008-001847-20-ES (EUCTR)	17/10/2008	11/08/2008	Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX.	Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX.	Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO04877533 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: METOTREXATO SODIO Other descriptive name: METHOTREXATE SODIUM	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
2119	EUCTR2007-002536-29-BG (EUCTR)	16/10/2008	01/10/2008	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - August II	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - August II	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Finland;Germany;Czech Republic;France;Bulgaria;Spain;Italy;Greece;Poland;Austria;Sweden
2120	EUCTR2008-001105-42-DE (EUCTR)	16/10/2008	04/08/2008	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: LY2127399 INN or Proposed INN: N/A Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Germany;Belgium;France;Poland;Austria
2121	EUCTR2008-000742-30-BG (EUCTR)	15/10/2008	14/08/2008	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	Rigel Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 2	Hungary;Bulgaria;Poland
2122	EUCTR2007-003288-36-NL (EUCTR)	15/10/2008	11/07/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2123	EUCTR2008-002046-27-ES (EUCTR)	14/10/2008	06/05/2010	Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato.	Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato.	Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20	GlaxoSmithKline S.A.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 1/2	Germany;Belgium;France;Spain
2124	EUCTR2006-004139-31-GR (EUCTR)	14/10/2008	06/11/2009	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metotab® INN or Proposed INN: methotrexate	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden
2125	EUCTR2008-005212-40-SE (EUCTR)	14/10/2008	14/08/2008	Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING	Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING	Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Remicade. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10060016;Term: Alpha tumor necrosis factor MedDRA version: 9.1;Classification code 10029817;Term: Nuclear magnetic resonance imaging brain MedDRA version: 9.1;Classification code 10053689;Term: Cardiovascular autonomic function test	Trade Name: Remicade INN or Proposed INN: Infliximab	Karolinska Institute	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no			Sweden
2126	EUCTR2008-000587-17-BE (EUCTR)	13/10/2008	19/08/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-Sure	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-Sure	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece
2127	EUCTR2008-001105-42-FR (EUCTR)	10/10/2008	28/08/2008	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: LY2127399 INN or Proposed INN: N/A Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	France;Poland;Belgium;Austria;Germany
2128	EUCTR2007-001625-10-AT (EUCTR)	09/10/2008	04/06/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel 50 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2129	EUCTR2007-000830-38-AT (EUCTR)	09/10/2008	09/09/2008	A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.	A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	France;Poland;Austria;Germany;Italy
2130	EUCTR2008-004398-16-SE (EUCTR)	08/10/2008	12/08/2008	A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical remission - ADMIRE	A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical remission - ADMIRE	Adalimumab has the indication for life-long treatment of RA but can adalimumab be discontinued in patients who are in stable clinical remission (DAS28<2.6) with retained low disease activity or will the RA symptoms relapse? If relapse occurs, how is the response if adalimumab is reinstituted? MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab	Abbott Scandinavia AB	NULL	Not Recruiting			Female: yes Male: yes	50		Sweden
2131	EUCTR2007-003288-36-AT (EUCTR)	01/10/2008	18/08/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
2132	EUCTR2007-001625-10-DE (EUCTR)	01/10/2008	05/05/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel 50 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;United Kingdom;Germany;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2133	NCT00768053 (ClinicalTrials.gov)	October 2008	3/10/2008	Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients	Open-Label Study To Evaluate The EULAR-RAID Score, Rheumatoid Arthritis Impact Of Disease Score, In Rheumatoid Arthritis Patients Eligible To Etanercept And Who Will Receive Etanercept	Rheumatoid Arthritis	Drug: Etanercept	Wyeth is now a wholly owned subsidiary of Pfizer	Lincoln Medical and Mental Health Center;Umanis;SODIA;depolabo	Completed	18 Years	N/A	All	108	Phase 4	France;Monaco
2134	NCT00771329 (ClinicalTrials.gov)	October 2008	10/10/2008	BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: BIIB023;Other: Placebo (sterile normal saline)	Biogen Idec	NULL	Completed	18 Years	65 Years	Both	53	Phase 1	United States;Russian Federation;Ukraine
2135	EUCTR2008-000587-17-DK (EUCTR)	22/09/2008	04/07/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2136	EUCTR2008-001241-26-HU (EUCTR)	18/09/2008	02/06/2008	A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a.	A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a.	Active rheumatoid arthritis, functional class II-III MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: BT061 (CD4 monoclonal antibody) Product Code: BT971 INN or Proposed INN: BT061 (CD4 monoclonal antibody)	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	110		Hungary;Bulgaria
2137	EUCTR2008-000742-30-PL (EUCTR)	17/09/2008	30/09/2008	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	Rigel Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 2	Hungary;Bulgaria;Poland
2138	EUCTR2006-004139-31-NO (EUCTR)	16/09/2008	19/12/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden
2139	EUCTR2008-001105-42-BE (EUCTR)	16/09/2008	14/07/2008	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: LY2127399 INN or Proposed INN: N/A Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	France;Poland;Belgium;Austria;Germany
2140	EUCTR2008-000587-17-CZ (EUCTR)	15/09/2008	20/06/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Greece
2141	EUCTR2007-005434-37-IT (EUCTR)	12/09/2008	11/06/2008	Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate.(Short title: MTX-IR Study) Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008) - MTX-IR Study	Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate.(Short title: MTX-IR Study) Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008) - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia INN or Proposed INN: ABATACEPT Product Name: abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;United Kingdom;Italy
2142	EUCTR2008-000587-17-IE (EUCTR)	11/09/2008	05/06/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab (Actemra) Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2143	EUCTR2008-000743-34-IT (EUCTR)	11/09/2008	01/10/2008	Studio di Fase II multicentrico, randomizzato, in doppio cieco, controllato verso placebo, parallel-dose di R935788 in pazienti affetti da artrite reumatoide che hanno sperimentato fallimento di almeno un biologico - ND	Studio di Fase II multicentrico, randomizzato, in doppio cieco, controllato verso placebo, parallel-dose di R935788 in pazienti affetti da artrite reumatoide che hanno sperimentato fallimento di almeno un biologico - ND	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: R935788	RIGEL PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	195		Germany;France;Italy
2144	EUCTR2008-000743-34-DE (EUCTR)	10/09/2008	10/06/2008	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	Rigel Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	Germany;France;Italy
2145	EUCTR2007-001625-10-PL (EUCTR)	10/09/2008	09/06/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Greece;Austria;Poland;Italy;Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain
2146	EUCTR2008-004126-16-FI (EUCTR)	05/09/2008	15/07/2008	Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs	Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	Roche Oy	NULL	Not Recruiting			Female: yes Male: yes			Finland
2147	EUCTR2007-006150-25-BE (EUCTR)	05/09/2008	24/06/2008	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	216	Phase 2	France;Hungary;Belgium;Austria;Netherlands;Germany
2148	EUCTR2008-002046-27-FR (EUCTR)	05/09/2008	15/07/2008	OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate	OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 1;Phase 2	France;Spain;Belgium;Germany
2149	EUCTR2007-001377-28-DE (EUCTR)	01/09/2008	15/05/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;Austria
2150	NCT00750880 (ClinicalTrials.gov)	September 2008	10/9/2008	An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.	International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1681	Phase 3	Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States
2151	NCT00706797 (ClinicalTrials.gov)	September 2008	25/6/2008	Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects	An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity	Rheumatoid Arthritis	Drug: etanercept (EnbrelTM);Drug: methotrexate	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Terminated	18 Years	N/A	All	141	Phase 4	Czech Republic;France;Germany;Hungary;Italy;Poland;Spain;Turkey;United Kingdom;Austria;Croatia;United States
2152	EUCTR2008-000170-20-ES (EUCTR)	26/08/2008	03/06/2008	A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, para evaluar la eficacia clínica y la seguridad de BMS-582949 administrado por vía oral a sujetos con artritis reumatoide que han mostrado respuesta inadecuada al metotrexato.Protocolo Revisado 01, que incorpora la carta administrativa 01 y la enmienda 03 (version 1.0, de fecha 12-Mar-2008).	A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, para evaluar la eficacia clínica y la seguridad de BMS-582949 administrado por vía oral a sujetos con artritis reumatoide que han mostrado respuesta inadecuada al metotrexato.Protocolo Revisado 01, que incorpora la carta administrativa 01 y la enmienda 03 (version 1.0, de fecha 12-Mar-2008).	subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX)sujetos con artritis reumatoide (AR) que estan recibiendo tratamiento de fondo con metotrexato (MTX). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BMS-582949	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	France;Czech Republic;Spain
2153	EUCTR2008-000587-17-FI (EUCTR)	20/08/2008	05/06/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2154	EUCTR2008-000105-11-DE (EUCTR)	19/08/2008	16/05/2008	Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis	Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes			Germany
2155	EUCTR2007-001585-33-DE (EUCTR)	19/08/2008	14/04/2008	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany
2156	EUCTR2007-002951-18-DE (EUCTR)	16/08/2008	30/06/2008	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	GlaxoSmithKline Research & Development	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 3	France;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
2157	EUCTR2007-007539-14-HU (EUCTR)	15/08/2008	26/08/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2158	EUCTR2008-001241-26-BG (EUCTR)	14/08/2008	27/09/2008	A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate	A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate	Active rheumatoid arthritis, functional class II-III. MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: BT061 (CD4 monoclonal antibody) Product Code: BT971	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	110		Hungary;Bulgaria
2159	EUCTR2008-000170-20-CZ (EUCTR)	14/08/2008	30/04/2008	A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 02, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) and Amendment 07 (version 1.0 dated on 01-Jul-2008).	A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 02, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) and Amendment 07 (version 1.0 dated on 01-Jul-2008).	subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BMS-582949	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	240		Czech Republic;France;Spain
2160	EUCTR2007-007539-14-BG (EUCTR)	14/08/2008	06/08/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2161	EUCTR2006-000923-32-GB (EUCTR)	13/08/2008	15/10/2007	A randomised, double-blind, placebo-controlled, Bayesian adaptive dose finding study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat intravenous infusions GSK315234A in patients with active rheumatoid arthritis (RA)	A randomised, double-blind, placebo-controlled, Bayesian adaptive dose finding study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat intravenous infusions GSK315234A in patients with active rheumatoid arthritis (RA)	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK315234 Product Code: GSK315234	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	112		United Kingdom
2162	EUCTR2008-000587-17-NL (EUCTR)	12/08/2008	10/09/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
2163	EUCTR2008-000587-17-FR (EUCTR)	12/08/2008	16/07/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tolicizumab Roche Product Code: RO4877533/F04-F05 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
2164	EUCTR2008-000587-17-PT (EUCTR)	08/08/2008	06/06/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2165	EUCTR2007-005434-37-BE (EUCTR)	08/08/2008	28/05/2008	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010), and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008) & Amendment 08-Site Specific (v1.0, date 11-May-2009). - MTX-IR Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010), and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008) & Amendment 08-Site Specific (v1.0, date 11-May-2009). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2166	EUCTR2007-005434-37-IE (EUCTR)	08/08/2008	22/05/2008	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2167	EUCTR2007-002951-18-GB (EUCTR)	07/08/2008	14/03/2008	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	GlaxoSmithKline Research & Development	NULL	Not Recruiting			Female: yes Male: yes	236	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden
2168	EUCTR2007-005434-37-DE (EUCTR)	05/08/2008	29/05/2008	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study).Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study).Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2169	EUCTR2007-007539-14-PL (EUCTR)	05/08/2008	30/06/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2170	EUCTR2006-005035-19-BG (EUCTR)	04/08/2008	10/06/2009	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: NA Other descriptive name: NA Product Name: Tofacitinib citrate (Proposed commercial formulation- debossed) Product Code: CP-690,550-10 INN or Proposed INN: NA Other descriptive name: NA	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 2;Phase 3	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2171	EUCTR2006-006373-25-BG (EUCTR)	04/08/2008	14/09/2009	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Czech Republic;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
2172	EUCTR2007-007888-24-FR (EUCTR)	31/07/2008	17/07/2008	Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW	Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW	RHEUMATOID ARTHRITIS	Trade Name: ENBREL INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	101	Phase 4	France
2173	EUCTR2007-005434-37-AT (EUCTR)	30/07/2008	20/06/2008	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 02 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007), Protocol amendment 03 (v1.0, date 25-Apr-2008), and Protocol Amendment 06 (v1.0, date 25-Sep-2008). And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008). - MTX-IR Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 02 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007), Protocol amendment 03 (v1.0, date 25-Apr-2008), and Protocol Amendment 06 (v1.0, date 25-Sep-2008). And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2174	EUCTR2007-002950-42-BE (EUCTR)	25/07/2008	24/06/2008	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	248	Phase 3	Czech Republic;Hungary;Spain;Poland;Belgium;Lithuania;United Kingdom
2175	EUCTR2007-005434-37-FR (EUCTR)	24/07/2008	19/05/2008	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2176	EUCTR2008-000587-17-ES (EUCTR)	22/07/2008	26/05/2008	Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Artritis reumatoideRheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
2177	EUCTR2008-000743-34-FR (EUCTR)	21/07/2008	17/04/2008	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	Rigel Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	France;Belgium;Germany;Italy
2178	EUCTR2007-005434-37-NL (EUCTR)	16/07/2008	30/05/2008	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
2179	EUCTR2007-000896-41-IT (EUCTR)	15/07/2008	30/07/2008	A RANDOMIZED, DOUBLE-BLIND STUDY COMPARING THE SAFETY AND EFFICACY OF ONCE-WEEKLY ADMINISTRATION OF ETANERCEPT 50 MG, ETANERCEPT 25 MG, AND PLACEBO IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE ACHIEVED AN ADEQUATE RESPONSE WITH ETANERCEPT 50 MG ONCE WEEKLY AND METHOTREXATE - ND	A RANDOMIZED, DOUBLE-BLIND STUDY COMPARING THE SAFETY AND EFFICACY OF ONCE-WEEKLY ADMINISTRATION OF ETANERCEPT 50 MG, ETANERCEPT 25 MG, AND PLACEBO IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE ACHIEVED AN ADEQUATE RESPONSE WITH ETANERCEPT 50 MG ONCE WEEKLY AND METHOTREXATE - ND	Moderately Active Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML INN or Proposed INN: ETANERCEPT Trade Name: ENBREL*SC 4FL 50MG+4SIR+4AGHI+ INN or Proposed INN: ETANERCEPT Product Name: metotrexato INN or Proposed INN: Methotrexate	Wyeth Pharmaceuticals France, Wyeth Research Division	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2180	EUCTR2007-001377-28-NL (EUCTR)	15/07/2008	29/05/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;Austria
2181	EUCTR2007-005434-37-HU (EUCTR)	09/07/2008	26/05/2008	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study	RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	2400	Phase 3	France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
2182	EUCTR2007-001625-10-DK (EUCTR)	08/07/2008	18/06/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2183	EUCTR2007-006150-25-HU (EUCTR)	04/07/2008	01/04/2009	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate	Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	216		France;Serbia;Hungary;Mexico;Belgium;Romania;Austria;Netherlands;Germany
2184	EUCTR2008-000587-17-SE (EUCTR)	03/07/2008	21/05/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2185	EUCTR2007-003508-36-GB (EUCTR)	02/07/2008	29/02/2008	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Lodotra® INN or Proposed INN: Prednisone	Nitec Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	350	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Germany;United Kingdom
2186	JPRN-UMIN000001240	2008/07/01	10/07/2008	The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial	The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial - The efficacy of tocilizumab to RA patients refractory to anti-TNF agents	rheumatoid arthritis	Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 years	Division of Rheumatology & Clinical Immunology, Jichi Medical University	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Not selected	Japan
2187	JPRN-UMIN000001798	2008/07/01	25/03/2009	Prevention of cartilage destruction in rheumatoid arthritis by etanercept (PRECEPT study)	Prevention of cartilage destruction in rheumatoid arthritis by etanercept (PRECEPT study) - PRECEPT study	Rheumatoid arthritis	Injection of etanercept by 50 mg/week for one year Injection of etanercept by 25 mg/week for one year	Team RA, Rheumatosurgery, Osaka City University Medical School	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	100	Not applicable	Japan
2188	JPRN-UMIN000001281	2008/07/01	31/07/2008	Strategic reduction of joint destruction in rheumatoid arthritis	Strategic reduction of joint destruction in rheumatoid arthritis - Strategic reduction of joint destruction in rheumatoid arthritis (ZERO-J study)	Rheumatoid arthritis	TNF-inhibitors plus MTX TNF-inhibitors are used for 54 weeks and exchange among them is approved MTX MTX is used for 54 weeks and addition of the other DMARD is approved	School of Medicine, University of Occupational and Environmental Health, Japan	NULL		Not applicable	Not applicable	Male and Female	120	Not selected	Japan
2189	JPRN-UMIN000002421	2008/07/01	04/09/2009	Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis	Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis - Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis	rheumatoid arthritis	tocilizumab Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab	AA amyloidosis clinical research conference	NULL	Recruiting	20years-old	Not applicable	Male and Female	40	Not selected	Japan
2190	NCT00729209 (ClinicalTrials.gov)	July 2008	4/8/2008	A Study of ARRY-371797 in Patients With Rheumatoid Arthritis		Rheumatoid Arthritis	Drug: ARRY-371797, p38 inhibitor; oral;Drug: Placebo	Array Biopharma, now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	All	28	Phase 1	United States
2191	NCT00782600 (ClinicalTrials.gov)	July 2008	27/10/2008	Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers	A Phase 1, Randomized, 4-Period, 4-Sequence Cross-Over Study Of The Pharmacokinetics Of 3 Durations Of Release Of A Controlled Release Formulation And A Single Dose Of An Immediate Release Oral Suspension Of CE-224,535 In Normal Healthy Volunteers	Rheumatoid Arthritis	Drug: suspension IR;Drug: CR 1;Drug: CR 2;Drug: CR 3	Pfizer	NULL	Completed	18 Years	55 Years	Both	16	Phase 1	United States
2192	EUCTR2007-000830-38-IT (EUCTR)	30/06/2008	21/07/2008	A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. - ND	A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. - ND	rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Level: PT;Term: Rheumatoid arthritis	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB S.A. (Casa Madre)	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	Germany;France;Italy;Poland;Austria
2193	EUCTR2007-001377-28-AT (EUCTR)	26/06/2008	27/05/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;Germany;Netherlands;France;Austria
2194	EUCTR2007-004399-38-LT (EUCTR)	26/06/2008	23/04/2008	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		United Kingdom;Estonia;Lithuania
2195	EUCTR2007-006150-25-FR (EUCTR)	24/06/2008	05/05/2008	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	216	Phase 2	France;Hungary;Belgium;Austria;Netherlands;Germany
2196	EUCTR2008-000327-25-PL (EUCTR)	24/06/2008	20/05/2008	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CE-224,535	Pfizer Inc. 235 East 42nd Street NY10017	NULL	Not Recruiting			Female: yes Male: yes	78	Phase 2	Czech Republic;Spain;Poland
2197	EUCTR2007-000896-41-DE (EUCTR)	20/06/2008	21/04/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders MedDRA version: 9.1;Classification code 10021428;Term: Immune system disorders	Trade Name: Enbrel 25 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Sodium Tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Sodium	Wyeth Research Division of Wyeth Pharmceuticals Inc. A Pfizer Company, Philadelphia, PA-19101, USA	NULL	Not Recruiting			Female: yes Male: yes	900		France;Czech Republic;Hungary;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
2198	EUCTR2007-001625-10-CZ (EUCTR)	19/06/2008	21/05/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Germany;United Kingdom;Czech Republic;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2199	EUCTR2008-000587-17-AT (EUCTR)	19/06/2008	09/05/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2200	EUCTR2008-000743-34-BE (EUCTR)	18/06/2008	09/04/2008	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	Rigel Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	France;Belgium;Germany;Italy
2201	EUCTR2007-006527-13-BG (EUCTR)	18/06/2008	14/06/2008	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients with Active Rheumatoid Arthritis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients with Active Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CF101 INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide Other descriptive name: IB-MECA INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide Other descriptive name: IB-MECA	Can-Fite BioPharma Ltd.	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Bulgaria
2202	EUCTR2008-000587-17-GB (EUCTR)	18/06/2008	18/04/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
2203	EUCTR2007-007539-14-IT (EUCTR)	17/06/2008	06/06/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - Escape	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - Escape	Male and female patients over 18 years of age, with active RA despite current treatment with methotrexate. All patients will continue with background methotrexate therapy. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Product Name: AZD5672 Product Code: AZD5672 INN or Proposed INN: ETANERCEPT	ASTRAZENECA	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2204	EUCTR2007-003508-36-HU (EUCTR)	17/06/2008	18/02/2008	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Lodotra® INN or Proposed INN: Prednisone	Nitec Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	350		Hungary;Germany;United Kingdom
2205	EUCTR2007-001625-10-HU (EUCTR)	16/06/2008	18/03/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
2206	EUCTR2007-007539-14-CZ (EUCTR)	12/06/2008	18/04/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2207	EUCTR2007-001377-28-FR (EUCTR)	11/06/2008	29/02/2008	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL	Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10	Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 4	Portugal;France;Austria;Netherlands;Germany
2208	EUCTR2007-007859-14-PL (EUCTR)	11/06/2008	09/05/2008	A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE	A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE	Active Rheumatoid Arthritis incompletely responsive to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ARRY-438162 Product Name: ARRY-438162	Array BioPharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Poland
2209	EUCTR2007-002951-18-SE (EUCTR)	11/06/2008	25/03/2008	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 3	Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden
2210	EUCTR2006-004834-33-PL (EUCTR)	09/06/2008	06/05/2008	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Rob 803 Product Code: Rob 803 6.25mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Name: Rob 803 Product Code: Rob 803 12.5mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Name: Rob 803 Product Code: Rob 803 15mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Name: Rob 803 Product Code: Rob 803 25mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline	OxyPharma AB	NULL	Not Recruiting			Female: yes Male: yes	224	Phase 2	United Kingdom;Bulgaria;Latvia;Poland
2211	EUCTR2007-005464-26-GB (EUCTR)	05/06/2008	11/04/2008	Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body.	The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II	Rheumatoid Arthritis MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	Kings College London	Guys and St Thomas'NHS Foundation Trust	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2212	EUCTR2007-000886-40-IT (EUCTR)	04/06/2008	21/03/2008	Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER	Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER	Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ARAVA INN or Proposed INN: Leflunomide Trade Name: ARAVA INN or Proposed INN: Leflunomide Trade Name: ARAVA INN or Proposed INN: Leflunomide	sanofi-aventis Groupe	NULL	Not Recruiting			Female: yes Male: yes	200		Portugal;Italy
2213	EUCTR2008-000170-20-FR (EUCTR)	03/06/2008	15/04/2008	A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)	A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)	subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BMS-582949	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	France;Czech Republic;Spain
2214	EUCTR2007-001625-10-FR (EUCTR)	03/06/2008	13/05/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
2215	EUCTR2007-002536-29-GR (EUCTR)	03/06/2008	12/02/2008	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2216	EUCTR2007-002951-18-DK (EUCTR)	03/06/2008	23/04/2008	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 3	France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2217	NCT00654368 (ClinicalTrials.gov)	June 2008	3/4/2008	CAMEO: Canadian Methotrexate and Etanercept Outcome Study	Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)	Rheumatoid Arthritis	Biological: Etanercept;Drug: Methotrexate	Amgen	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	All	258	Phase 4	Canada
2218	NCT02151409 (ClinicalTrials.gov)	June 2008	28/5/2014	Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects	A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.	Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Healthy	Drug: NNC 0151-0000-0000;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	55 Years	Male	60	Phase 1	Netherlands
2219	EUCTR2007-001625-10-ES (EUCTR)	28/05/2008	24/03/2008	Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderadaAn Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderadaAn Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	Artritis reumatoideRHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
2220	EUCTR2007-000828-40-DE (EUCTR)	27/05/2008	10/01/2008	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Germany;France;Italy;Poland;Austria
2221	EUCTR2008-000327-25-CZ (EUCTR)	27/05/2008	02/04/2008	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CE-224,535	Pfizer Inc. 235 East 42nd Street NY10017	NULL	Not Recruiting			Female: yes Male: yes	78	Phase 2	Czech Republic;Spain;Poland
2222	EUCTR2006-003054-26-HU (EUCTR)	22/05/2008	14/12/2007	A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: TAK-783	Takeda Global R&D (Europe) Ltd	NULL	Not Recruiting			Female: yes Male: yes	230		Hungary;Czech Republic;Latvia
2223	EUCTR2007-007859-14-HU (EUCTR)	22/05/2008	22/01/2008	A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE	A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE	Active Rheumatoid Arthritis incompletely responsive to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ARRY-438162 Product Name: ARRY-438162	Array BioPharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Poland
2224	EUCTR2007-005759-41-DE (EUCTR)	21/05/2008	21/02/2008	A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusion	A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusion	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	300		United Kingdom;Germany;France;Spain;Italy
2225	EUCTR2008-000327-25-ES (EUCTR)	19/05/2008	18/03/2008	ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITIS REUMATOIDE EN PACIENTES CON UN CONTROL INADECUADO CON METROTEXATOA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE	ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITIS REUMATOIDE EN PACIENTES CON UN CONTROL INADECUADO CON METROTEXATOA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE	Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CE-224,535	PFIZER S.A.	NULL	Not Recruiting			Female: yes Male: yes	78	Phase 2	Czech Republic;Poland;Spain
2226	EUCTR2007-007539-14-SK (EUCTR)	16/05/2008	16/04/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Latvia;Malta;Italy
2227	EUCTR2007-000896-41-BE (EUCTR)	16/05/2008	27/02/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 4	France;Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
2228	EUCTR2007-000828-40-IT (EUCTR)	15/05/2008	14/07/2008	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - ND	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - ND	Rheumatoid arthritis with moderate to low disease activity MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB S.A. (Casa Madre)	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Germany;France;Italy;Poland;Austria
2229	EUCTR2007-006288-56-AT (EUCTR)	14/05/2008	14/04/2008	Methotrexat-Polyglutamate als Marker fuer das klinische Outcome in der Therapie der rheumatoiden Arthritis	Methotrexat-Polyglutamate als Marker fuer das klinische Outcome in der Therapie der rheumatoiden Arthritis	Rheumatoid Arthritis	Trade Name: Ebetrexat INN or Proposed INN: METHOTREXATE	Ludwig Boltzmann Cluster für Rheumatologie, Balneologie und Rehabilitation	NULL	Not Recruiting			Female: yes Male: yes			Austria
2230	EUCTR2007-002951-18-FR (EUCTR)	14/05/2008	18/03/2008	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 3	France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2231	EUCTR2007-005905-23-DE (EUCTR)	13/05/2008	29/01/2008	A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing	A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	424		United Kingdom;Germany
2232	EUCTR2007-002536-29-DE (EUCTR)	08/05/2008	05/12/2007	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;France;Czech Republic;Greece;Finland;Spain;Poland;Austria;Bulgaria;Germany;Italy;Sweden
2233	EUCTR2007-007539-14-LV (EUCTR)	07/05/2008	12/05/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2234	EUCTR2007-000896-41-FR (EUCTR)	07/05/2008	29/02/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 4	France;Czech Republic;Hungary;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
2235	EUCTR2007-005759-41-IT (EUCTR)	06/05/2008	10/10/2008	A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy. - ND	A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy. - ND	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ocrelizumab Product Code: RO-496-4913	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	300		France;Spain;Germany;United Kingdom;Italy
2236	NCT00667758 (ClinicalTrials.gov)	May 2008	24/4/2008	Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis	Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial	Rheumatoid Arthritis	Drug: Cetrorelix;Drug: Placebo	Betanien Hospital	Norwegian Foundation for Health and Rehabilitation;University of Oslo	Completed	18 Years	N/A	Both	104	Phase 2	Norway
2237	NCT01224418 (ClinicalTrials.gov)	May 2008	14/10/2010	A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate	Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study	Rheumatoid Arthritis	Drug: Tacrolimus	Astellas Pharma Inc	Astellas Pharma Korea, Inc.	Completed	18 Years	75 Years	Both	50	Phase 4	Korea, Republic of
2238	EUCTR2007-000896-41-SE (EUCTR)	29/04/2008	06/02/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company, Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2239	EUCTR2007-005759-41-GB (EUCTR)	29/04/2008	29/02/2008	A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE	A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Spain;Germany;Italy;United Kingdom
2240	EUCTR2007-003508-36-DE (EUCTR)	25/04/2008	28/03/2008	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	INN or Proposed INN: Prednisone	Nitec Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	350		Hungary;Germany;United Kingdom
2241	EUCTR2007-007539-14-MT (EUCTR)	25/04/2008	12/05/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
2242	EUCTR2007-005759-41-ES (EUCTR)	23/04/2008	19/02/2008	Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy	Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy	Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;Spain;Germany;Italy;United Kingdom
2243	EUCTR2007-005905-23-GB (EUCTR)	22/04/2008	15/02/2008	A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing - M10-261, FINAL 30Nov07	A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing - M10-261, FINAL 30Nov07	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	424		Germany;United Kingdom
2244	EUCTR2007-004399-38-EE (EUCTR)	18/04/2008	29/02/2008	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		United Kingdom;Estonia;Lithuania
2245	EUCTR2007-000896-41-CZ (EUCTR)	14/04/2008	04/03/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2246	EUCTR2007-004878-31-HU (EUCTR)	09/04/2008	20/12/2007	An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403	An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	GlaxoSmithKline Research & Development Ltd.	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Hungary;Denmark;United Kingdom
2247	EUCTR2006-004834-33-BG (EUCTR)	03/04/2008	24/03/2008	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	Rheumatiod Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Rob 803 (capsules 6.25 mg) Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Product Name: Rob 803 (capsules 12.5 mg) Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Product Name: Rob 803 (capsules 15 mg) Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Product Name: Rob 803 (capsules 25 mg) Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali	OxyPharma AB	NULL	Not Recruiting			Female: yes Male: yes	224	Phase 2	United Kingdom;Bulgaria;Latvia;Poland
2248	EUCTR2007-003069-42-LT (EUCTR)	01/04/2008	05/02/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;United Kingdom;Estonia;Lithuania
2249	EUCTR2007-003647-75-FR (EUCTR)	01/04/2008	07/02/2008	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;Finland;Netherlands;United Kingdom;Sweden
2250	EUCTR2007-002066-35-HU (EUCTR)	28/03/2008	23/07/2007	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira®	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece
2251	EUCTR2007-000593-24-GB (EUCTR)	28/03/2008	01/08/2007	An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.	An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.	Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Humira INN or Proposed INN: adalimumab Other descriptive name: Humira	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	52	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom;Sweden
2252	EUCTR2007-000896-41-HU (EUCTR)	27/03/2008	16/10/2007	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 Trade Name: Methotrexate Product Name: Methotrexate	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2253	EUCTR2007-003069-42-HU (EUCTR)	27/03/2008	18/09/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;United Kingdom;Estonia;Lithuania
2254	EUCTR2007-005759-41-FR (EUCTR)	19/03/2008	12/02/2008	A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy	A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;Spain;Germany;Italy;United Kingdom
2255	EUCTR2007-000760-24-SK (EUCTR)	05/03/2008	10/04/2008	Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA	Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA	Patients with active rheumatoid arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SSR150106XB Product Code: SSR150106XB INN or Proposed INN: NA Other descriptive name: NA	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	Czech Republic;Slovakia
2256	EUCTR2007-004241-15-IT (EUCTR)	04/03/2008	27/06/2008	A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. - ND	A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. - ND	Psoriatic arthritis MedDRA version: 9.1;Level: LLT;Classification code 10032451;Term: Other rheumatoid arthritis with visceral or systemic involvement	Trade Name: ORENCIA INN or Proposed INN: abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy
2257	EUCTR2007-002536-29-CZ (EUCTR)	03/03/2008	16/11/2007	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2258	EUCTR2007-004399-38-GB (EUCTR)	03/03/2008	20/03/2008	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Dipyridamole INN or Proposed INN: Prednisolone Product Code: CRx-102 INN or Proposed INN: Dipyridamole INN or Proposed INN: Prednisolone	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		United Kingdom;Estonia;Lithuania
2259	EUCTR2007-002536-29-FR (EUCTR)	03/03/2008	04/10/2007	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Trade Name: Humira Product Name: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
2260	NCT00650767 (ClinicalTrials.gov)	March 2008	31/3/2008	A Study of ARRY-438162 in Patients With Rheumatoid Arthritis		Rheumatoid Arthritis	Drug: ARRY-438162, MEK inhibitor; oral;Drug: Placebo	Array Biopharma, now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	All	201	Phase 2	United States;Argentina;Brazil;Hungary;Peru;Poland;Romania
2261	NCT00605735 (ClinicalTrials.gov)	March 2008	18/1/2008	PoC in Rheumatoid Arthritis With Methotrexate	A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate	Rheumatoid Arthritis, NOS	Drug: BMS-582949;Drug: Placebo	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	Both	121	Phase 2	United States;Argentina;Czech Republic;France;Korea, Republic of;Mexico;Spain;Taiwan;Brazil
2262	NCT00628095 (ClinicalTrials.gov)	March 2008	25/2/2008	Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CE-224,535, An Antagonist Of The P2x7 Receptor, In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate	Arthritis, Rheumatoid	Drug: CE-224,535;Drug: Placebo	Pfizer	NULL	Completed	18 Years	N/A	Both	100	Phase 2/Phase 3	United States;Chile;Czech Republic;Korea, Republic of;Mexico;Poland;Spain
2263	EUCTR2006-006373-25-GR (EUCTR)	26/02/2008	20/09/2007		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2264	EUCTR2006-006591-37-GR (EUCTR)	26/02/2008	20/09/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	264		Greece;Austria
2265	EUCTR2006-005035-19-GR (EUCTR)	26/02/2008	20/09/2007	A LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/A	A LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/A	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden
2266	EUCTR2007-000828-40-FR (EUCTR)	26/02/2008	11/12/2007	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	France;Poland;Austria;Germany;Italy
2267	EUCTR2007-001585-33-GR (EUCTR)	26/02/2008	09/08/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman- La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2268	EUCTR2006-006562-42-GB (EUCTR)	21/02/2008	13/01/2009	An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia	An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia	Cachexia in patients with Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept 50mg	Derby Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	32	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2269	EUCTR2007-000828-40-AT (EUCTR)	21/02/2008	31/03/2008	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076	A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Germany;France;Italy;Poland;Austria
2270	EUCTR2004-002132-26-GB (EUCTR)	19/02/2008	11/03/2005	A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A	A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A	Rheumatoid Arthritis	Product Name: Ocrelizumab / rhuMAb 2H7 Product Code: Ro 496-4913 INN or Proposed INN: Ocrelizumab Other descriptive name: rhuMAb 2H7	F. Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	160	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Spain;United Kingdom
2271	EUCTR2007-003647-75-GB (EUCTR)	15/02/2008	10/12/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	90	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Finland;Netherlands;United Kingdom;Sweden
2272	EUCTR2007-002066-35-IT (EUCTR)	13/02/2008	07/09/2007	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND	CP-690,550 is being developed as a disease-modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: CP-690,550 Product Name: CP-690,550 Trade Name: Humira INN or Proposed INN: Adalimumab	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece
2273	EUCTR2007-002066-35-GR (EUCTR)	11/02/2008	20/09/2007	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira®	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy
2274	EUCTR2006-005036-24-BG (EUCTR)	08/02/2008	07/02/2008	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	483	Phase 2	Hungary;Czech Republic;Bulgaria;Sweden
2275	EUCTR2007-003647-75-NL (EUCTR)	07/02/2008	29/11/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;Finland;Netherlands;United Kingdom;Sweden
2276	EUCTR2007-003647-75-SE (EUCTR)	06/02/2008	04/12/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Finland;United Kingdom;Netherlands;France;Sweden
2277	EUCTR2007-000896-41-ES (EUCTR)	06/02/2008	18/12/2007	Estudio aleatorizado doble ciego que compara la seguridad y la eficacia de la administración semanal de 50 mg de etanercept, 25 mg de etanercept y placebo en combinación con metotrexato en pacientes con artritis reumatoide moderadamente activa que han obtenido una respuesta adecuada con 50 mg de etanercept semanal y metotrexatoA Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	Estudio aleatorizado doble ciego que compara la seguridad y la eficacia de la administración semanal de 50 mg de etanercept, 25 mg de etanercept y placebo en combinación con metotrexato en pacientes con artritis reumatoide moderadamente activa que han obtenido una respuesta adecuada con 50 mg de etanercept semanal y metotrexatoA Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	Artritis reumatoideRheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2278	EUCTR2006-004140-23-GB (EUCTR)	04/02/2008	07/11/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Finland;Portugal;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2279	EUCTR2007-002536-29-BE (EUCTR)	01/02/2008	20/11/2007	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
2280	EUCTR2007-002536-29-PT (EUCTR)	01/02/2008	21/11/2007	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Finland;Portugal;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2281	EUCTR2007-002066-35-DE (EUCTR)	01/02/2008	17/02/2009	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg Injektionslösung in Fertigspritze INN or Proposed INN: Adalimumab	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Hungary;Czech Republic;Germany;Bulgaria;Italy;Greece
2282	EUCTR2006-005035-19-DE (EUCTR)	01/02/2008	04/10/2007	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 2;Phase 3	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2283	NCT01072058 (ClinicalTrials.gov)	February 2008	18/2/2010	Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker	Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker	Arthritis, Rheumatoid;Spondylitis, Ankylosing	Drug: TNF blockers (infliximab, adalimumab, etanercept)	University of Sao Paulo	NULL	Active, not recruiting	18 Years	70 Years	Both	100	Phase 4	Brazil
2284	EUCTR2007-002066-35-BG (EUCTR)	31/01/2008	15/02/2008	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira®	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Czech Republic;Hungary;Greece;Bulgaria;Germany;Italy
2285	EUCTR2007-003647-75-FI (EUCTR)	31/01/2008	19/12/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Finland;United Kingdom;Netherlands;France;Sweden
2286	EUCTR2007-002536-29-IT (EUCTR)	30/01/2008	09/01/2008	A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED MULTICENTRE PHASE II STUDY OF ATACICEPT IN ANTI-TNFA NAIVE PATIENTS WITH MODERATE TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE - ATACICEPT IN ANTI TNF-a NAIVE SUBJECTS WITH RA	A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED MULTICENTRE PHASE II STUDY OF ATACICEPT IN ANTI-TNFA NAIVE PATIENTS WITH MODERATE TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE - ATACICEPT IN ANTI TNF-a NAIVE SUBJECTS WITH RA	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Trade Name: HUMIRA INN or Proposed INN: Adalimumab	MERCK SERONO INTERNATIONAL SA	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2287	EUCTR2007-006729-28-GB (EUCTR)	25/01/2008	04/12/2007	Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA	Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA	The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA. MedDRA version: 9.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up	Trade Name: Kenalog Product Name: Triamcinolone acetonide INN or Proposed INN: TRIAMCINOLONE ACETONIDE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE	Trafford NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	58		United Kingdom
2288	EUCTR2006-006591-37-AT (EUCTR)	25/01/2008	04/01/2008	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	264		Greece;Austria
2289	EUCTR2007-003069-42-GB (EUCTR)	24/01/2008	15/08/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;United Kingdom;Estonia;Lithuania
2290	EUCTR2007-000012-90-GB (EUCTR)	23/01/2008	28/03/2007	The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial	The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial	The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure. MedDRA version: 13.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 13.1;Level: PT;Classification code 10041591;Term: Spinal osteoarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Celebrex Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses	University of Dundee	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Denmark;Netherlands;United Kingdom
2291	EUCTR2007-002536-29-ES (EUCTR)	18/01/2008	14/02/2008	Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, fase II de atacicept en pacientes con artritis reumatoide moderada a gravemente activa, sin tratamiento previo con anti-TNFa y con respuesta insuficiente a metrotexato.A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti-TNFa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate. - Atacicept en pacientes con AR sin tratamiento previo con anti-TNFa	Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, fase II de atacicept en pacientes con artritis reumatoide moderada a gravemente activa, sin tratamiento previo con anti-TNFa y con respuesta insuficiente a metrotexato.A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti-TNFa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate. - Atacicept en pacientes con AR sin tratamiento previo con anti-TNFa	Artritis ReumatoideRheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
2292	EUCTR2007-000593-24-SE (EUCTR)	16/01/2008	21/11/2007	An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.	An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Humira INN or Proposed INN: adalimumab Other descriptive name: Humira	F.Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	52		United Kingdom;Sweden
2293	EUCTR2007-001420-12-CZ (EUCTR)	16/01/2008	13/11/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Czech Republic;France;Poland;Sweden
2294	EUCTR2007-002066-35-CZ (EUCTR)	09/01/2008	23/10/2007	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Product Name: CP-690,550 Other descriptive name: CP-690,550-10 Trade Name: Humira® 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: Humira®	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece
2295	EUCTR2007-002950-42-PL (EUCTR)	09/01/2008	24/08/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	GlaxoSmithKline Research and Development	NULL	Not Recruiting			Female: yes Male: yes	248	Phase 3	Czech Republic;Hungary;Spain;Poland;Lithuania;United Kingdom
2296	ChiCTR-CCC-10001054	2008-01-01	2010-08-25	Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis	Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis	ra	1:none;2:Infliximab ;	National Sciences Foundation of China	NULL	Completed	28	58	Both	1:39;2:39;		China
2297	NCT00603525 (ClinicalTrials.gov)	January 2008	16/1/2008	Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-a Antagonist Therapy	A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies	Arthritis, Rheumatoid	Drug: Ofatumumab;Drug: Placebo	GlaxoSmithKline	NULL	Terminated	18 Years	N/A	All	169	Phase 3	Argentina;Denmark;France;Germany;Italy;Korea, Republic of;Netherlands;Norway;Peru;Spain;Sweden;United Kingdom
2298	EUCTR2006-003577-27-ES (EUCTR)	21/12/2007	09/10/2007	ESTUDIO DE FASE IIA, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO, DE DOCE SEMANAS DE DURACIÓN PARA EVALUAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE PH-797804 ADMINISTRADO POR VIA ORAL UNA VEZ AL DÍA EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - n/a	ESTUDIO DE FASE IIA, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO, DE DOCE SEMANAS DE DURACIÓN PARA EVALUAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE PH-797804 ADMINISTRADO POR VIA ORAL UNA VEZ AL DÍA EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - n/a	Tratamiento de artritis reumatoide (AR) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide	Pfizer S.A.	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	Czech Republic;Estonia;Spain
2299	EUCTR2006-005137-38-GB (EUCTR)	21/12/2007	14/08/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Finland;Denmark;Germany;United Kingdom;Sweden
2300	EUCTR2007-001420-12-PL (EUCTR)	20/12/2007	17/10/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Czech Republic;France;Poland;Sweden
2301	EUCTR2006-005353-30-AT (EUCTR)	19/12/2007	23/05/2007	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis.	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	600		Spain;Lithuania;Austria;United Kingdom;Italy
2302	EUCTR2007-001035-58-PT (EUCTR)	14/12/2007	16/08/2007	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE - N/A	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE - N/A	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Maraviroc Product Code: UK-427,857 INN or Proposed INN: Maraviroc	Pfizer Inc, 235 East 42nd Street,New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	114	Phase 2	Portugal;Spain;Italy
2303	EUCTR2007-002536-29-SE (EUCTR)	12/12/2007	26/10/2007	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2304	EUCTR2007-001114-17-GB (EUCTR)	12/12/2007	13/02/2008	A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA).	A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA).	Rheumatoid Arthritis (RA)	Product Name: Actemra Product Code: RO4877533 (TCZ)	F. Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom
2305	EUCTR2007-002951-18-NL (EUCTR)	10/12/2007	09/08/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 3	Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden
2306	EUCTR2007-001665-15-IT (EUCTR)	10/12/2007	05/10/2007	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND	rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: Canakinumab Product Code: ACZ885	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	179	Phase 2	Germany;Netherlands;Spain;Italy
2307	EUCTR2006-005137-38-DK (EUCTR)	10/12/2007	08/06/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		France;Finland;Denmark;Germany;United Kingdom;Sweden
2308	EUCTR2007-004878-31-DK (EUCTR)	10/12/2007	09/10/2007	An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403	An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Hungary;Denmark;United Kingdom
2309	EUCTR2007-004878-31-GB (EUCTR)	07/12/2007	16/10/2007	An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403	An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	264	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Denmark;United Kingdom
2310	EUCTR2007-000491-16-AT (EUCTR)	06/12/2007	05/04/2007	A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available	A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	260		Germany;Spain;Austria
2311	EUCTR2006-004139-31-NL (EUCTR)	02/12/2007	26/04/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden
2312	NCT00647270 (ClinicalTrials.gov)	December 2007	27/3/2008	Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing	A Multi-center, Randomized, Double-blind,Placebo-controlled Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing	Rheumatoid Arthritis	Drug: adalimumab;Drug: Placebo	Abbott	NULL	Completed	18 Years	N/A	All	420	Phase 3	United States;Australia;Canada;Germany;Puerto Rico;United Kingdom
2313	EUCTR2007-002950-42-ES (EUCTR)	27/11/2007	11/10/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	248	Phase 3	Czech Republic;Hungary;Belgium;Poland;Spain;Lithuania;United Kingdom
2314	EUCTR2007-002951-18-ES (EUCTR)	27/11/2007	11/10/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 3	France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2315	EUCTR2007-001035-58-IT (EUCTR)	21/11/2007	05/10/2007	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE - ND	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATE - ND	Treatment of rheumatoid arthritis (RA). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Maraviroc Product Code: UK-427,857	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	114	Phase 2	Portugal;Spain;Italy
2316	EUCTR2007-002536-29-FI (EUCTR)	19/11/2007	15/10/2007	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
2317	EUCTR2007-001585-33-ES (EUCTR)	15/11/2007	13/09/2007	Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE	Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE	Artritis reumatoide (AR)Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2318	EUCTR2006-005035-19-CZ (EUCTR)	14/11/2007	20/09/2007	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citate (Phase III formulation) Product Code: CP-690,550-10 Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed) Product Code: CP-690,550-10	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4500	Phase 2;Phase 3	Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2319	EUCTR2006-006373-25-CZ (EUCTR)	14/11/2007	20/09/2007		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2320	EUCTR2007-001585-33-LT (EUCTR)	13/11/2007	05/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2321	EUCTR2007-000886-40-PT (EUCTR)	09/11/2007	07/08/2007	Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER	Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER	patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE	sanofi-aventis groupe	NULL	Not Recruiting			Female: yes Male: yes	200		Portugal;Italy
2322	EUCTR2007-002536-29-AT (EUCTR)	09/11/2007	15/10/2007	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden
2323	EUCTR2007-001665-15-NL (EUCTR)	09/11/2007	17/10/2007	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	179	Phase 2	Germany;Netherlands;Spain;Italy
2324	NCT00302952 (ClinicalTrials.gov)	November 6, 2007	13/3/2006	Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis	A Double Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Lovastatin;Drug: Placebo	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Terminated	18 Years	70 Years	All	64	Phase 2	United States
2325	EUCTR2007-000896-41-NL (EUCTR)	05/11/2007	17/10/2007	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
2326	EUCTR2007-000012-90-DK (EUCTR)	02/11/2007	25/09/2007	The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety StudyDansk:Klinisk forsøg med standardbehandling versus celecoxib (SCOT-forsøget)Et stort, strømlinet forsøg i lægemiddelsikkerhed - SCOT Trial	The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety StudyDansk:Klinisk forsøg med standardbehandling versus celecoxib (SCOT-forsøget)Et stort, strømlinet forsøg i lægemiddelsikkerhed - SCOT Trial	The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure. MedDRA version: 9.1;Level: LLT;Classification code 10041591;Term: Spinal osteoarthritis MedDRA version: 9.1;Classification code 10003268;Term: Arthritis rheumatoid	Trade Name: Celebra (celecoxib) INN or Proposed INN: CELECOXIB Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses	University of Dundee	NULL	Not Recruiting			Female: yes Male: yes	13682	Phase 4	Denmark;Netherlands;United Kingdom
2327	NCT00664573 (ClinicalTrials.gov)	November 2007	21/4/2008	Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Patients	Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.	Rheumatoid Arthritis	Biological: Baminercept alfa (BG9924)	Biogen Idec	NULL	Terminated	18 Years	75 Years	Both	339	Phase 2	Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom
2328	NCT00533897 (ClinicalTrials.gov)	November 2007	20/9/2007	Phase IIIB Subcutaneous Missed Dose Study	A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Abatacept;Drug: Placebo	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	270	Phase 3	United States;Argentina;Canada;Mexico;South Africa;Brazil
2329	NCT01245361 (ClinicalTrials.gov)	November 2007	19/11/2010	A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit	A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001.	Undifferentiated Arthritis	Drug: Infliximab;Drug: sodium chloride	Patrick Durez	NULL	Completed	N/A	N/A	Both	30	N/A	Belgium
2330	NCT00578305 (ClinicalTrials.gov)	November 2007	19/12/2007	A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate	A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis	Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	185	Phase 3	Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom
2331	NCT00554853 (ClinicalTrials.gov)	November 2007	6/11/2007	PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease	Peroxisome Proliferator-activated Receptor-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease	Rheumatoid Arthritis	Drug: pioglitazone;Drug: Sublingual nitroglycerine	University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)	Completed	21 Years	100 Years	All	143	Phase 3	United States
2332	NCT00840957 (ClinicalTrials.gov)	November 2007	10/2/2009	Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis	Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab	Rheumatoid Arthritis	Biological: infliximab	University Hospital, Tours	NULL	Completed	18 Years	N/A	Both	84	N/A	France
2333	EUCTR2007-003069-42-EE (EUCTR)	31/10/2007	10/08/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)	RHEUMATOID ARTHRITIS (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole INN or Proposed INN: Dipyridamole Product Code: CRx-102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole	CombinatoRx, Incorporated	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;United Kingdom;Estonia;Lithuania
2334	EUCTR2007-001035-58-ES (EUCTR)	30/10/2007	26/07/2007	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATEESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATEESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A	ARTRITIS REUMATOIDERHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Maraviroc Product Code: UK-427,857 INN or Proposed INN: Maraviroc	Pfizer, S. A.	NULL	Not Recruiting			Female: yes Male: yes	114	Phase 2	Portugal;Spain;Italy
2335	EUCTR2007-001585-33-DK (EUCTR)	26/10/2007	12/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2336	EUCTR2006-006591-37-BE (EUCTR)	25/10/2007	12/06/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	264		Greece;Belgium;Austria
2337	EUCTR2006-005137-38-DE (EUCTR)	23/10/2007	23/08/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:	Trade Name: Enbrel Product Name: Etanercept Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Etanercept Auto-Injector Product Code: L04AA11 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		France;Finland;Denmark;Germany;United Kingdom;Sweden
2338	EUCTR2007-002945-18-IT (EUCTR)	22/10/2007	07/02/2008	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - ND	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - ND	Rheumatoid arthritis MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies	Product Name: Ofatumumab Product Code: HuMax-CD20	GENMAB A/S	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Czech Republic;Italy
2339	EUCTR2006-005330-20-SE (EUCTR)	22/10/2007	27/08/2007	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800		France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2340	EUCTR2006-003768-67-ES (EUCTR)	19/10/2007	10/09/2007	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate.Estudio de fase IIIB, multicéntrico, aleatorizado, en doble ciego y controlado con placebo, para evaluar los cambios a corto plazo en la sinovitis y el daño estructural en sujetos con artritis reumatoide activa y respuesta inadecuada al metotrexato tratados con abatacept frente a placebo más un tratamiento de fondo de metotrexato+ Protocol Amendment 01 (Version 1.0, Dated 16-May-2007) and Administrative Letter (Version 1.0, Dated 13-Jun-2007).	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate.Estudio de fase IIIB, multicéntrico, aleatorizado, en doble ciego y controlado con placebo, para evaluar los cambios a corto plazo en la sinovitis y el daño estructural en sujetos con artritis reumatoide activa y respuesta inadecuada al metotrexato tratados con abatacept frente a placebo más un tratamiento de fondo de metotrexato+ Protocol Amendment 01 (Version 1.0, Dated 16-May-2007) and Administrative Letter (Version 1.0, Dated 13-Jun-2007).	RHEUMATOID ARTHRITIS,NOSARTRITIS REUMATOIDE, NOS MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 3	Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
2341	EUCTR2007-002950-42-HU (EUCTR)	18/10/2007	31/07/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	248	Phase 3	Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom
2342	EUCTR2007-001420-12-FR (EUCTR)	17/10/2007	23/07/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	France;Czech Republic;Slovakia;Poland;Belgium;Sweden
2343	EUCTR2007-001665-15-DE (EUCTR)	16/10/2007	30/07/2007	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed)	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	179	Phase 2	Germany;Netherlands;Spain;Italy
2344	EUCTR2007-002950-42-CZ (EUCTR)	15/10/2007	15/08/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	GlaxoSmithKline Research and Development	NULL	Not Recruiting			Female: yes Male: yes	248	Phase 3	Hungary;Czech Republic;Spain;Poland;Lithuania;United Kingdom
2345	EUCTR2007-002945-18-CZ (EUCTR)	15/10/2007	27/08/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Czech Republic
2346	EUCTR2007-001420-12-SK (EUCTR)	15/10/2007	18/04/2008	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	France;Czech Republic;Slovakia;Poland;Belgium;Sweden
2347	EUCTR2006-003698-29-EE (EUCTR)	12/10/2007	24/08/2007	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Hungary;United Kingdom;Czech Republic;Netherlands;France;Estonia;Ireland;Italy;Latvia;Austria;Sweden
2348	EUCTR2007-001420-12-SE (EUCTR)	12/10/2007	20/07/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Czech Republic;France;Poland;Sweden
2349	EUCTR2006-005353-30-LT (EUCTR)	10/10/2007	28/06/2007	A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) FILM.	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. - FILM	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	600		United States;Panama;Philippines;Taiwan;Thailand;Spain;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand;Korea, Republic of
2350	EUCTR2006-005330-20-IT (EUCTR)	10/10/2007	15/10/2007	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-α therapy. - ND	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-α therapy. - ND	Rheumatoid Arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: Ocrelizumab Product Code: RO 496-4913	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	1000		France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2351	EUCTR2007-001585-33-EE (EUCTR)	10/10/2007	18/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2352	EUCTR2007-001585-33-FR (EUCTR)	09/10/2007	23/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	France;Czech Republic;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2353	EUCTR2006-003698-29-IT (EUCTR)	05/10/2007	03/04/2007	A long term assessment of safety and physical function with AMG 108 subcutaneous monthly treatment in subjects with Rheumatoid Arthritis - AMG 108 20060119	A long term assessment of safety and physical function with AMG 108 subcutaneous monthly treatment in subjects with Rheumatoid Arthritis - AMG 108 20060119	Rheumatoid Arthritis AR MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: AMG 108 Product Code: AMG 108	AMGEN S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	784		Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2354	EUCTR2007-000733-19-HU (EUCTR)	04/10/2007	09/08/2007	A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202	A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Hungary;United Kingdom
2355	EUCTR2007-000733-19-GB (EUCTR)	02/10/2007	26/06/2007	A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202	A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Hungary;United Kingdom
2356	EUCTR2007-000734-38-GB (EUCTR)	02/10/2007	26/06/2007	An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203	An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom
2357	JPRN-UMIN000000837	2007/10/01	01/10/2007	Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study	Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study - "Bucillamine And Salazosulphapyridine In Combination therapy" study (BASIC study)	Rheumatoid arthritis	Bucillamine mono-therapy(It's possible to choose the combination therapy with salazosulphapyridine at 6 months after the start of the treatment) Salazosulphapyridine mono-therapy(It's possible to choose the combination therapy with bucillamineat 6 months after the start of the treatment) Combination therapy of bucillamine and salazosulphapyridine (over the study period)	BASIC study group	NULL	Recruiting	20years-old	75years-old	Male and Female	180	Not applicable	Japan
2358	EUCTR2006-005353-30-IT (EUCTR)	01/10/2007	19/07/2007	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - ND	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - ND	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO496-4913	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	600		Spain;Lithuania;Austria;United Kingdom;Italy
2359	NCT02699892 (ClinicalTrials.gov)	October 2007	25/2/2016	Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis	Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	130	N/A	Serbia
2360	NCT00554606 (ClinicalTrials.gov)	October 2007	5/11/2007	Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis	A 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: ACZ885	Novartis	NULL	Completed	18 Years	75 Years	All	115	Phase 2	United States;Belgium;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;Turkey
2361	NCT00595517 (ClinicalTrials.gov)	October 2007	7/1/2008	Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer	A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use	Gastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;Lumbago	Drug: Esomeprazole 20 mg	AstraZeneca	NULL	Completed	20 Years	N/A	All	395	Phase 3	Japan
2362	EUCTR2007-002951-18-IT (EUCTR)	28/09/2007	05/10/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-alfa; antagonist therapy - ND	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-alfa; antagonist therapy - ND	Rheumatoid arthritis MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies	Product Name: Ofatumumab Product Code: HuMax-CD20	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 3	France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
2363	EUCTR2007-001984-31-IT (EUCTR)	28/09/2007	17/12/2007	A PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO KIDNEY ALLOGRAFT RECIPIENTS - ND	A PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO KIDNEY ALLOGRAFT RECIPIENTS - ND	CP-690,550 is an immunosuppressive agent being developed for the prevention of kidney allograft rejection, and for the treatment of rheumatoid arthritis as a disease-modifying anti-rheumatic drug. MedDRA version: 9.1;Level: LLT;Classification code 10023439;Term: Kidney transplant rejection	Product Name: CP-690,550 Product Name: CP-690,550 Trade Name: SANDIMMUN NEORAL*50CPS 25MG INN or Proposed INN: Ciclosporin Trade Name: SANDIMMUN NEORAL*30CPS 100MG INN or Proposed INN: Ciclosporin	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Portugal;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy
2364	EUCTR2006-005147-28-GB (EUCTR)	25/09/2007	18/12/2008	MTX-IR Phase III	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.	Rheumatoid Arthritis (RA) MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2365	EUCTR2006-003768-67-AT (EUCTR)	20/09/2007	26/04/2007	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateAnd Protocol Amendment 01 (Version 1.0, Date 16-May-2007)	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateAnd Protocol Amendment 01 (Version 1.0, Date 16-May-2007)	RHEUMATOID ARTHRITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 3	Germany;United Kingdom;Netherlands;Spain;Austria;Sweden
2366	EUCTR2007-001585-33-NL (EUCTR)	20/09/2007	09/08/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands
2367	EUCTR2007-004694-26-BE (EUCTR)	17/09/2007	10/09/2007	A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA	A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA	Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: REMICADE® (Infliximab) Product Code: -	Saint-Luc Universitary Hospital	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	Belgium
2368	EUCTR2006-006127-40-GB (EUCTR)	16/09/2007	07/12/2006	Cerebral Blood Flow following TNF-alpha Antagonism in Rheumatoid Arthritis - a Pilot Study - TNF/CBF in RA	Cerebral Blood Flow following TNF-alpha Antagonism in Rheumatoid Arthritis - a Pilot Study - TNF/CBF in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira Product Name: Humira 40mg solution for injection in pre-filled syringe (adalimumab) INN or Proposed INN: recombinant human monoclonal antibody	Newcastle-upon-Tyne Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 4	United Kingdom
2369	EUCTR2007-001665-15-ES (EUCTR)	14/09/2007	27/06/2007	Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide.	Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide.	Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Farmaceutica S.A.	NULL	Not Recruiting			Female: yes Male: yes	179		Belgium;Spain;Netherlands;Germany;Italy
2370	EUCTR2006-004834-33-GB (EUCTR)	13/09/2007	14/06/2007	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: Rob 803 6.5mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Code: Rob 803 12.5mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Code: Rob 803 15mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Code: Rob 803 25mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline	OxyPharma AB	NULL	Not Recruiting			Female: yes Male: yes	224	Phase 2	Poland;Belgium;Lithuania;Bulgaria;Latvia;United Kingdom
2371	EUCTR2007-002950-42-LT (EUCTR)	13/09/2007	31/07/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	248	Phase 3	Hungary;United Kingdom;Czech Republic;Spain;Poland;Lithuania
2372	EUCTR2006-004140-23-FI (EUCTR)	13/09/2007	23/05/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono Int, a branch of Laboratoires Serono SA, an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Portugal;Finland;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2373	EUCTR2006-005036-24-HU (EUCTR)	11/09/2007	05/07/2007	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	483	Phase 2	Hungary;Czech Republic;Bulgaria;Sweden
2374	EUCTR2006-005147-28-GR (EUCTR)	11/09/2007	04/05/2007	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.	Rheumatoid Arthritis (RA) Lower Lever Term (LLT) code number 10039073	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000		United Kingdom;Germany;France;Spain;Greece;Austria
2375	EUCTR2006-005330-20-SK (EUCTR)	07/09/2007	10/04/2008	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	France;Czech Republic;Hungary;Slovenia;Slovakia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2376	EUCTR2006-004139-31-HU (EUCTR)	05/09/2007	17/05/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	Slovakia;Greece;Spain;Austria;United Kingdom;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Norway;Sweden
2377	EUCTR2007-001665-15-BE (EUCTR)	05/09/2007	02/08/2007	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis	A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	179	Phase 2	Spain;Belgium;Netherlands;Germany;Italy
2378	EUCTR2006-005640-81-GB (EUCTR)	04/09/2007	27/07/2007	A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA	A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA	Rheumatoid arthritis	Trade Name: Mabthera Product Name: Mabthera Product Code: Rituximab Trade Name: Methylprednisolone Product Name: Methylprednisolone Other descriptive name: Methylprednisolone	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Kingdom
2379	EUCTR2006-003698-29-LV (EUCTR)	03/09/2007	04/09/2007	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2380	NCT00523692 (ClinicalTrials.gov)	September 2007	30/8/2007	Remission Induction in Very Early Rheumatoid Arthritis	Remission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard Therapy	Rheumatoid Arthritis	Drug: Etanercept, methotrexate and depomedrone;Drug: depemedrone	University Hospital Birmingham	Wyeth is now a wholly owned subsidiary of Pfizer	Not yet recruiting	18 Years	N/A	Both	20	Phase 4	United Kingdom
2381	EUCTR2006-003054-26-CZ (EUCTR)	31/08/2007	06/08/2007	A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis - NA	A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis - NA	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: TAK-783	Takeda Global R&D (Europe) Ltd	NULL	Not Recruiting			Female: yes Male: yes	230		Hungary;Czech Republic;Latvia
2382	EUCTR2006-005330-20-SI (EUCTR)	30/08/2007	22/06/2007	anti-TNF-IR phase III	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2383	EUCTR2006-004139-31-DE (EUCTR)	30/08/2007	24/04/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Spain;Greece;Austria;Sweden
2384	EUCTR2006-005036-24-CZ (EUCTR)	27/08/2007	04/07/2007	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	483	Phase 2	Hungary;Czech Republic;Bulgaria;Sweden
2385	EUCTR2006-004834-33-BE (EUCTR)	25/08/2007	21/06/2007	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: Rob 803 6.5mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Code: Rob 803 12.5mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Code: Rob 803 15mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline Product Code: Rob 803 25mg capsule Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline	OxyPharma AB	NULL	Not Recruiting			Female: yes Male: yes	224	Phase 2	Poland;Belgium;Bulgaria;Latvia;United Kingdom
2386	EUCTR2007-001420-12-BE (EUCTR)	23/08/2007	09/07/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	France;Czech Republic;Poland;Belgium;Sweden
2387	EUCTR2007-001585-33-CZ (EUCTR)	22/08/2007	04/09/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2388	EUCTR2007-000734-38-BE (EUCTR)	17/08/2007	25/06/2007	An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203	An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	120		Belgium;United Kingdom
2389	EUCTR2006-005330-20-NL (EUCTR)	15/08/2007	13/06/2007	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. - SCRIPT	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. - SCRIPT	Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000		France;Hungary;Slovenia;Spain;Belgium;Germany;Netherlands;Italy;Sweden
2390	EUCTR2006-003698-29-IE (EUCTR)	08/08/2007	12/01/2007	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Estonia;France;Ireland;Italy;Latvia;Austria;Sweden;Hungary;United Kingdom;Czech Republic;Netherlands
2391	EUCTR2006-004139-31-CZ (EUCTR)	08/08/2007	15/02/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		Hungary;Germany;United Kingdom;Czech Republic;Netherlands;France;Spain;Greece;Austria;Sweden
2392	EUCTR2007-001754-11-IT (EUCTR)	03/08/2007	02/07/2007	Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND	Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Mabthera INN or Proposed INN: Rituximab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Italy
2393	NCT00505089 (ClinicalTrials.gov)	August 2007	19/7/2007	Efficacy and Safety of Subcutaneous Versus Intravenous ACZ885 in Adult Patients With Established Rheumatoid Arthritis	An Exploratory, Open Label Pharmacokinetic - Pharmacodynamic Study to Compare Subcutaneous Versus Intravenous Administration of ACZ885 in Adult Patients With Established Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: ACZ885	Novartis	NULL	Terminated	18 Years	75 Years	Both	11	Phase 1/Phase 2	Belgium;Germany;Netherlands;Poland
2394	NCT00542789 (ClinicalTrials.gov)	August 2007	11/10/2007	Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID	A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use	Gastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;Lumbago	Drug: Esomeprazole;Drug: Placebo	AstraZeneca	NULL	Completed	20 Years	N/A	All	343	Phase 3	Japan
2395	NCT00597818 (ClinicalTrials.gov)	August 2007	10/1/2008	Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury	A Multi-center, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone for the Prevention of NSAID-induced Gastroduodenal Injury in Patients With Osteoarthritis and/or Rheumatoid Arthritis Patients	NSAID-induced Gastroduodenal Injury;Ulcers;Rheumatoid Arthritis;Osteoarthritis	Drug: Cobiprostone;Drug: Placebo;Drug: Non-steroidal anti-inflammatory drug	Sucampo Pharma Americas, LLC	NULL	Completed	40 Years	70 Years	All	121	Phase 2	United States
2396	EUCTR2007-001585-33-LV (EUCTR)	26/07/2007	30/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
2397	EUCTR2006-004834-33-LV (EUCTR)	26/07/2007	08/06/2007	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	Rheumatiod Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Rob 803 Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Product Name: Rob 803 Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Product Name: Rob 803 Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali	OxyPharma AB	NULL	Not Recruiting			Female: yes Male: yes	224	Phase 2	United Kingdom;Bulgaria;Latvia;Poland
2398	EUCTR2006-005147-28-DE (EUCTR)	25/07/2007	05/02/2007	MTX-IR Phase III	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.	Rheumatoid Arthritis (RA) MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2399	EUCTR2006-005330-20-DE (EUCTR)	18/07/2007	09/03/2007	anti TNF-IR phase III	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	Rheumatoid arthritis MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2400	EUCTR2006-003698-29-AT (EUCTR)	18/07/2007	16/08/2006	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2401	EUCTR2006-004666-14-DE (EUCTR)	17/07/2007	02/04/2007	An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available	An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	32		Germany
2402	EUCTR2007-000886-40-CZ (EUCTR)	17/07/2007	30/05/2007	Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER	Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER	patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE	sanofi-aventis groupe	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Portugal;Czech Republic;Italy
2403	EUCTR2006-005330-20-FR (EUCTR)	16/07/2007	26/03/2007	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy.	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2404	EUCTR2006-003698-29-HU (EUCTR)	16/07/2007	29/05/2007	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2405	EUCTR2006-005035-19-SK (EUCTR)	10/07/2007	09/04/2008	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CP-690,550 Product Code: CP-690,550-10 Product Name: CP-690,550 Product Code: CP-690,550-10	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 2;Phase 3	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2406	EUCTR2006-004140-23-PT (EUCTR)	09/07/2007	05/03/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2407	EUCTR2005-001889-13-DE (EUCTR)	09/07/2007	21/12/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab	Schering-Plough Research Institute (SPRI)	NULL	Not Recruiting			Female: yes Male: yes	315		Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
2408	EUCTR2006-004834-33-LT (EUCTR)	05/07/2007	05/06/2007	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust	Rheumatiod Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Rob 803 Product Code: Rob 803 6.25mg capsule Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Product Name: Rob 803 Product Code: Rob 803 12.5mg capsule Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Product Name: Rob 803 Product Code: Rob 803 15mg capsule Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali Product Name: Rob 803 Product Code: Rob 803 25mg capsule Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali	OxyPharma AB	NULL	Not Recruiting			Female: yes Male: yes	224	Phase 2	Poland;Belgium;Lithuania;Bulgaria;Latvia;United Kingdom
2409	EUCTR2006-004140-23-GR (EUCTR)	03/07/2007	04/04/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	288	Phase 2	Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2410	EUCTR2006-006746-33-DE (EUCTR)	28/06/2007	12/03/2007	Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR	Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR	Rheumatoid arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	240		Germany
2411	EUCTR2006-005466-39-HU (EUCTR)	25/06/2007	22/03/2007	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Hungary;United Kingdom
2412	EUCTR2007-000491-16-BE (EUCTR)	22/06/2007	04/05/2007	A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available	A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes			Spain;Belgium;Austria;Germany
2413	EUCTR2007-000760-24-CZ (EUCTR)	21/06/2007	09/05/2007	Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA	Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA	Patients with active rheumatoid arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SSR150106XB Product Code: SSR150106XB INN or Proposed INN: NA Other descriptive name: NA	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	Czech Republic
2414	EUCTR2006-001553-10-DE (EUCTR)	19/06/2007	21/02/2007	A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204	A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204	Early Rheumatoid Arthritis in adults MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 Trade Name: Methotrexat 2,5 mg Tabletten medac Product Name: Methotrexate (MTX) INN or Proposed INN: Methotrexate Other descriptive name: MTX	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 2	Germany;Netherlands;Italy
2415	EUCTR2006-005137-38-FR (EUCTR)	19/06/2007	10/04/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:	Trade Name: Enbrel Product Name: Enbrel Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	724	Phase 3	France;Finland;Denmark;Germany;United Kingdom;Sweden
2416	EUCTR2006-005137-38-FI (EUCTR)	18/06/2007	15/05/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		Finland;Germany;United Kingdom;Denmark;France;Sweden
2417	EUCTR2007-000491-16-DE (EUCTR)	08/06/2007	22/03/2007	A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available	A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed)	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		Germany;Spain;Austria
2418	EUCTR2006-005330-20-BE (EUCTR)	07/06/2007	28/02/2007	anti TNF-IR phase III	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2419	EUCTR2006-004140-23-CZ (EUCTR)	06/06/2007	18/12/2006	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Sweden
2420	EUCTR2006-004666-14-BE (EUCTR)	04/06/2007	29/03/2007	An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available	An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	32		Belgium;Germany
2421	EUCTR2006-004140-23-SE (EUCTR)	04/06/2007	03/05/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono Int, a branch ofLaboratories Serono S.A. an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2422	EUCTR2006-005035-19-IT (EUCTR)	01/06/2007	04/07/2007	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS - ND	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS - ND	Relief of signs and symptoms, improvement of physical function, and structure preservation in rheumatoid arthritis RA . MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Product Name: CP-690,550	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2	Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden
2423	EUCTR2006-003768-67-GB (EUCTR)	01/06/2007	12/02/2007	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 02, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), and Administrative Letter dated 13-Jun-2007.	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 02, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), and Administrative Letter dated 13-Jun-2007.	RHEUMATOID ARTHRITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 3	Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
2424	EUCTR2006-003054-26-LV (EUCTR)	01/06/2007	12/09/2007	A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: TAK-783	Takeda Global R&D (Europe) Ltd	NULL	Not Recruiting			Female: yes Male: yes	230		Hungary;Czech Republic;Latvia
2425	EUCTR2006-005330-20-HU (EUCTR)	01/06/2007	10/04/2007	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000		France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden
2426	NCT00447759 (ClinicalTrials.gov)	June 2007	14/3/2007	The Standard Care Versus Celecoxib Outcome Trial	Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's	Osteoarthritis;Rheumatoid Arthritis	Drug: Celecoxib;Drug: Diclofenac	University of Dundee	University of Glasgow;University of Nottingham	Completed	60 Years	N/A	All	7297	Phase 4	Denmark;Netherlands;United Kingdom
2427	NCT00422227 (ClinicalTrials.gov)	June 2007	11/1/2007	Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region	A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	70 Years	All	300	Phase 4	Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand
2428	EUCTR2006-004140-23-DE (EUCTR)	31/05/2007	14/08/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono Int, a branch of Laboratoires Seron SA an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Portugal;Greece;Finland;Spain;Belgium;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Sweden
2429	EUCTR2006-005137-38-SE (EUCTR)	29/05/2007	30/04/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		Finland;Germany;United Kingdom;Denmark;France;Sweden
2430	EUCTR2006-005147-28-BE (EUCTR)	24/05/2007	21/02/2007	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.	Rheumatoid Arthritis (RA)	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2431	EUCTR2007-000082-38-DK (EUCTR)	24/05/2007	26/03/2007	The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study	The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study	In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira (adalimumab) Product Name: Humira® (adalimumab) Product Code: 2593 INN or Proposed INN: Adalimumab	Aarhus University Hospital, Denmark	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Denmark
2432	EUCTR2006-001553-10-NL (EUCTR)	23/05/2007	02/04/2007	A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204	A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204	Early Rheumatoid Arthritis in adults MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: ACZ885 Drug Substance Other descriptive name: ACZ885 Drug Substance	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	92	Phase 2	Germany;Netherlands;Italy
2433	EUCTR2006-005036-24-SK (EUCTR)	21/05/2007	03/04/2007	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-	Pfizer Ltd - Ramsgate Road, Sandwich CT139NJ, UK.	NULL	Not Recruiting			Female: yes Male: yes	483	Phase 2	Hungary;Czech Republic;Slovakia;Bulgaria;Sweden
2434	EUCTR2006-003768-67-NL (EUCTR)	16/05/2007	27/03/2007	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate	RHEUMATOID ARTHRITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 3	Germany;United Kingdom;Netherlands;Spain;Austria;Sweden
2435	EUCTR2007-001190-28-GB (EUCTR)	09/05/2007	17/04/2007	Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT	Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Methotrexate Product Code: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: Sulfasalazine Product Code: Sulfasalazine INN or Proposed INN: SULFASALAZINE Product Name: Hydroxychloroquine Product Code: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Product Name: Ciclosporin Product Code: Ciclosporin INN or Proposed INN: Ciclosporin Product Name: Leflunomide Product Code: Leflunomide INN or Proposed INN: Leflunomide Product Name: Sodium aurothiomalate (intramuscular gold) Product Code: Sodium aurothiomalate (intramuscular gold) INN or Proposed INN: Sodium aurothiomalate Product Name: methylprednisolone Product Code: methylprednisolone INN or Proposed INN: Methylprednisolone Product Name: Prednisolone Product Code: Predniso	King's College London	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 4	United Kingdom
2436	EUCTR2006-005467-26-BE (EUCTR)	08/05/2007	14/02/2007	A phase 2b, randomised, double-blind, placebo-controlled, multi-centre, dose-finding study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of BG9924 when given in combination with methotrexate to subjects with active Rheumatoid Arthritis who have had an inadequate response to anti-TNF therapy	A phase 2b, randomised, double-blind, placebo-controlled, multi-centre, dose-finding study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of BG9924 when given in combination with methotrexate to subjects with active Rheumatoid Arthritis who have had an inadequate response to anti-TNF therapy	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Belgium;United Kingdom
2437	EUCTR2006-005147-28-FR (EUCTR)	07/05/2007	06/03/2007	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.	Rheumatoid Arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2438	EUCTR2006-006373-25-SE (EUCTR)	04/05/2007	16/03/2007		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2439	EUCTR2006-005035-19-SE (EUCTR)	04/05/2007	16/03/2007	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4500	Phase 2;Phase 3	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2440	EUCTR2006-005036-24-SE (EUCTR)	04/05/2007	16/03/2007	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1- Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-	Pfizer Ltd - Ramsgate Road, Sandwich CT139NJ, UK.	NULL	Not Recruiting			Female: yes Male: yes	483	Phase 2	Hungary;Czech Republic;Bulgaria;Sweden
2441	EUCTR2006-004139-31-SE (EUCTR)	02/05/2007	12/02/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden
2442	NCT00455208 (ClinicalTrials.gov)	May 2007	30/3/2007	A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis	Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis	Rheumatoid Arthritis;Osteoarthritis	Drug: Cura-100	Cura Biotech LLC	NULL	Not yet recruiting	20 Years	50 Years	Both	20	Phase 1/Phase 2	United States
2443	NCT00504595 (ClinicalTrials.gov)	May 2007	19/7/2007	Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis	A 12-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR20) and to Determine a Biomarker Profile in Adult Patients With Established Rheumatoid Arthritis Responding to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) as Compared to Healthy Subjects Exposed to ACZ885	Rheumatoid Arthritis	Drug: ACZ885 (investigational);Drug: Placebo	Novartis	NULL	Completed	18 Years	75 Years	All	80	Phase 2	Russian Federation;Spain;Switzerland;Turkey
2444	EUCTR2007-000491-16-ES (EUCTR)	30/04/2007	05/03/2007	Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available	Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available	Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Farmacéutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Belgium;Spain;Austria;Germany
2445	EUCTR2006-003768-67-BE (EUCTR)	27/04/2007	23/04/2007	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.	RHEUMATOID ARTHRITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 3	Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
2446	EUCTR2006-004140-23-ES (EUCTR)	24/04/2007	05/03/2007	Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, en fase II para la determinación de la dosis de atacicept, administrado por vía subcutánea, en pacientes con artritis reumatoide y con respuesta insuficiente al tratamiento con antagonistas del TNF - Atacicept en pacientes con AR y fracaso a anti-TNF, Fase II	Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, en fase II para la determinación de la dosis de atacicept, administrado por vía subcutánea, en pacientes con artritis reumatoide y con respuesta insuficiente al tratamiento con antagonistas del TNF - Atacicept en pacientes con AR y fracaso a anti-TNF, Fase II	Pacientes con Artritis Reumatoide. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	288	Phase 2	Portugal;Slovakia;Greece;Finland;Spain;Italy;United Kingdom;Czech Republic;Belgium;Bulgaria;Netherlands;Germany;Sweden
2447	EUCTR2006-004139-31-ES (EUCTR)	23/04/2007	25/01/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA	Rheumatoid Arthritis. Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
2448	EUCTR2006-002216-10-NL (EUCTR)	20/04/2007	02/11/2006	A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER	A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: PG-760564 Product Code: PG-760564	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	270		Hungary;United Kingdom;Czech Republic;Netherlands
2449	EUCTR2005-002660-29-HU (EUCTR)	20/04/2007	08/11/2005	A Phase 1b/2 Multiple-Dose Safety and Pharmacokinetic/Pharmacodynamic Study of LY2189102 in Patients with Rheumatoid Arthritis	A Phase 1b/2 Multiple-Dose Safety and Pharmacokinetic/Pharmacodynamic Study of LY2189102 in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis	Product Name: Anti IL-1ß antibody Product Code: LY2189102 Other descriptive name: Anti IL-1ß antibody, subclass IgG4	Eli Lilly and Company Limited	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 1	Hungary;Spain
2450	EUCTR2006-006373-25-SK (EUCTR)	20/04/2007	03/04/2007	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
2451	EUCTR2006-005035-19-BE (EUCTR)	17/04/2007	09/01/2007	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4500	Phase 2;Phase 3	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2452	EUCTR2006-005147-28-AT (EUCTR)	16/04/2007	23/03/2007	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. - STAGE	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. - STAGE	Rheumatoid Arthritis (RA)	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	France;Greece;Spain;Belgium;Austria;Germany;United Kingdom
2453	EUCTR2006-005466-39-GB (EUCTR)	12/04/2007	07/01/2007	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	380	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;United Kingdom
2454	EUCTR2006-005467-26-GB (EUCTR)	12/04/2007	16/01/2007	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapy	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapy	Rheumatoid Arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Belgium;United Kingdom
2455	EUCTR2006-004140-23-BE (EUCTR)	10/04/2007	07/02/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2456	EUCTR2006-004669-32-ES (EUCTR)	09/04/2007	06/02/2007	Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available	Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available	Artritis reumatoide establecida MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Farmacéutica S.A	NULL	Not Recruiting			Female: yes Male: yes	80		Spain
2457	EUCTR2006-006032-22-GB (EUCTR)	04/04/2007	26/02/2007	TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RA	TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RA	Rheumatoid arthritis is associated with increased mortality from cardiovascular disease (CVD). Statins have a proven effect in reducing CVD events in at-risk populations, mostly due to their cholesterol-lowering properties, but possibly through anti-inflammatory and immunomodulatory effects. This trial will assess the hypothesis that atorvastatin is more effective than placebo in the primary prevention of cardiovascular events in patients with RA.	Product Name: Atorvastatin INN or Proposed INN: ATORVASTATIN	University of Manchester	Dudley Group of Hospitals NHS Trust	Not Recruiting			Female: yes Male: yes	5350	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Kingdom
2458	EUCTR2006-004139-31-BE (EUCTR)	03/04/2007	19/12/2006	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
2459	EUCTR2005-003558-83-EE (EUCTR)	02/04/2007	07/02/2007	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2460	EUCTR2006-004140-23-SK (EUCTR)	02/04/2007	19/01/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Portugal;Slovakia;Greece;Finland;Spain;Italy;United Kingdom;Czech Republic;Belgium;Bulgaria;Netherlands;Germany;Sweden
2461	NCT00484237 (ClinicalTrials.gov)	April 2007	7/6/2007	A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis	A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: etanercept	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	20 Years	75 Years	Both	80	Phase 3	Japan
2462	EUCTR2006-005035-19-ES (EUCTR)	26/03/2007	23/01/2007	ESTUDIO ABIERTO DE SEGUIMIENTO A LARGO PLAZO DE CP-690,550, UN INHIBIDOR DE LA JANUS QUINASA 3 MODERADAMENTE SELECTIVO, PARA EL TRATAMIENTO DE LA ARTRITIS REUMATOIDEA LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/A	ESTUDIO ABIERTO DE SEGUIMIENTO A LARGO PLAZO DE CP-690,550, UN INHIBIDOR DE LA JANUS QUINASA 3 MODERADAMENTE SELECTIVO, PARA EL TRATAMIENTO DE LA ARTRITIS REUMATOIDEA LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/A	Artritis reumatoide (AR)Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-ß-oxo-1- Product Name: CP-690,550 Other descriptive name: (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-ß-oxo-1-	Pfizer S.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2	Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden
2463	EUCTR2006-003768-67-SE (EUCTR)	23/03/2007	07/02/2007	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.	RHEUMATOID ARTHRITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 3	Germany;United Kingdom;Netherlands;Spain;Austria;Sweden
2464	EUCTR2006-006373-25-ES (EUCTR)	23/03/2007	24/01/2007		ESTUDIO OBSERVACIONAL PROSPECTIVO PARA EVALUAR LA SEGURIDAD A LARGO PLAZO Y EL ESTADO FUNCIONAL DE SUJETOS CON ARTRITIS REUMATOIDE INCLUIDOS PREVIAMENTE EN ESTUDIOS DE CP-690,550A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	CP-690,550 se está desarrollando como fármaco antirreumático modificador de la enfermedad (FARME) para el tratamiento de la artritis reumatoide (AR).CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer, S.A.	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2465	EUCTR2006-001553-10-BE (EUCTR)	20/03/2007	21/02/2007	A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204	A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204	Early Rheumatoid Arthritis in adults MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: ACZ885 Drug Substance Other descriptive name: ACZ885 Drug Substance	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	92	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Belgium;Netherlands;Germany;Italy
2466	EUCTR2006-003768-67-DE (EUCTR)	19/03/2007	19/02/2007	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007. And Protocol Amemdment 02 - Site specific (Version 1.0, Dated 16-May-2007)	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007. And Protocol Amemdment 02 - Site specific (Version 1.0, Dated 16-May-2007)	RHEUMATOID ARTHRITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 3	United Kingdom;Germany;Netherlands;Spain;Austria;Sweden
2467	EUCTR2006-004139-31-FR (EUCTR)	12/03/2007	12/02/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	Slovakia;Greece;Spain;Austria;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Norway;Sweden
2468	EUCTR2006-004140-23-BG (EUCTR)	09/03/2007	01/03/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	288	Phase 2	Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2469	EUCTR2005-002909-23-PT (EUCTR)	08/03/2007	03/01/2007	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden
2470	EUCTR2006-003146-41-DE (EUCTR)	08/03/2007	23/11/2006	A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARD	A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARD	Musculoskeletal disorders MedDRA version: 8.1;Level: LLT;Classification code 10048592;Term: Musculoskeletal disorder	Trade Name: Humira Product Name: HUMIRA INN or Proposed INN: Adalimumab Trade Name: Metex Product Name: Metex	Charité-Universitätsmedizin Berlin; Department of Rheumatology and Clinical Immunology	NULL	Not Recruiting			Female: yes Male: yes			Germany
2471	EUCTR2006-004139-31-GB (EUCTR)	06/03/2007	02/01/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
2472	EUCTR2005-003558-83-LV (EUCTR)	02/03/2007	12/02/2007	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2473	NCT00487825 (ClinicalTrials.gov)	March 2007	18/6/2007	Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis	A 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Drug: Canakinumab (investigational);Drug: Placebo;Drug: Methotrexate (MTX)	Novartis	NULL	Completed	18 Years	75 Years	All	78	Phase 2	United States;Belgium;Germany;Italy;Netherlands;Spain
2474	EUCTR2006-004140-23-IT (EUCTR)	26/02/2007	11/04/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A phase II dose-finding study of atacicept in RA	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ATACICEPT Product Code: TACI - FC5	SERONO INTERNATIONAL SA	NULL	Not Recruiting			Female: yes Male: yes	288	Phase 2	Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2475	EUCTR2006-006380-22-DE (EUCTR)	22/02/2007	28/12/2006	Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry	Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry	Patients with rheumatoid arthritis or seronegative spondylarthropathy with at least one inflamed finger joint (MCP, PIP, DIP) referred for RSO with with Erbium [169Er]citrate MedDRA version: 8.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Trade Name: ERMM-1 INN or Proposed INN: erbium citrate	CIS bio international	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 4	Germany
2476	EUCTR2006-005035-19-AT (EUCTR)	15/02/2007	12/02/2007	A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis	A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib citrate (Phase III formulation) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 2;Phase 3	United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden
2477	EUCTR2006-004139-31-SK (EUCTR)	15/02/2007	19/01/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	Slovakia;Greece;Spain;Austria;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Norway;Sweden
2478	EUCTR2006-006373-25-AT (EUCTR)	15/02/2007	12/02/2007		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
2479	EUCTR2006-002216-10-HU (EUCTR)	15/02/2007	25/10/2006	A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER	A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: PG-760564 Product Code: PG-760564	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	270		Hungary;United Kingdom;Czech Republic;Netherlands
2480	EUCTR2006-001550-27-FI (EUCTR)	13/02/2007	10/10/2006	A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available	A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available	Active Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: N/A Other descriptive name: N/A	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	260		Finland;Germany;Spain;Austria
2481	EUCTR2006-004139-31-AT (EUCTR)	13/02/2007	06/02/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA	Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden
2482	EUCTR2006-001550-27-DE (EUCTR)	13/02/2007	19/10/2006	A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate	A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate	Active Rheumatoid Arthritis	Product Name: ACZ885 Product Code: ACZ885	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	293		Finland;Spain;Austria;Germany
2483	EUCTR2004-002993-49-EE (EUCTR)	02/02/2007	23/02/2005		A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
2484	EUCTR2005-003558-83-IE (EUCTR)	01/02/2007	13/03/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Czech Republic;United Kingdom;Netherlands;Estonia;Spain;Ireland;Italy;Latvia;Austria;Sweden
2485	NCT00425932 (ClinicalTrials.gov)	February 2007	22/1/2007	Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis	Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Rituximab	Gaylis, Norman B., M.D.	Oklahoma Medical Research Foundation;Genentech, Inc.	Completed	18 Years	80 Years	Both	60	Phase 2	United States
2486	NCT00418717 (ClinicalTrials.gov)	February 2007	2/1/2007	Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA	An Open-label, Multicenter, Dose-regimen Study Evaluating the Efficacy and Safety of Etanercept 50 mg Once-weekly Dose in Japanese Subjects With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: etanercept	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	20 Years	75 Years	All	42	Phase 3	Japan
2487	EUCTR2004-001234-17-GR (EUCTR)	30/01/2007	18/09/2006	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: Celebrex Product Name: Celebrex INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltrarol SR Product Name: Voltrarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Trade Name: Losec Product Name: Losec INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole		Pfizer Hellas	Not Recruiting			Female: yes Male: yes	4402		Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2488	EUCTR2006-001553-10-IT (EUCTR)	26/01/2007	15/05/2007	A 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - ND	A 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - ND	Early rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	87	Phase 2	Germany;Netherlands;Italy
2489	EUCTR2006-002216-10-GB (EUCTR)	22/01/2007	16/02/2012	A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER	A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: PG-760564 Product Code: PG-760564	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	270	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Czech Republic;Netherlands;United Kingdom
2490	EUCTR2004-001234-17-EE (EUCTR)	22/01/2007	29/12/2005	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: Celebrex Product Name: Celebrex Product Code: not applicable INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltarol SR (generics also available in the EU) Product Name: Voltarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Trade Name: Losec Product Name: Losec Product Code: not applicable INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole		Pfizer Inc. New York	Not Recruiting			Female: yes Male: yes	4402		Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2491	EUCTR2006-003983-73-CZ (EUCTR)	17/01/2007	22/11/2006	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: RWJ-445380 Capsules 50 mg Product Code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC Product Name: RWJ-445380 capsule 100 mg Product Code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC Product Name: RWJ-445380 capsules 150 mg Product Code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Germany;Czech Republic
2492	EUCTR2006-006275-21-GB (EUCTR)	10/01/2007	18/10/2011	A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RA	A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RA	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Humira Trade Name: Enbrel	University Hospital Birmingham NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	124	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2493	NCT00716248 (ClinicalTrials.gov)	January 2007	8/7/2008	Bucillamine Study of Holding Remission After Infliximab Dose-off	The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate	Rheumatoid Arthritis	Drug: bucillamine;Drug: methotrexate	Saitama Medical University	Keio University	Active, not recruiting	20 Years	N/A	Both	40	Phase 4	Japan
2494	EUCTR2005-001889-13-FR (EUCTR)	27/12/2006	30/11/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up	Trade Name: Remicade INN or Proposed INN: Infliximab	Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):	Portugal;France;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2495	EUCTR2006-005386-19-BE (EUCTR)	19/12/2006	03/11/2006	Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini	Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini	Rheumatoid arthritis refractory to TNF blockers patients MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera	Cliniques Universitaires Saint-Luc	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Belgium
2496	EUCTR2006-003698-29-BE (EUCTR)	18/12/2006	13/11/2006	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		France;Estonia;Hungary;Czech Republic;Belgium;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2497	EUCTR2006-003698-29-GB (EUCTR)	14/12/2006	29/09/2006	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Hungary;Czech Republic;United Kingdom;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2498	EUCTR2006-004140-23-NL (EUCTR)	13/12/2006	26/04/2007	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5	Merck Serono Int.a branch of Laboratoires Serono SA an affiliate of Merck KgaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden
2499	EUCTR2005-003232-21-DE (EUCTR)	11/12/2006	04/09/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	625		Hungary;Germany;Malta;Latvia;Lithuania
2500	EUCTR2005-003232-21-MT (EUCTR)	07/12/2006	18/01/2007	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	625		Hungary;Germany;Malta;Latvia;Lithuania
2501	EUCTR2006-003577-27-EE (EUCTR)	01/12/2006	29/09/2006	A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - na	A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - na	Treatment of rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide	Pfizer Luxembourg SARL Branch Office Estonia	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	Czech Republic;Estonia;Spain
2502	NCT00440492 (ClinicalTrials.gov)	December 2006	23/2/2007	Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis	An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: PLA-695	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	75 Years	Both		Phase 1	United States;Canada
2503	NCT00420927 (ClinicalTrials.gov)	December 2006	9/1/2007	Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)	Rheumatoid Arthritis	Drug: methotrexate;Biological: placebo;Biological: adalimumab	Abbott	NULL	Completed	18 Years	N/A	All	1032	Phase 4	United States;Argentina;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Slovakia;South Africa;Spain;Sweden;United Kingdom;Greece
2504	NCT00413452 (ClinicalTrials.gov)	December 2006	15/12/2006	Etanercept SFP in RA Patients	Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: Etanercept	Amgen	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	Both	224	Phase 3	United States;Canada
2505	EUCTR2005-003232-21-LT (EUCTR)	30/11/2006	10/10/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab pre-filled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	625		Hungary;Germany;Malta;Latvia;Lithuania
2506	EUCTR2006-003142-42-DE (EUCTR)	30/11/2006	02/02/2007	A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis	A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SC12267	4SC AG	NULL	Not Recruiting			Female: yes Male: yes	120		Germany
2507	EUCTR2006-003577-27-CZ (EUCTR)	29/11/2006	11/10/2006	A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - na	A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - na	Treatment of rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide	Pfizer Ltd	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	Czech Republic;Estonia;Spain
2508	EUCTR2006-002216-10-CZ (EUCTR)	27/11/2006	12/10/2006	A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER	A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: PG-760564 Product Code: PG-760564	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	270		Hungary;United Kingdom;Czech Republic;Netherlands
2509	EUCTR2005-003632-22-ES (EUCTR)	22/11/2006	20/03/2012	A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.	An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritis	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3	Phase 2	Spain
2510	EUCTR2005-003232-21-HU (EUCTR)	22/11/2006	06/09/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	625		Hungary;Germany;Malta;Latvia;Lithuania
2511	NCT00761514 (ClinicalTrials.gov)	November 2006	25/9/2008	Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira	Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR)	Rheumatoid Arthritis	Drug: Humira (adalimumab)	Abbott	NULL	Terminated	18 Years	N/A	All	14	Phase 4	Puerto Rico
2512	NCT00395577 (ClinicalTrials.gov)	November 2006	1/11/2006	A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702	A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate	Rheumatoid Arthritis	Drug: VX-702	Vertex Pharmaceuticals Incorporated	NULL	Completed	18 Years	75 Years	Both	120	Phase 2	Bulgaria;Croatia;Former Serbia and Montenegro;Poland;Russian Federation;Slovenia
2513	NCT00072982 (ClinicalTrials.gov)	November 2006	13/11/2003	Treatment of Rheumatoid Arthritis With Marine and Botanical Oils	Treatment of Rheumatoid Arthritis With Marine and Botanical Oils	Rheumatoid Arthritis	Drug: fish oil;Drug: borage seed oil;Drug: combination fish oil and borage seed oil	National Center for Complementary and Integrative Health (NCCIH)	NULL	Active, not recruiting	18 Years	85 Years	Both	156	Phase 3	United States
2514	NCT00396812 (ClinicalTrials.gov)	November 2006	6/11/2006	Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)	An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Terminated	18 Years	N/A	All	4	Phase 1/Phase 2	United States
2515	NCT00424346 (ClinicalTrials.gov)	November 2006	17/1/2007	Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis	A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week Extensions	Rheumatoid Arthritis	Drug: Canakinumab;Drug: Placebo	Novartis	NULL	Completed	18 Years	N/A	All	274	Phase 2	United States;Austria;Belgium;Canada;Germany;Spain;Finland
2516	NCT02079532 (ClinicalTrials.gov)	November 2006	4/3/2014	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor	An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent	Rheumatoid Arthritis	Drug: rituximab [MabThera]	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	All	302	Phase 3	Germany
2517	EUCTR2006-003698-29-NL (EUCTR)	26/10/2006	14/06/2007	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2518	EUCTR2006-004715-22-SI (EUCTR)	26/10/2006	17/10/2006	A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with Methotrexate	A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with Methotrexate	Rheumatoid Arthritis	Product Code: VX-702	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Slovenia
2519	EUCTR2005-002219-26-HU (EUCTR)	25/10/2006	19/04/2006	A randomized, parallel group, placebo-controlled, double blind study to asses the safety and tolerability of SB 681323 at 7.5 mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatois arthritis”	A randomized, parallel group, placebo-controlled, double blind study to asses the safety and tolerability of SB 681323 at 7.5 mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatois arthritis”	Rheumatoid Arthritis patients with CRP higher than 10 mg/L	Product Code: SB 681323	GlaxoSmithKline	NULL	Not Recruiting			Female: yes Male: yes	82	Phase 2	Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2520	EUCTR2006-001550-27-BE (EUCTR)	23/10/2006	17/08/2006	A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available	A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available	Active Rheumatoid Arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: N/A Other descriptive name: N/A	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	260		Finland;Spain;Belgium;Austria;Germany
2521	EUCTR2006-003698-29-CZ (EUCTR)	20/10/2006	29/08/2006	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2522	EUCTR2006-003698-29-SK (EUCTR)	19/10/2006	29/09/2006	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784	Phase 2	Estonia;Slovakia;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Netherlands;Latvia;Sweden
2523	EUCTR2006-004673-98-HU (EUCTR)	16/10/2006	08/09/2006	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.	Trade Name: MabThera 500 mg concentrate for solution for infusion	Roche (Hungary) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20		Hungary
2524	EUCTR2006-003698-29-FR (EUCTR)	05/10/2006	14/09/2006	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784	Phase 2	Estonia;Slovakia;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Netherlands;Latvia;Sweden
2525	EUCTR2006-003698-29-SE (EUCTR)	03/10/2006	17/08/2006	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden
2526	EUCTR2006-000363-28-GB (EUCTR)	03/10/2006	28/04/2006	DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study	DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study	Rheumatoid arthritis and Psoriatic arthritis	Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: Etanercept	Greater Glasgow Health Board	Glasgow University	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2527	EUCTR2005-003232-21-LV (EUCTR)	02/10/2006	29/09/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis (RA)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	625		Hungary;Germany;Malta;Latvia;Lithuania
2528	JPRN-UMIN000000512	2006/10/01	03/11/2006	Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate	Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate - Combination therapy with Methotrexate, Infliximab, and Tacrolimus (COMMIT project)	Rheumatoid Arthritis	If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks. If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.	Rheumatosurgery, Osaka City University Medical School	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	30	Not applicable	Japan
2529	EUCTR2005-002396-33-HU (EUCTR)	26/09/2006	07/07/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
2530	EUCTR2006-005391-40-IT (EUCTR)	25/09/2006	05/06/2007	Study on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - ND	Study on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - ND	Patients with Rheumatoid Arthritis Level: PTClassification code 10039073	Product Name: Platelet Rich Plasma INN or Proposed INN: Triamcinolone	AZIENDA OSPEDALIERA SENESE	NULL	Not Recruiting			Female: yes Male: yes			Italy
2531	EUCTR2006-001000-37-DE (EUCTR)	19/09/2006	16/06/2006	Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST	Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST	Rheumatoid arthritis MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	300		Germany
2532	EUCTR2006-001550-27-AT (EUCTR)	18/09/2006	25/07/2006	A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available	A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available	Active Rheumatoid Arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: N/A Other descriptive name: N/A	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	260		Finland;Germany;Spain;Austria
2533	EUCTR2006-001428-38-GB (EUCTR)	18/09/2006	29/09/2006	Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA	Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA	Patients with early inflamatory arthritis (duration of symptoms of < 12 weeks) who are at very high risk of the development of rheumatoid arthritis (seropositivity for Rheumatoid factor and anti-CCP antibody)	Trade Name: Enbrel Trade Name: Methorexate Trade Name: Depo-Medrone Trade Name: Salazopyrin En-Tabs Trade Name: Plaquenil	University Hospitals Birmingham NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	United Kingdom
2534	EUCTR2005-002396-33-SK (EUCTR)	14/09/2006	15/06/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Finland;United Kingdom;Germany;Slovakia;Spain;Italy
2535	EUCTR2005-001742-16-NL (EUCTR)	06/09/2006	22/03/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - NA	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - NA	Active rheumatoid arthritis (RA)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	420		Germany;United Kingdom;Netherlands;Spain;Austria
2536	EUCTR2005-002219-26-NO (EUCTR)	05/09/2006	18/07/2005	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	Rheumatoid arthritis (RA)	Product Name: SB-681323 Tablets Product Code: SB-681323	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	82	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2537	EUCTR2004-001490-26-EE (EUCTR)	01/09/2006	08/03/2006	A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA	A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA	RHEUMATOID ARTHRITIS	Trade Name: Persantin 100 mg Product Name: N/A Product Code: CRx-150 INN or Proposed INN: Dipyridamole and Amoxapine Trade Name: Defanyl 50 and 100 mg Product Name: N/A Product Code: CRx-150	CombinatoRx, Inc	NULL	Not Recruiting			Female: yes Male: yes	72		United Kingdom;Estonia
2538	EUCTR2005-006165-14-CZ (EUCTR)	18/08/2006	24/08/2006	A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA	A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: MLN3897 Product Code: N/A INN or Proposed INN: N/A Other descriptive name: AVE9897 Trade Name: Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol. Product Name: Methotrexate Product Code: N/A INN or Proposed INN: Methotrexate Other descriptive name: N/A	Millennium Pharmaceuticals Inc	,NULL	Not Recruiting			Female: yes Male: yes	186	Phase 2	United Kingdom;Czech Republic;Netherlands
2539	EUCTR2005-006165-14-NL (EUCTR)	16/08/2006	01/06/2006	A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA	A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: MLN3897 Product Code: N/A INN or Proposed INN: N/A Other descriptive name: AVE9897 Trade Name: Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol Product Name: Methotrexate Product Code: N/A INN or Proposed INN: Methotrexate Other descriptive name: N/A	Millennium Pharmaceuticals Inc	,NULL	Not Recruiting			Female: yes Male: yes	186	Phase 2	Czech Republic;United Kingdom;Netherlands
2540	EUCTR2005-002326-63-EE (EUCTR)	09/08/2006	26/08/2005	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	Rheumatoid Arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	590	Phase 3	Czech Republic;Estonia;Latvia;Lithuania
2541	EUCTR2005-006165-14-GB (EUCTR)	03/08/2006	11/05/2006	A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA	A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: MLN3897 Product Code: N/A INN or Proposed INN: N/A Other descriptive name: AVE9897 Trade Name: Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol. Product Name: Methotrexate Product Code: N/A INN or Proposed INN: Methotrexate Other descriptive name: N/A	Millennium Pharmaceuticals Inc	,NULL	Not Recruiting			Female: yes Male: yes	186	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Netherlands;United Kingdom
2542	JPRN-C000000452	2006/08/01	01/08/2006	Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept	Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept - RIVERAME	rheumatoid arthritis	methotrexate 8mg/week methotrexate 8mg/week and etanercept(25mg x1-2/week) for 3 months methotrexate 8mg/week and etanercept(25mgx1-2/week) for 6 months	Johoku Biological Summit	NULL	Pending	Not applicable	Not applicable	Male and Female	50	Phase 4	Japan
2543	EUCTR2006-004062-13-IT (EUCTR)	18/07/2006	30/08/2006	Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A.	Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A.	RHEUMATOID ARTHRITIS MedDRA version: 6.1;Level: PT;Classification code 10039073	Trade Name: DEPALGOS*20+325MG 28CPR RP INN or Proposed INN: OXICODONE DC.IT INN or Proposed INN: PARACETAMOLO DC.IT FU	A.U.S.L. RIMINI	NULL	Not Recruiting			Female: yes Male: yes	149	Phase 2	Italy
2544	EUCTR2005-003558-83-NL (EUCTR)	13/07/2006	20/04/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - Not available	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - Not available	Rheumatoid arthritis (RA)	Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2545	EUCTR2005-001889-13-NL (EUCTR)	13/07/2006	20/04/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up	Trade Name: Remicade	Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):	France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2546	EUCTR2004-003296-36-HU (EUCTR)	10/07/2006	14/06/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA	Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	400		Hungary;Germany
2547	EUCTR2004-003295-10-HU (EUCTR)	04/07/2006	30/12/2005	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA	Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;United Kingdom;Spain;Italy
2548	EUCTR2004-001234-17-GB (EUCTR)	15/06/2006	15/09/2005	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: Celebrex Product Name: Celebrex Product Code: not applicable INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltrarol SR Product Name: Voltrarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Trade Name: Losec Product Name: Losec Product Code: not applicable INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Pfizer Limited	NULL	Not Recruiting			Female: yes Male: yes	4402	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes	Portugal;Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
2549	EUCTR2005-003558-83-BE (EUCTR)	09/06/2006	17/05/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Estonia;Czech Republic;Spain;Belgium;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2550	EUCTR2005-001742-16-DE (EUCTR)	07/06/2006	23/03/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER	Active rheumatoid arthritis (RA)	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	420		United Kingdom;Germany;Netherlands;Spain;Austria
2551	EUCTR2005-001742-16-ES (EUCTR)	02/06/2006	19/04/2006	Estudio múlticéntrico, aleatorio, doble ciego, controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFalfa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa tratados previamente con agentes biológicos anti-TNFalfa.	Estudio múlticéntrico, aleatorio, doble ciego, controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFalfa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa tratados previamente con agentes biológicos anti-TNFalfa.	Active rheumatoid arthritis (RA)Artritis Reumatoide activa	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	420		Germany;United Kingdom;Netherlands;Spain;Austria
2552	NCT00443950 (ClinicalTrials.gov)	June 2006	5/3/2007	Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis	A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate	Arthritis, Rheumatoid	Drug: Etanercept	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	Both	150	Phase 3	China
2553	EUCTR2006-000854-32-AT (EUCTR)	29/05/2006	19/05/2006	Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers	Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers	Rheumatoid Arthritis	Trade Name: Rituximab - MabThera Product Name: Rituximab MabThera Product Code: no	Vienna Medical University	NULL	Not Recruiting			Female: yes Male: yes	20		Austria
2554	EUCTR2005-001742-16-GB (EUCTR)	26/05/2006	03/03/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER	Active rheumatoid arthritis (RA)	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	420	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Finland;Spain;Austria;Germany;Netherlands;United Kingdom
2555	EUCTR2004-001234-17-SE (EUCTR)	22/05/2006	27/10/2005	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: celebra Product Name: Celebrex Product Code: not applicable INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Product Name: Voltrarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Product Name: Losec Product Code: not applicable INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Pfizer AB	NULL	Not Recruiting			Female: yes Male: yes	4402		Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2556	EUCTR2004-003295-10-GB (EUCTR)	17/05/2006	08/12/2005	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA	Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Hungary;Spain;Austria;Italy;United Kingdom
2557	EUCTR2005-001742-16-FI (EUCTR)	17/05/2006	04/04/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER	Active rheumatoid arthritis (RA)	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	420		Finland;Spain;Austria;Germany;Netherlands;United Kingdom
2558	EUCTR2005-002909-23-IS (EUCTR)	08/05/2006	25/04/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Germany;Iceland;Italy;United Kingdom;Sweden
2559	EUCTR2005-001889-13-DK (EUCTR)	04/05/2006	16/03/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab. MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up	Trade Name: Remicade	Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315		Portugal;Germany;Netherlands;Belgium;Denmark;France;Greece;Sweden
2560	EUCTR2005-000158-61-LT (EUCTR)	03/05/2006	06/01/2006		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celebrex INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2561	EUCTR2005-001889-13-GR (EUCTR)	02/05/2006	23/05/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Remicade	Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):	France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2562	EUCTR2005-001742-16-AT (EUCTR)	01/05/2006	30/03/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER	Active rheumatoid arthritis (RA)	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	420		Germany;United Kingdom;Netherlands;Spain;Austria
2563	EUCTR2005-003558-83-IT (EUCTR)	28/04/2006	23/06/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis. - AMG 108	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis. - AMG 108	Rheumatoid Arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Code: AMG 108 Product Code: AMG 108 Product Code: AMG 108	AMGEN S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	784		Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2564	EUCTR2005-002396-33-DE (EUCTR)	27/04/2006	10/11/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
2565	EUCTR2005-002395-15-DE (EUCTR)	27/04/2006	22/11/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2566	EUCTR2004-003295-10-ES (EUCTR)	25/04/2006	17/02/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid ArthritisEnsayo múlticéntrico, aleatorizado, en doble ciego y controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa no tratados previamente con metotrexato	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid ArthritisEnsayo múlticéntrico, aleatorizado, en doble ciego y controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa no tratados previamente con metotrexato	Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)Artritis Reumatoide activa (no tratada previamente con metotrexato)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;United Kingdom;Spain;Italy
2567	EUCTR2005-002392-32-DE (EUCTR)	20/04/2006	29/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
2568	EUCTR2005-002909-23-FI (EUCTR)	19/04/2006	23/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
2569	EUCTR2005-000158-61-DE (EUCTR)	18/04/2006	16/05/2006		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Hungary;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2570	EUCTR2004-001930-18-EE (EUCTR)	17/04/2006	19/01/2006	A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA	A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA	RHEUMATOID ARTHRITIS	Trade Name: Persantin 100 mg and Product Name: N/A Product Code: CRx-102 INN or Proposed INN: prednisolone & dipyridamole	CombinatoRx, Inc	NULL	Not Recruiting			Female: yes Male: yes	60		Estonia
2571	EUCTR2004-005102-68-CZ (EUCTR)	14/04/2006	14/04/2006	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006.	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006.	RHEUMATOID ARTHRITIS,NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Germany;United Kingdom;Czech Republic;Belgium;Spain;Ireland;Italy
2572	EUCTR2005-003558-83-AT (EUCTR)	13/04/2006	20/03/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2573	EUCTR2005-002909-23-IT (EUCTR)	11/04/2006	14/03/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra INN or Proposed INN: Ro Actemra	F. Hoffmann - La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	2420		Sweden;Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;United Kingdom;Italy
2574	EUCTR2004-004995-35-DK (EUCTR)	10/04/2006	20/09/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;Germany;United Kingdom;Denmark;Italy
2575	EUCTR2005-001889-13-PT (EUCTR)	07/04/2006	17/01/2006	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab	Schering Plough Research Institute, a Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	315		Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
2576	EUCTR2005-003558-83-CZ (EUCTR)	07/04/2006	23/01/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108	Rheumatoid arthritis (RA)	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		United Kingdom;Czech Republic;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2577	EUCTR2005-005013-37-GB (EUCTR)	06/04/2006	20/01/2006	A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA	A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA	Early Rheumatoid Arthritis	Trade Name: Remicade Product Name: Remicade Product Code: Infliximab Trade Name: Mextrex Product Name: Methotrexate Product Code: Mextrex INN or Proposed INN: n/a Other descriptive name: Methotrexate Trade Name: Ferrograd Folic Tablets Product Name: Folic Acid Product Code: Ferrograd INN or Proposed INN: n/a Other descriptive name: Folic Acid Trade Name: Solu-Medrone 2 Gram Product Name: Methylprednisolone Product Code: Solu-Medrone 2 Gram INN or Proposed INN: n/a Other descriptive name: Methylprednisolone Trade Name: Solu-Medrone 2 Gram Product Name: Methylprednisolone Product Code: Solu-Medrone 2 Gram INN or Proposed INN: n/a	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	112	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2578	EUCTR2005-003558-83-ES (EUCTR)	04/04/2006	16/02/2006	Estudio aleatorizado, doble ciego, controlado con placebo, y de dosis múltiple, para evaluar la eficacia, seguridad y farmacocinética de AMG 108 subcutáneo en sujetos con artritis reumatoide. (A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis).	Estudio aleatorizado, doble ciego, controlado con placebo, y de dosis múltiple, para evaluar la eficacia, seguridad y farmacocinética de AMG 108 subcutáneo en sujetos con artritis reumatoide. (A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis).	Artritis Reumatoide (Rheumatoid arthritis - RA)	Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784	Phase 2	Estonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2579	EUCTR2004-001234-17-PT (EUCTR)	30/03/2006	26/05/2006	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: Celebrex Product Name: Celebrex INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltrarol SR Product Name: Voltrarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Trade Name: Losec Product Name: Losec INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Laboratórios Pfizer, Lda	NULL	Not Recruiting			Female: yes Male: yes	4402		Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2580	EUCTR2005-002909-23-NO (EUCTR)	30/03/2006	11/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Norway;Germany;Iceland;Sweden
2581	EUCTR2004-003296-36-DE (EUCTR)	29/03/2006	24/11/2005	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA	Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	400		Hungary;Germany
2582	EUCTR2005-002396-33-GB (EUCTR)	28/03/2006	11/05/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):	Hungary;Slovakia;Finland;Belgium;Spain;Germany;Italy;United Kingdom
2583	EUCTR2005-002909-23-GB (EUCTR)	27/03/2006	13/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
2584	EUCTR2005-004582-41-GB (EUCTR)	24/03/2006	27/01/2006	Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA	Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA	Active Rheumatoid Arthritis	Trade Name: Mabthera Product Name: Mabthera Product Code: Rituximab Trade Name: Arava Product Name: Arava Product Code: Leflunomide Trade Name: Solu-Medrone 2 Gram Product Name: Solu-Medrone 2mg Product Code: Methylprednisolone	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	15	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2585	EUCTR2005-003558-83-SK (EUCTR)	22/03/2006	23/01/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108	Rheumatoid arthritis (RA)	Product Name: AMG 108 Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784	Phase 2	Estonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2586	EUCTR2005-000784-26-AT (EUCTR)	22/03/2006	21/02/2006	A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005, andProtocol Amendments 3 & 4 - Site Specific dated 28-Dec-2005.	A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005, andProtocol Amendments 3 & 4 - Site Specific dated 28-Dec-2005.	Rheumatoid Arthritis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria
2587	EUCTR2005-003558-83-GB (EUCTR)	21/03/2006	13/01/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Estonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
2588	EUCTR2004-001234-17-DE (EUCTR)	20/03/2006	14/12/2005	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - CONDOR	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - CONDOR	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: Celebrex 200 mg Hartkapseln Product Name: Celebrex INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltarol SR Product Name: Voltarol SR INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]- phenyl]-acetate Trade Name: Losec Capsules 20 mg Product Name: Losec INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy- 3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Pfizer Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	4402		Portugal;Estonia;Czech Republic;Greece;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
2589	EUCTR2005-002219-26-GB (EUCTR)	20/03/2006	13/01/2006	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	Rheumatoid arthritis (RA)	Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: SB-681323 Tablets Product Code: SB-681323	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	82	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2590	EUCTR2005-002909-23-SI (EUCTR)	16/03/2006	20/02/2006	A long-term 5-year study investigation whethetr tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		United States;Portugal;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden
2591	EUCTR2005-002909-23-CZ (EUCTR)	13/03/2006	13/01/2006	A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2420		France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden;Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland
2592	EUCTR2005-002909-23-LT (EUCTR)	07/03/2006	11/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: tocilizumab	F Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden
2593	EUCTR2005-002396-33-FI (EUCTR)	06/03/2006	22/12/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab Product Name: Methotrexate Product Code: Methotrexate	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		United Kingdom;Germany;Spain;Italy;Hungary;Finland;Slovakia
2594	EUCTR2005-001889-13-BE (EUCTR)	06/03/2006	19/12/2005	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab	Schering Plough Research Institute, a Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	315	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2595	EUCTR2004-003771-37-HU (EUCTR)	03/03/2006	03/11/2005	A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II	A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II	Active Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073	Product Name: HuMax-CD20 Product Code: HuMax-CD20 INN or Proposed INN: N/A Other descriptive name: Human monoclonal antibody directed against CD20 on B-cells	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 1/2	Hungary
2596	NCT00603993 (ClinicalTrials.gov)	March 2006	10/1/2008	Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis	A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Adalimumab	Abbott	Abbott Japan Co.,Ltd;Eisai Co., Ltd.	Completed	20 Years	N/A	All	88	Phase 3	Japan
2597	EUCTR2005-003495-38-GR (EUCTR)	27/02/2006	30/06/2006	Part A: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.Part B: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 1 dose of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy	Part A: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.Part B: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 1 dose of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 2	Estonia;Greece;Spain;Ireland;Germany;United Kingdom
2598	EUCTR2005-002395-15-CZ (EUCTR)	27/02/2006	27/02/2006	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2599	EUCTR2004-001234-17-LV (EUCTR)	27/02/2006	13/02/2008	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Product Name: Celebrex Product Code: not applicable INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Product Name: Voltrarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Product Name: Losec Product Code: not applicable INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole		NULL	Not Recruiting			Female: yes Male: yes	4402		Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2600	EUCTR2005-002629-30-LV (EUCTR)	27/02/2006	01/03/2006	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	Rheumatoid arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Czech Republic;Estonia;Latvia;Lithuania
2601	EUCTR2005-003694-25-CZ (EUCTR)	27/02/2006	17/03/2006	A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).	A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).	Rheumatoid Arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Trade Name: Methotrexate Sodium 2.5mg Tablets Product Name: Methotrexate Sodium 2.5mg Tablets Product Code: PL 00095/5079R Other descriptive name: Methotrexate Sodium 2.5mg Tablets	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	200		Czech Republic;Spain;Italy
2602	EUCTR2004-004995-35-GB (EUCTR)	24/02/2006	16/03/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Trade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;Austria;Denmark;Germany;Italy;United Kingdom
2603	EUCTR2005-002909-23-DK (EUCTR)	21/02/2006	23/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
2604	EUCTR2004-003295-10-IT (EUCTR)	20/02/2006	29/11/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF 945; Monoclonal Antibody, Administered Subcutaneously, in Methotrexatena ve Subjects with Active Rheumatoid Arthritis - CNTO148 T05	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF 945; Monoclonal Antibody, Administered Subcutaneously, in Methotrexatena ve Subjects with Active Rheumatoid Arthritis - CNTO148 T05	RA in subjects who are naive to metotrexate MedDRA version: 8.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders	Product Name: golimumab Product Code: CNTO148 INN or Proposed INN: Methotrexate Product Name: golimumab Product Code: CNTO148	CENTOCOR	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Hungary;Spain;Austria;United Kingdom;Italy
2605	EUCTR2005-003558-83-SE (EUCTR)	16/02/2006	24/01/2006	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis (RA)	Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784		Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden
2606	EUCTR2005-003436-21-CZ (EUCTR)	15/02/2006	07/11/2005	A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114	A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SMP-114 Product Code: SMP-114 INN or Proposed INN: rimacalib	Dainippon Sumitomo Pharma Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Hungary;Germany;United Kingdom;Czech Republic
2607	EUCTR2005-002629-30-CZ (EUCTR)	15/02/2006	01/02/2006	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	Rheumatoid arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Inc	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Czech Republic;Estonia;Latvia;Lithuania
2608	EUCTR2005-002629-30-EE (EUCTR)	13/02/2006	23/02/2006	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	Rheumatoid arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Inc	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Czech Republic;Estonia;Lithuania;Latvia
2609	EUCTR2005-002395-15-SE (EUCTR)	13/02/2006	12/12/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2610	EUCTR2005-002909-23-SE (EUCTR)	09/02/2006	23/12/2005	A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Germany;Norway;Sweden
2611	EUCTR2005-002629-30-SK (EUCTR)	03/02/2006	04/01/2006	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	Rheumatoid arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Estonia;Czech Republic;Slovakia;Lithuania;Latvia
2612	EUCTR2004-001234-17-BE (EUCTR)	02/02/2006	24/10/2005	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: Celebrex Product Name: Celebrex Product Code: not applicable INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltarol SR (generics also available in the EU) Product Name: Voltarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Trade Name: Losec Product Name: Losec Product Code: not applicable INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Pfizer SA/NV	NULL	Not Recruiting			Female: yes Male: yes	4402		Portugal;Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
2613	EUCTR2005-005295-32-GB (EUCTR)	01/02/2006	02/12/2005	Trial in rheumatoid arthritis of lisinopril (TRALIS) - TRALIS	Trial in rheumatoid arthritis of lisinopril (TRALIS) - TRALIS	Rheumatoid arthritis	Trade Name: Lisinopril Product Name: Lisinopril Product Code: N/A	Research and Development Department, Addenbrookes NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2614	NCT00502996 (ClinicalTrials.gov)	February 2006	17/7/2007	A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.	Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)	Rheumatoid Arthritis	Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	246	Phase 3	Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela
2615	EUCTR2005-002629-30-LT (EUCTR)	30/01/2006	06/12/2005	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050	Rheumatoid arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Inc	NULL	Not Recruiting			Female: yes Male: yes	634	Phase 3	Czech Republic;Estonia;Latvia;Lithuania
2616	EUCTR2005-003694-25-ES (EUCTR)	27/01/2006	28/11/2005	Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR)A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).	Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR)A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).	Artritis ReumatoideRheumatoid Arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Trade Name: Methotrexate Sodium 2.5mg Tablets Product Name: Methotrexate Sodium 2.5mg Tablets Product Code: PL 00095/5079R Other descriptive name: Methotrexate Sodium 2.5mg Tablets	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Czech Republic;Spain;Italy
2617	EUCTR2005-000784-26-IT (EUCTR)	25/01/2006	17/01/2007	A phase IIIB multi-center, randomized, double-blind study to evaluate remission and joint damage progression in methotrexate naive early erosive RA subjects treated with abatacept plus methotrexate compared with methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.	A phase IIIB multi-center, randomized, double-blind study to evaluate remission and joint damage progression in methotrexate naive early erosive RA subjects treated with abatacept plus methotrexate compared with methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.	Arthritis rheumatoid treatment MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: abatacept Product Code: BMS-188667 INN or Proposed INN: abatacept	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
2618	EUCTR2004-003295-10-AT (EUCTR)	20/01/2006	16/12/2005	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid Arthritis - NA	Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;Spain;Austria;Italy;United Kingdom
2619	EUCTR2005-002395-15-GB (EUCTR)	20/01/2006	25/04/2006	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):	Czech Republic;Finland;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
2620	EUCTR2005-000158-61-CZ (EUCTR)	18/01/2006	05/12/2005		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Czech Republic;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania;Hungary;Germany;United Kingdom
2621	EUCTR2005-003436-21-DE (EUCTR)	18/01/2006	24/10/2005	A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114	A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SMP-114 Product Code: SMP-114 INN or Proposed INN: rimacalib	Dainippon Sumitomo Pharma Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Hungary;Czech Republic;United Kingdom;Germany
2622	EUCTR2005-000158-61-EE (EUCTR)	16/01/2006	11/11/2005		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2623	EUCTR2004-001234-17-IE (EUCTR)	16/01/2006	02/11/2006	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Product Name: Celebrex Product Code: not applicable INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Product Name: Voltrarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Product Name: Losec Product Code: not applicable INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Pfizer Healthcare Ireland	NULL	Not Recruiting			Female: yes Male: yes	4402	Phase 4	Portugal;Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden
2624	EUCTR2005-003694-25-IT (EUCTR)	12/01/2006	27/01/2006	A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis RA . - ND	A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis RA . - ND	rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: P38 Map Kinase Inhibitor Product Name: P38 Map Kinase Inhibitor Product Name: P38 Map Kinase Inhibitor INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	200		Czech Republic;Spain;Italy
2625	EUCTR2005-002909-23-DE (EUCTR)	10/01/2006	07/10/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
2626	EUCTR2005-002395-15-FI (EUCTR)	09/01/2006	26/10/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab Product Name: Methotrexate Product Code: Methotrexate INN or Proposed INN: methotrexate	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2627	EUCTR2005-002395-15-DK (EUCTR)	06/01/2006	19/06/2007	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853	Phase 3	Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2628	EUCTR2005-004385-16-GB (EUCTR)	03/01/2006	08/12/2005	CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS	CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS	Rheumatoid arthritis	Product Name: Prednisone INN or Proposed INN: Prednisone	United Bristol Healthcare NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	12	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):	United Kingdom
2629	EUCTR2005-004530-40-AT (EUCTR)	30/12/2005	25/11/2005	Induction of remission in RA patients at low disease activity by additional Infliximab-therapy	Induction of remission in RA patients at low disease activity by additional Infliximab-therapy	Patients with a diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year (max. 10 years) prior to start of therapy with active disease: DAS 28 between 2,8 and 3,5 and a change in DAS 28 score <0.6 during the last 6 weeks before inclusion.	Trade Name: Remicade Product Name: Remicade	AESCA Pharma Ges.m.b.H	NULL	Not Recruiting			Female: yes Male: yes	160		Austria
2630	EUCTR2005-002395-15-ES (EUCTR)	29/12/2005	31/10/2005	Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”	Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”	Artritis reumatoide / Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853		Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
2631	EUCTR2004-001234-17-LT (EUCTR)	29/12/2005	23/11/2005	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - N/A	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Celebrex Product Name: Celebrex Product Code: not applicable INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltarol SR (generics also available in the EU) Product Name: Voltarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Trade Name: Losec Product Name: Losec Product Code: not applicable INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	4402		Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Sweden;Lithuania
2632	EUCTR2005-002395-15-BE (EUCTR)	29/12/2005	24/11/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy;Sweden
2633	EUCTR2005-002396-33-ES (EUCTR)	27/12/2005	28/10/2005	Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Artritis Reumatoide (Rheumatoid arthritis)	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
2634	EUCTR2005-002396-33-BE (EUCTR)	27/12/2005	24/11/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 3	Hungary;Slovakia;Finland;Spain;Belgium;Germany;United Kingdom;Italy
2635	EUCTR2004-001234-17-ES (EUCTR)	20/12/2005	21/10/2005	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: Celebrex Product Name: Celebrex INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltrarol SR Product Name: Voltrarol SR INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Trade Name: Losec Product Name: Losec INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Pfizer, S.A.	NULL	Not Recruiting			Female: yes Male: yes	4402		Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2636	EUCTR2005-002423-13-HU (EUCTR)	19/12/2005	05/11/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Germany;Bulgaria;Italy
2637	EUCTR2005-003436-21-HU (EUCTR)	15/12/2005	11/10/2005	A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114	A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073	Product Name: SMP-114 Product Code: SMP-114	Sumitomo Pharmaceuticals Europe Limited	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Hungary;Czech Republic;Germany;United Kingdom
2638	EUCTR2004-001234-17-CZ (EUCTR)	14/12/2005	31/10/2005	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable	Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients MedDRA version: 8.0;Level: LLT;Classification code 10039073	Trade Name: Celebrex Product Name: Celebrex Product Code: not applicable INN or Proposed INN: Celecoxib Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide Trade Name: Voltrarol SR Product Name: Voltrarol SR Product Code: Not Applicable INN or Proposed INN: Diclofenac sodium Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate Trade Name: Losec Product Name: Losec Product Code: not applicable INN or Proposed INN: Omeprazole Other descriptive name: benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole	Pfizer Limited	NULL	Not Recruiting			Female: yes Male: yes	4402		Portugal;United Kingdom;Czech Republic;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden
2639	EUCTR2005-003495-38-DE (EUCTR)	13/12/2005	06/10/2005	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	440		United Kingdom;Germany;Estonia;Spain;Ireland;Greece
2640	EUCTR2005-000902-30-GB (EUCTR)	09/12/2005	05/08/2005	A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients	A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients	Rheumatoid arthritis	Trade Name: Prednisolone Tablets USP 5 mg Product Name: Prednisolone Tablets USP 5 mg INN or Proposed INN: Prednisolone	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2641	EUCTR2005-002392-32-GB (EUCTR)	07/12/2005	15/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Slovenia;Ireland;Germany;United Kingdom;Sweden
2642	EUCTR2005-003495-38-EE (EUCTR)	05/12/2005	29/11/2005	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	440		United Kingdom;Germany;Estonia;Spain;Ireland;Greece
2643	EUCTR2004-002482-20-GB (EUCTR)	02/12/2005	15/02/2005	A Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact Study	A Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact Study	Symptoms of Depression as defined by the Hospital Anxiety and Depression Questionnaire associated with Rheumatoid Arthritis	Trade Name: Efexor XL 75 mg Product Name: Efexor XL 75 mg (venlafaxine) Product Code: NA INN or Proposed INN: Venlafaxine Hydrochloride	Newcastle upon Tyne Hospitals NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	20		United Kingdom
2644	EUCTR2005-002395-15-IT (EUCTR)	02/12/2005	02/03/2006	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: METHOTREXATE*100CPR 2,5MG INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*25CPR 2,5MG INN or Proposed INN: Methotrexate Trade Name: MabThera INN or Proposed INN: Rituximab	F. Hoffmann - La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden
2645	NCT00669942 (ClinicalTrials.gov)	December 2005	29/4/2008	Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients	A Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients With Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated Dose	Rheumatoid Arthritis	Biological: AIN457;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	104	Phase 1/Phase 2	United States;Belgium;Germany;Netherlands;Singapore;Spain
2646	EUCTR2005-002396-33-IT (EUCTR)	30/11/2005	01/03/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Mabthera INN or Proposed INN: Rituximab	F. Hoffmann- La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
2647	EUCTR2005-003495-38-ES (EUCTR)	25/11/2005	06/10/2005	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	Rheumatoid Arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Estonia;Greece;Spain;Ireland;Germany;United Kingdom
2648	EUCTR2005-002969-37-ES (EUCTR)	25/11/2005	19/10/2005	A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship.Estudio aleatorizado, de grupos paralelos y controlado con placebo de la administración de una dosis única de GW856553 en pacientes con Artritis Reumatoide activa para investigar la relación entre la dosis y respuesta sobre la proteína C reactiva - GM2005/00244/00	A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship.Estudio aleatorizado, de grupos paralelos y controlado con placebo de la administración de una dosis única de GW856553 en pacientes con Artritis Reumatoide activa para investigar la relación entre la dosis y respuesta sobre la proteína C reactiva - GM2005/00244/00	Rheumatoid Arthritis	Product Code: GW856553 Product Code: GW856553 Product Code: GW856553	GlaxoSmithKline S.A.	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	Spain;Germany;Sweden
2649	EUCTR2005-000784-26-GB (EUCTR)	25/11/2005	15/07/2005	A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.	A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.	Rheumatoid Arthritis, Nos	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Italy;United Kingdom
2650	EUCTR2005-001889-13-SE (EUCTR)	24/11/2005	13/10/2005	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3	Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: infliximab	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	315		Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden
2651	EUCTR2005-000784-26-DE (EUCTR)	23/11/2005	28/09/2005	A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007).	A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007).	Rheumatoid Arthritis, Nos	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Italy;United Kingdom
2652	EUCTR2005-002392-32-IE (EUCTR)	23/11/2005	13/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Slovenia;Ireland;Germany;United Kingdom;Sweden
2653	EUCTR2004-005210-37-FI (EUCTR)	17/11/2005	14/03/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200		Finland;Czech Republic;Germany;Spain;Sweden
2654	EUCTR2005-003495-38-IE (EUCTR)	17/11/2005	13/09/2005	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	Rheumatoid Arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Estonia;Greece;Spain;Ireland;Germany;United Kingdom
2655	EUCTR2004-005102-68-BE (EUCTR)	15/11/2005	25/07/2005	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008)	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008)	RHEUMATOID ARTHRITIS,NOS	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
2656	EUCTR2005-002219-26-IT (EUCTR)	11/11/2005	16/03/2007	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein CRP in subjects with rheumatoid arthritis RA	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein CRP in subjects with rheumatoid arthritis RA	Rheumatoid arthritis RA MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: SB-681323 Product Code: SB-681323 Product Name: SB-681323 Product Code: SB-681323	GLAXO SMITHKLINE	NULL	Not Recruiting			Female: yes Male: yes			Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden
2657	EUCTR2005-002219-26-DE (EUCTR)	09/11/2005	20/07/2005	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	Rheumatoid arthritis (RA)	Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: SB-681323 Tablets Product Code: SB-681323	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	82		Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden
2658	EUCTR2004-000482-35-LT (EUCTR)	08/11/2005	26/09/2005	A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/03	A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/03	Rheumatoid Arthritis	Product Name: Rosiglitazone Extended Release Tablets Product Code: BRL-049653 INN or Proposed INN: Rosiglitazone Other descriptive name: Rosiglitazone maleate	GlaxoSmithKline Research & Development Ltd.	NULL	Not Recruiting			Female: yes Male: yes	96		United Kingdom;Lithuania
2659	EUCTR2004-004995-35-IT (EUCTR)	08/11/2005	02/02/2007	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD	Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment. MedDRA version: 6.1;Level: PT;Classification code 10039073	INN or Proposed INN: Paroxetine INN or Proposed INN: Paroxetine Trade Name: Prednisolene tablets BP 1 mg INN or Proposed INN: Prednisolone	COMBINATORX, INC	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;Austria;Denmark;Germany;United Kingdom;Italy
2660	EUCTR2004-005102-68-IT (EUCTR)	03/11/2005	04/11/2005	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options	Rheumatiod arthritis MedDRA version: 6.1;Level: HLT;Classification code 10039075	Product Name: abatacept Product Code: BMS-188667	BRISTOL-M.SQUIBB	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
2661	NCT00316771 (ClinicalTrials.gov)	November 2005	20/4/2006	A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy	A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.	Rheumatoid Arthritis	Drug: P38 Inhibitor (4) 150mg;Drug: P38 Inhibitor (4) 25mg;Drug: P38 Inhibitor (4) 300mg;Drug: P38 Inhibitor (4) 50mg;Drug: P38 Inhibitor (4) 75mg;Drug: Placebo	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	374	Phase 2	South Africa;Spain;United Kingdom;United States;Australia;Brazil;Canada;Estonia;Germany;Greece;Ireland;Mexico;New Zealand;Poland
2662	NCT00320450 (ClinicalTrials.gov)	November 2005	28/4/2006	SB-681323 In Subjects With Rheumatoid Arthritis	A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)	Arthritis, Rheumatoid	Drug: SB-681323	GlaxoSmithKline	NULL	Completed	18 Years	N/A	Both	78	Phase 2	Denmark;Germany;Hong Kong;Italy;Norway;Poland;Spain;Sweden;United Kingdom;Hungary
2663	NCT00160641 (ClinicalTrials.gov)	November 2005	8/9/2005	A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis	A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050	Rheumatoid Arthritis	Biological: Certolizumab Pegol	UCB Pharma	NULL	Completed	18 Years	N/A	All	567	Phase 3	United States;Bulgaria;Croatia;Czechia;Estonia;Israel;Latvia;Lithuania;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro
2664	NCT00162292 (ClinicalTrials.gov)	November 2005	9/9/2005	Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background	Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background	Rheumatoid Arthritis	Drug: BMS-582949 and Methotrexate	Bristol-Myers Squibb	NULL	Completed	18 Years	70 Years	Both	33	Phase 1	United States;Mexico
2665	NCT00380744 (ClinicalTrials.gov)	November 2005	22/9/2006	A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis	A Phase 1b/2 Multiple-Dose Safety Study and Pharmacokinetic/ Pharmacodynamic Study of LY2189102 in Patients With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: LY2189102;Drug: placebo	Eli Lilly and Company	NULL	Completed	18 Years	75 Years	All	121	Phase 1/Phase 2	United States;Poland;Argentina;Hungary;Spain
2666	NCT00256919 (ClinicalTrials.gov)	November 2005	21/11/2005	Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)	A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship	Arthritis, Rheumatoid	Drug: GW856553	GlaxoSmithKline	NULL	Completed	18 Years	N/A	Both	51	Phase 2	Bulgaria;Germany;Spain;Sweden;Ukraine
2667	NCT00292422 (ClinicalTrials.gov)	November 2005	15/2/2006	Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis	A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy	Rheumatoid Arthritis	Drug: BG9924	Biogen Idec	NULL	Completed	18 Years	75 Years	Both	50	Phase 2	United States;Poland
2668	EUCTR2005-002326-63-LV (EUCTR)	28/10/2005	22/11/2005	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	Rheumatoid Arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	590	Phase 3	Czech Republic;Estonia;Latvia;Lithuania
2669	EUCTR2005-000158-61-LV (EUCTR)	28/10/2005	22/11/2005		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2670	EUCTR2005-003436-21-GB (EUCTR)	26/10/2005	05/09/2005	A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114	A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114	Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: SMP-114 Product Code: SMP-114 INN or Proposed INN: rimacalib	Dainippon Sumitomo Pharma Europe Ltd	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Hungary;Czech Republic;Germany;United Kingdom
2671	EUCTR2005-000784-26-BE (EUCTR)	21/10/2005	28/10/2005	A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007).	A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007).	Rheumatoid Arthritis, Nos	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria
2672	EUCTR2005-000158-61-IE (EUCTR)	21/10/2005	13/09/2005		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: Celebrex Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Spain;Ireland;Italy;Latvia;Lithuania
2673	EUCTR2005-000784-26-IE (EUCTR)	21/10/2005	15/08/2005	A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005 + Amendment 1 dated 16-May-2005.	A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005 + Amendment 1 dated 16-May-2005.	Rheumatoid Arthritis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria
2674	EUCTR2005-001319-23-IT (EUCTR)	21/10/2005	30/09/2005	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy	Rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: ERB-041 Product Code: ERB-041 Other descriptive name: NA Product Name: ERB-041 Product Code: ERB-041 Other descriptive name: NA Product Name: ERB-041 Product Code: ERB-041 Other descriptive name: NA	WYETH LEDERLE	NULL	Not Recruiting			Female: yes Male: yes			Hungary;Spain;Italy
2675	EUCTR2005-002421-31-DE (EUCTR)	20/10/2005	03/11/2005	A phase II randomised, double-blind, multicenter, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate. - Efficacy, safety and tolerability of AD 452 in patients wih RA	A phase II randomised, double-blind, multicenter, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate. - Efficacy, safety and tolerability of AD 452 in patients wih RA	The purpose of this clinical trial is to evaluate the clinical efficacy, safety and tolerability of three doses of AD 452 in comparison with placebo in the treatment of subjects with active rheumatoid arthritis. MedDRA version: 7.0;Level: PT;Classification code 10039073	Product Name: AD 452 INN or Proposed INN: (+) isomer of racemic mefloquine Other descriptive name: (+)erythromefloquine Product Name: AD 452 INN or Proposed INN: (+) isomer of racemic mefloquine Other descriptive name: (+) erythromefloquine Product Name: AD 452 INN or Proposed INN: (+) isomer or racemic mefloquine Other descriptive name: (+) erythromefloquine	Arakis Ltd.	NULL	Not Recruiting			Female: yes Male: yes	292	Phase 2	United Kingdom;Germany
2676	EUCTR2005-002423-13-SK (EUCTR)	18/10/2005	20/09/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Austria;Bulgaria;Germany;Italy
2677	EUCTR2005-003495-38-GB (EUCTR)	18/10/2005	18/10/2005	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.	Rheumatoid Arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	330	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):	Estonia;Greece;Spain;Ireland;Germany;United Kingdom
2678	EUCTR2004-004995-35-AT (EUCTR)	16/10/2005	09/11/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Trade Name: Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;Denmark;Austria;Germany;Italy;United Kingdom
2679	EUCTR2005-002969-37-SE (EUCTR)	14/10/2005	29/08/2005	A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/02	A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/02	Rheumatoid Arthritis	Product Code: GW856553 Product Code: GW856553 Product Code: GW856553	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;Spain;Sweden
2680	EUCTR2005-001319-23-ES (EUCTR)	14/10/2005	22/06/2005	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy.Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, dirigido a evaluar la eficacia y la seguridad de 3 dosis orales distintas de ERB-041 en sujetos con artritis reumatoide en tratamiento de fondo con metotrexato	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy.Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, dirigido a evaluar la eficacia y la seguridad de 3 dosis orales distintas de ERB-041 en sujetos con artritis reumatoide en tratamiento de fondo con metotrexato	Rheumatoid arthritis	Product Name: ERB-041 Product Code: ERB-041 Product Name: ERB-041 Product Code: ERB-041 Product Name: ERB-041 Product Code: ERB-041	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 2	Hungary;Spain;Italy
2681	EUCTR2004-002846-36-AT (EUCTR)	13/10/2005	08/09/2005	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: CP690,550 Product Code: CP690,550 INN or Proposed INN: N/A Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, Product Name: CP690,550 Product Code: CP690,550 INN or Proposed INN: N/A Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,	Pfizer Corporation Austria Ges.m.b.H.	NULL	Not Recruiting			Female: yes Male: yes	312	Phase 2	Spain;Austria;Germany;Italy
2682	EUCTR2005-002392-32-SE (EUCTR)	12/10/2005	19/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
2683	EUCTR2005-002392-32-SI (EUCTR)	11/10/2005	26/10/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
2684	EUCTR2005-000784-26-ES (EUCTR)	11/10/2005	13/09/2005	A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate.	A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate.	Rheumatoid Arthritis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Italy;United Kingdom
2685	EUCTR2005-000784-26-CZ (EUCTR)	04/10/2005	04/10/2005	A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendment 4 - Site Specific - dated 28-Dec-2005.	A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendment 4 - Site Specific - dated 28-Dec-2005.	Rheumatoid Arthritis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Germany;United Kingdom;Czech Republic;Belgium;Spain;Ireland;Italy;Austria
2686	EUCTR2004-002846-36-SK (EUCTR)	03/10/2005	19/07/2005	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: CP690,550 Product Code: CP690,550 INN or Proposed INN: N/A Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, Product Name: CP690,550 Product Code: CP690,550 INN or Proposed INN: N/A Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,	Pfizer Global & Developement, Pfizer Limited	NULL	Not Recruiting			Female: yes Male: yes	312	Phase 2	Slovakia;Spain;Austria;Germany;Italy
2687	EUCTR2005-001138-33-PT (EUCTR)	29/09/2005	21/09/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Denmark;Slovenia;Norway;Spain;Italy
2688	EUCTR2005-001138-33-IT (EUCTR)	28/09/2005	01/02/2007	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis.	rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: Ro 48-77533 Trade Name: METHOTREXATE*25CPR 2,5MG INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Denmark;Slovenia;Norway;Spain;Italy
2689	EUCTR2005-002423-13-IT (EUCTR)	28/09/2005	04/11/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra INN or Proposed INN: RoActemra	F.Hoffmann La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Bulgaria;Germany;Italy
2690	EUCTR2005-002326-63-LT (EUCTR)	21/09/2005	04/08/2005	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	Rheumatoid Arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	590	Phase 3	Czech Republic;Estonia;Latvia;Lithuania
2691	EUCTR2005-002219-26-ES (EUCTR)	21/09/2005	10/10/2005	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	Rheumatoid arthritis (RA)	Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: SB-681323 Tablets Product Code: SB-681323	GlaxoSmithKline S.A.	NULL	Not Recruiting			Female: yes Male: yes	82	Phase 2	Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2692	EUCTR2005-002909-23-ES (EUCTR)	21/09/2005	08/09/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
2693	EUCTR2005-002326-63-SK (EUCTR)	20/09/2005	05/08/2005	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	Rheumatoid Arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	590	Phase 3	Estonia;Czech Republic;Slovakia;Lithuania;Latvia
2694	EUCTR2005-001889-13-AT (EUCTR)	15/09/2005	08/11/2005	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3	Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.	Trade Name: Remicade Product Name: Remicade	Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.	NULL	Not Recruiting			Female: yes Male: yes	315		France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden
2695	EUCTR2004-005102-68-DE (EUCTR)	15/09/2005	15/07/2005	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006.	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006.	RHEUMATOID ARTHRITIS,NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;United Kingdom;Germany;Belgium;Spain;Ireland;Italy
2696	EUCTR2004-005115-29-DE (EUCTR)	14/09/2005	16/05/2006	A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship	A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship	Rheumatoid arthritis	Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: Overencapsulated Prednisolone Tablets INN or Proposed INN: Prednisolone	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	77		United Kingdom;Germany
2697	EUCTR2005-001977-82-GB (EUCTR)	09/09/2005	14/07/2005	A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects	A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects	Rheumatoid arthritis	Product Name: GW274150 Tablets Product Code: GW274150 Trade Name: Deltacortril Enteric Product Name: Prednisolone INN or Proposed INN: Prednisolone	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
2698	EUCTR2005-002219-26-SE (EUCTR)	08/09/2005	14/07/2005	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	Rheumatoid arthritis (RA)	Product Name: SB-681323 Tablets Product Code: SB-681323	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	82		Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden
2699	EUCTR2005-002423-13-DE (EUCTR)	06/09/2005	05/07/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Rheumatoid arthritis	Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Germany;Bulgaria;Italy
2700	EUCTR2005-002326-63-CZ (EUCTR)	05/09/2005	08/08/2005	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.	Rheumatoid Arthritis Classification code 10039073	Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	634	Phase 3	Czech Republic;Estonia;Latvia;Lithuania
2701	EUCTR2005-000551-15-GB (EUCTR)	05/09/2005	05/08/2005	Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate	Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate	Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory polyarthritis associated with excess cardiovascular (CV) mortality. Hyperhomocysteinaemia is recognized as an independent CV risk factor and homocysteine levels are frequently elevated in RA patients.Endothelial dysfunction is considered a marker of early atherosclerotic disease and seems to correlate well with future increase CV risk. RA patients are known to have endothelial dysfunction.	Product Name: Allopurinol Product Code: Allopurinol INN or Proposed INN: Allopurinol Product Name: Folic acid Product Code: Folic acid INN or Proposed INN: Folic acid	University of Dundee	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	United Kingdom
2702	EUCTR2004-005102-68-GB (EUCTR)	01/09/2005	27/05/2005	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5.	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5.	RHEUMATOID ARTHRITIS,NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom
2703	NCT00720798 (ClinicalTrials.gov)	September 2005	22/7/2008	An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies	Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Disease-modifying anti-rheumatic drugs;Drug: Non-steroidal anti-inflammatory drugs;Drug: Oral corticosteroids	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	2067	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Czech Republic;Denmark;Finland;France;Germany;Hong Kong;Iceland;Israel;Italy;Lithuania;Mexico;Netherlands;Norway;Panama;Peru;Portugal;Puerto Rico;Russian Federation;Serbia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;United Kingdom
2704	EUCTR2004-004995-35-CZ (EUCTR)	30/08/2005	30/08/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Trade Name: Prednisolone Tablets BP 1 mg Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Germany;United Kingdom;Czech Republic;Denmark;Italy
2705	EUCTR2005-001138-33-DK (EUCTR)	23/08/2005	20/06/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Slovenia;Denmark;Norway;Spain;Italy
2706	EUCTR2005-002219-26-DK (EUCTR)	23/08/2005	09/08/2005	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)	Rheumatoid arthritis (RA)	Product Name: SB-681323 Tablets Product Code: SB-681323	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	82	Phase 2	Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
2707	EUCTR2005-002423-13-AT (EUCTR)	22/08/2005	18/07/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Rheumatoid arthritis	Trade Name: RoActemra Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Austria;Bulgaria;Germany;Italy
2708	EUCTR2004-005102-68-ES (EUCTR)	16/08/2005	17/06/2005	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1.	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1.	RHEUMATOID ARTHRITIS,NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom
2709	EUCTR2005-000884-25-SE (EUCTR)	11/08/2005	07/06/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	450		United Kingdom;Germany;Iceland;Italy;Sweden
2710	EUCTR2005-000158-61-AT (EUCTR)	10/08/2005	07/06/2005	A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis	A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: CELEBREX Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Czech Republic;Estonia;Hungary;Spain;Ireland;Lithuania;Denmark;Austria;Germany;Latvia;Italy;United Kingdom
2711	EUCTR2005-000158-61-ES (EUCTR)	09/08/2005	09/06/2005	A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis	A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: Artilog Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline s.a.	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Czech Republic;Estonia;Hungary;Spain;Ireland;Lithuania;Austria;Denmark;Germany;Latvia;Italy;United Kingdom
2712	EUCTR2005-000158-61-HU (EUCTR)	08/08/2005	08/06/2005		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2713	EUCTR2004-005102-68-IE (EUCTR)	05/08/2005	02/06/2005	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1.	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1.	RHEUMATOID ARTHRITIS,NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy
2714	EUCTR2005-001350-24-FI (EUCTR)	04/08/2005	23/06/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Hungary;Finland;Czech Republic;Estonia;Latvia;Lithuania
2715	EUCTR2005-001350-24-HU (EUCTR)	01/08/2005	19/05/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
2716	NCT00141830 (ClinicalTrials.gov)	August 2005	30/8/2005	Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy	Rheumatoid Arthritis	Drug: Methotrexate plus ERB-041 for 12 weeks;Drug: Placebo for 12 weeks	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	80 Years	All	159	Phase 2	United States;Canada;Hungary;Italy;Mexico;Spain
2717	EUCTR2005-001319-23-HU (EUCTR)	22/07/2005	03/06/2005	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy	Rheumatoid arthritis	Product Name: ERB-041 Product Code: ERB-041 INN or Proposed INN: Not available Product Name: ERB-041 Product Code: ERB-041 INN or Proposed INN: Not available Product Name: ERB-041 Product Code: ERB-041 INN or Proposed INN: Not available	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development	NULL	Not Recruiting			Female: yes Male: yes	260		Hungary;Spain;Italy
2718	EUCTR2004-002215-80-HU (EUCTR)	20/07/2005	17/05/2005	A Double-Blind, Parallel, Randomized Extension Trial to Evaluate Safety and Efficacy of TMI-005 (Apratastat) in Subjects with Rheumatoid Arthritis on Methotrexate Who Have Completed Protocol 3140A1-200-WW	A Double-Blind, Parallel, Randomized Extension Trial to Evaluate Safety and Efficacy of TMI-005 (Apratastat) in Subjects with Rheumatoid Arthritis on Methotrexate Who Have Completed Protocol 3140A1-200-WW	Rheumatoid Arthritis	Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005 Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005 Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005	Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary
2719	EUCTR2005-000158-61-GB (EUCTR)	18/07/2005	27/05/2005		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Trade Name: Celebrex 200 mg capsule, hard Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2720	EUCTR2005-001350-24-EE (EUCTR)	18/07/2005	14/06/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Hungary;Czech Republic;Estonia;Finland;Lithuania;Latvia
2721	EUCTR2005-001350-24-LT (EUCTR)	14/07/2005	08/06/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
2722	EUCTR2005-001138-33-LT (EUCTR)	14/07/2005	30/05/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
2723	EUCTR2004-004995-35-DE (EUCTR)	14/07/2005	17/03/2005	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine Product Name: N/A Product Code: CRX-139 INN or Proposed INN: Prednisolone Product Name: N/A Product Code: CRX-139 INN or Proposed INN: paroxetine	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;United Kingdom;Germany;Denmark;Italy
2724	EUCTR2005-000884-25-GB (EUCTR)	11/07/2005	19/04/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	450	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Iceland;Germany;Italy;United Kingdom;Sweden
2725	EUCTR2005-001138-33-NO (EUCTR)	06/07/2005	06/06/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 3	Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
2726	EUCTR2005-001138-33-ES (EUCTR)	05/07/2005	16/05/2006	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 3	Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
2727	EUCTR2004-005210-37-CZ (EUCTR)	01/07/2005	30/06/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200		Finland;Germany;Czech Republic;Spain;Sweden
2728	NCT00109408 (ClinicalTrials.gov)	July 2005	27/4/2005	A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis	A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	673	Phase 3	United States;Argentina;Australia;Canada;China;Denmark;France;Israel;Italy;Lithuania;Mexico;Norway;Peru;Portugal;Serbia;Slovenia;South Africa;Spain;Croatia;Former Serbia and Montenegro
2729	EUCTR2004-002620-18-BE (EUCTR)	30/06/2005	04/08/2005	A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis	A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis	Rheumatoid Arthritis, NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	250		United Kingdom;Germany;Belgium;Spain;Italy
2730	EUCTR2005-000884-25-IS (EUCTR)	27/06/2005	27/04/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Germany;Iceland;Italy;United Kingdom;Sweden
2731	EUCTR2004-005115-29-GB (EUCTR)	24/06/2005	27/05/2005	A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship	A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship	Rheumatoid arthritis	Product Name: SB-681323 Tablets Product Code: SB-681323 Product Name: SB-681323 Tablets Product Code: SB-681323 Trade Name: Prednisolone Tablets BP Product Name: Overencapsulated Prednisolone Tablets INN or Proposed INN: Prednisolone	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	77	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Germany;United Kingdom
2732	EUCTR2005-000158-61-DK (EUCTR)	24/06/2005	02/06/2005		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: GW406381 Product Code: GW406381X Other descriptive name: GW406381X Product Name: Celecoxib INN or Proposed INN: Celecoxib	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	2210	Phase 3	Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2733	EUCTR2005-001350-24-LV (EUCTR)	21/06/2005	21/06/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
2734	EUCTR2004-003741-40-SK (EUCTR)	16/06/2005	07/12/2004	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	630	Phase 3	Hungary;Slovakia;Austria;Germany;Italy
2735	EUCTR2005-000549-13-CZ (EUCTR)	15/06/2005	02/05/2005	A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA	A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA	rheumatoid arthritis	Product Code: VX-702	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Czech Republic
2736	EUCTR2004-002846-36-DE (EUCTR)	14/06/2005	01/03/2005	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLT;Classification code 10039073	Product Name: CP690,550 Product Code: CP690,550 INN or Proposed INN: N/A Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, Product Name: CP690,550 Product Code: CP690,550 INN or Proposed INN: N/A Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,	Pfizer Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	312	Phase 2	Germany;Spain;Italy
2737	EUCTR2005-000884-25-DE (EUCTR)	14/06/2005	13/04/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	450		United Kingdom;Germany;Iceland;Italy;Sweden
2738	EUCTR2005-000158-61-IT (EUCTR)	09/06/2005	05/01/2006		A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -	RHEUMATOID ARTHRITIS MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: GW406381 Product Code: GW406381 Product Name: GW406381 Product Code: GW406381 Product Name: GW406381 Product Code: GW406381 Product Name: GW406381 Product Code: GW406381 Trade Name: CELEBREX 200MG 20CPS INN or Proposed INN: Celecoxib	GLAXO SMITHKLINE	NULL	Not Recruiting			Female: yes Male: yes	2208	Phase 3	Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania
2739	NCT00113308 (ClinicalTrials.gov)	June 2005	7/6/2005	COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis	A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: GW406381	GlaxoSmithKline	NULL	Completed	18 Years	N/A	All	2208	Phase 3	United States;Argentina;Austria;Belgium;Bulgaria;Canada;Chile;Costa Rica;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Norway;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;Estonia;Lithuania;Pakistan;Slovakia;Taiwan
2740	EUCTR2005-001350-24-SK (EUCTR)	31/05/2005	21/04/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Latvia
2741	EUCTR2005-001350-24-CZ (EUCTR)	27/05/2005	04/05/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
2742	EUCTR2004-002620-18-DE (EUCTR)	13/05/2005	16/02/2005	A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis.Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01	A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis.Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01	Rheumatoid Arthritis, NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	250		United Kingdom;Germany;Belgium;Spain;Italy
2743	EUCTR2004-002620-18-IT (EUCTR)	11/05/2005	19/09/2005	A multi-national randomized, double-blind exploratory study of Abatacept versus placebo in preventing the development of rheumatoid arthritis in adults subjects with undifferentiated inflammatory arthritis at high risk for the development of rheumatoid arthritis.	A multi-national randomized, double-blind exploratory study of Abatacept versus placebo in preventing the development of rheumatoid arthritis in adults subjects with undifferentiated inflammatory arthritis at high risk for the development of rheumatoid arthritis.	rheumatoid arthritis MedDRA version: 6.1;Level: HLT;Classification code 10039075	Product Name: CTLA4Ig Product Code: BMS-188667	BRISTOL-M.SQUIBB	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom;Germany;Belgium;Spain;Italy
2744	EUCTR2004-002620-18-ES (EUCTR)	06/05/2005	29/03/2006	A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis	A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis	Rheumatoid Arthritis, NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	Belgium;Spain;Germany;Italy;United Kingdom
2745	EUCTR2004-002993-49-BE (EUCTR)	05/05/2005	19/07/2005	A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate.	A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate.	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol	Celltech R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Estonia;Czech Republic;Hungary;Finland;Belgium;Lithuania;Latvia;Sweden
2746	EUCTR2004-005210-37-DE (EUCTR)	04/05/2005	10/03/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200		Finland;Czech Republic;Germany;Spain;Sweden
2747	EUCTR2005-000549-13-SK (EUCTR)	03/05/2005	05/04/2005	A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA	A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA	rheumatoid arthritis	Product Code: VX-702	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Czech Republic;Slovakia
2748	EUCTR2005-000884-25-IT (EUCTR)	02/05/2005	22/06/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: Tocilizumab Product Code: Ro 48-77533 Trade Name: METHOTREXATE*2,5MG 25CPR INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*7,5MG/ML 4SIR. INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*10MG/1,33ML 4S INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*20MG/2,66ML 4S INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*15MG/2ML 4SIR INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	570		United Kingdom;Germany;Iceland;Italy;Sweden
2749	EUCTR2004-005210-37-SE (EUCTR)	26/04/2005	10/03/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200		Finland;Czech Republic;Germany;Spain;Sweden
2750	EUCTR2004-002846-36-IT (EUCTR)	26/04/2005	20/06/2005	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP-690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP-690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: CP 690,550 Product Code: CP 690,550 Product Name: CP 690,550 Product Code: CP 690,550 Product Name: CP 690,550 Product Code: CP 690,550	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	312	Phase 2	Germany;Spain;Italy
2751	EUCTR2004-003741-40-HU (EUCTR)	15/04/2005	07/02/2005	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Germany;Italy
2752	EUCTR2004-002620-18-GB (EUCTR)	14/04/2005	15/06/2005	A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid ArthritisRevised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01	A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid ArthritisRevised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01	Rheumatoid Arthritis, NOS	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	Spain;Belgium;Germany;Italy;United Kingdom
2753	EUCTR2004-002846-36-ES (EUCTR)	12/04/2005	24/01/2006	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTERSTUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE IGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTERSTUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE IGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 7.1;Level: LLD;Classification code 10039073	Product Name: CP690,550 Product Code: CP690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, Product Name: CP690,550 Product Code: CP690,550 Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,	Pfizer, S.A.	NULL	Not Recruiting			Female: yes Male: yes	312	Phase 2	Slovakia;Spain;Austria;Germany;Italy
2754	EUCTR2005-000674-43-GB (EUCTR)	06/04/2005	03/10/2005	AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis	AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis	Rheumatoid Arthritis	Trade Name: Mabthera Product Name: Mabthera Product Code: N/A INN or Proposed INN: n/a Other descriptive name: none	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	15	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
2755	NCT00124982 (ClinicalTrials.gov)	April 2005	30/6/2005	Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options	Rheumatoid Arthritis	Drug: Abatacept;Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD);Drug: Anti-Tumor Necrosing Factor (TNF) Therapy	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	1286	Phase 3	United States;Belgium;Czech Republic;France;Germany;Ireland;Italy;Mexico;Spain;United Kingdom;Canada
2756	EUCTR2004-005210-37-ES (EUCTR)	29/03/2005	04/11/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Czech Republic;Finland;Spain;Germany;Sweden
2757	EUCTR2004-002993-49-FI (EUCTR)	29/03/2005	16/12/2004	A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870	Celltech R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Estonia;Czech Republic;Hungary;Slovakia;Finland;Belgium;Lithuania;Latvia;Sweden
2758	EUCTR2004-004302-24-DE (EUCTR)	23/03/2005	11/01/2005	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073	Product Name: L-000883191 Product Code: L-000883191 INN or Proposed INN: NA Other descriptive name: NA	Merck & Co. Inc.	NULL	Not Recruiting			Female: yes Male: yes	136		Finland;Czech Republic;Germany;Spain;Italy
2759	EUCTR2004-003733-14-FI (EUCTR)	23/03/2005	17/11/2004	A study investigating whether tocilizumab (study drug) prevents joint damage, and how safe it is, in patients with moderate to severe rheumatoid arthritis randomly divided to groups receiving treatment with tocilizumab and methotrexate or methotrexate and placebo.	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. - LITHE	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: Tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1170	Phase 3	United States;Greece;Finland;Spain;Italy;France;Mexico;Brazil;Poland;Australia;Denmark;South Africa;Norway;China
2760	EUCTR2005-000129-47-SE (EUCTR)	21/03/2005	25/02/2005	The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study.	The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study.	Rheumatoid Arthritis.	Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab	Dept. of Rhematology UMAS	NULL	Not Recruiting			Female: yes Male: yes	15		Sweden
2761	EUCTR2004-000922-59-CZ (EUCTR)	15/03/2005	15/03/2005	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	Rheumatoid Arthrithis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	675	Phase 3	Czech Republic;Denmark;Spain;Sweden
2762	EUCTR2004-002993-49-SE (EUCTR)	15/03/2005	05/01/2005		A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870	UCB Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania;Sweden
2763	EUCTR2004-000074-31-BE (EUCTR)	15/03/2005	07/07/2004	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis	rheumatoid arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073	Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Trade Name: paracetamol (acetaminophen) Product Name: paracetamol (acetaminophen)	Merck Sharp & Dohme BV	NULL	Not Recruiting			Female: yes Male: yes	150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Belgium;Sweden
2764	EUCTR2004-004302-24-IT (EUCTR)	09/03/2005	10/08/2007	A Randomized, Placebo-Controlled, Parallel-Group, Double Blind, 12 week study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Parallel-Group, Double Blind, 12 week study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: L-883191	MERCK SHARP DOHME	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Czech Republic;Finland;Spain;Germany;Italy
2765	EUCTR2004-004302-24-CZ (EUCTR)	09/03/2005	04/02/2005	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073	Product Name: L-000883191 Product Code: L-000883191 INN or Proposed INN: NA Other descriptive name: NA Trade Name: PARALEN 500 Product Name: PARALEN 500 Product Code: 8594739041288 INN or Proposed INN: paracetamol Other descriptive name: NA	Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 2	Czech Republic;Finland;Spain;Germany;Italy
2766	EUCTR2004-000563-96-FI (EUCTR)	08/03/2005	11/10/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Hungary;Finland;Denmark;Norway;Ireland;Spain;Italy;Sweden
2767	NCT00503503 (ClinicalTrials.gov)	March 2005	16/7/2007	Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan	Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan	Rheumatoid Arthritis	Drug: Enbrel (etanercept)	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	11 Years	90 Years	Both			NULL
2768	EUCTR2004-003741-40-DE (EUCTR)	28/02/2005	01/12/2004	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Germany;Italy
2769	EUCTR2004-002993-49-LV (EUCTR)	28/02/2005	28/02/2005		A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol	Celltech R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
2770	EUCTR2004-000012-13-IT (EUCTR)	18/02/2005	12/04/2007		A Double-Blind, Placebo-controlled, Parallel, Randomized Study to evaluate the Efficacy and Safety of 3 Oral Dose levels of TMI-005 in Subjects with Active Rheumatoid Arthritis on A Background of Methotrexate -	heumatoid Artrhitis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: TMI-005 WAY-177005 Product Code: TMI-005 WAY-177005 INN or Proposed INN: Apratastat Product Name: TMI-005 WAY-177005 Product Code: TMI-005 WAY-177005 INN or Proposed INN: Apratastat Product Name: TMI-005 WAY-177005 Product Code: TMI-005 WAY-177005 INN or Proposed INN: Apratastat	WYETH LEDERLE	NULL	Not Recruiting			Female: yes Male: yes	360		Czech Republic;Estonia;Italy
2771	EUCTR2004-004302-24-ES (EUCTR)	16/02/2005	04/11/2005	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073	Product Name: L-000883191 Product Code: L-000883191 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Paracetamol Product Name: Paracetamol Product Code: NA INN or Proposed INN: NA Other descriptive name: NA	Merck & Co. Inc.	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 2	Czech Republic;Finland;Spain;Germany;Italy
2772	EUCTR2004-002993-49-CZ (EUCTR)	11/02/2005	04/02/2005		A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Finland;Hungary;Germany;Czech Republic;Estonia;Latvia;Sweden;Lithuania
2773	EUCTR2004-002993-49-HU (EUCTR)	11/02/2005	15/12/2004		A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol	Celltech R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
2774	EUCTR2004-002993-49-LT (EUCTR)	09/02/2005	03/01/2005		A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania
2775	EUCTR2004-002993-49-SK (EUCTR)	08/02/2005	31/01/2005	A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study	Rheumatoid Arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Estonia;Czech Republic;Hungary;Slovakia;Finland;Belgium;Lithuania;Latvia;Sweden
2776	EUCTR2004-002132-26-ES (EUCTR)	07/02/2005	07/12/2005	A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of rhuMAb 2H7 (Ro 496-4913, PRO70769) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A	A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of rhuMAb 2H7 (Ro 496-4913, PRO70769) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A	Rheumatoid Arthritis	Product Name: rhuMAb 2H7 Product Code: Ro 496-4913 INN or Proposed INN: N/A Other descriptive name: rhuMAb 2H7	F Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 1;Phase 2	Spain;United Kingdom
2777	EUCTR2004-004893-96-GB (EUCTR)	04/02/2005	15/02/2005	Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritis	Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritis	Patients with medical diagnosis of Rheumatoid Arthritis	Trade Name: Dalacin C phosphate Product Name: Clindamycin Trade Name: Tetraccycline Product Name: Tetraccycline-hydrochloride	Hammersmith Hospitals NHS trust	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	United Kingdom
2778	EUCTR2004-001909-10-GB (EUCTR)	02/02/2005	15/08/2005	Effect of Rosuvastatin on surrogate markers for cardiovascular events and joint disease progression in patients with rheumatoid arthritis - RORA trial	Effect of Rosuvastatin on surrogate markers for cardiovascular events and joint disease progression in patients with rheumatoid arthritis - RORA trial	Rheumatoid Arthritis	Trade Name: rosuvastatin Product Name: rosuvastatin Product Code: ZD 4522	University of Dundee	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
2779	EUCTR2004-000922-59-DK (EUCTR)	02/02/2005	01/12/2004	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	Rheumatoid Arthrithis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	675	Phase 3	Czech Republic;Denmark;Spain;Sweden
2780	EUCTR2004-003733-14-ES (EUCTR)	28/01/2005	07/12/2005	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1170		Finland;Denmark;Spain;Italy
2781	EUCTR2004-003733-14-DK (EUCTR)	26/01/2005	07/12/2004	A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis.	Rheumatoid arthritis	Trade Name: RoActemra® Product Name: Tocilizumab Roche Product Code: RO4877533 INN or Proposed INN: Tocilizumab Roche Other descriptive name: MRA, Actemra	F Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1170		Finland;Spain;Denmark;Italy
2782	EUCTR2004-000012-13-EE (EUCTR)	20/01/2005	20/01/2005		A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate -	Rheumatoid Arthritis	Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005 Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005 Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005	Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	360		Czech Republic;Estonia;Italy
2783	EUCTR2004-000563-96-AT (EUCTR)	19/01/2005	15/12/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: METHOTREXAT Lederle - Tabletten Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: METHOTREXAT Lederle - Tabletten Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden
2784	EUCTR2004-004302-24-FI (EUCTR)	18/01/2005	17/11/2004	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073	Product Name: L-000883191 Product Code: L-000883191 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Paracetamol Product Name: Paracetamol Product Code: NA INN or Proposed INN: NA Other descriptive name: NA	Suomen MSD Oy	NULL	Not Recruiting			Female: yes Male: yes	136		Finland;Czech Republic;Germany;Spain;Italy
2785	NCT00132769 (ClinicalTrials.gov)	January 2005	2/8/2005	A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)	A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: MK-0873;Drug: Comparator: Placebo	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	65 Years	All	106	Phase 2	Belgium;Canada;Czech Republic;Finland;Germany;Italy;Norway;Spain;Switzerland
2786	NCT00106535 (ClinicalTrials.gov)	January 2005	25/3/2005	A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)	A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1196	Phase 3	United States;Australia;Brazil;China;Denmark;Finland;France;Greece;Italy;Mexico;Norway;Poland;Puerto Rico;South Africa;Spain;Switzerland
2787	EUCTR2004-002157-30-SK (EUCTR)	27/12/2004	10/11/2004	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis	Rheumatoid Arthritis	Product Code: TAK-715 Product Code: TAK-715	Takeda Europe R&D Centre Ltd. (TEuR&D)	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 2	Slovakia;Finland;Denmark
2788	EUCTR2004-000563-96-ES (EUCTR)	22/12/2004	26/10/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: METOTREXATO-LEDERLE 2,5 MG COMPRIMIDOS Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: METOTREXATO-LEDERLE 2,5 MG COMPRIMIDOS Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2789	EUCTR2004-000922-59-ES (EUCTR)	21/12/2004	18/05/2005	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate	Rheumatoid Arthrithis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	675	Phase 3	Czech Republic;Spain;Denmark;Sweden
2790	EUCTR2005-000492-18-IT (EUCTR)	16/12/2004	09/11/2007	Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome	Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome	Metabolic Syndrome and Rheumatoid Arthritis MedDRA version: 6.1;Level: SOC;Classification code 10021428	Trade Name: REMICADE*EV F 100MG+F 2ML INN or Proposed INN: Infliximab	POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI	NULL	Not Recruiting			Female: yes Male: yes			Italy
2791	EUCTR2004-002157-30-DK (EUCTR)	07/12/2004	05/11/2004	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis	Rheumatoid Arthritis	Product Code: TAK-715 Product Code: TAK-715	Takeda Europe R&D Centre Ltd. (TEuR&D)	NULL	Not Recruiting			Female: yes Male: yes	400		Finland;Denmark
2792	EUCTR2004-002157-30-FI (EUCTR)	01/12/2004	22/10/2004	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis	Rheumatoid Arthritis	Product Code: TAK-715 Product Code: TAK-715	Takeda Europe R&D Centre Ltd. (TEuR&D)	NULL	Not Recruiting			Female: yes Male: yes	400		Finland;Denmark
2793	EUCTR2004-000922-59-SE (EUCTR)	01/12/2004	13/10/2004	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006).	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006).	Rheumatoid Arthrithis, Nos	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	660	Phase 3	Czech Republic;Denmark;Spain;Sweden
2794	EUCTR2004-000563-96-IE (EUCTR)	26/11/2004	29/01/2007	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Trade Name: Enbrel Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Methotrexate sodium tablets 2.5mg Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: Methotrexate sodium tablets 2.5mg Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Spain;Ireland;Italy;Sweden
2795	EUCTR2004-003741-40-AT (EUCTR)	26/11/2004	22/10/2004	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: Tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Austria;Germany;Italy
2796	EUCTR2004-000563-96-DK (EUCTR)	23/11/2004	28/08/2007	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2797	EUCTR2004-000563-96-SE (EUCTR)	17/11/2004	15/09/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2798	EUCTR2004-002006-30-GB (EUCTR)	17/11/2004	17/02/2005	Triple therapy in early active rheumatoid arthritis - TEAR	Triple therapy in early active rheumatoid arthritis - TEAR	Rheumatoid arthritis	Product Name: Methotrexate INN or Proposed INN: Methotrexate Trade Name: Salazopyrin En-Tabs Product Name: sulfasalazine INN or Proposed INN: Sulfasalazine Trade Name: Plaquenil Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine	North Glasgow NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	96		United Kingdom
2799	EUCTR2004-000563-96-HU (EUCTR)	12/11/2004	13/09/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Methotrexate-Lachema Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: Methotrexate-Lachema Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2800	EUCTR2004-003733-14-IT (EUCTR)	09/11/2004	18/05/2005	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	active rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: Tocilizumab Product Code: RO 487-7533 INN or Proposed INN: Tocilizumab Other descriptive name: NA Trade Name: METHOTREXATE*2,5MG 25CPR Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*10MG/1,33ML 4S Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*15MG/2ML 4SIR Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*20MG/2,66ML 4S Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	1170		Finland;Denmark;Spain;Italy
2801	NCT00854321 (ClinicalTrials.gov)	November 2004	2/3/2009	Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital	One Centre Follow-up Study on Safety and Efficacy	Rheumatoid Arthritis	Drug: rituximab;Drug: rituximab, observational study amon patients with active RA	Kuopio University Hospital	NULL	Completed	18 Years	N/A	Both	49	N/A	Finland
2802	NCT00170872 (ClinicalTrials.gov)	November 2004	9/9/2005	6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis	A 6 Week, Multicenter, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Lumiracoxib 200mg o.d. in Patients With Primary Knee Osteoarthritis or Rheumatoid Arthritis	Osteoarthritis;Rheumatoid Arthritis	Drug: Lumiracoxib	Novartis	NULL	Completed	18 Years	N/A	Both	135	Phase 3	NULL
2803	NCT00747214 (ClinicalTrials.gov)	November 2004	3/9/2008	A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA	A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA	Rheumatoid Arthritis	Drug: CRx-102;Drug: Placebo;Drug: DMARD Therapy	Zalicus	NULL	Completed	18 Years	N/A	All	59	Phase 2	NULL
2804	NCT01600521 (ClinicalTrials.gov)	November 2004	5/4/2012	A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications	A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications	Rheumatoid Arthritis	Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs	University of Minnesota - Clinical and Translational Science Institute	NULL	Completed	18 Years	N/A	Both	1748	N/A	China
2805	NCT00236028 (ClinicalTrials.gov)	November 2004	7/10/2005	A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis	A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Infliximab	Centocor, Inc.	NULL	Completed	18 Years	75 Years	Both	607	Phase 3	NULL
2806	NCT00195494 (ClinicalTrials.gov)	November 2004	13/9/2005	Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis	A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept;Drug: Methotrexate;Drug: Placebo	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	All	542	Phase 4	United States
2807	NCT00379600 (ClinicalTrials.gov)	November 2004	21/9/2006	The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis	A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Anti-inflammatory and Metabolic Effects of Rosiglitazone XR, 8mg Once Daily, in Subjects With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: rosiglitazone XR	GlaxoSmithKline	NULL	Completed	18 Years	N/A	Both	96	Phase 2	Lithuania;United Kingdom
2808	EUCTR2004-003741-40-IT (EUCTR)	28/10/2004	21/09/2005	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Active rheumatoid arthritis. MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: Tocilizumab Product Code: RO 487-7533 INN or Proposed INN: Tocilizumab Trade Name: METHOTREXATE*2,5MG 25CPR Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*10MG/1,33ML 4S Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*15MG/2ML 4SIR Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*20MG/2,66ML 4S Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Hungary;Germany;Italy
2809	EUCTR2004-000012-13-CZ (EUCTR)	26/10/2004	03/11/2004	A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate	A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate	Rheumatoid Arthritis	Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005 Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005 Product Name: TMI-005 (WAY-177005) Product Code: TMI-005 (WAY-177005) INN or Proposed INN: Not yet established Other descriptive name: WAY-177005	Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Estonia;Czech Republic;Italy
2810	EUCTR2004-000482-35-GB (EUCTR)	11/10/2004	08/02/2005	A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/00	A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/00	Rheumatoid Arthritis	Product Name: Rosiglitazone Extended Release Tablets Product Code: BRL-049653 INN or Proposed INN: Rosiglitazone Other descriptive name: Rosiglitazone maleate	GlaxoSmithKline Research & Development Ltd.	NULL	Not Recruiting			Female: yes Male: yes	66	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Lithuania;United Kingdom
2811	EUCTR2004-001490-26-GB (EUCTR)	15/09/2004	01/06/2005	A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA	A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA	RHEUMATOID ARTHRITIS	Trade Name: Asendis 50 mg Product Name: N/A Product Code: CRx-150 INN or Proposed INN: Amoxapine & dipyridamole	CombinatoRx, Inc	NULL	Not Recruiting			Female: yes Male: yes			Estonia;United Kingdom
2812	EUCTR2004-000563-96-IT (EUCTR)	13/09/2004	14/03/2007	A 24-Month, Randomized, Double-Blind, Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects with Active Early Rheumatoid Arthritis COMET	A 24-Month, Randomized, Double-Blind, Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects with Active Early Rheumatoid Arthritis COMET	Active Early Rheumatoid Arthritis MedDRA version: 6.1;Level: SOC;Classification code 10028395	Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML Product Name: ETANERCEPT INN or Proposed INN: Etanercept	WYETH LEDERLE	NULL	Not Recruiting			Female: yes Male: yes	540		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
2813	EUCTR2004-000612-54-SE (EUCTR)	11/09/2004	07/07/2004	A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study	A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study	Osteoarthritis (OA) ICD: M19.9 MedDRA: 10031161Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037	Product Name: L-001069957 Product Code: L-001069957 INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate Product Name: L-001069957 Product Code: L-001069957 INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate Trade Name: Aspirin Tablets Product Name: Acetylsalicylic acid INN or Proposed INN: Acetylsalicylic acid Other descriptive name: Acetylsalicylic Acid Trade Name: Celebrex Product Name: Celecoxib INN or Proposed INN: Celecoxib	Merck Sharp & Dohme (Sweden) AB	NULL	Not Recruiting			Female: yes Male: yes	1360	Phase 2	Sweden
2814	EUCTR2004-000106-41-SE (EUCTR)	07/09/2004	03/08/2004	A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis - GW406381 and methotrexate	A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis - GW406381 and methotrexate	The patients entering the trial have rheumatoid arthritis although treatment of the disease itself is not under investigation in this study.	Product Name: GW406381 Product Code: GW406381	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes			Sweden
2815	NCT00279734 (ClinicalTrials.gov)	August 2004	19/1/2006	Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers	An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects	Rheumatoid Arthritis	Drug: Tetanus + pnemococcal vaccines alone;Drug: Abatacept + vaccines;Drug: Abatacept + Vaccines	Bristol-Myers Squibb	NULL	Completed	18 Years	65 Years	Both	80	Phase 1	United States
2816	EUCTR2004-000362-12-CZ (EUCTR)	23/07/2004	20/08/2004	A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A	A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10028395	Product Name: K-832 Product Code: K-832 INN or Proposed INN: To be confirmed Other descriptive name: N/A Product Name: K-832 Product Code: K-832 INN or Proposed INN: To be confirmed Other descriptive name: N/A	Kowa Research Europe Ltd	NULL	Not Recruiting			Female: yes Male: yes	260		Czech Republic
2817	EUCTR2004-000074-31-SE (EUCTR)	06/07/2004	21/05/2004	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis	rheumatoid arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073	Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Trade Name: paracetamol (acetaminophen) Product Name: paracetamol (acetaminophen)	Merck Sharp & Dohme (Sweden) AB	NULL	Not Recruiting			Female: yes Male: yes	150		Sweden
2818	NCT00089921 (ClinicalTrials.gov)	July 2004	17/8/2004	SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate	A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine	Arthritis, Rheumatoid	Drug: SCIO-469;Drug: Placebo	Scios, Inc.	NULL	Completed	18 Years	N/A	Both	302	Phase 2	United States
2819	NCT00154336 (ClinicalTrials.gov)	July 2004	8/9/2005	A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.	3-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety & Tolerability of Imatinib 400 mg Daily in Combination With Methotrexate (MTX)Compared to MTX Alone in the Treatment of Rheumatoid Arthritis (RA).	Rheumatoid Arthritis	Drug: Imatinib;Drug: Methotrexate;Drug: Imatinib Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	50	Phase 2	Austria;Canada;Finland;United Kingdom
2820	NCT02097745 (ClinicalTrials.gov)	June 2004	20/3/2014	A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies	An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies	Rheumatoid Arthritis	Drug: methotrexate;Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	Biogen	Completed	18 Years	80 Years	All	341	Phase 3	United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
2821	NCT00252668 (ClinicalTrials.gov)	June 2004	9/11/2005	Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects	An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects	Rheumatoid Arthritis	Drug: Etanercept;Drug: Methotrexate	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	Both	300	Phase 4	NULL
2822	NCT00468377 (ClinicalTrials.gov)	March 2004	30/4/2007	Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa Therapies	An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies	Arthritis, Rheumatoid	Drug: Rituximab	Hoffmann-La Roche	Genentech, Inc.	Active, not recruiting	18 Years	80 Years	Both	341	Phase 3	United States
2823	NCT00484809 (ClinicalTrials.gov)	March 2004	8/6/2007	Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children	A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).	Rheumatoid Arthritis	Drug: Enbrel (Etanercept)	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	4 Years	N/A	Both	100		NULL
2824	NCT00619905 (ClinicalTrials.gov)	December 2003	8/2/2008	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate	A Randomized, Double-Blind, Placebo-Controlled, Cohort Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 (Anti-Interleukin-1Beta Monoclonal Antibody) in Patients With Active Rheumatoid Arthritis (RA) Despite Ongoing Treatment With Methotrexate (MTX) 15 mg or More Weekly for at Least 3 Months.	Rheumatoid Arthritis	Drug: ACZ885	Novartis	NULL	Completed	18 Years	75 Years	Both	53	Phase 1/Phase 2	Germany;Netherlands;Switzerland
2825	NCT00076206 (ClinicalTrials.gov)	December 2003	15/1/2004	Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy	A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy	Rheumatoid Arthritis	Drug: CCI-779;Drug: Placebo	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Terminated	18 Years	75 Years	Both		Phase 2	United States
2826	NCT00207714 (ClinicalTrials.gov)	November 2003	13/9/2005	An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis	A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate	Rheumatoid Arthritis	Drug: Golimumab;Drug: MTX;Drug: Placebo;Drug: Infliximab	Centocor, Inc.	Centocor BV	Completed	18 Years	N/A	All	172	Phase 2	NULL
2827	NCT00195364 (ClinicalTrials.gov)	July 2003	13/9/2005	Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain	Long-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain	Rheumatoid Arthritis;Inflammation	Drug: Etanercept	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	Both	93		Spain
2828	NCT00245934 (ClinicalTrials.gov)	June 2003	26/10/2005	Study Evaluating Enbrel in Patients With Rheumatoid Arthritis	Observational Study With Enbrel in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Enbrel	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	Both	1500	N/A	NULL
2829	NCT00095342 (ClinicalTrials.gov)	May 2003	2/11/2004	Study Evaluating TMI-005 in Active Rheumatoid Arthritis	A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate	Rheumatoid Arthritis	Drug: TMI-005	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	75 Years	Both	390	Phase 2	United States;Canada
2830	NCT00468546 (ClinicalTrials.gov)	May 2003	30/4/2007	A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy	A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies	Rheumatoid Arthritis	Drug: MabThera/Rituxan;Drug: Methotrexate;Other: Placebo	Hoffmann-La Roche	Biogen	Completed	18 Years	80 Years	All	520	Phase 3	United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
2831	NCT00195377 (ClinicalTrials.gov)	April 2003	13/9/2005	Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain	Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study	Arthritis, Psoriatic;Arthritis, Rheumatoid	Drug: Etanercept	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	4 Years	N/A	Both	1000		Spain
2832	NCT00244556 (ClinicalTrials.gov)	March 2003	12/10/2005	Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy	A Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate Therapy	Rheumatoid Arthritis	Drug: Methotrexate plus ENBREL or ENBREL alone	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	Both	300	Phase 4	NULL
2833	NCT00908089 (ClinicalTrials.gov)	March 2003	22/5/2009	TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis	Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan+Salazopyrin+Oxiklorin+prednisolone + placebo	Helsinki University	Seinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-Hame	Active, not recruiting	18 Years	60 Years	Both	100	Phase 4	Finland
2834	NCT00546533 (ClinicalTrials.gov)	January 2003	18/10/2007	Study Evaluating the Efficacy and Safety of Etanercept	Open-Label Evaluation Of The Efficacy And Safety Of Etanercept In Patients With Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Etanercept	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	N/A	N/A	Both	40	Phase 4	NULL
2835	NCT00116727 (ClinicalTrials.gov)	October 2002	30/6/2005	Rheumatoid Arthritis DMARD Intervention and UtilizationStudy	Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)	Rheumatoid Arthritis	Drug: ENBREL®	Amgen	Immunex Corporation;Wyeth is now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	Both	5103	N/A	United States
2836	NCT00282412 (ClinicalTrials.gov)	September 2002	24/1/2006	Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism	Rheumatoid Arthritis: Tolerance Induction by Mixed Chimerism	Rheumatoid Arthritis	Biological: Hematopoietic Stem Cell Transplantation	Northwestern University	NULL	Terminated	18 Years	60 Years	Both	4	Phase 1	United States
2837	NCT02180516 (ClinicalTrials.gov)	October 2001	1/7/2014	Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome	Safety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome	Arthritis, Rheumatoid	Drug: Meloxicam;Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac	Boehringer Ingelheim	NULL	Completed	N/A	N/A	Both	9984	N/A	NULL
2838	NCT00116714 (ClinicalTrials.gov)	October 2001	30/6/2005	Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy	Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 1)	Rheumatoid Arthritis	Drug: DMARD	Amgen	Immunex Corporation;Wyeth is now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	Both	4968	N/A	United States
2839	NCT00195663 (ClinicalTrials.gov)	December 2000	13/9/2005	Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis	A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFa Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).	Early Rheumatoid Arthritis	Biological: Adalimumab;Drug: Methotrexate;Biological: Adalimumab placebo;Drug: Methotrexate placebo	AbbVie (prior sponsor, Abbott)	NULL	Completed	18 Years	N/A	All	799	Phase 3	United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Slovakia;Spain;Sweden;Switzerland;United Kingdom
2840	NCT00393471 (ClinicalTrials.gov)	October 2000	26/10/2006	Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.	A Double-Blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.	Active Rheumatoid Arthritis	Drug: Etanercept	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	Male	615	Phase 3	Australia;Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Israel;Italy;Netherlands;Norway;Poland;Portugal;Romania;Spain;Sweden;United Kingdom
2841	NCT00006055 (ClinicalTrials.gov)	March 2000	5/7/2000	Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases		Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis	Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation	Fairview University Medical Center	NULL	Active, not recruiting	1 Year	55 Years	Both	10	N/A	United States
2842	NCT00000435 (ClinicalTrials.gov)	September 1999	21/1/2000	dnaJ Peptide for Relieving Rheumatoid Arthritis	A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: dnaJ peptide;Drug: None-placebo	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NULL	Completed	18 Years	85 Years	Both	160	Phase 2	United States
2843	EUCTR2012-001145-40-Outside-EU/EEA (EUCTR)		07/03/2012	Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritis	Open-label Extension Treatment with TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials	Rheumatoid arthritis (RA) in adults and juvenile idiopathic arthritis (JIA) for subjects who did not respond to conventional DMARDS;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel (Etanercept) INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel (Etanercept) INN or Proposed INN: ETANERCEPT	Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320	NULL	NA			Female: yes Male: yes	783		Canada;United States
2844	EUCTR2009-017438-32-DE (EUCTR)		22/02/2010	A 12-week study of 4 doses of VX-509 in subjects with active rheumatoid arthritis	A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis	Active rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: VX-509 Product Code: VX-509 Product Code: VX-509	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Russian Federation;Germany;Serbia;Belgium;Romania;United States;Croatia;Poland
2845	EUCTR2007-002536-29-PL (EUCTR)		15/01/2008	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Austria;Poland;Sweden
2846	EUCTR2006-003983-73-DE (EUCTR)		23/03/2007	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: RWJ-445380 Capsules 50 mg Product Code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC Product Name: RWJ-445380 capsule 100 mg Product Code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC Product Name: RWJ-445380 capsules 150 mg Product Code: RWJ-445380-002 Other descriptive name: JNJ-16240159-AAC	Janssen-Cliag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Germany
2847	EUCTR2007-003591-19-DE (EUCTR)		05/09/2007	AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/ml	AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/ml	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Methotrexate 50mg/ml solution for injection, pre-filled syringe INN or Proposed INN: Methotrexate disodium Other descriptive name: Methotrexate disodium Trade Name: Metex 10 mg/ml Injektionslösung, Fertigspritze INN or Proposed INN: methotrexate disodium Other descriptive name: Methotrexate disodium	medac Gesellschaft für klinische Spezialpräparate mbH	NULL	Not Recruiting			Female: yes Male: yes			Germany
2848	EUCTR2005-001138-33-SI (EUCTR)		13/06/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Denmark;Slovenia;Norway;Spain;Italy
2849	EUCTR2010-023692-26-DE (EUCTR)		07/12/2010	Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared with Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)	(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: previously known as R935788 INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	370	Phase 2	United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands
2850	EUCTR2012-003655-11-DE (EUCTR)		09/12/2013	Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life	A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis	Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	739	Phase 2	United States;Czechia;Spain;Guatemala;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of
2851	EUCTR2005-002969-37-DE (EUCTR)		17/05/2006	A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/00	A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/00	Rheumatoid Arthritis	Product Code: GW856553 Product Code: GW856553 Product Code: GW856553 Product Name: Methotrexat INN or Proposed INN: Methotrexate Disodium	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;Spain;Sweden
2852	EUCTR2011-002896-40-ES (EUCTR)		26/06/2012	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES	RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
2853	EUCTR2004-000563-96-NO (EUCTR)		06/10/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580	Phase 4	Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden
2854	JPRN-JapicCTI-111601		05/09/2011	A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents	A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents	Rheumatoid Arthritis	Intervention name : Secukinumab INN of the intervention : Secukinumab Dosage And administration of the intervention : s.c. i.v.	Novartis Pharma K.K.	NULL		18		BOTH		Phase 3	NULL
2855	JPRN-JapicCTI-132134		23/05/2013	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs	A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis	Intervention name : Baricitinib Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52. Control intervention name : Placebo Dosage And administration of the control intervention : Baricitinib placebo administered orally once daily through Week 52 and MTX placebo administered orally once weekly through Week 52. Control intervention name : Methotrexate Dosage And administration of the control intervention : Methotrexate (MTX) administered orally once weekly with dose ranging from 7.5 to 12.5 mg per week through Week 52.	Eli Lilly Japan K.K.	NULL	complete	18		BOTH		Phase 3	NULL
2856	JPRN-JapicCTI-080531		21/02/2008	A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use	A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use	Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago	Intervention name : esomeprazole Dosage And administration of the intervention : Oral	AstraZeneca	NULL		20		BOTH		Phase 3	NULL
2857	EUCTR2012-000609-58-ES (EUCTR)		09/07/2012	A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNF? biologics	A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNF? biologics	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	268	Phase 2	United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany
2858	JPRN-JapicCTI-080565		09/04/2008	A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use	A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use	Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago	Intervention name : esomeprazole Dosage And administration of the intervention : Oral	AstraZeneca	NULL		20		BOTH		Phase 3	NULL
2859	EUCTR2005-002423-13-BG (EUCTR)		03/08/2010	Study of safety and efficacy of long-term treatment with tocilizumab in adult patients with rheumatoid arthritis.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - GROWTH95	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Germany;Switzerland;Bulgaria;France;Italy;Singapore;Hong Kong;Austria;Australia;Brazil;Israel;Slovakia;Canada;Mexico;Argentina;Thailand
2860	EUCTR2011-001626-15-ES (EUCTR)		20/10/2011	A study of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with rheumatoid arthritis with inadequate response to prior treatment with methotrexate and low disease activity with the combination de RoActemra/Actemra y methotrexate.	A multi-centre, randomized, double-blind study of the safety and efficacy of tocilizumab (TCZ) in combination with methotrexate (MTX), versus TCZ (placebo controlled) in patients with active rheumatoid arthritis (RA) with inadequate response to prior MTX treatment and low disease activity (DAS 28 ? 3.2) with the combination TCZ and MTX.	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	Roche Farma, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain
2861	EUCTR2008-000744-13-DE (EUCTR)		07/10/2008	An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study	An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788 Product Name: R935788 INN or Proposed INN: Fostamatinib Disodium Other descriptive name: R788 Sodium, R788 Na, R788	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	800		France;Belgium;Bulgaria;Germany;Italy

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58. 肥大型心筋症

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臨床試験数 : 126 /  薬物数 : 135 - (DrugBank : 42) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 162

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05025644 (ClinicalTrials.gov)	March 2023	11/8/2021	Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test	Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test	Hypertrophic Obstructive Cardiomyopathy	Drug: Pre and post-CPB Drug: Dobutamine Hydrochloride;Drug: Post-CPB Drug: Dobutamine Hydrochloride	University Health Network, Toronto	NULL	Not yet recruiting	18 Years	N/A	All	60	Phase 4	NULL
2	EUCTR2021-005329-26-ES (EUCTR)	26/01/2023	01/11/2022	A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Cardiomyopathy	A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy - Mavacamten in nonobstructive HCM	Symptomatic Nonobstructive Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10049813;Term: Non-obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	Myokardia, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Denmark;Australia;Norway;Germany;Netherlands;Japan;Korea, Republic of
3	EUCTR2021-005329-26-FR (EUCTR)	24/01/2023	07/10/2022	A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Cardiomyopathy	A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy - Mavacamten in nonobstructive HCM	Symptomatic Nonobstructive Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10049813;Term: Non-obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	Myokardia, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Denmark;Australia;Norway;Germany;Netherlands;Japan;Korea, Republic of
4	NCT05582395 (ClinicalTrials.gov)	December 14, 2022	14/9/2022	A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy	A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy	Cardiomyopathy, Hypertrophic	Drug: Mavacamten;Other: Placebo	Bristol-Myers Squibb	NULL	Recruiting	18 Years	N/A	All	420	Phase 3	United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Netherlands;Norway;Poland;Portugal;Spain;United Kingdom
5	NCT05569382 (ClinicalTrials.gov)	August 10, 2022	4/10/2022	Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy	Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy	Non-obstructive Hypertrophic Cardiomyopathy	Drug: Verapamil;Drug: Bisoprolol;Drug: Placebo	Morten Steen Kvistholm Jensen	Bispebjerg Hospital;Rigshospitalet, Denmark;Viborg Regional Hospital;Zealand University Hospital;Odense University Hospital;Gentofte University Hospital	Recruiting	18 Years	N/A	All	140	Phase 4	Denmark
6	JPRN-jRCT2031220178	21/06/2022	02/07/2022	A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy( HORIZON-HCM )	A Phase 3, Open-label, Single Arm, Clinical Study to Evaluate Efficacy, Safetyand Tolerability of Mavacamten in Adults With Symptomatic ObstructiveHypertrophic Cardiomyopathy	Obstructive Hypertrophic Cardiomyopathy	Single Group Assignment: Mavacamten Participants will receive treatment with 1, 2.5, 5, 10, 1mg dose once daily.	Florea Victoria	NULL	Pending	>= 18age old	Not applicable	Both	30	Phase 3	Japan
7	NCT05182658 (ClinicalTrials.gov)	June 1, 2022	21/12/2021	Empagliflozin in Hypertrophic Cardiomyopathy	The Use of Empagliflozin in Patients With Hypertrophic Cardiomyopathy	Hypertrophic Cardiomyopathy;Heart Failure	Drug: Empagliflozin 10 MG;Drug: Placebo	Institute of Cardiology, Warsaw, Poland	Medical University of Bialystok;University of Eastern Finland;Amsterdam UMC, location VUmc	Not yet recruiting	18 Years	70 Years	All	250	Phase 3	Poland
8	EUCTR2021-006953-77-DK (EUCTR)	11/04/2022	31/01/2022	The effect of Bisoprolol and Verapamil in non-obstructive hypertrophic cardiomyopathy	Treatment effects of Bisoprolol and Verapamil in symptomatic patients with non-obstructive hypertrophic cardiomyopathy - TEMPO II	Non-obstructive Hypertrophic cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10007636;Term: Cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0;Classification code 10049813;Term: Non-obstructive cardiomyopathy;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: LLT;Classification code 10061029;Term: Cardiomyopathy primary;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Bisoprolol INN or Proposed INN: BISOPROLOL Trade Name: Isoptin INN or Proposed INN: VERAPAMIL HYDROCHLORIDE	Aarhus University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	Denmark
9	NCT05174416 (ClinicalTrials.gov)	January 4, 2022	13/12/2021	A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM	A Phase III, Randomized, Double-blinded, Placebo-controlled Clinical Study With A Long-term Extension to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy	Obstructive Hypertrophic Cardiomyopathy	Drug: Mavacamten;Drug: Placebo	LianBio LLC	NULL	Active, not recruiting	18 Years	99 Years	All	81	Phase 3	China
10	NCT04905173 (ClinicalTrials.gov)	November 2021	23/5/2021	Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy	Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy	Hypertrophic Cardiomyopathy;Hypertrophic Obstructive Cardiomyopathy;Cardiomyopathy, Hypertrophic	Other: Squat-to-stand maneuver;Drug: Amyl nitrite inhalation;Other: Valsalva	Mayo Clinic	NULL	Not yet recruiting	18 Years	N/A	All	200	N/A	United States
11	ChiCTR2100048388	2021-07-01	2021-07-06	The prognostic value of myocardial fibrosis in patients with hypertrophic cardiomyopathy	The prognostic value of myocardial fibrosis in patients with hypertrophic cardiomyopathy: a prospective study based on 18FAl-NOTA-FAPI-04 imaging	hypertrophic cardiomyopathy	Gold Standard:Clinical outcome;Index test:18FAl-NOTA-FAPI imaging quantitatively detect myocardial fibrosis;	Beijing Chaoyang Hospital, Capital Medical University	NULL	Pending	14		Both	Target condition:100;Difficult condition:0		China
12	NCT04826185 (ClinicalTrials.gov)	June 14, 2021	18/3/2021	A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial	A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy	Non-obstructive Hypertrophic Cardiomyopathy	Drug: IMB-1018972;Drug: Placebo	Imbria Pharmaceuticals, Inc.	NULL	Recruiting	18 Years	80 Years	All	60	Phase 2	United States;United Kingdom
13	ChiCTR2000033626	2020-06-01	2020-06-07	Endocardial Radiofrequency Septal Ablation Versus Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy	Endocardial Radiofrequency Septal Ablation Versus Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy: a Randomized, Controlled, Open-Label Non-Inferiority Study	Hypertrophic Obstructive Cardiomyopathy	diofrequency ablation:radiofrequency ablation;Alcohol Ablation:Alcohol Septal Ablation;	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	NULL	Recruiting	18	75	Both	diofrequency ablation:40;Alcohol Ablation:40;		China
14	EUCTR2019-003098-24-GB (EUCTR)	30/04/2020	21/02/2020	Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy	A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM)	non-obstructive hypertrophic cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Entresto Product Name: LCZ696 50 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 100 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 200 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	44	Phase 2	United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
15	EUCTR2019-003098-24-GR (EUCTR)	16/04/2020	13/04/2020	Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy	A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM)	non-obstructive hypertrophic cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Entresto Product Name: LCZ696 50 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 100 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 200 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	44	Phase 2	United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
16	EUCTR2019-003098-24-FI (EUCTR)	15/04/2020	02/03/2020	Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy	A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM)	non-obstructive hypertrophic cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Entresto Product Name: LCZ696 50 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 100 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 200 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 2	United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
17	EUCTR2019-003098-24-ES (EUCTR)	19/02/2020	02/12/2019	Study of efficacy of oral sacubitril/valsartan adult patients with non-obstructive hypertrophic cardiomyopathy	A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM)	non-obstructive hypertrophic cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Entresto Product Name: LCZ696 50 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 100 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 200 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN	Novartis Farmacéutica, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	44	Phase 2	Greece;United States;Finland;Korea, Republic of;United Kingdom;Germany;Spain
18	NCT04219826 (ClinicalTrials.gov)	January 10, 2020	3/1/2020	REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in HCM	A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy	Hypertrophic Cardiomyopathy (HCM)	Drug: CK-3773274 (5 - 15 mg);Drug: CK-3773274 (10 - 30 mg);Drug: Placebo for CK-3773274	Cytokinetics	NULL	Active, not recruiting	18 Years	85 Years	All	95	Phase 2	United States;Italy;Netherlands;Spain
19	NCT04164732 (ClinicalTrials.gov)	January 8, 2020	13/11/2019	Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy	A Multi-center, Randomized, Placebo-controlled Patient and Investigator-blinded Study to Explore the Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy (nHCM)	Cardiomyopathy, Hypertrophic	Drug: LCZ696;Drug: Placebo	Novartis Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	45	Phase 2	United States;Germany;Greece;Korea, Republic of;Spain;United Kingdom;Finland
20	EUCTR2019-003098-24-DE (EUCTR)	18/12/2019	05/11/2019	Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy	A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM)	non-obstructive hypertrophic cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Entresto Product Name: LCZ696 50 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 100 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN Trade Name: Entresto Product Name: LCZ696 200 mg Product Code: LCZ696 INN or Proposed INN: sacubitril/valsartan Other descriptive name: SACUBITRIL VALSARTAN	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	44	Phase 2	United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
21	EUCTR2018-004039-64-ES (EUCTR)	07/08/2019	02/09/2019	A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)	A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
22	ChiCTR1900021706	2019-03-10	2019-03-05	MicroRNA is involved in the mechanism of myocardial fibrosis in hypertrophic cardiomyopathy	Hypertrophic cardiomyopathy myocardial fibrosis	Hypertrophic obstructive myocardium	HOCM:NO;	West China Hospital, Sichuan University	NULL	Pending	18	70	Both	HOCM:40;	N/A	China
23	EUCTR2017-002530-23-NL (EUCTR)	10/12/2018	09/08/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany
24	EUCTR2017-002530-23-DK (EUCTR)	19/11/2018	24/09/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
25	EUCTR2017-002530-23-PL (EUCTR)	31/10/2018	14/08/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
26	EUCTR2017-002530-23-CZ (EUCTR)	25/10/2018	27/06/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
27	EUCTR2017-002530-23-GB (EUCTR)	22/10/2018	08/05/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
28	EUCTR2017-002530-23-BE (EUCTR)	22/10/2018	06/07/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
29	NCT03723655 (ClinicalTrials.gov)	October 5, 2018	24/10/2018	A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM	A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)	Hypertrophic Cardiomyopathy;Obstructive Hypertrophic Cardiomyopathy;Non-obstructive Hypertrophic Cardiomyopathy	Drug: mavacamten	Bristol-Myers Squibb	NULL	Active, not recruiting	18 Years	N/A	All	282	Phase 2/Phase 3	United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
30	EUCTR2017-002530-23-DE (EUCTR)	04/10/2018	03/05/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
31	EUCTR2017-002530-23-ES (EUCTR)	19/09/2018	12/06/2018	A study to evaluate the safety and benefit of Mavacamten (MYK-461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
32	EUCTR2017-002530-23-PT (EUCTR)	17/09/2018	21/05/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
33	EUCTR2017-002530-23-IT (EUCTR)	11/09/2018	10/11/2020	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: Mavacamten Other descriptive name: Mavacamten Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: Mavacamten Other descriptive name: Mavacamten Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: Mavacamten Other descriptive name: Mavacamten Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: Mavacamten Other descriptive name: Mavacamten	MYOKARDIA, INC.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
34	EUCTR2017-002530-23-FR (EUCTR)	11/09/2018	31/01/2019	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN	MyoKardia, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
35	NCT03496168 (ClinicalTrials.gov)	April 26, 2018	5/4/2018	Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER	An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)	Hypertrophic Cardiomyopathy	Drug: mavacamten	Bristol-Myers Squibb	NULL	Active, not recruiting	18 Years	N/A	All	13	Phase 2	United States
36	NCT03442764 (ClinicalTrials.gov)	March 30, 2018	9/2/2018	A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)	A Randomized, Double-blind, Placebo-controlled, Concentration-guided, Exploratory Study of Mavacameten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) and Preserved Left Ventricular Ejection Fraction	Non-obstructive Hypertrophic Cardiomyopathy	Drug: mavacamten;Drug: Placebo	MyoKardia, Inc.	NULL	Completed	18 Years	N/A	All	59	Phase 2	United States
37	EUCTR2017-004478-32-DK (EUCTR)	10/01/2018	14/12/2017	The effect of metoprolol in hypertrophic obstructive cardiomyopathy	The effect of metoprolol on myocardial function, hemodynamics and heart failure symptoms in patients with hypertrophic obstructive cardiomyopathy - TEMPO	Hypertrophic obstructive cardiomyopathy MedDRA version: 20.0;Level: LLT;Classification code 10020876;Term: Hypertrophic obstructive cardiomyopathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Metoprololsuccinat INN or Proposed INN: metoprololsuccinat Other descriptive name: METOPROLOL SUCCINATE	Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	Denmark
38	NCT03251287 (ClinicalTrials.gov)	November 2017	11/8/2017	Nitrite in Hypertrophic Cardiomyopathy (HCM) Study	Mechanistic Study of the Effect of Inorganic Sodium Nitrate on Cardiac and Skeletal Muscle Metabolic Efficiency in Patients With Hypertrophic Cardiomyopathy	Cardiomyopathy, Hypertrophic	Drug: Sodium Nitrate;Drug: Placebo;Diagnostic Test: Phosphorous Magnetic Resonance Spectroscopy;Diagnostic Test: Exercise Stress Transthoracic Echocardiogram	University of East Anglia	Norfolk and Norwich University Hospitals NHS Foundation Trust;British Medical Research Council	Recruiting	18 Years	80 Years	All	18	Phase 1	United Kingdom
39	NCT03249272 (ClinicalTrials.gov)	September 5, 2017	8/8/2017	Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve	Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve	Hypertrophic Cardiomyopathy;Non-ischemic Dilated Cardiomyopathy;Microvascular Ischaemia of Myocardium	Drug: Regadenoson;Drug: Adenosine	Duke University	NULL	Terminated	18 Years	N/A	All	31	Phase 4	United States
40	NCT03953989 (ClinicalTrials.gov)	October 2016	13/5/2019	Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy	A Pilot Study Assessing the Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy	HCM - Hypertrophic Non-Obstructive Cardiomyopathy	Drug: Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die	IRCCS San Raffaele	Menarini International Operations Luxembourg SA	Completed	18 Years	80 Years	All	26	Phase 2	Italy
41	EUCTR2015-002283-16-DK (EUCTR)	08/03/2016	16/12/2015	An international study of the effect of Valsartan in hypertrophic cardiomyopathy.	Phase II randomized, placebo-controlled, double blind clinical trial of valsartan for attenuating disease evolution in early sarcomeric HCM - VANISH	Hypertrophic cardiomyopathy MedDRA version: 19.0;Level: LLT;Classification code 10020204;Term: HOCM Hypertrophic obstructive cardiomyopathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Diovan 40 mg INN or Proposed INN: VALSARTAN Other descriptive name: Diovan Trade Name: Diovan 80 mg INN or Proposed INN: VALSARTAN Other descriptive name: Diovan Trade Name: Diovan 160 mg INN or Proposed INN: VALSARTAN	National Heart, Lung, and Blood Institute / National Institutes of Health	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	Denmark
42	EUCTR2015-002432-40-IT (EUCTR)	03/03/2016	27/05/2021	Safety and Efficacy of yIFN treatment in Friedreich ataxia	Safety and Efficacy of yIFN treatment in Friedreich ataxia - ¿IFN in Friedreich Ataxia	FRDA is a progressive neurodegenerative disease inherited as recessive trait. It manifests itself usually in adolescence and affects various systems including the central and peripheral nervous system (balance, coordination, speech and sensitivity), the heart with hypertrophic cardiomyopathy, the bones with skeletal deformities (scoliosis, claw foot) and in some cases diabetes mellitus. The disease causes severe and progressive disability, significantly reducing the life expectancy of patients. MedDRA version: 20.0;Level: PT;Classification code 10017374;Term: Friedreich's ataxia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: IMUKIN - 6 FLACONI 0.5 ML 100 MCG Product Name: Imukin	ASSOCIAZIONE LA NOSTRA FAMIGLIA - SEZIONE SCIENTIFICA I.R.C.C.S. E.MEDEA	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	Italy
43	NCT02560467 (ClinicalTrials.gov)	December 1, 2015	22/9/2015	Perfusion Imaging With Myocardial Contrast Echocardiography in HCM		Hypertrophic Cardiomyopathy	Drug: Echo and myocardial contrast echocardiography perfusion imaging	Oregon Health and Science University	NULL	Active, not recruiting	19 Years	80 Years	All	10	N/A	United States
44	EUCTR2013-004429-97-IT (EUCTR)	15/05/2015	12/05/2015	A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic Cardiomyopathy	A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy - NA	Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed) MedDRA version: 18.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: GS-6615 3 mg INN or Proposed INN: No INN or proposed INN available Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one Product Code: GS-6615 6 mg INN or Proposed INN: No INN or proposed INN available Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	France;United States;Israel;Netherlands;Germany;United Kingdom;Italy
45	EUCTR2013-004429-97-NL (EUCTR)	13/04/2015	17/12/2014	A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic Cardiomyopathy	A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy	Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed) MedDRA version: 18.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: GS-6615 3 mg INN or Proposed INN: No INN or proposed INN available Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one Product Code: GS-6615 6 mg INN or Proposed INN: No INN or proposed INN available Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	France;United States;Israel;Germany;Netherlands;Italy;United Kingdom
46	EUCTR2013-004429-97-GB (EUCTR)	24/03/2015	05/11/2014	A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic Cardiomyopathy	A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy	Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed) MedDRA version: 19.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: GS-6615 3 mg White Product Code: GS-6615 3 mg White INN or Proposed INN: No INN or proposed INN available Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one Product Name: GS-6615 6 mg White Product Code: GS-6615 6 mg White INN or Proposed INN: No INN or proposed INN available Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one Product Name: GS-6615 3 mg Pink Product Code: GS-6615 3 mg Pink INN or Proposed INN: No INN or proposed INN available Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4- (trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4- (trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	France;United States;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
47	EUCTR2014-001577-13-GB (EUCTR)	15/07/2014	04/06/2014	Trientine in Hypertrophic Cardiomyopathy	Copper Chelation in Hypertrophic Cardiomyopathy: Open-label pilot study of Trientine in patients with hypertrophic cardiomyopathy - Copper (II) Chelation therapy in the treatment of HCM	Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Trientine dihydrochloride Product Name: Trientine dihydrochloride INN or Proposed INN: Trientine Dihydrochloride	Manchester University NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
48	NCT01904396 (ClinicalTrials.gov)	August 2013	15/7/2013	Identification of Carnitine-Responsive Cardiomyopathy	Identification of Carnitine-responsive Cardiomyopathy and Myopathy in Adult Patients With Dilated and/or Hypertrophic Cardiomyopathy and Limb Girdle Weakness.	Carnitine Deficiency	Drug: Carnitine	University Health Network, Toronto	The Physicians' Services Incorporated Foundation	Not yet recruiting	18 Years	N/A	Both	30	Phase 4	Canada
49	NCT01721967 (ClinicalTrials.gov)	November 2012	2/11/2012	Ranolazine for the Treatment of Chest Pain in HCM Patients	Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation	Hypertrophic Cardiomyopathy	Drug: Ranolazine	Duke University	Gilead Sciences	Completed	18 Years	N/A	All	14	Phase 4	United States
50	EUCTR2011-004507-20-DE (EUCTR)	02/07/2012	17/10/2011	SHCM	RANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS (RESTYLE- HCM STUDY) - RESTYLE- HCM STUDY	symptomatic hypertrophic cardiomyopathy (SHCM) MedDRA version: 17.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Ranexa Product Code: Ranolazine 500 mg PR tablets INN or Proposed INN: RANOLAZINE Trade Name: Ranexa Product Name: Ranolazine 750 mg PR tablets INN or Proposed INN: RANOLAZINE Trade Name: Ranexa Product Name: Ranolazine 1000 mg PR tablets INN or Proposed INN: RANOLAZINE	Menarini International Operations Luxembourg S.A.	NULL	Not Recruiting			Female: yes Male: yes	100		Spain;Germany;Italy
51	NCT01696370 (ClinicalTrials.gov)	April 2012	27/9/2012	Trimetazidine Therapy in Hypertrophic Cardiomyopathy	A Phase 2b Randomised, Double Blind, Placebo-controlled Trial of Trimetazidine Therapy in Patients With Non-obstructive Hypertrophic Cardiomyopathy	Hypertrophic Cardiomyopathy	Drug: Trimetazidine;Other: Placebo capsule	University College, London	British Heart Foundation	Recruiting	18 Years	N/A	Both	90	Phase 2	United Kingdom
52	EUCTR2011-004507-20-IT (EUCTR)	22/02/2012	08/03/2012	SHMC	RANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS	symptomatic hypertrophic cardiomyopathy (SHCM) MedDRA version: 14.1;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: RANEXA*60CPR 500MG R.P. INN or Proposed INN: RANOLAZINE Other descriptive name: NA Trade Name: RANEXA*60CPR 750MG R.P. INN or Proposed INN: RANOLAZINE Other descriptive name: NA Trade Name: RANEXA INN or Proposed INN: RANOLAZINE Other descriptive name: NA	MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Spain;Germany;Italy
53	NCT01556568 (ClinicalTrials.gov)	February 2012	15/3/2012	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy	An Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy	Cardiomegaly	Drug: MEK162	Array Biopharma, now a wholly owned subsidiary of Pfizer	NULL	Withdrawn	18 Years	65 Years	All	0	Phase 2	United States;United Kingdom
54	EUCTR2011-003392-10-GB (EUCTR)	23/01/2012	24/08/2011	A study to look at the effect of the study drug on heart muscle thickness, the amount of drug that ends up in the blood, and the safety and tolerability of study drug in Noonan syndrome patients.	An open label study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEK162 in Noonan syndrome hypertrophic cardiomyopathy.	Noonan syndrome hypertrophic cardiomyopathy MedDRA version: 14.1;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: MEK162	Novartis Pharma Services AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	22		United Kingdom;United States
55	EUCTR2011-004507-20-ES (EUCTR)	19/01/2012	13/10/2011	SHMC	RANOLAZINE IN PATIENTS WITH SYMPTOMATICHYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDYASSESSING THE EFFECTS ON EXERCISE CAPACITY,DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS	symptomatic hypertrophic cardiomyopathy (SHCM) MedDRA version: 14.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Ranexa Product Code: Ranolazine 500 mg PR tablets INN or Proposed INN: RANOLAZINE Trade Name: Ranexa Product Name: Ranolazine 750 mg PR tablets INN or Proposed INN: RANOLAZINE Trade Name: Ranexa Product Name: Ranolazine 1000 mg PR tablets INN or Proposed INN: RANOLAZINE	Menarini International Operations Luxembourg S.A.	NULL	Not Recruiting			Female: yes Male: yes	100		Spain;Germany;Italy
56	NCT01447654 (ClinicalTrials.gov)	November 2011	4/10/2011	Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy	INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.	Hypertrophic Cardiomyopathy	Drug: Losartan;Drug: Placebo	Henning Bundgaard	NULL	Completed	18 Years	N/A	Both	130	Phase 2	Denmark
57	EUCTR2011-001191-19-DK (EUCTR)	26/10/2011	12/09/2011	Effects on the heart in patients with hypertophic cardiomyopathy when treated with losartan.	Cardiac effects of inhibition of the renin angiotensin system with losartan in patients with hypertrophic cardiomyopathy.	Hypertrophic cardiomyopathy MedDRA version: 14.0;Level: LLT;Classification code 10020876;Term: Hypertrophic obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Losartan Bluefish 50 mg Product Name: Losartan	Hjertemedicinsk klinik B, 2142, Rigshospitalet	NULL	Not Recruiting			Female: yes Male: yes			Denmark
58	EUCTR2011-000038-12-GB (EUCTR)	13/09/2011	17/08/2011	Trimetazidine therapy in Hypertrophic Cardiomyopathy	A Phase 2b randomised, double blind, placebo-controlled trial of trimetazidine therapy in patients with non-obstructive hypertrophic cardiomyopathy. - Trimetazidine therapy in hypertrophic cardiomyopathy	Hypertrophic cardiomyopathy (non-obstructive) MedDRA version: 16.1;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Vastarel 20mg film coated tablets Product Name: Trimetazidine Dihydrochloride 20mg Product Code: not applicable INN or Proposed INN: trimetazidine dihydrochloride Other descriptive name: 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride	University College London (UCL)	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	United Kingdom
59	NCT00879060 (ClinicalTrials.gov)	November 2007	8/4/2009	Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy	Clinical and Therapeutic Implications of Fibrosis in Hypertrophic	Myocardial Fibrosis;Hypertrophic Cardiomyopathy	Drug: spironolactone	Tufts Medical Center	NULL	Recruiting	18 Years	70 Years	Both	95	Phase 4	United States
60	NCT00430833 (ClinicalTrials.gov)	March 2007	31/1/2007	CHANCE - Candesartan in Hypertrophic Cardiomyopathy	Candesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate (The CHANCE): a Double-Blind, Placebo-Controlled, Randomized, Multicenter Study	Hypertrophic Cardiomyopathy	Drug: candesartan	Charles University, Czech Republic	AstraZeneca	Active, not recruiting	18 Years	N/A	Both		Phase 2	Czech Republic
61	NCT01150461 (ClinicalTrials.gov)	February 2007	22/6/2010	Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy	Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy	Hypertrophic Cardiomyopathy	Drug: losartan;Drug: placebo	Massachusetts General Hospital	NULL	Completed	18 Years	N/A	All	20	Phase 2	United States
62	NCT00011076 (ClinicalTrials.gov)	February 2001	9/2/2001	Pirfenidone to Treat Hypertrophic Cardiomyopathy	Double-Blind Placebo-Controlled Study of Pirfenidone, A Novel Anti-Fibrotic Drug in Symptomatic Patients With Hypertrophic Cardiomyopathy (HCM) Associated With Left Ventricular Diastolic Function	Hypertrophic Cardiomyopathy	Drug: Pirfenidone	National Heart, Lung, and Blood Institute (NHLBI)	NULL	Completed	N/A	N/A	Both	50	Phase 2	United States
63	NCT00001534 (ClinicalTrials.gov)	September 1996	3/11/1999	Long Term Effects of Enalapril and Losartan on Genetic Heart Disease	Double-Blind, Placebo-Controlled Study of the Long Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Hypertrophy in Non-Obstructive HCM	Hypertrophic Cardiomyopathy;Left Ventricular Hypertrophy;Myocardial Ischemia	Drug: Losartan	National Heart, Lung, and Blood Institute (NHLBI)	NULL	Completed	N/A	N/A	Both	112	N/A	United States

先頭へ

62. 発作性夜間ヘモグロビン尿症

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臨床試験数 : 292 /  薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05731050 (ClinicalTrials.gov)	June 2025	1/2/2023	Study of NM8074 in Soliris-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase II, Open Label, Multi Dose Study of NM8074 in Soliris-Treated Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)	PNH - Paroxysmal Nocturnal Hemoglobinuria	Drug: NM8074	NovelMed Therapeutics	NULL	Not yet recruiting	18 Years	65 Years	All	6	Phase 2	NULL
2	NCT05646524 (ClinicalTrials.gov)	November 2023	30/11/2022	Study of Efficacy and Safety of NM8074 in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy	A Phase II, Open-Label Study of NM8074 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Drug: NM8074	NovelMed Therapeutics	NULL	Not yet recruiting	18 Years	N/A	All	12	Phase 2	NULL
3	NCT05646563 (ClinicalTrials.gov)	September 2023	30/11/2022	Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris	A Phase II, Open-Label Study of NM8074 in Soliris®-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Drug: NM8074;Drug: Soliris	NovelMed Therapeutics	NULL	Not yet recruiting	18 Years	N/A	All	12	Phase 2	NULL
4	NCT05630001 (ClinicalTrials.gov)	May 30, 2023	18/11/2022	This is a Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.	A Multicenter, Single Arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Have Hb=10 g/dL in Response to Anti-C5 Antibody and Switch to Iptacopan	Paroxysmal Nocturnal Hemoglobinuria	Drug: Iptacopan	Novartis Pharmaceuticals	NULL	Not yet recruiting	18 Years	N/A	All	50	Phase 3	NULL
5	NCT05744921 (ClinicalTrials.gov)	March 9, 2023	6/2/2023	A Study to Examine the Long-term Safety, Tolerability, and Effectiveness of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria	An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria	Drug: Pozelimab;Drug: Cemdisiran	Regeneron Pharmaceuticals	NULL	Not yet recruiting	18 Years	N/A	All	300	Phase 3	NULL
6	EUCTR2021-004253-22-GR (EUCTR)	23/01/2023	29/11/2022	A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to C5i in Patients with PNH.	A Long-term Extension (LTE) Study to Characterize the Safety and Efficacy of Danicopan as an Add-on Therapy to a Complement Component 5 Inhibitor (C5i) in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Previously Treated with Danicopan in an Alexion-sponsored Clinical Study.	Patients with Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Danicopan Product Code: ALXN2040 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN Product Name: Danicopan Product Code: ALXN2040 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	95	Phase 3	United States;Czechia;Greece;Thailand;Spain;Israel;United Kingdom;Italy;France;Canada;Brazil;Malaysia;Poland;Japan;Korea, Republic of
7	NCT05741346 (ClinicalTrials.gov)	January 18, 2023	14/2/2023	Long-term Safety of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria	An Open-label Study to Evaluate the Long-term Safety of BCX9930 Monotherapy in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Previously Received BCX9930 in a BioCryst-sponsored Study	Paroxysmal Nocturnal Hemoglobinuria	Drug: BCX9930	BioCryst Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	30	Phase 2	Hungary;Malaysia
8	EUCTR2021-004931-10-GR (EUCTR)	04/01/2023	22/11/2022	A study to examine the long-term safety, tolerability, and effectiveness of Pozelimab and Cemdisiran combination therapy in adult patients with Paroxysmal Nocturnal Hemoglobinuria	An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria - ACCESS-EXTENSION	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: Cemdisiran Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	288	Phase 3	United States;Philippines;Taiwan;Greece;Thailand;Spain;Colombia;Italy;India;France;Jordan;Malaysia;Peru;South Africa;China;Korea, Democratic People's Republic of;Turkey;United Kingdom;Hungary;Mexico;Canada;Brazil;Poland;Singapore;Romania;Germany;Japan
9	EUCTR2020-002761-33-FR (EUCTR)	06/12/2022	21/03/2022	Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria	A RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: CEMDISIRAN Other descriptive name: CEMDISIRAN Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz) INN or Proposed INN: Ravulizumab Other descriptive name: Ravulizumab Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Trade Name: Soliris ™ (eculizumab) Product Name: Eculizumab INN or Proposed INN: Eculizumab	Regeneron Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Poland;Brazil;Singapore;Romania;Netherlands;Germany;Japan;Korea, Republic of
10	NCT05476887 (ClinicalTrials.gov)	November 25, 2022	25/7/2022	To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104	An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Complement Inhibitor-naïve Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Drug: KP104	Kira Pharmacenticals (US), LLC.	NULL	Recruiting	18 Years	N/A	All	35	Phase 2	China
11	NCT05389449 (ClinicalTrials.gov)	October 28, 2022	20/5/2022	A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH	A Long-term Extension (LTE) Study to Characterize the Safety and Efficacy of Danicopan as an Add-on Therapy to a Complement Component 5 Inhibitor (C5i) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Previously Treated With Danicopan in an Alexion-sponsored Clinical Study	Paroxysmal Nocturnal Hemoglobinuria	Drug: Danicopan	Alexion Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	100	Phase 3	United States;Italy;United Kingdom
12	NCT05131204 (ClinicalTrials.gov)	October 6, 2022	12/11/2021	Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria	A Randomized, Open-Label, Eculizumab and Ravulizumab Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Currently Treated With Eculizumab or Ravulizumab	Paroxysmal Nocturnal Hemoglobinuria	Drug: Cemdisiran;Drug: Eculizumab;Drug: Pozelimab;Drug: Ravulizumab	Regeneron Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	2	Phase 3	United States
13	EUCTR2020-004438-39-NL (EUCTR)	04/10/2022	05/01/2022	BCX9930 treatment in patients with an inadequate response to C5 inhibitors	A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Trade Name: Solaris Product Name: eculizumab Product Code: eculizumab INN or Proposed INN: Eculizumab Other descriptive name: Soliris Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ravulizumab INN or Proposed INN: RAVULIZUMAB Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BioCryst Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	United States;Taiwan;Slovakia;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;Netherlands;China;Japan;Korea, Republic of
14	NCT05133531 (ClinicalTrials.gov)	August 1, 2022	12/11/2021	Ravulizumab-Controlled Non-Inferiority Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor Therapy	A Randomized, Open-Label, Ravulizumab-Controlled,Non-Inferiority Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor Therapy	Paroxysmal Nocturnal Hemoglobinuria	Drug: Ravulizumab;Drug: Pozelimab;Drug: Cemdisiran	Regeneron Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	148	Phase 3	United States;Canada;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Singapore;Spain;Taiwan;Turkey
15	EUCTR2020-002761-33-DE (EUCTR)	20/06/2022	03/03/2022	Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria	A RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: CEMDISIRAN Other descriptive name: CEMDISIRAN Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz) INN or Proposed INN: Ravulizumab Other descriptive name: Ravulizumab Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Trade Name: Soliris ™ (eculizumab) Product Name: Eculizumab INN or Proposed INN: Eculizumab	Regeneron Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Brazil;Poland;Singapore;Romania;Germany;Netherlands;Japan;Korea, Republic of
16	EUCTR2020-002761-33-GR (EUCTR)	17/06/2022	12/04/2022	Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria	A RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED, NON-INFERIORITY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB - ACCESS-2	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: CEMDISIRAN Other descriptive name: CEMDISIRAN Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz) INN or Proposed INN: Ravulizumab Other descriptive name: Ravulizumab Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Trade Name: Soliris ™ (eculizumab) Product Name: Eculizumab INN or Proposed INN: Eculizumab	Regeneron Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 3	Portugal;United States;Philippines;Taiwan;Greece;Spain;Thailand;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Brazil;Poland;Singapore;Romania;Germany;Netherlands;Japan;Korea, Republic of
17	EUCTR2020-004486-40-GR (EUCTR)	17/06/2022	08/04/2022	Ravulizumab-Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria who are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor Therapy	A RANDOMIZED, OPEN-LABEL, RAVULIZUMAB-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE COMPLEMENT INHIBITOR TREATMENT-NAIVE OR HAVE NOT RECENTLY RECEIVED COMPLEMENT INHIBITOR THERAPY	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: CEMDISIRAN Other descriptive name: CEMDISIRAN Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz) INN or Proposed INN: Ravulizumab Other descriptive name: Ravulizumab Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	124	Phase 3	Portugal;United States;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Canada;Jordan;Poland;Brazil;Malaysia;Singapore;Romania;Peru;South Africa;Netherlands;China;Japan;Korea, Republic of
18	NCT05642585 (ClinicalTrials.gov)	May 27, 2022	30/11/2022	A Study of Single-dose MY008211A in Healthy Adults	A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Doses Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic/Pharmacodynamics Characteristics of MY008211A Tablets in Healthy Adult Volunteers	Paroxysmal Nocturnal Hemoglobinuria	Drug: MY008211A tablets;Drug: Placebo	Wuhan Createrna Science and Technology Co., Ltd	NULL	Active, not recruiting	18 Years	45 Years	All	46	Phase 1	China
19	EUCTR2020-002761-33-ES (EUCTR)	09/05/2022	11/03/2022	Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria	A RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: CEMDISIRAN Other descriptive name: CEMDISIRAN Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz) INN or Proposed INN: Ravulizumab Other descriptive name: Ravulizumab Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Trade Name: Soliris ™ (eculizumab) Product Name: Eculizumab INN or Proposed INN: Eculizumab	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Poland;Brazil;Singapore;Romania;Netherlands;Germany;Japan;Korea, Republic of
20	EUCTR2020-004486-40-ES (EUCTR)	09/05/2022	11/03/2022	Ravulizumab-Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria who are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor Therapy	A RANDOMIZED, OPEN-LABEL, RAVULIZUMAB-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE COMPLEMENT INHIBITOR TREATMENT-NAIVE OR HAVE NOT RECENTLY RECEIVED COMPLEMENT INHIBITOR THERAPY	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: CEMDISIRAN Other descriptive name: CEMDISIRAN Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz) INN or Proposed INN: Ravulizumab Other descriptive name: Ravulizumab Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	124	Phase 3	Portugal;United States;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Canada;Jordan;Poland;Brazil;Malaysia;Singapore;Romania;Peru;South Africa;Netherlands;China;Japan;Korea, Republic of
21	JPRN-jRCT2031220046	28/04/2022	28/04/2022	Pegcetacoplan Long-term Safety and Efficacy Extension Study	AN OPEN-LABEL, NONRANDOMIZED, MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - APL2-307	Paroxysmal Nocturnal Hemoglobinuria (PNH)	A subcutaneous dose of pegcetacoplan (APL-2) 1080 mg twice a week, 3 times a week or every 3 days	Machaidze Zurab	NULL	Not Recruiting	>= 18age old	Not applicable	Both	10	Phase 3	the United States;South Korea;Australia;Malaysia;Hong Kong;Philippines;Singapore;Thailand;Peru;Colombia;Mexico;Canada;Bulgaria;Serbia;Belgium;France;Germany;Italy;the Netherlands;Russia;Spain;the United Kingdom;Japan
22	NCT04965597 (ClinicalTrials.gov)	April 19, 2022	21/6/2021	Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)	Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases	Bone Marrow Failure Syndrome;Congenital Amegakaryocytic Thrombocytopenia;Congenital Pure Red Cell Aplasia;Hereditary Sideroblastic Anemia;Myeloid Neoplasms With Germline GATA2 Mutation;Paroxysmal Nocturnal Hemoglobinuria;Shwachman-Diamond Syndrome	Drug: Treosulfan;Drug: Fludarabine Phosphate;Drug: Tacrolimus;Drug: Methotrexate;Biological: Lapine T-Lymphocyte Immune Globulin;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Bone Marrow Transplantation;Other: Quality-of-Life Assessment	Fred Hutchinson Cancer Center	Blood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow Donor Program;National Heart, Lung, and Blood Institute (NHLBI)	Recruiting	1 Year	49 Years	All	40	Phase 2	United States
23	EUCTR2020-002761-33-PL (EUCTR)	14/04/2022	22/03/2022	Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria	A RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: CEMDISIRAN Other descriptive name: CEMDISIRAN Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz) INN or Proposed INN: Ravulizumab Other descriptive name: Ravulizumab Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Trade Name: Soliris ™ (eculizumab) Product Name: Eculizumab INN or Proposed INN: Eculizumab	Regeneron Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Poland;Brazil;Singapore;Romania;Germany;Netherlands;Japan;Korea, Republic of
24	EUCTR2020-004403-14-CZ (EUCTR)	31/03/2022	24/09/2021	BCX9930 compared to placebo in the treatment of PNH	A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria - REDEEM 2	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930	BioCryst Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	57	Phase 2	United States;Serbia;Czechia;Spain;Turkey;Lithuania;Azerbaijan;Italy;Czech Republic;Canada;Argentina;Brazil;Poland;Romania;South Africa;Albania;China;Sweden
25	EUCTR2019-003829-18-GR (EUCTR)	08/03/2022	14/01/2022	Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH) (ALPHA)	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)	Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Danicopan Product Code: ALXN2040 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN Product Name: Danicopan Product Code: ALXN2040 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 3	United States;Czechia;Taiwan;Greece;Thailand;Spain;Turkey;Israel;Colombia;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Malaysia;Netherlands;Germany;Japan;Korea, Republic of
26	JPRN-jRCT2031210645	04/03/2022	04/03/2022	A Phase 3, Randomized, Multicenter, Open-label, Active-comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 3, Randomized, Multicenter, Open-label, Active-comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS	Paroxysmal Nocturnal Hemoglobinuria (PNH)	A subcutaneous dose of pegcetacoplan (APL-2) 1080 mg twice weekly (or change to a dose of 1080 mg every 3 days as necessary).	Machaidze Zurab	NULL	Complete	>= 18age old	Not applicable	Both	8	Phase 3	the U.S.;Korea;Australia;Canada;Belgium;France;Germany;Russia;Spain;the United Kingdom;Japan
27	EUCTR2019-004931-21-RO (EUCTR)	14/02/2022	19/05/2022	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Germany;Japan;Sweden
28	NCT05083364 (ClinicalTrials.gov)	February 2, 2022	8/10/2021	Study of ARO-C3 in Adult Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria and Complement-Mediated Renal Disease	A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and/or Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria and Adult Patients With Complement-Mediated Renal Disease	Paroxysmal Nocturnal Hemoglobinuria;C3 Glomerulopathy;IgA Nephropathy	Drug: ARO-C3;Drug: Placebo	Arrowhead Pharmaceuticals	NULL	Recruiting	18 Years	70 Years	All	84	Phase 1	Australia;Korea, Republic of;New Zealand;Thailand
29	EUCTR2020-004385-19-NL (EUCTR)	11/01/2022	17/11/2021	Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria	An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan.	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;Taiwan;Spain;Lithuania;Italy;France;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of
30	EUCTR2020-004385-19-CZ (EUCTR)	16/12/2021	27/07/2021	Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria	An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan.	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;Taiwan;Spain;Lithuania;Italy;France;Czech Republic;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of
31	JPRN-jRCT2021210059	09/12/2021	17/12/2021	Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria	An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan.	Paroxysmal Nocturnal Hemoglobinuria	Taken orally b.i.d. Dosage supplied: 200 mg Dosage form: hard gelatin capsule Route of administration: oral	Suzuki Kazuyuki	NULL	Recruiting	>= 18age old	Not applicable	Both	19	Phase 3	Italy;Republic of Korea;Taiwan;Japan
32	NCT05116774 (ClinicalTrials.gov)	December 6, 2021	2/11/2021	BCX9930 for Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy	A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: BCX9930;Drug: Eculizumab;Drug: Ravulizumab	BioCryst Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	81	Phase 2	France;Hungary;Italy;Spain;United Kingdom;Taiwan;United States
33	EUCTR2020-004438-39-SK (EUCTR)	29/11/2021	29/07/2021	BCX9930 treatment in patients with an inadequate response to C5 inhibitors	A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Trade Name: Solaris Product Name: eculizumab Product Code: eculizumab INN or Proposed INN: Eculizumab Other descriptive name: Soliris Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ravulizumab INN or Proposed INN: RAVULIZUMAB Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BioCryst Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	United States;Taiwan;Slovakia;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;China;Japan;Korea, Republic of
34	EUCTR2020-004403-14-ES (EUCTR)	11/11/2021	14/07/2021	BCX9930 compared to placebo in the treatment of PNH	A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria - REDEEM 2	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930	BioCryst Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	57	Phase 2	Serbia;United States;Spain;Turkey;Lithuania;Azerbaijan;European Union;Canada;Argentina;Brazil;Albania;South Africa;China
35	EUCTR2020-004438-39-IT (EUCTR)	10/11/2021	27/01/2022	BCX9930 treatment in PNH patients with an inadequate response to C5 inhibitors	A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ULTOMIRIS - 300 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 3 ML (100 MG / ML) - 1 FLACONCINO Product Name: ravulizumab Product Code: [ravulizumab] INN or Proposed INN: Ravulizumab Other descriptive name: Ultomiris Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML) Product Name: Eculizumab Product Code: [Eculizumab] INN or Proposed INN: ECULIZUMAB Other descriptive name: Soliris Product Name: BCX9930 Product Code: [BCX9930] INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BIOCRYST PHARMACEUTICALS INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	81	Phase 2	United States;Taiwan;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;China;Japan;Korea, Republic of
36	EUCTR2019-003830-17-ES (EUCTR)	02/11/2021	14/07/2021	Study of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy	A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy - Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALXN2050 Product Code: ALXN2050 INN or Proposed INN: N/A Other descriptive name: ACH-0145228	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	26	Phase 2	France;Canada;Spain;Turkey;Germany;United Kingdom;Italy;New Zealand;Korea, Republic of
37	EUCTR2020-004438-39-ES (EUCTR)	02/11/2021	23/07/2021	BCX9930 treatment in patients with an inadequate response to C5 inhibitors	A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Trade Name: Solaris Product Name: eculizumab Product Code: eculizumab INN or Proposed INN: Eculizumab Other descriptive name: Soliris Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ravulizumab INN or Proposed INN: RAVULIZUMAB	BioCryst Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	81	Phase 2	United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;China;Japan;Korea, Republic of
38	NCT05116787 (ClinicalTrials.gov)	October 26, 2021	2/11/2021	BCX9930 for the Treatment of PNH in Subjects Not Receiving Other Complement Inhibitor Therapy	A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: BCX9930 monotherapy;Drug: Placebo	BioCryst Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	57	Phase 2	Malaysia;South Africa;Spain;Taiwan;United States
39	EUCTR2020-004403-14-IT (EUCTR)	20/10/2021	22/10/2021	BCX9930 compared to placebo in the treatment of PNH	A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria - REDEEM 2	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BCX9930 Product Code: [BCX9930] INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BIOCRYST PHARMACEUTICALS INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	57	Phase 2	Serbia;United States;Spain;Lithuania;Turkey;Italy;Azerbaijan;European Union;Canada;Argentina;Brazil;Albania;South Africa;China
40	EUCTR2020-004403-14-LT (EUCTR)	14/10/2021	18/08/2021	BCX9930 compared to placebo in the treatment of PNH	A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria - REDEEM 2	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930	BioCryst Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	57	Phase 2	United States;Serbia;European Union;Canada;Argentina;Brazil;Turkey;Lithuania;South Africa;Albania;China;Azerbaijan
41	EUCTR2019-003830-17-IT (EUCTR)	13/10/2021	23/06/2020	Study of the Oral Factor D (fD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with background use of an Approved C5 Inhibitor	A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with an Approved C5 Inhibitor as Background Therapy	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALXN2050 Product Code: ACH-0145228 INN or Proposed INN: N/A Other descriptive name: ACH-0145228 Product Name: ALXN2050 Product Code: ACH-0145228 INN or Proposed INN: N/A Other descriptive name: ACH-0145228	Achillion Pharmaceuticals, Inc., a wholly owned subsidiary of Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	26	Phase 2	United States;Spain;United Kingdom;New Zealand;Italy;Korea, Republic of
42	EUCTR2020-000597-26-IE (EUCTR)	23/09/2021	13/01/2021	A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and efficacy of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	190	Phase 3	Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
43	EUCTR2020-004438-39-HU (EUCTR)	01/09/2021	02/07/2021	BCX9930 treatment in patients with an inadequate response to C5 inhibitors	A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Trade Name: Solaris Product Name: eculizumab Product Code: eculizumab INN or Proposed INN: Eculizumab Other descriptive name: Soliris Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ravulizumab INN or Proposed INN: RAVULIZUMAB	BioCryst Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	United States;Taiwan;Slovakia;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;Netherlands;China;Japan;Korea, Republic of
44	EUCTR2020-004385-19-FR (EUCTR)	31/08/2021	15/07/2021	Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria	An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan.	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;France;Taiwan;Spain;Malaysia;Brazil;Singapore;Lithuania;Italy;Japan;China;Korea, Republic of
45	EUCTR2020-004438-39-FR (EUCTR)	26/08/2021	16/06/2021	BCX9930 treatment in patients with an inadequate response to C5 inhibitors	A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Trade Name: Solaris Product Name: eculizumab Product Code: eculizumab INN or Proposed INN: Eculizumab Other descriptive name: Soliris Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ravulizumab INN or Proposed INN: RAVULIZUMAB	BioCryst Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	81	Phase 2	United States;Taiwan;Turkey;Colombia;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;China;Japan;Korea, Republic of
46	EUCTR2020-003172-41-CZ (EUCTR)	12/08/2021	10/06/2021	Study of Efficacy and Safety of Twice Daily Oral iptacopan in Adult PNH Patients who are naïve to complement inhibitor therapy	A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who are naive to complement inhibitor therapy	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	France;United States;Czechia;Czech Republic;Malaysia;Singapore;Germany;United Kingdom;Italy;Japan;China;Korea, Republic of
47	EUCTR2020-004385-19-ES (EUCTR)	30/07/2021	23/06/2021	Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria	An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan.	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Farmacéutica, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;Taiwan;Malaysia;Brazil;Spain;Singapore;Japan;China;Korea, Republic of
48	NCT04811716 (ClinicalTrials.gov)	July 28, 2021	19/3/2021	Pozelimab and Cemdisiran Combination Treatment in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy	A Randomized, Open-label, Two-arm Study to Evaluate the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Treatment in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy	Paroxysmal Nocturnal Hemoglobinuria	Drug: Pozelimab;Drug: Cemdisiran	Regeneron Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	24	Phase 2	Hong Kong;Hungary;Korea, Republic of;Malaysia;Taiwan;United Kingdom
49	NCT04747613 (ClinicalTrials.gov)	July 27, 2021	5/2/2021	Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria	An Open Label, Multicenter Roll-over Extension Program (REP) to Characterize the Long-term Safety and Tolerability of Iptacopan (LNP023) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Completed PNH Phase 2 and Phase3 Studies With Iptacopan	Paroxysmal Nocturnal Hemoglobinuria	Drug: Iptacopan	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	167	Phase 3	United States;Brazil;China;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Lithuania;Malaysia;Netherlands;Singapore;Spain;Taiwan;United Kingdom
50	EUCTR2020-003172-41-IT (EUCTR)	20/07/2021	17/08/2021	Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients who are naïve to complement inhibitor therapy.	A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who are naive to complement inhibitor therapy. - -	Paroxysmal Nocturnal Hemoglobinuria (PNH). MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: HIBERIX - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE 1 FLACONCINO DI POLVERE + 1 SIRINGA PRERIEMPITA DI SOLVENTE DA 0.5 ML Product Name: - Product Code: [-] INN or Proposed INN: VACCINO HAEMOPHILUS INFLUENZAE B CONIUGATO CON TOSSOIDETETANICO Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO Trade Name: BEXSERO – Sospensione iniettabile – Siringa preriempita Product Name: - Product Code: [-] INN or Proposed INN: VACCINO CONTRO IL MEMINGOCOCCO DI GRUPPO B Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE	NOVARTIS PHARMA AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	France;United States;Czechia;Malaysia;Singapore;Germany;United Kingdom;Japan;China;Italy;Korea, Republic of
51	NCT04820530 (ClinicalTrials.gov)	July 19, 2021	25/3/2021	Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy	A Multicenter, Single-arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: Iptacopan (LNP023)	Novartis Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	40	Phase 3	China;France;Germany;Italy;Korea, Republic of;Malaysia;Singapore;United Kingdom;Czechia;Japan
52	EUCTR2019-004931-21-LT (EUCTR)	15/07/2021	19/05/2021	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan;Sweden
53	EUCTR2020-004385-19-LT (EUCTR)	15/07/2021	20/04/2021	Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria	An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan.	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;Taiwan;Spain;Lithuania;Italy;France;Brazil;Malaysia;Singapore;Netherlands;China;Japan;Korea, Republic of
54	NCT04888507 (ClinicalTrials.gov)	July 8, 2021	23/4/2021	Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy	A Single Arm, Open-Label Study to Assess the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy	Paroxysmal Nocturnal Hemoglobinuria	Drug: Pozelimab;Drug: Cemdisiran	Regeneron Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	6	Phase 2	United Kingdom
55	EUCTR2019-004931-21-EE (EUCTR)	30/06/2021	24/04/2021	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Portugal;United States;Philippines;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Germany;Japan;Sweden
56	EUCTR2020-000597-26-EE (EUCTR)	30/06/2021	24/04/2021	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Germany;Japan;Sweden
57	JPRN-jRCT2021210014	28/06/2021	28/06/2021	Pivotal study of danicopan as add-on therapy to a C5 inhibitor (eculizumab or ravulizumab) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have Clinically Evident EVH	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)	Paroxysmal Nocturnal Hemoglobinuria Paroxysmal Nocturnal Hemoglobinuria;D006457	Additional Danicopan (ALXN2040) given to patients diagnosed with paroxysmal nocturnal hemoglobinuria and receiving complement C5 inhibitors	Kamata Takeo	NULL	Recruiting	>= 18age old	Not applicable	Both	84	Phase 3	America;Japan
58	EUCTR2020-004385-19-IT (EUCTR)	15/06/2021	08/06/2021	Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria	An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan. - -	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO Product Name: iptacopan Product Code: [LNP023] INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: [LNP023] INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: ACTHIB - POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO POLVERE+1 SIRINGA PRERIEMPITA SOLVENTE 0.5 ML Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: MENVEO - POLV.E SOLUZ.PER SOLUZ. INIETT.-USO INTRAMUSCOLARE-COMP. CONIUG.LIOFILIZZ.MENA:FLAC.(VETRO) COMP. GONIUG.LIQUI.MENCWY:FLAC.(VETRO)-1 FLAC+1FLAC Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: BEXSERO - SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - SIRINGA P	NOVARTIS PHARMA AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	165	Phase 3	United States;Taiwan;Spain;Malaysia;Brazil;Singapore;Korea, Democratic People's Republic of;Lithuania;Japan;China;Italy
59	EUCTR2020-003172-41-FR (EUCTR)	03/06/2021	15/04/2021	Study of Efficacy and Safety of Twice Daily Oral iptacopan in Adult PNH Patients who are naïve to complement inhibitor therapy	A multicenter, single-arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who are naive to complement inhibitor therapy	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;France;Czechia;Malaysia;Singapore;Germany;United Kingdom;Italy;Japan;China;Korea, Republic of
60	EUCTR2019-003829-18-NL (EUCTR)	21/05/2021	07/10/2020	Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)	Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Danicopan (ALXN2040) Product Code: ACH-0144471 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN Product Name: Danicopan (ALXN2040) Product Code: ACH-0144471 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 3	United States;Taiwan;Finland;Thailand;Spain;Austria;United Kingdom;Switzerland;Italy;France;Canada;Poland;Brazil;Malaysia;Australia;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of
61	EUCTR2019-004931-21-PT (EUCTR)	19/05/2021	28/10/2020	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Soliris 300 mg concentrate for solution for infusion INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Japan;Sweden
62	EUCTR2020-000597-26-PT (EUCTR)	18/05/2021	23/12/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: SOLIRIS® (eculizumab) injection, for intravenous use Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Portugal;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
63	EUCTR2020-005005-17-HU (EUCTR)	07/05/2021	05/03/2021	Pozelimab and Cemdisiran Combination Treatment in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy	A Randomized, Open-label, Two-arm Study to Evaluate the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Treatment in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pozelimab Product Code: REGN3918 INN or Proposed INN: Pozelimab Product Name: Cemdisiran Product Code: ALN-CC5 INN or Proposed INN: Cemdisiran Other descriptive name: CEMDISIRAN	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	Taiwan;Hong Kong;Hungary;Malaysia;United Kingdom;Korea, Republic of
64	EUCTR2020-000597-26-CZ (EUCTR)	28/04/2021	22/12/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Germany;Japan;Sweden
65	EUCTR2019-003829-18-PL (EUCTR)	08/04/2021	04/11/2020	Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)	Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Danicopan (ALXN2040) Product Code: ACH-0144471 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN Product Name: Danicopan (ALXN2040) Product Code: ACH-0144471 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 3	United States;Taiwan;Spain;Thailand;United Kingdom;Italy;France;Canada;Poland;Brazil;Malaysia;Germany;Netherlands;Japan;Korea, Republic of
66	NCT04729062 (ClinicalTrials.gov)	April 5, 2021	25/1/2021	Pegcetacoplan Early Access Program for PNH	Early Access Program (EAP) For The Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) With Pegcetacoplan	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: Pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	No longer available	18 Years	N/A	All			United States
67	EUCTR2019-004665-40-CZ (EUCTR)	31/03/2021	03/11/2020	Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment	A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	91	Phase 3	United States;Czechia;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of
68	NCT04320602 (ClinicalTrials.gov)	March 26, 2021	23/3/2020	Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab	Phase 4, Single-Arm Study of Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab	Paroxysmal Nocturnal Hemoglobinuria	Biological: Eculizumab;Biological: Ravulizumab	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	All	18	Phase 4	United Kingdom
69	JPRN-jRCT2051200132	26/03/2021	09/02/2021	Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment	Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment - APPLY-PNH	Paroxysmal nocturnal hemoglobinuria PNH	Arm A : LNP023 monotherapy Arm B : Anti-C5 antibody treatment(Eculizumab or Ravulizumab)	Suzuki Kazuyuki	NULL	Not Recruiting	>= 18age old	Not applicable	Both	91	Phase 3	Netherlands;Japan
70	NCT04654468 (ClinicalTrials.gov)	March 17, 2021	30/11/2020	A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition	A Phase III, Multicenter, Single Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition	Paroxysmal Nocturnal Hemoglobinuria	Drug: Crovalimab	Hoffmann-La Roche	NULL	Active, not recruiting	12 Years	N/A	All	51	Phase 3	China
71	EUCTR2019-003829-18-DE (EUCTR)	03/02/2021	23/01/2020	Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH) (ALPHA)	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)	Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Danicopan Product Code: ALXN2040 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN Product Name: Danicopan Product Code: ALXN2040 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 3	United States;Czechia;Taiwan;Greece;Spain;Thailand;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Malaysia;Poland;Netherlands;Germany;Japan;Korea, Republic of
72	EUCTR2019-004665-40-DE (EUCTR)	29/01/2021	22/09/2020	Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment	A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris 300mg/30ml Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris 300mg/30ml Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	91	Phase 3	United States;Czechia;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of
73	EUCTR2019-004931-21-FR (EUCTR)	26/01/2021	18/09/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden
74	NCT04558918 (ClinicalTrials.gov)	January 25, 2021	27/8/2020	Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment	A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody.	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: LNP023;Drug: Eculizumab;Drug: Ravulizumab	Novartis Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	97	Phase 3	United States;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Taiwan;United Kingdom;Hungary
75	EUCTR2019-004931-21-BE (EUCTR)	22/01/2021	23/11/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan;Sweden
76	EUCTR2020-000597-26-BE (EUCTR)	11/01/2021	15/10/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	United States;Portugal;Philippines;Taiwan;Estonia;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Romania;Germany;Japan;Sweden
77	ChiCTR2000039675	2021-01-01	2020-11-05	Phase II clinical trial of the superiority of all-trans retinoic acid in the treament of paroxysmal nocturnal hemoglobinuria	Phase II clinical trial of the superiority of all-trans retinoic acid in the treament of paroxysmal nocturnal hemoglobinuria	paroxysmal nocturnal hemoglobinuria	experimental group:Tretinoin 0.33mg/kg.d; methylprednisolone 0.8mg/kg.d;Control test:methylprednisolone 0.8mg/kg.d;	Department of Hematology, Second Medical Center, Chinese PLA General Hospital	NULL	Recruiting	14	80	Both	experimental group:10;Control test:10;	Phase 2	Chinese
78	NCT05490017 (ClinicalTrials.gov)	December 30, 2020	4/8/2022	To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104	SYNERGY-1: A Phase 1 First-in-human, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104 in Healthy Subjects	Paroxysmal Nocturnal Hemoglobinuria	Drug: KP104;Drug: Placebo	Kira Pharmacenticals (US), LLC.	NULL	Completed	18 Years	55 Years	All	80	Phase 1	Australia
79	EUCTR2019-004665-40-IT (EUCTR)	23/12/2020	15/06/2021	Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment	A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody - Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia d	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Iptacopan Product Code: [LNP023] INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: [LNP023] INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab Product Code: [-] INN or Proposed INN: ECULIZUMAB Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO	NOVARTIS PHARMA AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	91	Phase 3	United States;Czechia;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;United Kingdom;France;Hungary;Canada;Brazil;Germany;Netherlands;Japan
80	NCT04702568 (ClinicalTrials.gov)	December 18, 2020	7/1/2021	A Long Term Safety Study of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria;PNH	Drug: BCX9930	BioCryst Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	200	Phase 2	Austria;South Africa;United Kingdom
81	NCT04469465 (ClinicalTrials.gov)	December 16, 2020	9/7/2020	Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)	Paroxysmal Nocturnal Hemoglobinuria	Drug: Danicopan;Drug: Placebo;Drug: C5 Inhibitor	Alexion Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	86	Phase 3	United States;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;Poland;Spain;Taiwan;Thailand;United Kingdom
82	EUCTR2019-004931-21-IT (EUCTR)	10/12/2020	24/05/2021	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS - N/A	Paroxysmal Nocturnal Hemoglobinuria (PNH);Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: [RO7112689] INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab Product Code: [NA] INN or Proposed INN: Eculizumab	F. HOFFMANN - LA ROCHE LTD.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Portugal;Estonia;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden
83	EUCTR2020-000597-26-IT (EUCTR)	10/12/2020	22/06/2021	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS - na	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: crovalimab Product Code: [RO7112689] INN or Proposed INN: crovalimab Trade Name: Eculizumab Product Name: eculizumab Product Code: [na] INN or Proposed INN: eculizumab Other descriptive name: NA	F. HOFFMANN - LA ROCHE LTD.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Brazil;Belgium;Poland;Germany;Japan;Sweden
84	EUCTR2019-004931-21-GR (EUCTR)	04/12/2020	16/10/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden
85	EUCTR2020-000597-26-GR (EUCTR)	04/12/2020	16/10/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Eculizumab Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	United States;Portugal;Hong Kong;Taiwan;Greece;Spain;Thailand;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
86	EUCTR2019-004931-21-DE (EUCTR)	01/12/2020	14/07/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITH COMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Germany;Japan;Sweden
87	EUCTR2020-000597-26-DE (EUCTR)	01/12/2020	14/07/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Brazil;Belgium;Poland;Germany;Japan;Sweden
88	EUCTR2020-000501-93-AT (EUCTR)	27/11/2020	08/09/2020	A long term study of BCX9930 in patients with PNH	A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BioCryst Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	European Union;Denmark;Austria;South Africa;Italy;United Kingdom
89	EUCTR2019-004931-21-PL (EUCTR)	24/11/2020	18/09/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Germany;Japan;Sweden
90	EUCTR2020-000597-26-PL (EUCTR)	23/11/2020	16/09/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Brazil;Poland;Belgium;Germany;Japan;Sweden
91	EUCTR2019-004665-40-NL (EUCTR)	20/11/2020	09/11/2020	Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment	A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris 300mg/30ml Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris 300mg/30ml Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	91	Phase 3	United States;Czechia;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Netherlands;Germany;Japan;Korea, Republic of
92	EUCTR2019-004665-40-HU (EUCTR)	17/11/2020	23/09/2020	Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment	A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	91	Phase 3	United States;Taiwan;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of
93	EUCTR2019-004931-21-HU (EUCTR)	05/11/2020	08/09/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	10	Phase 3	Hungary;United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden
94	EUCTR2019-003829-18-FR (EUCTR)	04/11/2020	22/01/2020	Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)	Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Danicopan (ALXN2040) Product Code: ACH-0144471 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN Product Name: Danicopan (ALXN2040) Product Code: ACH-0144471 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 3	United States;Taiwan;Finland;Spain;Thailand;Austria;United Kingdom;Switzerland;Italy;France;Canada;Poland;Brazil;Malaysia;Australia;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of
95	EUCTR2019-003829-18-IT (EUCTR)	03/11/2020	24/05/2021	Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) - .	Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Danicopan (ALXN2040) Product Code: [ACH-0144471] Product Name: Danicopan (ALXN2040) Product Code: [ACH-0144471]	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 3	United States;Taiwan;Finland;Spain;Thailand;Austria;United Kingdom;Switzerland;Italy;France;Canada;Poland;Brazil;Malaysia;Australia;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of
96	EUCTR2019-004665-40-FR (EUCTR)	03/11/2020	18/09/2020	Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment	A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	91	Phase 3	United States;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of
97	EUCTR2020-000501-93-IT (EUCTR)	02/11/2020	25/01/2021	A long term study of BCX9930 in patients with HPN	A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH) - A long term study of BCX9930 in patients with HPN	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: BCX9930 Product Code: [BCX9930] INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BIOCRYST PHARMACEUTICALS INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	European Union;Denmark;Austria;South Africa;United Kingdom;Italy
98	EUCTR2020-000501-93-DK (EUCTR)	27/10/2020	11/09/2020	A long term study of BCX9930 in patients with PNH	A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BioCryst Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	European Union;Austria;Denmark;South Africa;Italy;United Kingdom
99	EUCTR2019-004931-21-SE (EUCTR)	26/10/2020	03/06/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Portugal;Philippines;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan;Sweden
100	NCT04434092 (ClinicalTrials.gov)	October 8, 2020	3/6/2020	A Phase III Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.	A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.	Paroxysmal Nocturnal Hemoglobinuria	Drug: Crovalimab;Drug: Eculizumab	Hoffmann-La Roche	Chugai Pharmaceutical	Active, not recruiting	N/A	N/A	All	214	Phase 3	Argentina;Australia;Brazil;China;France;Germany;Greece;Hong Kong;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Portugal;Romania;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Belgium;Canada;Chile;Colombia;Czechia;Estonia;Hungary;Ireland;Israel;Italy;Peru;Saudi Arabia;South Africa;United States
101	JPRN-JapicCTI-205425	08/10/2020	21/08/2020	A Phase III Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. ( COMMODORE 2 )	A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.	Paroxysmal Nocturnal Hemoglobinuria	Intervention name : Crovalimab INN of the intervention : crovalimab Dosage And administration of the intervention : Participants will receive an initial intravenous (IV) loading dose on Week 1 Day 1, followed by 4 weekly crovalimab subcutaneous (SC) doses on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter, for a total of at least 24 weeks of study treatment. Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Control intervention name : Eculizumab INN of the control intervention : eculizumab Dosage And administration of the control intervention : Participants will receive initial IV weekly doses for 4 weeks which will be followed by Q2W (every 2 weeks) IV administrations starting on Week 5. Eculizumab will be administered at a dose of 600 mg for the first 4 weeks, followed by maintenance doses of 900 mg starting on Week 5.	Chugai Pharmaceutical Co., Ltd.	NULL	recruiting			BOTH	200	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
102	NCT04432584 (ClinicalTrials.gov)	September 30, 2020	3/6/2020	A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors	A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Safety, Pharmacokinetics, Pharmacodynamic And Efficacy of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors	Paroxysmal Nocturnal Hemoglobinuria	Drug: Crovalimab;Drug: Eculizumab	Hoffmann-La Roche	Chugai Pharmaceutical	Recruiting	N/A	N/A	All	190	Phase 3	United States;Australia;Belgium;Brazil;Canada;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Saudi Arabia;Singapore;Spain;Sweden;Taiwan;Turkey;United Kingdom;Colombia;Israel;Mexico;Slovakia
103	EUCTR2020-000501-93-GB (EUCTR)	29/09/2020	09/07/2020	A long term study of BCX9930 in patients with PNH	A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BioCryst Pharmaceuticals Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	European Union;South Africa;United Kingdom
104	JPRN-JapicCTI-205430	29/9/2020	24/08/2020	A Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors. (COMMODORE 1)	A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors.	Paroxysmal Nocturnal Hemoglobinuria	Intervention name : Crovalimab INN of the intervention : crovalimab Dosage And administration of the intervention : Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of at least 24 weeks of study treatment. Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Control intervention name : Eculizumab INN of the control intervention : eculizumab Dosage And administration of the control intervention : Participants will receive an approved maintenance dose of eculizumab starting on Day 1 and Q2W (every 2 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of study eculizumab treatment, participants will have the option to switch to crovalimab or to discontinue from the study after completion of 10 weeks of safety follow-up. Eculizumab will be administered at a dose of 900 mg every 2 weeks.	Chugai Pharmaceutical Co., Ltd.	NULL	recruiting			BOTH	250	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania
105	EUCTR2019-003829-18-GB (EUCTR)	18/09/2020	05/02/2020	Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)	A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)	Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Danicopan (ALXN2040) Product Code: ACH-0144471 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN Product Name: Danicopan (ALXN2040) Product Code: ACH-0144471 INN or Proposed INN: DANICOPAN Other descriptive name: DANICOPAN	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 3	United States;Taiwan;Finland;Thailand;Spain;Austria;Switzerland;United Kingdom;Italy;France;Canada;Poland;Brazil;Malaysia;Australia;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of
106	EUCTR2019-003830-17-GB (EUCTR)	16/09/2020	16/06/2020	Study of the Oral Factor D (fD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with background use of an Approved C5 Inhibitor	A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with an Approved C5 Inhibitor as Background Therapy	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALXN2050 Product Code: ACH-0145228 INN or Proposed INN: N/A Other descriptive name: ACH-0145228 Product Name: ALXN2050 Product Code: ACH-0145228 INN or Proposed INN: N/A Other descriptive name: ACH-0145228	Achillion Pharmaceuticals, Inc., a wholly owned subsidiary of Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	26	Phase 2	United States;New Zealand;Italy;United Kingdom;Korea, Republic of
107	EUCTR2018-002734-20-CZ (EUCTR)	07/08/2020	15/03/2019	A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor Therapy	An Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918 Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	Regeneron Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
108	EUCTR2019-003440-74-GB (EUCTR)	14/05/2020	17/03/2020	Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab	Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab - ALXN1210-PNH-401	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: ULTOMIRIS Product Name: ULTOMIRIS Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 4	United Kingdom
109	EUCTR2019-000130-20-GB (EUCTR)	23/04/2020	19/11/2019	REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.	An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918 Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	147	Phase 3	United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
110	EUCTR2019-000130-20-NL (EUCTR)	01/04/2020	16/10/2019	A trial with REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.	An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	147	Phase 3	United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Netherlands;Germany
111	EUCTR2017-001418-27-FI (EUCTR)	01/04/2020	08/10/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Netherlands;Germany;Norway;Sweden
112	EUCTR2017-001418-27-PT (EUCTR)	04/03/2020	28/11/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Portugal;Czech Republic;Slovenia;Spain;Ireland;Norway;Netherlands;Germany;Italy;United Kingdom
113	NCT04330534 (ClinicalTrials.gov)	March 3, 2020	23/3/2020	First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNH	A Phase 1 Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BCX9930 in Healthy Subjects and in Subjects With Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria	Drug: BCX9930;Drug: Placebo	BioCryst Pharmaceuticals	NULL	Completed	18 Years	N/A	All	168	Phase 1/Phase 2	Austria;South Africa;United Kingdom
114	EUCTR2017-001418-27-SE (EUCTR)	20/02/2020	08/11/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - proposed biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;Portugal;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden
115	EUCTR2019-000130-20-CZ (EUCTR)	12/02/2020	14/11/2019	REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.	An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	Regeneron Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	147	Phase 3	United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
116	EUCTR2019-001106-23-FR (EUCTR)	04/02/2020	15/10/2019	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	119	Phase 3	United States;Serbia;Hong Kong;Thailand;Spain;Russian Federation;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
117	EUCTR2019-000130-20-HU (EUCTR)	27/01/2020	25/11/2019	REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.	An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	147	Phase 3	United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
118	EUCTR2019-001106-23-ES (EUCTR)	22/01/2020	14/01/2020	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	119	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Poland;Malaysia;Belgium;Australia;Bulgaria;Germany;Japan;Korea, Republic of
119	EUCTR2017-001418-27-IE (EUCTR)	15/01/2020	02/10/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden
120	EUCTR2019-001106-23-GB (EUCTR)	19/12/2019	30/09/2019	An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).	An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: pegcetacoplan Other descriptive name: Pegcetacoplan (APL-2)	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 3	Serbia;United States;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Malaysia;Australia;Bulgaria;Japan;Korea, Republic of
121	NCT04170023 (ClinicalTrials.gov)	December 16, 2019	6/11/2019	Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy	A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: ALXN2050	Alexion Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	26	Phase 2	Canada;Italy;Korea, Republic of;New Zealand;Spain;Turkey;United Kingdom;Germany;United States
122	EUCTR2019-000130-20-IT (EUCTR)	12/12/2019	24/05/2021	REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.	An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria - R3918-PNH-1868	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: [REGN3918] INN or Proposed INN: REGN3918	REGENERON PHARMACEUTICALS, INC.	NULL	Not Recruiting			Female: yes Male: yes	147	Phase 3	United States;Hong Kong;Taiwan;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands;Korea, Republic of
123	NCT04162470 (ClinicalTrials.gov)	December 3, 2019	11/11/2019	REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.	An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria	Drug: REGN3918	Regeneron Pharmaceuticals	NULL	Completed	18 Years	N/A	All	24	Phase 3	Hong Kong;Hungary;Korea, Republic of;Malaysia;Taiwan;United Kingdom
124	EUCTR2017-001418-27-CZ (EUCTR)	22/11/2019	05/08/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden
125	EUCTR2017-001418-27-SI (EUCTR)	23/10/2019	10/09/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden
126	EUCTR2017-001418-27-NO (EUCTR)	18/10/2019	22/08/2019	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Norway;Germany;Netherlands;Sweden
127	EUCTR2019-001453-10-ES (EUCTR)	16/09/2019	09/08/2019	A Low-Interventional Study Documenting the Efficacy, Health-Related Quality of Life, and Safety of Standard-Of-Care Treatment with Eculizumab or Treatment with Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria	A MULTICENTER, LOW-INTERVENTIONAL STUDY DOCUMENTING THE EFFICACY, HEALTH-RELATED QUALITY OF LIFE, AND SAFETY OF STANDARD-OF-CARE TREATMENT WITH ECULIZUMAB OR TREATMENT WITH RAVULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA	Paroxysmal nocturnal hemoglobinuria (PNH) that is treated with either eculizumab or ravulizumab as per local label MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Soliris 300 Product Name: ECULIZUMAB INN or Proposed INN: ECULIZUMAB Trade Name: ULTOMIRIS Product Name: Ultomiris INN or Proposed INN: RAVULIZUMAB Other descriptive name: Ultomiris	Roche Farma S. A. U. que realiza el ensayo en España y que actua como representante F.Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United States;Taiwan;Greece;Spain;Turkey;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Romania;Netherlands;Germany;Japan;Sweden;Korea, Republic of
128	NCT04085601 (ClinicalTrials.gov)	August 27, 2019	9/9/2019	A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH	A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Drug: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	53	Phase 3	Colombia;Hong Kong;Malaysia;Mexico;Peru;Philippines;Poland;Serbia;Singapore;Thailand
129	EUCTR2019-001106-23-BG (EUCTR)	09/08/2019	09/05/2019	An Open-label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)	An Open-label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: pegcetacoplan Product Code: pegcetacoplan INN or Proposed INN: pegcetacoplan Other descriptive name: pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 3	Serbia;United States;Hong Kong;Spain;Thailand;Ireland;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Malaysia;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
130	NCT04058158 (ClinicalTrials.gov)	August 7, 2019	12/8/2019	A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria	A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria	Drug: SB12 (proposed eculizumab biosimilar);Drug: Soliris (eculizumab)	Samsung Bioepis Co., Ltd.	NULL	Completed	18 Years	N/A	All	50	Phase 3	India;Korea, Republic of;Malaysia;Mexico;Romania;Taiwan;Thailand;Ukraine
131	EUCTR2018-002734-20-NL (EUCTR)	29/07/2019	02/04/2019	A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor Therapy	An Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	42	Phase 2	United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Netherlands;Germany
132	EUCTR2018-002734-20-GB (EUCTR)	24/07/2019	22/03/2019	A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor Therapy	An Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918 Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	42	Phase 2	United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
133	EUCTR2018-004220-11-PL (EUCTR)	23/07/2019	13/05/2019	A Research Study to Gather Scientific Information About the Efficacy and Safety of the Investigational Drug APL-2 In Treating Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated with Anemia, In a Randomly Assigned Comparison with the Current Standard of Care Treatment Approved for PNH	A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PRINCE	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: pegcetacoplan Other descriptive name: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	54	Phase 3	Serbia;Philippines;Hungary;Hong Kong;Mexico;Argentina;Thailand;Malaysia;Brazil;Poland;Peru;Colombia
134	EUCTR2017-002370-39-DE (EUCTR)	02/07/2019	15/11/2018	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 3	Russian Federation;United States;United Kingdom;Spain;Canada;Austria;Czech Republic;Netherlands;Sweden;Turkey;Belgium;Finland;Brazil;Korea, Republic of;Italy;Australia;France;Germany
135	EUCTR2017-002370-39-NL (EUCTR)	01/07/2019	27/11/2018	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Phase 3	United States;Czechia;Finland;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Brazil;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of
136	NCT04671810 (ClinicalTrials.gov)	June 13, 2019	1/12/2020	Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®	Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria® in Patients With Paroxysmal Nocturnal Hemoglobinuria.	Paroxysmal Nocturnal Hemoglobinuria	Biological: Elizaria®	AO GENERIUM	NULL	Active, not recruiting	18 Years	N/A	All	44		Russian Federation
137	EUCTR2017-004268-36-NL (EUCTR)	23/05/2019	09/08/2018	A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS	PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
138	EUCTR2018-002734-20-IT (EUCTR)	16/05/2019	25/05/2021	A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor Therapy	An Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy - -	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: [REGN3918] INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	REGENERON PHARMACEUTICALS, INC.	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
139	NCT03946748 (ClinicalTrials.gov)	May 16, 2019	8/5/2019	Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	An Open-Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor-Naive or Have Not Recently Received Complement Inhibitor Therapy	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: REGN3918	Regeneron Pharmaceuticals	NULL	Completed	18 Years	N/A	All	24	Phase 2	Hong Kong;Hungary;Korea, Republic of;Malaysia;United Kingdom
140	EUCTR2018-002734-20-HU (EUCTR)	10/05/2019	25/03/2019	A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor Therapy	An Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918 Product Name: REGN3918 Product Code: REGN3918 INN or Proposed INN: REGN3918 Other descriptive name: REGN3918	Regeneron Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
141	NCT03818607 (ClinicalTrials.gov)	April 24, 2019	17/1/2019	A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH	A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Drug: ABP 959;Drug: Eculizumab	Amgen	NULL	Completed	18 Years	N/A	All	42	Phase 3	United States;Czechia;Finland;France;Ireland;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Turkey;United Kingdom;Germany;Taiwan
142	EUCTR2017-002370-39-CZ (EUCTR)	09/04/2019	02/01/2019	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 3	Russian Federation;United States;United Kingdom;Spain;Canada;Czech Republic;Austria;Netherlands;Sweden;Turkey;Belgium;Finland;Brazil;Korea, Republic of;Italy;Australia;France;Germany
143	NCT03896152 (ClinicalTrials.gov)	April 5, 2019	28/3/2019	Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria	A Multi-center, Randomized, Open-label, Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Study, Assessing Multiple LNP023 Doses in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria and Active Hemolysis	Paroxysmal Nocturnal Hemoglobinuria	Drug: LNP023	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	13	Phase 2	Korea, Republic of;Malaysia;Singapore;Taiwan;Russian Federation
144	NCT04060264 (ClinicalTrials.gov)	April 4, 2019	13/8/2019	Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria	Randomized, Open-Label, International, Multi-center, Comparative Study of Efficacy and Safety of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Patients With Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria	Biological: BCD-148;Biological: Soliris	Biocad	NULL	Completed	18 Years	65 Years	All	28	Phase 3	Russian Federation
145	EUCTR2017-002370-39-AT (EUCTR)	01/04/2019	24/01/2019	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 3	United States;Finland;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Brazil;Australia;Germany;Netherlands;Sweden;Korea, Republic of
146	NCT03866681 (ClinicalTrials.gov)	April 1, 2019	28/2/2019	Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory PNH	Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory Classic Paroxysmal Nocturnal Hemoglobinuria ,a Prospective Study	Paroxysmal Nocturnal Hemoglobinuria	Drug: sirolimus	Peking Union Medical College Hospital	NULL	Not yet recruiting	18 Years	70 Years	All	40	Phase 4	China
147	EUCTR2017-002370-39-SE (EUCTR)	27/03/2019	30/11/2018	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Trade Name: ULTOMIRIS Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Phase 3	United States;Czechia;Finland;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Brazil;Australia;Netherlands;Germany;Sweden;Korea, Republic of
148	EUCTR2016-004129-18-LT (EUCTR)	15/03/2019	29/01/2019	An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial study	CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study	Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: rVA576 INN or Proposed INN: rVA576 Other descriptive name: COVERSIN	Akari Therapeutics Plc	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom;India
149	EUCTR2017-002370-39-BE (EUCTR)	13/03/2019	23/11/2018	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Phase 3	United States;Czechia;Finland;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Brazil;Australia;Germany;Netherlands;Korea, Republic of;Sweden
150	NCT03748823 (ClinicalTrials.gov)	March 5, 2019	19/11/2018	Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria	Combination Product: Ravulizumab OBDS;Biological: Ravulizumab	Alexion Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	136	Phase 3	United States;Australia;Austria;Belgium;Brazil;Canada;Finland;France;Italy;Netherlands;Russian Federation;Spain;Sweden;Turkey
151	EUCTR2017-004268-36-IT (EUCTR)	04/03/2019	26/09/2018	A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS	PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of
152	EUCTR2017-002370-39-IT (EUCTR)	21/02/2019	18/01/2021	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab.	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab. - NA	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: NA Product Name: Ravulizumab Product Code: [ALXN1210] Other descriptive name: Ravulizumab Trade Name: NA Product Name: Ravulizumab Product Code: [ALXN1210] Other descriptive name: Ravulizumab	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Phase 3	United States;Czechia;Finland;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Brazil;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of
153	EUCTR2017-002370-39-GB (EUCTR)	19/02/2019	26/11/2018	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Finland;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Brazil;Australia;Netherlands;Germany;Korea, Republic of;Sweden
154	NCT03520647 (ClinicalTrials.gov)	February 19, 2019	9/5/2018	Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis	Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis	Severe Aplastic Anemia (SAA);Hypo-Plastic Myelodysplastic Syndrome (MDS);Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: Cyclophosphamide;Other: Peripheral Blood Stem Cells	National Heart, Lung, and Blood Institute (NHLBI)	NULL	Recruiting	4 Years	75 Years	All	56	Phase 2	United States
155	EUCTR2018-003956-19-FI (EUCTR)	13/02/2019	28/01/2019	Study of Zilucoplan in Treatment-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Phase 3, Multicenter, Open-Label, Single-Arm Study to Confirm the Safety and Efficacy of Zilucoplan in Treatment-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria - Phase 3 Study in Treatment-Naive Paroxysmal Nocturnal Hemoglobinuria Patients	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Zilucoplan Product Code: RA101495 INN or Proposed INN: ZILUCOPLAN Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker	Ra Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	United States;Hong Kong;Taiwan;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Georgia;Germany;New Zealand;Korea, Republic of
156	EUCTR2017-002370-39-ES (EUCTR)	08/02/2019	18/01/2019	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Finland;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Brazil;Australia;Netherlands;Germany;Korea, Republic of;Sweden
157	EUCTR2017-002370-39-FI (EUCTR)	29/01/2019	21/12/2018	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Phase 3	United States;Czechia;Finland;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Brazil;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of
158	EUCTR2017-001418-27-DE (EUCTR)	29/01/2019	27/07/2017	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Czech Republic;Slovenia;Spain;Ireland;Norway;Netherlands;Germany;Italy;United Kingdom
159	EUCTR2017-001418-27-NL (EUCTR)	22/01/2019	02/11/2017	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Spain;Norway;Germany;Netherlands;Italy;United Kingdom;Korea, Republic of
160	EUCTR2017-004268-36-GB (EUCTR)	08/01/2019	21/08/2018	A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug Pegcetacoplan In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS	PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of
161	EUCTR2017-002370-39-FR (EUCTR)	28/12/2018	20/11/2018	This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab	A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Finland;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Brazil;Australia;Netherlands;Germany;Korea, Republic of;Sweden
162	EUCTR2017-001418-27-GB (EUCTR)	14/12/2018	11/12/2018	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, eculizumab, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This study will assess if the investigational medicine is safe and effective in treating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - ABP 959 in PNH	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Spain;Norway;Netherlands;Germany;Italy;United Kingdom
163	EUCTR2017-002820-26-NO (EUCTR)	07/12/2018	16/10/2018	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: ALXN1210 Other descriptive name: ALXN1210	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 3	United States;France;Netherlands;Norway;United Kingdom
164	EUCTR2017-004268-36-BE (EUCTR)	25/10/2018	23/07/2018	A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS	PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of
165	EUCTR2017-004268-36-FR (EUCTR)	05/10/2018	20/08/2018	A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS	PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of
166	EUCTR2017-004268-36-DE (EUCTR)	01/10/2018	14/06/2018	A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS	PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of
167	EUCTR2017-004268-36-ES (EUCTR)	19/09/2018	07/08/2018	A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS	PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Apellis Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of
168	NCT03531255 (ClinicalTrials.gov)	August 27, 2018	9/5/2018	Pegcetacoplan Long Term Safety and Efficacy Extension Study	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)	PNH	Drug: Pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	Active, not recruiting	18 Years	N/A	All	160	Phase 3	United States;Australia;Belgium;Bulgaria;Canada;France;Germany;Hong Kong;Japan;Korea, Republic of;Malaysia;Russian Federation;Serbia;Singapore;Spain;Thailand;United Kingdom
169	NCT03593200 (ClinicalTrials.gov)	August 16, 2018	28/6/2018	A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With PNH	Phase IIa, Open Label, Multiple Dose Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH).	PNH	Drug: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	4	Phase 2	Bulgaria;Serbia;Greece;Poland;Romania
170	EUCTR2017-000665-79-GB (EUCTR)	23/07/2018	27/04/2018	A treatment study of ACH-0144471 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who Completed Clinical Study ACH471-100	An Open-Label Study to Evaluate Efficacy and Safety of Long-term Treatment with ACH-0144471 in Patients with PNH who Completed Clinical Study ACH471-100	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471	Achillion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	New Zealand;Italy;United Kingdom;Korea, Republic of
171	EUCTR2016-003526-16-GB (EUCTR)	20/07/2018	23/04/2018	A treatment study of ACH-0144471 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have poor Response to Eculizumab Monotherapy	A Phase 2 Open-label Study of ACH-0144471 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have an Inadequate Response to Eculizumab Monotherapy	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Danicopan Product Code: ALXN2040 (ACH-0144471) INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Name: Danicopan Product Code: ALXN2040 (ACH-0144471) INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Name: Danicopan Product Code: ALXN2040 (ACH-0144471) INN or Proposed INN: Not available Other descriptive name: ACH-0144471	Alexion Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	14	Phase 2	United States;Italy;United Kingdom
172	EUCTR2017-005140-16-BG (EUCTR)	18/07/2018	26/03/2018	Phase IIa study of APL-2 in patients with PNH	A Phase IIa, Open Label, Multiple Dose Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: APL-2 INN or Proposed INN: Not yet assigned	Apellis Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Serbia;Greece;Poland;Romania;Bulgaria
173	NCT03500549 (ClinicalTrials.gov)	June 14, 2018	10/4/2018	Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Drug: APL-2;Drug: Soliris	Apellis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	80	Phase 3	United States;Australia;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Russian Federation;Spain;United Kingdom
174	NCT03588026 (ClinicalTrials.gov)	June 7, 2018	1/6/2018	Treating Paroxysmal Nocturnal Haemoglobinuria Patients With rVA576	Investigational Product ; Coversin. Phase III Safety and Efficacy in Three-Part, Two-Arm, Randomised Open Label Evaluation in Patients With Paroxysmal Nocturnal Haemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: rVA576;Other: Standard of care (SOC)	AKARI Therapeutics	NULL	Completed	18 Years	N/A	All	9	Phase 3	Kazakhstan;Lithuania;Sri Lanka
175	NCT03472885 (ClinicalTrials.gov)	May 8, 2018	15/3/2018	Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab	A Phase 2 Open-label Study of ACH-0144471 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have an Inadequate Response to Eculizumab Monotherapy	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: Danicopan;Drug: Eculizumab	Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion	Completed	18 Years	65 Years	All	12	Phase 2	United States;Italy;United Kingdom
176	EUCTR2017-005140-16-GR (EUCTR)	04/05/2018	02/04/2018	Phase IIa study of APL-2 in patients with PNH	A Phase IIa, Open Label, Multiple Dose Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: APL-2 INN or Proposed INN: Not yet assigned	Apellis Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;Greece;Poland;Romania;Bulgaria
177	EUCTR2017-002820-26-NL (EUCTR)	21/03/2018	10/01/2018	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: ALXN1210	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	13	Phase 3	France;United States;Russian Federation;Norway;Netherlands;United Kingdom
178	EUCTR2016-002652-25-IT (EUCTR)	16/03/2018	08/02/2021	A treatment study of ACH-0144471 in Untreated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of ACH-0144471 in Untreated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) - A treatment study of ACH-0144471 in Untreated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH	Untreated Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ACH-0144471 Product Code: ACH-0144471 Other descriptive name: ACH-0144471 Product Code: ACH-0144471 Other descriptive name: ACH-0144471	ACHILLION PHARMACEUTICALS, INC.	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	United Kingdom;New Zealand;Italy;Korea, Republic of
179	EUCTR2017-003847-39-LT (EUCTR)	12/03/2018	23/01/2018	A study to assess the safety and efficacy of rVA576 in patients with Paroxysmal Nocturnal Haemoglobinuria (PNH)	CAPSTONE: Phase III Confirmatory Assessment Protocol: rVA576 Safety and Efficacy in Three-Part, Two-Arm, Randomised Open Label Evaluation in patients with Paroxysmal Nocturnal Haemoglobinuria (PNH) - CAPSTONE	Paroxysmal Nocturnal Haemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: rVA576 INN or Proposed INN: NA	Akari Therapeutics Plc.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	Ecuador;Romania;Turkey;Lithuania;Peru;Kazakhstan;Sri Lanka
180	NCT03406507 (ClinicalTrials.gov)	February 22, 2018	5/1/2018	A Study of Ravulizumab (ALXN1210) in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Biological: Ravulizumab	Alexion Pharmaceuticals	NULL	Completed	N/A	17 Years	All	13	Phase 3	United States;France;Netherlands;Norway;Russian Federation;United Kingdom
181	EUCTR2016-004129-18-NL (EUCTR)	14/02/2018	16/11/2017	An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial study	CONSERVE: Coversin Long Term Safety and Efficacy Surveillance Study	Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Coversin Product Code: rVA576 INN or Proposed INN: COVERSIN Other descriptive name: COVERSIN	Akari Therapeutics Plc	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	Argentina;Poland;Lithuania;Netherlands;United Kingdom
182	EUCTR2017-000888-33-DE (EUCTR)	05/02/2018	17/10/2017	A Study evaluating the safety and efficacy of LNP023 in patients with a blood disorder called paroxysmal nocturnal hemoglobinuria (PNH)	An open label, single arm, multiple dose study to assess efficacy, safety, pharmacokinetics and pharmacodynamics of LNP023 when administered in addition to Standard of Care (SoC) in patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: HLGT;Classification code 10018911;Term: Haemolyses and related conditions;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 2	France;Germany;Italy
183	EUCTR2016-002652-25-GB (EUCTR)	02/02/2018	27/10/2017	A treatment study of ACH-0144471 in Untreated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of ACH-0144471 in Untreated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Untreated Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471	Achillion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	12	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	New Zealand;Italy;United Kingdom;Korea, Republic of
184	EUCTR2017-000888-33-FR (EUCTR)	15/01/2018	22/01/2018	A Study evaluating the safety and efficacy of LNP023 in patients with a blood disorder called paroxysmal nocturnal hemoglobinuria (PNH)	An open label, single arm, multiple dose study to assess efficacy, safety, pharmacokinetics and pharmacodynamics of LNP023 when administered in addition to Standard of Care (SoC) in patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: HLGT;Classification code 10018911;Term: Haemolyses and related conditions;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	10	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Germany;Italy
185	NCT03333486 (ClinicalTrials.gov)	December 7, 2017	2/11/2017	Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer	A Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem Cells	Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Acute Leukemia in Remission;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia With FLT3/ITD Mutation;Acute Myeloid Leukemia With Gene Mutations;Aplastic Anemia;B-Cell Non-Hodgkin Lymphoma;CD40 Ligand Deficiency;Chronic Granulomatous Disease;Chronic Leukemia in Remission;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Congenital Amegakaryocytic Thrombocytopenia;Congenital Neutropenia;Congenital Pure Red Cell Aplasia;Glanzmann Thrombasthenia;Immunodeficiency Syndrome;Myelodysplastic Syndrome;Myelofibrosis;Myeloproliferative Neoplasm;Paroxysmal Nocturnal Hemoglobinuria;Plasma Cell Myeloma;Polycythemia Vera;Recurrent Non-Hodgkin Lymphoma;Refractory Non-Hodgkin Lymphoma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndrome;Severe Aplastic Anemia;Shwachman-Diamond Syndrome;Sickle Cell Disease;T-Cell Non-Hodgkin Lymphoma;Thalassemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich Syndrome	Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body Irradiation	Roswell Park Cancer Institute	NULL	Active, not recruiting	1 Year	75 Years	All	31	Phase 2	United States
186	NCT04463056 (ClinicalTrials.gov)	November 29, 2017	3/7/2020	Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH	A Multicenter, Open Label, Randomized, Parallel-group Study of Efficacy and Safety of Eculizumab (JSC GENERIUM, Russia) vs. Soliris® (Alexion Pharma GmbH, Switzerland) in Patients With Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria;Marchiafava-Micheli Syndrome;Paroxysmal Hemoglobinuria	Biological: Elizaria®;Biological: Soliris®	AO GENERIUM	NULL	Completed	18 Years	75 Years	All	32	Phase 3	Russian Federation
187	EUCTR2017-002820-26-GB (EUCTR)	24/11/2017	26/10/2017	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: ALXN1210	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	13	Phase 3	United States;France;Russian Federation;Norway;Netherlands;United Kingdom
188	JPRN-JapicCTI-173517	17/10/2017	17/02/2017	An adaptive Phase I/II study of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)	An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Intervention name : RO7112689 INN of the intervention : Crovalimab Dosage And administration of the intervention : Intravenous and Subcutaneous Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	CHUGAI PHARMACEUTICAL CO., LTD.	NULL	complete	18	75	BOTH	44	Phase 1-2	Japan, Asia except Japan, Europe
189	EUCTR2016-002128-10-IT (EUCTR)	19/09/2017	06/02/2018	Studio volto a valutare la sicurezza, l’efficacia, la farmacocinetica e la farmacodinamica di RO7112689 in volontari sani e in pazienti con Emoglobinuria Parossistica Notturna	An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) - An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: RO7112689/F01 Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230	F. HOFFMANN - LA ROCHE LTD.	NULL	Not Recruiting			Female: yes Male: yes	49	Phase 1;Phase 2	France;Hungary;Brazil;Netherlands;Germany;New Zealand;Japan;Italy;Korea, Republic of
190	EUCTR2017-001418-27-ES (EUCTR)	28/08/2017	31/07/2017	This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine.	A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable	Paroxysmal Nocturnal Hemoglobinuria (PNH);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Portugal;Slovenia;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of
191	EUCTR2016-002128-10-FR (EUCTR)	17/08/2017	08/09/2017	A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria	An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: RO7112689/F01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	49	Phase 1;Phase 2	France;Hungary;Netherlands;Germany;Japan;Italy;Korea, Republic of
192	EUCTR2016-002026-36-NL (EUCTR)	27/07/2017	27/03/2017	ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	197	Phase 3	United States;Spain;Germany;Netherlands;Italy;United Kingdom
193	EUCTR2016-002026-36-IT (EUCTR)	24/07/2017	08/06/2021	ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal NocturnalHemoglobinuria (PNH) Currently Treated With Eculizumab - ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML) INN or Proposed INN: ECULIZUMAB	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	192	Phase 3	United States;Spain;Netherlands;Germany;United Kingdom;Italy
194	NCT03225287 (ClinicalTrials.gov)	July 17, 2017	17/7/2017	Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study	A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: Zilucoplan (RA101495)	Ra Pharmaceuticals, Inc.	NULL	Terminated	18 Years	N/A	All	19	Phase 2	United States;Australia;Canada;Finland;Germany;Hungary;New Zealand;United Kingdom;Denmark
195	NCT03181633 (ClinicalTrials.gov)	June 22, 2017	5/6/2017	A Long-Term Treatment Study of ACH-0144471 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)	An Open-Label Study to Evaluate Efficacy and Safety of Long-Term Treatment With ACH-0144471 in Participants Who Completed Clinical Study ACH471-100	Paroxysmal Nocturnal Hemoglobinuria	Drug: ACH-0144471	Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion	Completed	18 Years	N/A	All	8	Phase 2	Italy;Korea, Republic of;New Zealand
196	EUCTR2016-003522-16-FI (EUCTR)	20/06/2017	27/12/2016	Study of RA101495 in Paroxysmal Nocturnal Hemoglobinuria (PNH)	A PHASE 2 MULTICENTER,OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RA101495 IN SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: RA101495 Product Code: RA101495 INN or Proposed INN: RA101495 sodium Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide	Ra Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Hungary;Canada;Finland;Denmark;Australia;Germany;New Zealand;United Kingdom
197	EUCTR2016-002026-36-DE (EUCTR)	14/06/2017	23/02/2017	ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	192	Phase 3	France;United States;Canada;Spain;Australia;Netherlands;Germany;Japan;Italy;United Kingdom;Korea, Republic of
198	EUCTR2016-002026-36-ES (EUCTR)	31/05/2017	22/03/2017	ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 19.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	192	Phase 3	United States;Spain;Germany
199	EUCTR2016-002026-36-GB (EUCTR)	30/05/2017	14/02/2017	ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	192	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Netherlands;Germany;United Kingdom
200	EUCTR2016-003522-16-DK (EUCTR)	01/05/2017	14/02/2017	Study of RA101495 in Paroxysmal Nocturnal Haemoglobinuria (PNH)	A PHASE 2 MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RA101495 IN SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA	Paroxysmal Nocturnal Haemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: RA101495 Product Code: RA101495 INN or Proposed INN: RA101495 sodium Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a ethyleneglycol24	Ra Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Hungary;Canada;Finland;Australia;Denmark;Germany;New Zealand;United Kingdom
201	EUCTR2016-003523-34-DK (EUCTR)	01/05/2017	14/02/2017	Extension Study of RA101495 in Paroxysmal Nocturnal Haemoglobinuria (PNH)	A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study	Paroxysmal Nocturnal Haemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: RA101495 Product Code: RA101495 INN or Proposed INN: RA101495 sodium Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a ethyleneglycol24	Ra Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 2	United States;Hungary;Canada;Finland;Australia;Denmark;Germany;United Kingdom;New Zealand
202	EUCTR2016-002025-11-FI (EUCTR)	28/04/2017	01/11/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of;Sweden
203	EUCTR2016-003523-34-FI (EUCTR)	06/04/2017	27/12/2016	Extension Study of RA101495 in Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Zilucoplan Product Code: RA101495 INN or Proposed INN: Zilucoplan Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a ethyleneglycol24 palmitoylated linker	Ra Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 2	United States;Hungary;Finland;Denmark;Australia;Germany;United Kingdom;New Zealand
204	NCT03053102 (ClinicalTrials.gov)	March 31, 2017	1/2/2017	A Treatment Study of ACH-0144471 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of ACH-0144471 in Untreated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: ACH-0144471	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	All	10	Phase 2	Italy;Korea, Republic of;New Zealand;United Kingdom
205	EUCTR2016-002025-11-NL (EUCTR)	27/03/2017	08/11/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Belgium;Poland;Denmark;Netherlands;Germany;Korea, Republic of
206	EUCTR2016-004129-18-GB (EUCTR)	17/03/2017	21/12/2016	An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial study	CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study	Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: rVA576 INN or Proposed INN: rVA576 Other descriptive name: rVA576	Akari Therapeutics Plc	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom
207	EUCTR2016-003523-34-HU (EUCTR)	17/03/2017	31/01/2017	Extension Study of RA101495 in Paroxysmal Nocturnal Haemoglobinuria (PNH)	A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study	Paroxysmal Nocturnal Haemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: RA101495 Product Code: RA101495 INN or Proposed INN: RA101495 sodium Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a ethyleneglycol24	Ra Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 2	United States;Hungary;Finland;Denmark;Australia;Germany;United Kingdom;New Zealand
208	EUCTR2016-003522-16-HU (EUCTR)	17/03/2017	31/01/2017	Study of RA101495 in Paroxysmal Nocturnal Haemoglobinuria (PNH)	A PHASE 2 MULTICENTER,OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RA101495 IN SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA	Paroxysmal Nocturnal Haemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: RA101495 Product Code: RA101495 INN or Proposed INN: RA101495 sodium Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a ethyleneglycol24	Ra Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Hungary;Finland;Denmark;Australia;Germany;New Zealand;United Kingdom
209	EUCTR2016-002025-11-PL (EUCTR)	16/03/2017	20/03/2017	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Ultomiris Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	301	Phase 3	Portugal;United States;Taiwan;Estonia;Thailand;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Germany;Japan;Sweden
210	EUCTR2016-002128-10-DE (EUCTR)	14/03/2017	24/10/2016	A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria	An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: RO7112689/F01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Code: RO7112689/F03-01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Code: RO7112689/F03-10 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	49	Phase 1;Phase 2	France;Hungary;Netherlands;Germany;Italy;Japan;Korea, Republic of
211	EUCTR2016-002025-11-BE (EUCTR)	14/03/2017	17/10/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Ultomiris Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	301	Phase 3	Portugal;Taiwan;Estonia;Thailand;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Netherlands;Czechia;Finland;Korea, Democratic People's Republic of;Turkey;United States Minor Outlying Islands;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
212	NCT03829449 (ClinicalTrials.gov)	March 13, 2017	20/12/2018	rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study	CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study	Paroxysmal Nocturnal Hemoglobinuria	Drug: rVA576 (Coversin)	AKARI Therapeutics	NULL	Terminated	18 Years	N/A	All	15	Phase 3	Poland
213	EUCTR2016-004129-18-PL (EUCTR)	07/03/2017	18/01/2017	An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial study	CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study	Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS) MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: rVA576 (Coversin) Product Code: rVA576 INN or Proposed INN: rVA576 (COVERSIN) Other descriptive name: rVA576 (COVERSIN)	Akari Therapeutics Plc	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom
214	EUCTR2016-002025-11-EE (EUCTR)	20/02/2017	23/01/2017	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Ultomiris Product Name: Ultomiris Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	301	Phase 3	Portugal;United States;Taiwan;Estonia;Thailand;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
215	EUCTR2016-003523-34-GB (EUCTR)	20/02/2017	26/09/2017	Extension Study of RA101495 in Paroxysmal Nocturnal Haemoglobinuria (PNH)	A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study	Paroxysmal Nocturnal Haemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: RA101495 Product Code: RA101495 INN or Proposed INN: RA101495 sodium Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a ethyleneglycol24	Ra Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	28	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Hungary;Canada;Finland;Denmark;Australia;Germany;New Zealand;United Kingdom
216	EUCTR2016-003522-16-GB (EUCTR)	15/02/2017	03/01/2017	Study of RA101495 in Paroxysmal Nocturnal Hemoglobinuria (PNH)	A PHASE 2 MULTICENTER,OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RA101495 IN SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: RA101495 Product Code: RA101495 INN or Proposed INN: RA101495 sodium Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a ethyleneglycol24	Ra Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Hungary;Canada;Finland;Denmark;Australia;Germany;New Zealand;United Kingdom
217	EUCTR2016-002025-11-IT (EUCTR)	07/02/2017	17/06/2021	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Na¿ve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a compleme	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ALXN1210 Product Code: ALXN1210 Trade Name: Soliris Product Name: ALXN1210 Product Code: [ALXN1210] INN or Proposed INN: ECULIZUMAB	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Portugal;Estonia;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of;Sweden
218	EUCTR2016-002025-11-CZ (EUCTR)	02/02/2017	17/10/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;United Kingdom;Portugal;Spain;Czech Republic;Sweden;Netherlands;Austria;Belgium;Finland;Korea, Republic of;Denmark;Poland;Italy;Germany;Estonia
219	EUCTR2016-002025-11-PT (EUCTR)	30/01/2017	21/10/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 19.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	214	Phase 3	United States;Portugal;Estonia;Poland;Spain;Austria;Denmark;Germany;United Kingdom;Korea, Republic of
220	EUCTR2016-002128-10-HU (EUCTR)	24/01/2017	14/11/2016	A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria	An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 19.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: RO7112689/F01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	49	Phase 1;Phase 2	France;Hungary;Brazil;Netherlands;Germany;New Zealand;Japan;Italy;Korea, Republic of
221	EUCTR2016-002025-11-ES (EUCTR)	16/01/2017	04/11/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 19.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	214	Phase 3	United States;Spain;Austria;Denmark;Germany;Korea, Republic of
222	EUCTR2016-002025-11-AT (EUCTR)	11/01/2017	14/12/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	Portugal;United States;Estonia;Taiwan;Spain;Thailand;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
223	EUCTR2016-002025-11-DK (EUCTR)	23/12/2016	20/10/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Belgium;Poland;Denmark;Germany;Netherlands;Korea, Republic of
224	NCT02946463 (ClinicalTrials.gov)	December 20, 2016	25/10/2016	ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Biological: Ravulizumab;Biological: Eculizumab	Alexion Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	246	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Estonia;France;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Poland;Russian Federation;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;United Kingdom;Colombia
225	EUCTR2016-002025-11-DE (EUCTR)	20/12/2016	07/10/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	214	Phase 3	Portugal;United States;Taiwan;Estonia;Thailand;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
226	EUCTR2016-002025-11-GB (EUCTR)	02/12/2016	07/10/2016	Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor.	A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB	Alexion Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	214	Phase 3	United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of;Sweden
227	EUCTR2016-002943-40-ES (EUCTR)	21/11/2016	30/09/2016	A Clinical Study with Investigational Drug, ALN-CC5, in patients with Paroxysmal Nocturnal Hemoglobinuria who are Inadequate Responders to Eculizumab	A Phase 2, Open-label, Single Dose, Study of Subcutaneously Administered ALN-CC5 in Patients with Paroxysmal Nocturnal Hemoglobinuria who are Inadequate Responders to Eculizumab	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 19.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALN-CC5 INN or Proposed INN: ALN-62643	Alnylam Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 2	Taiwan;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;Korea, Republic of;Sweden
228	NCT03157635 (ClinicalTrials.gov)	November 14, 2016	1/11/2016	Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria	An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Hemoglobinuria, Nocturnal	Drug: Crovalimab;Drug: Placebo	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	75 Years	All	59	Phase 1/Phase 2	France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands
229	EUCTR2016-002128-10-NL (EUCTR)	14/09/2016	05/09/2016	A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria	An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 19.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: RO7112689/F01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: no Male: yes	74	Phase 1;Phase 2	France;Hungary;Czech Republic;Brazil;Germany;Netherlands;Japan;Italy;United Kingdom
230	EUCTR2016-002067-33-GB (EUCTR)	18/07/2016	16/08/2016	An Open Clincal Trial of Coversin in Patients with PNH	COBALT: Coversin Global Study: An Open-Label, Safety and Efficacy Trial in PNH Patients	Paroxysmal nocturnal haemoglobinuria (PNH) MedDRA version: 20.0;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Coversin Product Code: rVA576 INN or Proposed INN: COVERSIN Other descriptive name: COVERSIN	Akari Therapeutics Plc	NULL	Not Recruiting			Female: yes Male: yes	10	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
231	NCT02591862 (ClinicalTrials.gov)	February 2016	10/9/2015	Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)	Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms	Paroxysmal Nocturnal Haemoglobinuria (PNH)	Drug: Coversin	AKARI Therapeutics	Radboud University	Completed	18 Years	80 Years	All	6	Phase 2	Netherlands
232	EUCTR2015-003778-34-NL (EUCTR)	13/01/2016	10/12/2015	Coversin in Paroxysmal Nocturnal Haemoglobulinuria (PNH) in patients with resistance to Eculizumab due to complement C5 Polymorphisms	Coversin in Paroxysmal Nocturnal Haemoglobulinuria (PNH) in patients with resistance to Eculizumab due to complement C5 Polymorphisms - Coversin in PNH patients with resistance to Eculizumab	Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms. MedDRA version: 18.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Coversin Product Code: rVA576 INN or Proposed INN: Not applicable Other descriptive name: coversin	Volution Immuno Pharmaceuticals (UK) Ltd	NULL	Not Recruiting			Female: yes Male: yes	6	Phase 2	Netherlands
233	NCT02605993 (ClinicalTrials.gov)	January 4, 2016	11/11/2015	Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 2, Open-label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria;PNH	Biological: Ravulizumab	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	All	26	Phase 2	Canada;France;Germany;Korea, Republic of;Spain;Taiwan;United Kingdom;Sweden
234	EUCTR2015-002674-20-DE (EUCTR)	04/12/2015	11/08/2015	A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria	A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: ALXN1210 Product Code: ALXN1210 INN or Proposed INN: ALXN1210	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	26	Phase 2	France;United States;Taiwan;Canada;Finland;Spain;Russian Federation;Germany;United Kingdom;Sweden;Korea, Republic of
235	EUCTR2015-002674-20-SE (EUCTR)	30/11/2015	02/10/2015	A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria	A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 18.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: ALXN1210	Alexion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 2	Germany;United Kingdom;Sweden;France;Taiwan;Canada;Finland;Spain;Russian Federation
236	EUCTR2015-002674-20-ES (EUCTR)	27/11/2015	05/10/2015	A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria	A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 18.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: ALXN1210	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	18	Phase 2	France;Taiwan;Canada;Finland;Spain;Russian Federation;Germany;United Kingdom;Sweden
237	NCT02598583 (ClinicalTrials.gov)	November 2015	2/11/2015	Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)	An Open-Label, Intrapatient, Dose-Escalation Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria	PNH	Biological: ALXN1210	Alexion Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	13	Phase 1/Phase 2	Australia;Korea, Republic of
238	NCT02588833 (ClinicalTrials.gov)	November 2015	27/10/2015	Pilot Study to Assess Safety, Preliminary Efficacy and Pharmacokinetics of S.C. APL-2 in PNH Subjects	A Phase Ib, Open Label, Multiple Ascending Dose, Pilot Study to Assess the Safety, Preliminary Efficacy and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria	Drug: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	20	Phase 1	Hong Kong;Malaysia;New Zealand;Thailand
239	EUCTR2015-002674-20-GB (EUCTR)	28/10/2015	01/10/2015	A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria	A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: ALXN1210 Product Code: ALXN1210 INN or Proposed INN: ALXN1210	Alexion Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	26	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Taiwan;Canada;Finland;Spain;Russian Federation;Germany;United Kingdom;Korea, Republic of;Sweden
240	NCT02534909 (ClinicalTrials.gov)	September 9, 2015	7/8/2015	Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria	An Open-label Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316, an Anti-C5 Monoclonal Antibody in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria PNH	Biological: LFG316;Drug: LNP023	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	10	Phase 2	Czechia;Japan;Lithuania;Czech Republic;Moldova, Republic of
241	EUCTR2014-005338-74-LT (EUCTR)	07/07/2015	09/06/2015	To find out whether LFG316 is able to reduce the destruction of red blood cells in patients with PNH	An open-label proof of concept study to assess the efficacy, safety and pharmacokinetics of LFG316, an anti-C5 monoclonal antibody in patients with paroxysmal nocturnal hemoglobinuria (PNH) - CLFG316X2201	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LFG316 INN or Proposed INN: No Other descriptive name: human monoclonal antibody directed against complement 5 protein Product Code: LFG316 INN or Proposed INN: No Other descriptive name: human monoclonal antibody directed against complement 5 protein Product Name: iptacopan Product Code: LNP023 Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	9	Phase 2	Czechia;Czech Republic;Lithuania;Japan
242	EUCTR2014-005338-74-CZ (EUCTR)	17/06/2015	23/04/2015	To find out whether LFG316 is able to reduce the destruction of red blood cells in patients with PNH	An open-label proof of concept study to assess the efficacy, safety and pharmacokinetics of LFG316, an anti-C5 monoclonal antibody in patients with paroxysmal nocturnal hemoglobinuria (PNH) - CLFG316X2201	Paroxysmal nocturnal hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LFG316 INN or Proposed INN: No Other descriptive name: human monoclonal antibody directed against complement 5 protein Product Code: LFG316 INN or Proposed INN: No Other descriptive name: human monoclonal antibody directed against complement 5 protein Product Name: iptacopan Product Code: LNP023 Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 Other descriptive name: LNP023 HYDROCHLORIDE SALT	Novartis Pharma Services AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	9	Phase 2	Czechia;Czech Republic;Lithuania;Japan
243	NCT02264639 (ClinicalTrials.gov)	February 23, 2015	8/10/2014	A Phase I Study to Assess the Safety APL-2 as an Add-On to Standard of Care in Subjects With PNH	An Open Label, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL-2 as an Add-On to Standard of Care in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH).	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	9	Phase 1	United States
244	NCT02352493 (ClinicalTrials.gov)	January 2015	23/1/2015	A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH	A Phase 1/2 Single-ascending and Multiple-ascending Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-CC5 in Healthy Adult Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: ALN-CC5;Drug: Sterile Normal Saline (0.9% NaCl)	Alnylam Pharmaceuticals	NULL	Completed	18 Years	45 Years	All	62	Phase 1/Phase 2	Spain;United Kingdom
245	NCT02179359 (ClinicalTrials.gov)	September 2, 2014	27/6/2014	Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies	MT2014-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders	Sickle Cell Disease;Transfusion Dependent Alpha- or Beta- Thalassemia;Diamond Blackfan Anemia;Paroxysmal Nocturnal Hemoglobinuria;Glanzmann Thrombasthenia;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Non-Malignant Hematologic Disorders	Drug: Reduced Toxicity Ablative Regimen;Drug: Reduced Intensity Preparative Regimen;Drug: Myeloablative Preparative Regimen	Masonic Cancer Center, University of Minnesota	NULL	Recruiting	N/A	55 Years	All	25	N/A	United States
246	ChiCTR-TRC-14004219	2014-01-24	2014-01-24	A prospective, randomized, open label, single-center trial of comparing intravenous iron sucrose versus iron dextran tablet in the treatment of iron deficiency anemia and classic paroxysmal nocturnal hemoglobinuria	A prospective, randomized, open label, single-center trial of comparing intravenous iron sucrose versus iron dextran tablet in the treatment of iron deficiency anemia and classic paroxysmal nocturnal hemoglobinuria	iron deficiency anemia and classic paroxysmal nocturnal hemoglobinuria	intravenous iron sucrose:intravenous iron sucrose;iron dextran tablet:Oral iron dextran tablet;	Institute of Hematology and Blood Diseases Hospital,Chinese Academy of Medical Sciences	NULL	Recruiting	18	65	Both	intravenous iron sucrose:24;iron dextran tablet:24;		China
247	ChiCTR-ONC-13003994	2014-01-01	2013-11-06	Chemotherapy plus hematopoietic growth factors (DAG) for refractory paroxysmal nocturnal hemoglobinuria: diminishing PNH clone and stimulating hematopoisis	Chemotherapy plus hematopoietic growth factors (DAG) for refractory paroxysmal nocturnal hemoglobinuria: diminishing PNH clone and stimulating hematopoisis	paroxymal nocturnal hemoglobinuria	A1:DA chemotherapy regimen plus G-CSF ;	Tianjin Medical University General Hospital	NULL	Recruiting	16	75	Both	A1:50;		China
248	NCT01760096 (ClinicalTrials.gov)	January 2013	1/1/2013	Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)	Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)	Paroxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, Hemolytic	Drug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: Glucocorticoids	Institute of Hematology & Blood Diseases Hospital	NULL	Active, not recruiting	18 Years	N/A	Both	50	Phase 2	China
249	NCT01642979 (ClinicalTrials.gov)	July 2012	14/7/2012	Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria	Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, Hemolytic	Drug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: Glucocorticoids	Institute of Hematology & Blood Diseases Hospital	NULL	Active, not recruiting	18 Years	N/A	Both	120	Phase 2	China
250	NCT01529827 (ClinicalTrials.gov)	February 28, 2012	6/2/2012	Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies	A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation	Accelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich Syndrome	Drug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation	Roswell Park Cancer Institute	NULL	Completed	3 Years	75 Years	All	94	Phase 2	United States
251	NCT01335165 (ClinicalTrials.gov)	April 2011	12/4/2011	Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 1, Single Ascending Dose Study of the Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: ALXN1102;Drug: ALXN1103	Alexion Pharmaceuticals	NULL	Terminated	18 Years	N/A	Both	10	Phase 1	United States;Czech Republic;Italy;Poland;United Kingdom
252	NCT00867932 (ClinicalTrials.gov)	October 2, 2009	23/3/2009	Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)	An Open-Label Multi-Center Study of Eculizumab in Children and Adolescents With a Diagnosis of Paroxysmal Nocturnal Hemoglobinuria	Hemoglobinuria, Paroxysmal	Drug: Eculizumab	Alexion Pharmaceuticals	NULL	Completed	2 Years	17 Years	All	7	Phase 4	United States
253	NCT00856388 (ClinicalTrials.gov)	January 14, 2009	4/3/2009	Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders	A Pilot Trial Of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan, And Low Dose Total Body Irradiation	Accelerated Phase Chronic Myelogenous Leukemia;Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;de Novo Myelodysplastic Syndromes;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Fanconi Anemia;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Splenic Marginal Zone Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Small Lymphocytic Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Small Lymphocytic Lymphoma;Waldenström Macroglobulinemia	Drug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Procedure: allogeneic hematopoietic stem cell transplantation;Biological: anti-thymocyte globulin	Roswell Park Cancer Institute	National Cancer Institute (NCI)	Completed	3 Years	75 Years	All	62	N/A	United States
254	NCT01194804 (ClinicalTrials.gov)	April 2008	30/8/2010	E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients	Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol	Paroxysmal Nocturnal Hemoglobinuria	Drug: Eculizumab	Alexion Pharmaceuticals	CMIC Co, Ltd. Japan	Completed	12 Years	N/A	All	27	Phase 2	NULL
255	NCT01192399 (ClinicalTrials.gov)	November 2007	30/8/2010	Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients	Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients	Paroxysmal Nocturnal Hemoglobinuria	Biological: Eculizumab	Alexion Pharmaceuticals	NULL	Completed	12 Years	N/A	All	29	Phase 2	NULL
256	NCT00438789 (ClinicalTrials.gov)	February 2007	20/2/2007	The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol		Hemoglobinuria, Paroxysmal	Drug: eculizumab	Alexion Pharmaceuticals	NULL	Approved for marketing	18 Years	N/A	Both		Phase 3	United States
257	EUCTR2005-000043-28-ES (EUCTR)	07/04/2006	21/10/2005	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Germany;United Kingdom;Ireland;Spain;Italy;Sweden
258	NCT00397813 (ClinicalTrials.gov)	January 2006	9/11/2006	Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders	Low-Dose TBI Dose Escalation to Decrease Risks of Progression and Graft Rejection After Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning as Treatment for Untreated Myelodysplastic Syndrome or Myeloproliferative Disorders - A Multi-Center Trial	Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Chronic Myelomonocytic Leukemia;de Novo Myelodysplastic Syndrome;Essential Thrombocythemia;Myeloproliferative Neoplasm;Paroxysmal Nocturnal Hemoglobinuria;Polycythemia Vera;Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase;Primary Myelofibrosis;Refractory Anemia;Refractory Anemia With Excess Blasts;Refractory Anemia With Ring Sideroblasts;Refractory Cytopenia With Multilineage Dysplasia;Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts	Drug: Cyclosporine;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body Irradiation	Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI)	Completed	50 Years	75 Years	All	77	Phase 2	United States;Denmark;Germany;Italy
259	EUCTR2005-000043-28-IT (EUCTR)	01/09/2005	06/02/2007	A Phase III Open label extension study of Eculizumab in patients with transfusion dependent hemolytic paroxysmal nocturnal hemoglobinuria PNH who have participated in Triumph C04-001 , Shepherd C04-002 or X03-001 studies	A Phase III Open label extension study of Eculizumab in patients with transfusion dependent hemolytic paroxysmal nocturnal hemoglobinuria PNH who have participated in Triumph C04-001 , Shepherd C04-002 or X03-001 studies	paroxymal nocturnal hemoglobinuria MedDRA version: 6.1;Level: PT;Classification code 10034042	Product Name: Eculizumab Product Code: h5G1.1-mAb Product Name: Eculizumab Product Code: h5G1.1-mAb	ALEXION PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Germany;United Kingdom;Spain;Ireland;Italy;Sweden
260	NCT00130000 (ClinicalTrials.gov)	August 9, 2005	11/8/2005	Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria	SHEPHERD: Safety in Hemolytic PNH Patients Treated With Eculizumab: A Multi-Center Open-Label Research Design	Paroxysmal Hemoglobinuria, Nocturnal	Drug: Eculizumab	National Heart, Lung, and Blood Institute (NHLBI)	NULL	Completed	18 Years	N/A	All	87	Phase 3	United States
261	NCT00143559 (ClinicalTrials.gov)	August 2005	1/9/2005	Stem Cell Transplantation as Immunotherapy for Hematologic Malignancies	Haploidentical Hematopoietic Stem Cell Transplantation Utilizing Partial T-Cell Depletion as Immunotherapy for Hematologic Malignancies	Leukemia;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Chronic Myeloid Leukemia;Juvenile Myelomonocytic Leukemia;Myelodysplastic Syndrome;Paroxysmal Nocturnal Hemoglobinuria;Hodgkin's Lymphoma;Non-Hodgkin Lymphoma	Drug: Systematic chemotherapy and antibodies;Procedure: Allogeneic stem cell transplantation;Device: Miltenyi CliniMACS	St. Jude Children's Research Hospital	NULL	Completed	2 Years	21 Years	Both	17	Phase 2	United States
262	EUCTR2005-000043-28-DE (EUCTR)	06/07/2005	08/04/2005	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 MedDRA version: 9.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria	Product Name: eculizumab Product Code: L04AA25 INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	United Kingdom;Germany;Spain;Ireland;Italy;Sweden
263	EUCTR2005-000043-28-IE (EUCTR)	27/05/2005	06/04/2005	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Spain;Ireland;Germany;Italy;United Kingdom;Sweden
264	EUCTR2005-000043-28-SE (EUCTR)	24/05/2005	07/04/2005	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 MedDRA version: 9.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Germany;United Kingdom;Spain;Ireland;Italy;Sweden
265	EUCTR2004-002795-42-ES (EUCTR)	24/05/2005	22/02/2006	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	85	Phase 3	Spain;Ireland;Germany;Italy;United Kingdom;Sweden
266	NCT00122317 (ClinicalTrials.gov)	May 2005	20/7/2005	Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)	Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH	Paroxysmal Hemoglobinuria, Nocturnal	Drug: eculizumab	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	All	187	Phase 3	United States;Australia;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
267	EUCTR2004-002795-42-IT (EUCTR)	29/04/2005	06/07/2005	SHEPHERD: Safety in hemolytic PNH patients treated with Eculizumab: a multi-center open label research design study	SHEPHERD: Safety in hemolytic PNH patients treated with Eculizumab: a multi-center open label research design study	paroxysmal nocturnal hemoglobinuria MedDRA version: 6.1;Level: PT;Classification code 10034042	Product Name: Eculizumab	ALEXION PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	85		United Kingdom;Germany;Spain;Ireland;Italy;Sweden
268	EUCTR2004-002795-42-GB (EUCTR)	20/04/2005	23/02/2005	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	85	Phase 3	Spain;Ireland;Germany;Italy;United Kingdom;Sweden
269	EUCTR2005-000043-28-GB (EUCTR)	19/04/2005	16/03/2005	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension	A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	170	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Spain;Ireland;Germany;Italy;United Kingdom;Sweden
270	EUCTR2004-002795-42-DE (EUCTR)	24/03/2005	23/12/2004	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	85		United Kingdom;Germany;Spain;Ireland;Italy;Sweden
271	EUCTR2004-002795-42-SE (EUCTR)	16/02/2005	09/12/2004	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	85		United Kingdom;Germany;Spain;Ireland;Italy;Sweden
272	EUCTR2004-002795-42-IE (EUCTR)	03/02/2005	09/12/2004	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	85	Phase 3	Spain;Ireland;Germany;Italy;United Kingdom;Sweden
273	EUCTR2004-000646-20-GB (EUCTR)	02/12/2004	14/02/2005	A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH	A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	75	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):	Ireland;Italy;United Kingdom;Sweden
274	NCT00122304 (ClinicalTrials.gov)	December 2004	19/7/2005	Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab	Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study	Hemoglobinuria, Paroxysmal	Drug: eculizumab	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	Both	85	Phase 3	United States;Australia;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
275	NCT00098280 (ClinicalTrials.gov)	December 2004	3/12/2004	Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria	A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients	Hemoglobinuria, Paroxysmal	Drug: Eculizumab	National Heart, Lung, and Blood Institute (NHLBI)	NULL	Completed	N/A	N/A	Both	75	Phase 3	United States
276	EUCTR2004-000646-20-IT (EUCTR)	01/11/2004	23/12/2005	TRIUMPH A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients	TRIUMPH A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients	paaroxysmal nocturnal hemoglobinuria MedDRA version: 6.1;Level: PT;Classification code 10034042	Product Name: Eculizumab INN or Proposed INN: VARI	ALEXION PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	75		Ireland;Italy;Sweden
277	NCT00112983 (ClinicalTrials.gov)	November 2004	2/6/2005	Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria	TRIUMPH: A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients	Leukemia	Biological: eculizumab	Jonsson Comprehensive Cancer Center	NULL	Completed	18 Years	N/A	Both		Phase 3	United States
278	EUCTR2004-000646-20-IE (EUCTR)	26/10/2004	16/08/2004	A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH	A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 3	Ireland;Italy;United Kingdom;Sweden
279	NCT00122330 (ClinicalTrials.gov)	October 2004	18/7/2005	Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients	Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients	Hemoglobinuria, Paroxysmal	Drug: eculizumab	Alexion Pharmaceuticals	NULL	Completed	18 Years	N/A	Both	75	Phase 3	United States;Australia;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Sweden;Switzerland;United Kingdom
280	EUCTR2004-000646-20-SE (EUCTR)	21/09/2004	19/07/2004	A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH	A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH	paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042	Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	75		Ireland;Italy;Sweden
281	NCT00145613 (ClinicalTrials.gov)	June 2003	1/9/2005	Haploidentical Stem Cell Transplant for Treatment Refractory Hematological Malignancies	Haploidentical Stem Cell Transplantation Utilizing T-Cell Depletion as Therapy for Patients With Refractory Hematological Malignancies	Acute Lymphoblastic Leukemia (ALL);Acute Myeloid Leukemia (AML);Secondary AML;Myelodysplastic Syndrome (MDS);Secondary MDS;Chronic Myeloid Leukemia;Juvenile Myelomonocytic Leukemia (JMML);Paroxysmal Nocturnal Hemoglobinuria (PNH);Lymphoma, Non-Hodgkin;Hodgkin Disease	Procedure: Stem Cell Transplantation;Device: Miltenyi Biotec CliniMACS;Drug: Systemic chemotherapy and antibodies	St. Jude Children's Research Hospital	NULL	Completed	2 Years	21 Years	Both	25	Phase 2	United States
282	NCT00587054 (ClinicalTrials.gov)	June 2001	21/12/2007	Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders	Phase II Trial of Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Treatment of Adult Patients (>18 Years) With Lymphohematopoietic Disorders	Allogeneic Stem Cell Transplant;Leukemia;Non-Hodgkins;Lymphoblastic Lymphoma;Myelodysplastic Syndrome;Paroxysmal Nocturnal Hemoglobinuria (PNH)	Drug: cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant	Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)	Completed	18 Years	55 Years	All	129	Phase 2	United States
283	NCT00012376 (ClinicalTrials.gov)	March 2001	3/3/2001	Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer	Dose Finding Study of Bryostatin-1 and GM-CSF in Refractory Myeloid Malignancies	Accelerated Phase Chronic Myelogenous Leukemia;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Blastic Phase Chronic Myelogenous Leukemia;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Paroxysmal Nocturnal Hemoglobinuria;Previously Treated Myelodysplastic Syndromes;Recurrent Adult Acute Myeloid Leukemia;Refractory Anemia;Refractory Anemia With Ringed Sideroblasts;Relapsing Chronic Myelogenous Leukemia;Thrombocytopenia;Untreated Adult Acute Myeloid Leukemia	Drug: bryostatin 1;Biological: sargramostim;Other: laboratory biomarker analysis;Other: pharmacological study	National Cancer Institute (NCI)	NULL	Completed	18 Years	N/A	Both	35	Phase 1	United States
284	NCT00004143 (ClinicalTrials.gov)	September 1999	10/12/1999	Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes	Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro Campath for Hemoglobinopathies and Bone Marrow Failure Syndromes	Sickle Cell Anemia;Severe Aplastic Anemia;Paroxysmal Nocturnal Hemoglobinuria (PNH);Pure Red Cell Aplasia	Drug: Campath, Chemo and/or TBI Allo SCT	David Rizzieri, MD	NULL	Completed	18 Years	N/A	All	2	Phase 2	United States
285	NCT00004464 (ClinicalTrials.gov)	February 1996	18/10/1999	Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria	High Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria	Aplastic Anemia;Paroxysmal Hemoglobinuria, Nocturnal	Drug: cyclophosphamide;Drug: filgrastim	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	NULL	Completed	N/A	70 Years	All	69	Phase 2	United States
286	EUCTR2020-000597-26-SE (EUCTR)		02/06/2020	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: Crovalimab Product Code: RO7112689/F03-01 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F.Hoffmann-La Roche Ltd	NULL	NA			Female: yes Male: yes	250	Phase 3	United States;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Romania;Germany;Japan;Sweden
287	EUCTR2019-001106-23-DE (EUCTR)		30/09/2019	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).	An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Aspaveli Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: pegcetacoplan Other descriptive name: Pegcetacoplan (APL-2)	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 3	United States;Serbia;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Malaysia;Australia;Bulgaria;Germany;Japan;Korea, Republic of
288	EUCTR2009-010402-11-Outside-EU/EEA (EUCTR)		30/04/2012	Not Applicable	AN OPEN-LABEL MULTI-CENTER STUDY OF ECULIZUMAB IN CHILDREN AND ADOLESCENTS WITH A DIAGNOSIS OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA	PAROXYSMAL NOCTURNAL HEMOGLOBINURIA MedDRA version: 14.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB Other descriptive name: Anti-C5 antibody	ALEXION PHARMACEUTICALS, INC.	NULL	NA			Female: yes Male: yes	6		United States
289	EUCTR2020-001350-21-CZ (EUCTR)		08/12/2020	A single arm study to evaluate the safety and biological activity of pegcetacoplan in patients 12- 17 years old with paroxysmal nocturnal hemoglobinuria	An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients with Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: pegcetacoplan Product Code: pegcetacoplan INN or Proposed INN: Pegcetacoplan Other descriptive name: pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	NA			Female: yes Male: yes	12	Phase 2	Serbia;United States;Czechia;Spain;Thailand;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;Germany;Netherlands
290	EUCTR2019-004931-21-IE (EUCTR)		13/01/2021	A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors	A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Product Name: Crovalimab Product Code: RO7112689/F03-10 INN or Proposed INN: CROVALIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden
291	EUCTR2020-001350-21-NL (EUCTR)		11/07/2022	A single arm study to evaluate the safety and biological activity of pegcetacoplan in patients 12- 17 years old with paroxysmal nocturnal hemoglobinuria	An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients with Paroxysmal Nocturnal Hemoglobinuria	Paroxysmal Nocturnal Hemoglobinuria MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Aspaveli Product Name: pegcetacoplan Product Code: pegcetacoplan INN or Proposed INN: Pegcetacoplan Other descriptive name: pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	NA			Female: yes Male: yes	12	Phase 2	Serbia;United States;Czechia;Thailand;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;Netherlands;Germany
292	EUCTR2017-002820-26-FR (EUCTR)		12/01/2018	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)	A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)	Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ALXN1210 INN or Proposed INN: ALXN1210 Other descriptive name: ALXN1210	Alexion Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	12	Phase 3	United States;France;Netherlands

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86. 肺動脈性肺高血圧症

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臨床試験数 : 1,205 /  薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05660863 (ClinicalTrials.gov)	June 1, 2023	1/12/2022	A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets	A Bridged Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Dose of MN-08 in Healthy Subjects	Pulmonary Arterial Hypertension	Drug: MN-08 24 mg/day;Drug: MN-08 60 mg/day	Guangzhou Magpie Pharmaceuticals Co., Ltd.	NULL	Not yet recruiting	18 Years	45 Years	All	16	Phase 1	NULL
2	NCT05764265 (ClinicalTrials.gov)	March 27, 2023	10/1/2023	Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants	An Open-label Extension Study to Investigate Efficacy, Safety and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: LTP001	Novartis Pharmaceuticals	NULL	Not yet recruiting	18 Years	75 Years	All	40	Phase 2	NULL
3	NCT04778046 (ClinicalTrials.gov)	February 15, 2023	26/2/2021	Pulmonary Hypertension SOLAR	Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH	Interstitial Lung Disease;COPD;Pulmonary Arterial Hypertension	Drug: Hyperpolarized 129Xe	Bastiaan Driehuys	NULL	Recruiting	18 Years	N/A	All	30	Phase 2	United States
4	NCT05179356 (ClinicalTrials.gov)	January 1, 2023	16/12/2021	Dapagliflozin in Pulmonary Arterial Hypertension	Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial)	Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension	Drug: Dapagliflozin 10 MG [Farxiga];Drug: Placebo	Mads Ersbøll	NULL	Not yet recruiting	18 Years	N/A	All	52	Phase 2	NULL
5	EUCTR2022-000478-25-ES (EUCTR)	23/12/2022	13/10/2022	Sotatercept in Children with Pulmonary Artery Hypertension on Standard of Care	A Phase 2 Open-label Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care - Sotatercept in Children with PAH on SoC	Pulmonary arterial hypertension MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Sotatercept Product Code: MK-7962 INN or Proposed INN: Sotatercept	Merck Sharp & Dohme LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	42	Phase 2	United States;Spain;Turkey;Israel;Colombia;United Kingdom;France;Mexico;Poland;Australia;South Africa;Netherlands;Germany
6	EUCTR2021-001910-13-NL (EUCTR)	08/12/2022	16/02/2022	Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH.	IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT	Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available	Aerovate Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 2;Phase 3	United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden
7	NCT05167825 (ClinicalTrials.gov)	November 14, 2022	24/11/2021	A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension	A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 Months to <15 Years) With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Macitentan	Janssen Pharmaceutical K.K.	NULL	Recruiting	3 Months	15 Years	All	6	Phase 3	Japan
8	NCT05557942 (ClinicalTrials.gov)	November 2, 2022	15/9/2022	Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)	A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL)	Pulmonary Arterial Hypertension	Drug: AV-101	Aerovate Therapeutics	NULL	Recruiting	18 Years	75 Years	All	462	Phase 3	United States;Australia
9	NCT04915300 (ClinicalTrials.gov)	October 2022	19/5/2021	Apabetalone for Pulmonary Arterial Hypertension	Apabetalone for Pulmonary Arterial Hypertension: a Phase 2 Clinical Study	Pulmonary Arterial Hypertension	Drug: Apabetalone;Drug: Placebo	Laval University	Canadian Institutes of Health Research (CIHR);Resverlogix Corp	Not yet recruiting	18 Years	75 Years	All	72	Phase 2	Canada
10	NCT05135000 (ClinicalTrials.gov)	June 30, 2022	16/11/2021	Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension	A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Investigate Efficacy, Safety, and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: LTP001;Drug: Placebo	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	75 Years	All	44	Phase 2	Argentina;Germany;Netherlands;Poland;Spain;United Kingdom
11	JPRN-jRCT2051220042	07/06/2022	09/06/2022	Clinical trial of Nitric Oxide inhalation therapy in patients with severe PH	A Single-Center, Randomised, Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide therapy in the patients with severe right heart failure due to pulmonary hypertension	Pulmonary arterial hypertension (PAH), and Chronic thromboembolic pulmonary hypertension (CTEPH) PH, Nitric oxide, PAH, CTEPH, Right heart failure;D006976	Study drug: Nitric Oxide (INOflo for inhalation 800ppm) Start inhalation at a concentration of 20 ppm, and if the blood methemoglobin concentration is below 2%, increase the dose by 10 ppm every 5 minutes to a maximum concentration of 40 ppm. On withdrawal from inhalation, if hemodynamics and oxygenation are stable, reduce inhalation dose by half every 5 minutes, gradually decreasing to 5 ppm. And then, If hemodynamics and oxygenation are stable at 1 ppm, attempt inhalation withdrawal every 5 minutes.	Ogo Takeshi	NULL	Pending	>= 18age old	Not applicable	Both	30	Phase 2	Japan
12	EUCTR2021-001910-13-ES (EUCTR)	28/04/2022	25/01/2022	Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH.	IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT	Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available	Aerovate Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 2;Phase 3	United States;Portugal;Greece;Spain;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden
13	EUCTR2021-000670-28-DE (EUCTR)	19/04/2022	15/11/2021	Study of efficacy and safety of LTP001 in pulmonary arterial hypertension participants	A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: LTP001 Product Code: LTP001 INN or Proposed INN: not available Other descriptive name: LTP001 Product Name: LTP001 Product Code: LTP001 INN or Proposed INN: not available Other descriptive name: LTP001	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	44	Phase 2	United States;Argentina;Spain;Poland;Russian Federation;Netherlands;Germany;United Kingdom
14	EUCTR2021-001633-40-DE (EUCTR)	07/03/2022	06/12/2021	Clinical trial investigating the effect of riociguat among patients with slightly elevated blood pressure in lung vessels	Efficacy and safety of riociguat (MK-4836) in incipient pulmonary vascular disease as an indicator for early pulmonary arterial Hypertension Doubleblind, randomized, multicentre, multinational, placebo-controlled phase IIastudyESRA - ESRA	early pulmonary vascular disease, defined as either a) mean pulmonary arterial pressure (mPAP) =25 mmHg with pulmonary vascular resistance (PVR) =2 to <3 WU and pulmonary arterial wedge pressure (PAWP) =15 mmHg or b) mPAP 21-<25 mmHg with PVR =2 WU, and PAWP =15 mmHg associated with connective tissue disease (CTD) or as idiopathic/heritable form. MedDRA version: 20.0;Level: HLT;Classification code 10037455;Term: Pulmonary vascular disorders NEC;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521	Thoraxklinik Heidelberg gGmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 2	France;Austria;Norway;Germany;United Kingdom;Switzerland;Italy
15	EUCTR2021-001910-13-FR (EUCTR)	21/02/2022	23/12/2021	Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH.	IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT	Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available Product Name: AV-101 INN or Proposed INN: IMATINIB Other descriptive name: Not Available	Aerovate Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 2;Phase 3	United States;Portugal;Greece;Spain;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden
16	NCT05185011 (ClinicalTrials.gov)	December 16, 2021	22/12/2021	Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function	A Phase I Clinical Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild Liver Insufficiency, Moderate Liver Insufficiency and Normal Liver Function	Erectile Dysfunction;Pulmonary Arterial Hypertension	Drug: TPN171H	Vigonvita Life Sciences	Shanghai Institute of Materia Medica, Chinese Academy of Sciences	Completed	18 Years	65 Years	All	24	Phase 1	China
17	EUCTR2021-004002-21-AT (EUCTR)	26/11/2021	06/09/2021	A non-randomized, single-center, open, two-period study with paired design to compare measured steady-state treprostinil concentrations in human plasma under treatment with a 10 mg/ml treprostinil formulation and following a switch to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH)	A single center, open-label, two-period, non-randomized, paired-design study to compare steady-state plasma levels following switch from a 10 mg/ml treprostinil formulation to a 20 mg/ml treprostinil formulation in patients with pulmonary arterial hypertension (PAH)	pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: 20 mg/ml Treprostinil INN or Proposed INN: treprostinil sodium Other descriptive name: TREPROSTINIL SODIUM Trade Name: Trisuva(r) Product Name: Trisuva(r) INN or Proposed INN: treprostinil sodium Other descriptive name: TREPROSTINIL SODIUM	AOP Orphan Pharmaceuticals GmbH	NULL	Not Recruiting			Female: yes Male: yes	16	Phase 2	Austria
18	EUCTR2019-002533-11-BG (EUCTR)	08/11/2021	02/09/2021	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;Japan;Sweden
19	NCT04884971 (ClinicalTrials.gov)	November 3, 2021	7/5/2021	Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study	Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study	Pulmonary Arterial Hypertension	Drug: Intestinal microbiota transplant (IMT)	University of Minnesota	NULL	Recruiting	18 Years	75 Years	All	12	Phase 1	United States
20	NCT05039086 (ClinicalTrials.gov)	September 1, 2021	1/9/2021	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5 Inhibitors vs Endothelin Receptor Antagonist	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- PDE5 Inhibitors vs Endothelin Receptor Antagonist	Pulmonary Arterial Hypertension	Drug: PDE5 inhibitor;Drug: Endothelin Receptor Antagonists	Brigham and Women's Hospital	National Institute on Aging (NIA);Rutgers University;Johns Hopkins University	Active, not recruiting	65 Years	N/A	All	12947		United States
21	EUCTR2017-003934-10-PL (EUCTR)	23/06/2021	26/07/2019	A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary hypertension and who were previously treated with macitentan in clinical studies.	mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA	Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 3	France;Belarus;Belgium;Poland;Ukraine;Turkey;Russian Federation;Germany
22	JPRN-jRCT2061200058	23/06/2021	19/02/2021	Outcome Study Assessing a 75 milligrams (mg) Dose of Macitentan in Patients with Pulmonary Arterial Hypertension	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS	Pulmonary Arterial Hypertension	Macitentan 10 mg: Participants will receive macitentan 10 mg film-coated tablets orally. Macitentan 37.5 mg: Participants will receive macitentan 37.5 mg film-coated tablets orally. Macitentan 75 mg: Participants will receive macitentan 75 mg film-coated tablets orally. Placebo: Participants will receive matching placebo film-coated tablets orally.	Nakano Masayoshi	NULL	Recruiting	>= 18age old	Not applicable	Both	900	Phase 3	Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Korea, Republic Of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Japan
23	EUCTR2020-004142-11-DE (EUCTR)	12/05/2021	19/01/2021	A Phase 3 Study of Sotatercept for the Treatment of PAH	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH	Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc	Acceleron Pharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	284	Phase 3	Argentina;United States;Czechia;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Sweden;Netherlands;Czech Republic;Belgium;Ireland;Brazil;Korea, Republic of;Poland;Mexico;Italy;Israel;Australia;France;Serbia;Germany
24	EUCTR2019-001598-10-AT (EUCTR)	29/04/2021	23/01/2020	Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension	A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension	Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera	PhaseBio Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
25	EUCTR2019-002669-37-CZ (EUCTR)	21/01/2021	22/10/2020	Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: Seralutinib Other descriptive name: (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM	GB002, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Austria;Israel;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Serbia;Czechia;Spain;United States
26	EUCTR2019-002533-11-SK (EUCTR)	12/11/2020	13/08/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;Japan;Sweden
27	EUCTR2019-002533-11-AT (EUCTR)	12/11/2020	04/09/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
28	NCT04084678 (ClinicalTrials.gov)	October 29, 2020	6/9/2019	A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy	PAH;Pulmonary Hypertension;Hypertension;Connective Tissue Disease;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease;Pulmonary Arterial Hypertension	Drug: Ralinepag;Drug: Placebo	United Therapeutics	NULL	Active, not recruiting	18 Years	N/A	All	10	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Germany;Italy;Poland;Spain
29	EUCTR2019-002533-11-NO (EUCTR)	29/10/2020	03/08/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Norway;Germany;Japan;Sweden
30	NCT04567602 (ClinicalTrials.gov)	October 6, 2020	23/9/2020	A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag	Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)	Pulmonary Arterial Hypertension	Drug: PAH medication	Janssen-Cilag S.p.A.	NULL	Active, not recruiting	18 Years	N/A	All	186		Italy
31	EUCTR2019-002533-11-NL (EUCTR)	29/09/2020	29/04/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	655	Phase 3	United States;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Japan;Sweden
32	EUCTR2020-002788-80-DE (EUCTR)	09/09/2020	08/06/2020	Study to evaluate the safety, tolerability and efficacy of AZD4831 in thetreatment of patients with pulmonary hypertension	An explorative study to assess the safety, tolerability, and efficacy of AZD4831 in the treatment of pulmonary arterial hypertension (PAH)(MPO-PAH)	Group 1: Pulmonary arterial hypertension (PAH)Group 2: Postcapillary pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AZD4831	University of Cologne	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 2	Germany
33	EUCTR2019-002533-11-PT (EUCTR)	31/08/2020	11/05/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Belarus;Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden
34	NCT04273945 (ClinicalTrials.gov)	June 30, 2020	31/1/2020	Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg	Pulmonary Arterial Hypertension	Drug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: Placebo	Actelion	NULL	Recruiting	18 Years	N/A	All	900	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Romania
35	EUCTR2019-002533-11-GB (EUCTR)	30/06/2020	16/03/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
36	EUCTR2019-002533-11-DE (EUCTR)	17/06/2020	14/02/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Bulgaria;Norway;Germany;Japan;Sweden
37	EUCTR2019-002533-11-DK (EUCTR)	27/05/2020	31/03/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;Japan;Sweden
38	EUCTR2019-001598-10-PL (EUCTR)	26/05/2020	13/02/2020	Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension	A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension	Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera	PhaseBio Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Serbia;United States;Czechia;Greece;Spain;Austria;Italy;Hungary;Poland;Belgium;Romania;Bulgaria;Germany
39	EUCTR2019-002533-11-CZ (EUCTR)	07/05/2020	11/03/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
40	EUCTR2019-002533-11-SE (EUCTR)	06/05/2020	13/03/2020	A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmacteuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Bulgaria;Norway;Germany;Japan;Sweden
41	EUCTR2019-002533-11-IT (EUCTR)	15/04/2020	15/06/2021	A Randomized Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period with Macitentan 75 mg.	A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan tablets Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN Product Name: macitentan tablets Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN	ACTELION PHARMACEUTICALS LTD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden
42	NCT04309838 (ClinicalTrials.gov)	March 2020	20/2/2020	Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension	LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;PAH	Combination Product: Treprostinil via implanted pump	University Medicine Greifswald	OMT GmbH & Co. KG	Not yet recruiting	18 Years	N/A	All	30		Germany
43	EUCTR2019-001598-10-ES (EUCTR)	28/02/2020	20/12/2019	Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension	A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension	Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera	PhaseBio Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
44	EUCTR2019-001598-10-GR (EUCTR)	28/02/2020	13/12/2019	Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension	A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension	Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera	PhaseBio Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
45	EUCTR2019-001598-10-BG (EUCTR)	12/02/2020	09/01/2020	Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension	A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension	Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera	PhaseBio Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
46	EUCTR2019-001598-10-HU (EUCTR)	24/01/2020	10/12/2019	Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial Hypertension	A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension	Symptomatic Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Vasomera (PB1046) Injection Product Code: PB1046 INN or Proposed INN: not available Other descriptive name: PB1046, VIP-ELP1-120, Vasomera	PhaseBio Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	Serbia;United States;Greece;Spain;Austria;Italy;Hungary;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany
47	EUCTR2019-002817-21-ES (EUCTR)	07/01/2020	11/11/2019	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	237	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;Belarus;United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
48	EUCTR2019-002414-40-GB (EUCTR)	17/12/2019	24/10/2019	An extension study, at multiple study sites, for patients with Pulmonary Arterial Hypertension who took part in study CXA-10-301, to look at the continuing safety of CXA-10 and how well it works long term: all patients will receive CXA-10 treatment.	A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301. - Open label extension of CXA-10 in Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension (PAH). MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: CXA-10 Product Code: CXA-10 INN or Proposed INN: 10-nitro-9(E)-octadec-9-enoic acid	Complexa Inc.	NULL	Not Recruiting			Female: yes Male: yes	115	Phase 2	United States;United Kingdom
49	NCT03782818 (ClinicalTrials.gov)	November 20, 2019	17/12/2018	Olaparib for PAH: a Multicenter Clinical Trial	Olaparib for Pulmonary Arterial Hypertension: a Multicenter Clinical Trial	Pulmonary Arterial Hypertension	Drug: Olaparib	Laval University	Canadian Institutes of Health Research (CIHR);AstraZeneca	Recruiting	18 Years	75 Years	All	20	Phase 1/Phase 2	Canada
50	NCT03884465 (ClinicalTrials.gov)	November 11, 2019	4/3/2019	Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil	A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects	Pulmonary Arterial Hypertension	Drug: Inhaled dry powder treprostinil (LIQ861)	Liquidia Technologies, Inc.	FGK Clinical Research GmbH	Recruiting	18 Years	N/A	All	32	Phase 2	France;Germany
51	EUCTR2018-002448-10-DE (EUCTR)	08/11/2019	17/08/2018	Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.	An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH	Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058	Bial - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Portugal;France;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy
52	NCT03950739 (ClinicalTrials.gov)	September 17, 2019	9/5/2019	Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso	An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso	Pulmonary Arterial Hypertension	Drug: Treprostinil Inhalation Powder	United Therapeutics	NULL	Active, not recruiting	18 Years	N/A	All	51	Phase 1	United States
53	EUCTR2019-001699-12-GB (EUCTR)	27/08/2019	30/07/2019	Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participants	An open-label, randomized three period cross-over relative bioavailability study to compare the pharmacokinetic parameters of a lower dose formulation of ambrisentan (GSK1325760) with marketed ambrisentan in healthy adult participants	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ambrisentan Tablet Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid Trade Name: Volibris Product Name: Ambrisentan 5mg film-coated tablets [marketed product] INN or Proposed INN: AMBRISENTAN Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid	GlaxoSmithKline Research and Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 1	United Kingdom
54	EUCTR2018-003093-27-GB (EUCTR)	16/08/2019	12/06/2019	Clinical Study of Inhaled GB002 for the Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH)	A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH) - GB002 in Adult Subjects with PAH	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: GB002 Capsules Product Code: GB002 INN or Proposed INN: GB002	GB002, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	16	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Denmark;Netherlands;United Kingdom;Sweden
55	EUCTR2018-002796-18-PT (EUCTR)	30/07/2019	30/10/2018	To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.	An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058	Bial - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Portugal;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy
56	NCT03904693 (ClinicalTrials.gov)	July 29, 2019	4/4/2019	Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)	Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy	Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)	Drug: FDC macitentan/tadalafil;Drug: Macitentan 10 mg;Drug: Tadalafil 40 mg;Drug: Placebo FDC;Drug: Placebo macitentan;Drug: Placebo tadalafil	Actelion	NULL	Active, not recruiting	18 Years	N/A	All	187	Phase 3	United States;Australia;Brazil;Bulgaria;Canada;China;Czechia;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;South Africa;Spain;Taiwan;Turkey
57	NCT03992755 (ClinicalTrials.gov)	July 18, 2019	5/6/2019	Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil	A Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients	Primary Pulmonary Hypertension	Drug: LIQ861 Inhaled Treprostinil	Liquidia Technologies, Inc.	Nuventra, Inc.	Active, not recruiting	18 Years	N/A	All	92	Phase 3	United States
58	EUCTR2016-001062-28-FI (EUCTR)	03/07/2019	03/07/2019	A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)	A multicenter, open-label, randomized, study with single-arm extension period to assess the pharmacokinetics, safety and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN	ACTELION Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Israel;Russian Federation;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of
59	EUCTR2018-001187-33-HR (EUCTR)	20/05/2019	05/06/2019	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	700	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
60	EUCTR2016-001067-36-PL (EUCTR)	08/05/2019	18/02/2019	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
61	EUCTR2018-001187-33-GR (EUCTR)	03/04/2019	20/03/2019	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A Study Evaluating the Efficacy and Safety of Ralinepag to ImproveTreatment Outcomes in PAH Patients - ADVANCE-Outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
62	JPRN-UMIN000035389	2019/04/01	01/04/2019	Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension	Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH study	Pulmonary arterial hypertension	Dose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month	Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science	NULL	Recruiting	20years-old	Not applicable	Male and Female	76	Not selected	Japan
63	NCT03522935 (ClinicalTrials.gov)	March 18, 2019	1/2/2018	Subcutaneous Elafin in Healthy Subjects	Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects	Pulmonary Arterial Hypertension	Drug: Elafin;Drug: Placebo	Roham T. Zamanian	Duke University;SRI International	Completed	18 Years	55 Years	All	30	Phase 1	United States
64	EUCTR2018-001189-40-FR (EUCTR)	15/02/2019	16/11/2018	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden
65	EUCTR2018-001189-40-SE (EUCTR)	11/02/2019	19/11/2018	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden
66	EUCTR2018-002448-10-GB (EUCTR)	11/02/2019	19/06/2019	Multi centre study to assess the safety, effective and movement of Zamicastat within the body when given to a patient with pulmonary arterial hypertension as an additional medication.	An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmcokinetics, safety and efficacy of BIA-5-1058 in PAH	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Zamicastat Product Code: BIA 5-1058	Bial - Portela & Ca, S.A	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	Portugal;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom
67	EUCTR2018-001187-33-SE (EUCTR)	05/02/2019	29/10/2018	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
68	EUCTR2018-003414-40-DE (EUCTR)	31/01/2019	06/11/2018	A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension Patients	A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects	Pulmonary Arterial Hypertension (WHO Group 1) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: LIQ861 26.5 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 53 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 79.5 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 106 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: Nitric Oxide INN or Proposed INN: NITRIC OXIDE	Liquidia Technologies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	France;Germany
69	EUCTR2018-003414-40-FR (EUCTR)	21/01/2019	06/11/2018	A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension Patients	A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects	Pulmonary Arterial Hypertension (WHO Group 1) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: LIQ861 25 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 50 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 75 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM Product Name: LIQ861 100 µg INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM	Liquidia Technologies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	France;Germany
70	NCT03754660 (ClinicalTrials.gov)	January 21, 2019	23/11/2018	This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)	A Non-randomized Two Part Multi-center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel-group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592	Hypertension, Pulmonary	Drug: BAY1237592	Bayer	NULL	Completed	18 Years	80 Years	All	38	Phase 1	Austria;Czechia;Germany;Poland
71	EUCTR2018-002796-18-ES (EUCTR)	17/01/2019	16/11/2018	To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.	An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058	Bial - Portela & Ca, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Portugal;Spain;Ukraine;Austria;United Kingdom
72	EUCTR2017-004738-27-BE (EUCTR)	04/01/2019	31/08/2018	A Phase 2 Study of Sotatercept for the Treatment of PAH	A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc	Acceleron Pharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Brazil;Spain;Belgium;Australia;Israel;Germany;United Kingdom
73	EUCTR2018-002796-18-AT (EUCTR)	20/12/2018	06/11/2018	To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.	An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Zamicastat Product Code: BIA-5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058	Bial - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
74	EUCTR2018-002448-10-PT (EUCTR)	26/11/2018	04/09/2018	Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.	An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058	Bial - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Portugal;Spain;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom;Italy
75	NCT04041648 (ClinicalTrials.gov)	November 9, 2018	23/7/2019	Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606	A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of L606 for Inhalation in Healthy Subjects	Pulmonary Arterial Hypertension	Drug: L606 (Liposomal Treprostinil) Inhalation Solution 51ug;Device: L606 Inhalation System;Other: Placebo Solution	Pharmosa Biopharm Inc.	PPD	Recruiting	18 Years	50 Years	All	64	Phase 1	United States
76	EUCTR2018-002448-10-AT (EUCTR)	31/10/2018	08/08/2018	Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.	An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH	Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Zamicastat Product Code: BIA 5-1058 INN or Proposed INN: ZAMICASTAT Other descriptive name: BIA 5-1058	Bial - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
77	EUCTR2017-004738-27-GB (EUCTR)	18/10/2018	24/06/2019	A Phase 2 Study of Sotatercept for the Treatment of PAH	A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc	Acceleron Pharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
78	EUCTR2013-004362-34-LV (EUCTR)	03/10/2018	02/07/2018	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3;Phase 4	United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden
79	EUCTR2017-000216-42-FR (EUCTR)	27/09/2018	23/07/2018	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;Sweden
80	EUCTR2017-004738-27-ES (EUCTR)	04/09/2018	05/09/2018	A Phase 2 Study of Sotatercept for the Treatment of PAH	A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc	Acceleron Pharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United States;France;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
81	EUCTR2015-005223-90-BE (EUCTR)	16/08/2018	24/05/2016	This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.	A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
82	EUCTR2017-004738-27-DE (EUCTR)	15/08/2018	03/08/2018	A Phase 2 Study of Sotatercept for the Treatment of PAH	A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Sotatercept Product Code: ACE-011 INN or Proposed INN: SOTATERCEPT Other descriptive name: ActRIIA-IgG1Fc	Acceleron Pharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;France;Spain;Brazil;Belgium;Australia;Israel;Germany;United Kingdom
83	NCT03492177 (ClinicalTrials.gov)	July 23, 2018	3/4/2018	A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension	A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: selexipag (Uptravi)	Actelion	NULL	Active, not recruiting	2 Years	17 Years	All	63	Phase 2	United States;Belarus;Belgium;Canada;China;France;Germany;Hungary;Israel;Malaysia;Poland;Russian Federation;Serbia;Taiwan;Ukraine;United Kingdom;Romania
84	EUCTR2015-003438-28-GB (EUCTR)	21/06/2018	13/11/2017	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
85	EUCTR2017-000216-42-PT (EUCTR)	14/05/2018	03/11/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
86	EUCTR2017-003934-10-FR (EUCTR)	19/03/2018	19/01/2018	A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies.	mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	94	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France
87	NCT03464864 (ClinicalTrials.gov)	March 9, 2018	1/3/2018	Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers	A Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal Volunteers	Pulmonary Arterial Hypertension	Drug: Treprostinil Inhalation Powder	Mannkind Corporation	NULL	Completed	18 Years	55 Years	All	36	Phase 1	United States
88	NCT02939599 (ClinicalTrials.gov)	February 1, 2018	12/10/2016	Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients	Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension	Drug: QCC374	Novartis Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	5	Phase 2	United States;Germany;United Kingdom
89	EUCTR2015-003438-28-ES (EUCTR)	19/01/2018	01/12/2017	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
90	EUCTR2016-001411-20-GB (EUCTR)	12/01/2018	09/01/2017	Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients	Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	38	Phase 2	United States;Taiwan;Germany;United Kingdom;Korea, Republic of
91	EUCTR2017-000137-31-NL (EUCTR)	19/12/2017	19/07/2017	Treatment of Pulmonary Hypertension with 6 Mercaptopurine	Pulmonary Hypertension REversal in Clusters of Patients With Identical Pathobiological Substrates. 6-Mercaptopurine Proof-of-Concept Trial - PRECISE-MP	Pulmonary arterial hypertension MedDRA version: 20.0;Level: HLGT;Classification code 10037454;Term: Pulmonary vascular disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Trade Name: Puri-Nethol	VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Netherlands
92	NCT03364244 (ClinicalTrials.gov)	November 30, 2017	30/11/2017	Revatio Special Investigation for Long-term Use in Pediatric Patients	Revatio Special Investigation - Investigation for Long-Term Use of Revatio in Pediatric Patients	Pulmonary Arterial Hypertension	Drug: Sildenafil	Viatris Pharmaceuticals Japan Inc	NULL	Completed	0 Years	14 Years	All	1023		Japan
93	EUCTR2017-000216-42-DE (EUCTR)	30/11/2017	26/05/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
94	NCT03078907 (ClinicalTrials.gov)	November 8, 2017	6/3/2017	Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.	A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts	Pulmonary Arterial Hypertension	Drug: Selexipag;Drug: Placebo	Actelion	NULL	Completed	18 Years	75 Years	All	108	Phase 4	United States;Austria;France;Germany;Ireland;Norway;Portugal;Sweden;Switzerland;United Kingdom
95	EUCTR2017-000216-42-SE (EUCTR)	24/10/2017	16/05/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
96	EUCTR2016-001411-20-DE (EUCTR)	17/10/2017	07/08/2017	Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients	Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	38	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Taiwan;Germany;United Kingdom;Korea, Republic of
97	NCT03145298 (ClinicalTrials.gov)	October 1, 2017	2/5/2017	ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy	A Phase I Study of the Safety and Feasibility of Central Intravenous Delivery of Allogeneic Human Cardiosphere-Derived Stem Cells in Patients With Pulmonary Arterial Hypertension ALPHA Trial	Pulmonary Arterial Hypertension (PAH)	Biological: Allogeneic Human Cardiosphere-Derived Stem Cells;Biological: Placebo	Cedars-Sinai Medical Center	California Institute for Regenerative Medicine (CIRM)	Active, not recruiting	18 Years	75 Years	All	26	Phase 1	United States
98	NCT03001414 (ClinicalTrials.gov)	September 28, 2017	15/12/2016	Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCs	A Multicentre, Late Phase Clinical Trial to Establish the Efficacy and Safety of Repeat Dosing of Autologous Endothelial Progenitor Cells (EPCs) Transfected With Human Endothelial NO-synthase (eNOS) in Patients With Pulmonary Arterial Hypertension (PAH) on Top of Conventional Treatments	Hypertension,Pulmonary	Biological: Placebo followed by Autologous EPCs transfected with human eNOS;Biological: Autologous EPCs transfected with human eNOS followed by Placebo;Biological: Autologous EPCs transfected with human eNOS	Northern Therapeutics	Ottawa Hospital Research Institute	Active, not recruiting	18 Years	80 Years	All	12	Phase 2/Phase 3	Canada
99	NCT02927366 (ClinicalTrials.gov)	September 19, 2017	5/10/2016	Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients	A Randomized, Parallel-group, Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: QCC374;Drug: Placebo Matching	Novartis Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	8	Phase 2	United States;Germany;Korea, Republic of;United Kingdom;Taiwan
100	EUCTR2017-000216-42-IE (EUCTR)	12/09/2017	05/05/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
101	EUCTR2017-000212-41-DE (EUCTR)	01/09/2017	27/06/2017	Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH)	An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: GSK2586881 Product Code: GSK2586881 INN or Proposed INN: GSK2586881 Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	United States;Germany;Spain
102	EUCTR2017-000216-42-AT (EUCTR)	29/08/2017	09/06/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
103	EUCTR2015-005223-90-HR (EUCTR)	23/08/2017	12/09/2017	This is a multicenter, double-blind, randomized, placebo-controlled,parallel-group study to investigate the efficacy, tolerability and safety ofpulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longerfor 18 weeks in symptomatic subjects with pulmonary arterialhypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.	A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED,CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
104	EUCTR2017-000212-41-ES (EUCTR)	10/08/2017	22/06/2017	Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH).	An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension. - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: GSK2586881 Product Code: GSK2586881 INN or Proposed INN: GSK2586881 Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01	GlaxoSmithKline, S.A.	NULL	Not Recruiting			Female: yes Male: yes	24	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;Germany
105	EUCTR2016-001412-38-DE (EUCTR)	27/07/2017	03/04/2017	Safety, pharmacokinetics and efficacy study of QCC374 in PAH patients	A randomized, parallel-group, placebo-controlled subject and investigator blinded study to assess the safety, tolerability, pharmacokinetics and efficacy of QCC374 in the treatment of pulmonary arterial hypertension	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QCC374 0.015 mg INN or Proposed INN: TBD Product Code: QCC374 0.06 mg INN or Proposed INN: TBD	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	38	Phase 2	United States;Taiwan;Germany;United Kingdom;Korea, Republic of
106	NCT03045029 (ClinicalTrials.gov)	July 18, 2017	2/2/2017	ADAPT - A Patient Registry of the Real-world Use of Orenitram®	ADAPT - A Patient Registry of the Real-world Use of Orenitram®	Pulmonary Arterial Hypertension	Drug: Oral treprostinil	United Therapeutics	NULL	Active, not recruiting	18 Years	N/A	All	300		United States
107	EUCTR2017-000216-42-GB (EUCTR)	11/07/2017	05/05/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden
108	JPRN-UMIN000027284	2017/07/01	01/07/2017	The effect of iloprost on pulmonary hypertension and exercuse capacity	The effect of iloprost on pulmonary hypertension and exercuse capacity - Iloprost for Pulmonary Hypertension	Pulmonary arterial hypertension	inhale of iloprost	The University of Tokushima Graduate School of Health Biosciences	NULL	Pending	20years-old	90years-old	Male and Female	20	Not selected	Japan
109	EUCTR2014-003952-29-BE (EUCTR)	07/06/2017	03/01/2017	Riociguat for treatment of PAH in children from 6 to less than 18 years old	Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
110	EUCTR2016-004035-21-DE (EUCTR)	23/05/2017	14/02/2017	A study to evaluate whether it is safe for patients with pulmonary arterial hypertension to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag)	A multicenter, open-label, single-sequence cross-over study to assess safety, tolerability, and pharmacokinetics of intravenous selexipag in subjects with stable pulmonary arterial hypertension switching from an oral stable dose of selexipag	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Germany
111	EUCTR2016-001067-36-DE (EUCTR)	22/03/2017	10/11/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
112	EUCTR2016-001067-36-DK (EUCTR)	15/03/2017	23/12/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
113	JPRN-JapicCTI-132356	08/3/2017	22/11/2013	H6D-MC-LVHV	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Hypertension, Pulmonary	Intervention name : Tadalafil INN of the intervention : - Dosage And administration of the intervention : Tadalafil doses may range from 5 mg to 40 mg depending on body weight cohorts. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Tadalafil doses may range from 5 mg to 40 mg depending on body weight cohorts.	Eli Lilly Japan K.K.	NULL	complete			BOTH	5	Phase 3	Japan, Asia except Japan, North America, South America, Europe
114	EUCTR2016-001067-36-GR (EUCTR)	02/03/2017	17/01/2017	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	Switzerland;Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
115	EUCTR2015-005223-90-AT (EUCTR)	28/02/2017	16/01/2017	This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.	A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
116	EUCTR2016-001067-36-NL (EUCTR)	23/02/2017	07/12/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
117	EUCTR2016-001067-36-BE (EUCTR)	20/02/2017	14/11/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
118	EUCTR2016-001067-36-CZ (EUCTR)	19/01/2017	13/10/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF	Bayer AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	218	Phase 4	Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
119	EUCTR2015-005223-90-NL (EUCTR)	17/01/2017	05/09/2016	This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.	A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
120	EUCTR2014-000667-40-SK (EUCTR)	17/01/2017	01/04/2016	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
121	NCT02891850 (ClinicalTrials.gov)	January 11, 2017	26/8/2016	Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy	A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal	Pulmonary Arterial Hypertension	Drug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: Tadalafil	Bayer	NULL	Completed	18 Years	75 Years	All	225	Phase 4	United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland
122	JPRN-UMIN000025176	2017/01/01	15/12/2016	Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension.	Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. - Efficacy, tolerability, and safety of transition from beraprost to selexipag	Pulmonary arterial hypertension	Medicine transition from beraprost to selexipag In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed. The maximum dose allowed is 1.6mg twice daily.	Hamamatsu University School of Medicine	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	33	Not selected	Japan
123	EUCTR2016-001067-36-PT (EUCTR)	29/12/2016	13/09/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Tadalafil INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
124	EUCTR2016-001067-36-GB (EUCTR)	21/12/2016	24/10/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Tadalafil INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
125	EUCTR2015-005223-90-DE (EUCTR)	16/12/2016	09/05/2016	This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part2) which provides active therapy to all subjects completing the first 18 weeks.	A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Colombia;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Czech Republic;Netherlands;Austria;Belgium;Korea, Republic of;Italy;Israel;Australia;France;Serbia;Germany;Croatia
126	EUCTR2016-001067-36-IT (EUCTR)	12/12/2016	05/11/2020	A study to find out whether some PAH patients may benefit by replacing their current hosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 1.0 INN or Proposed INN: Riociguat Other descriptive name: Riociguat Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 1.5 mg INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 0.5 mg compressa rivestita con film INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 2.0 mg INN or Proposed INN: Riociguat Other descriptive name: Riociguat Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 2.5 mg INN or Proposed INN: Riociguat	BAYER AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Germany;Japan;New Zealand;Portugal;United States;Taiwan;Greece;Spain;Italy;Switzerland
127	EUCTR2010-024585-22-DE (EUCTR)	01/12/2016	17/08/2016	What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?	What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients	Idiopathic or familial pulmonary arterial hypertension MedDRA version: 19.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Ferinject Product Name: Ferinject INN or Proposed INN: FERRIC CARBOXYMALTOSE	Imperial College Academic Healthsciences Centre	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Germany;United Kingdom
128	EUCTR2015-005223-90-PT (EUCTR)	30/11/2016	09/05/2016	This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 16 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension.	A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1	Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
129	EUCTR2016-001067-36-ES (EUCTR)	21/11/2016	09/09/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	218	Phase 4	United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
130	EUCTR2016-001067-36-AT (EUCTR)	10/11/2016	20/09/2016	A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat	A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy	Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF	Bayer AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	218	Phase 4	Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
131	EUCTR2016-000196-24-GB (EUCTR)	18/10/2016	28/11/2016	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST	Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester	Reata Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
132	EUCTR2016-000196-24-BE (EUCTR)	17/10/2016	11/07/2016	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST	Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester	Reata Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	130	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
133	EUCTR2016-000196-24-NL (EUCTR)	10/10/2016	13/07/2016	BADOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST	Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester	Reata Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
134	EUCTR2015-005223-90-CZ (EUCTR)	27/09/2016	22/06/2016	This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.	A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
135	EUCTR2015-005223-90-IT (EUCTR)	15/09/2016	22/06/2021	This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.	A phase 3, placebo controlled, double-blind, randomized, clinical study to determine efficacy, safety and tolerability of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH): INOvation-1 (Part 1 and Part 2) - Efficacy and safety of iNO in Pulmonary Arterial Hypertension, v1.0	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: Ossido Nitrico Other descriptive name: inhaled NO with pulsed delivery	BELLEROPHON PULSE TECHNOLOGIES LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	Portugal;Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
136	JPRN-UMIN000025158	2016/09/01	07/12/2016	A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension	A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension - A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension	Connective Tissue Disease-Associated Pulmonary Arterial Hypertension	Drug: Bardoxolone Methyl Bardoxolone methyl dose escalated to a maximum of 10 mg. Dosing period is up to 6 months. Drug: Placebo Oral Capsule Capsule containing an inert placebo is administrated up to 6 months.	Reata Pharmaceuticals, Inc.	NULL	Complete: follow-up complete	18years-old	75years-old	Male and Female	20	Phase 3	Japan,North America,South America,Australia,Europe
137	EUCTR2016-000196-24-CZ (EUCTR)	30/08/2016	18/07/2016	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST	Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester	Reata Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
138	EUCTR2015-003438-28-DK (EUCTR)	17/08/2016	30/05/2016	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden
139	EUCTR2016-000196-24-DE (EUCTR)	11/08/2016	27/06/2016	BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST	Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester	Reata Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Netherlands;Japan
140	NCT02825160 (ClinicalTrials.gov)	August 1, 2016	15/6/2016	Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)	Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)	Hypertension, Pulmonary	Drug: Ventavis (Iloprost, BAYQ6256)	Bayer	NULL	Recruiting	N/A	N/A	All	270		Japan
141	EUCTR2014-003952-29-PL (EUCTR)	28/07/2016	13/04/2016	Riociguat for treatment of PAH in children from 6 to less than 18 years old	Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD	Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat	Bayer AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Belgium;Romania;Netherlands;Germany;Japan
142	EUCTR2015-005223-90-GB (EUCTR)	12/07/2016	11/04/2016	This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.	A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO INN or Proposed INN: NITRIC OXIDE Other descriptive name: inhaled NO with pulsed delivery	Bellerophon Pulse Technologies LLC	NULL	Not Recruiting			Female: yes Male: yes	188	Phase 3	United States;Serbia;Portugal;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
143	EUCTR2016-000196-24-ES (EUCTR)	04/07/2016	01/06/2016	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION	A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST	Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester Product Name: Bardoxolone Methyl Product Code: RTA 402 INN or Proposed INN: bardoxolone methyl Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester	Reata Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	130	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
144	EUCTR2015-003438-28-FR (EUCTR)	20/06/2016	21/04/2016	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON	Pulmonary arterial hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 3	United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
145	NCT02558231 (ClinicalTrials.gov)	May 1, 2016	22/9/2015	The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension	The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study	Pulmonary Arterial Hypertension	Drug: Macitentan;Drug: Tadalafil;Drug: Selexipag	Actelion	NULL	Completed	18 Years	75 Years	All	247	Phase 3	United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway
146	EUCTR2015-003438-28-NO (EUCTR)	11/04/2016	09/03/2016	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON	Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 3	United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
147	EUCTR2014-003952-29-ES (EUCTR)	01/04/2016	17/02/2016	Riociguat for treatment of PAH in children from 6 to less than 18 years old	Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD	Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat	Bayer Healthcare AG	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 3	United Kingdom;France;Hungary;Belgium;Poland;Spain;Turkey;Netherlands;Germany;Japan;Italy
148	EUCTR2015-003438-28-DE (EUCTR)	04/03/2016	19/01/2016	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH	Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
149	EUCTR2015-003438-28-BE (EUCTR)	03/03/2016	09/06/2020	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH	Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
150	NCT02652429 (ClinicalTrials.gov)	March 2016	17/12/2015	Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH	An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO Therapy	Pulmonary Arterial Hypertension	Drug: Inhaled Nitric Oxide	Bellerophon Pulse Technologies	NULL	Active, not recruiting	N/A	N/A	All	22	Phase 3	United States;Canada
151	EUCTR2012-000098-21-PL (EUCTR)	27/02/2016	20/01/2016	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of;Greece;United States;Taiwan
152	EUCTR2012-000097-26-PL (EUCTR)	27/02/2016	20/01/2016	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy.	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	Israel;Chile;Italy;United Kingdom;India;United States;Taiwan;Greece;Austria;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
153	EUCTR2014-002590-10-FR (EUCTR)	11/02/2016	02/03/2016	Effect of bronchodilators on effort induced dyspnoea in lung hypertension patients	Effect of bronchodilators on effort induced dyspnoea in patients suffering lung hypertension - BD-HTAP	Idiopathic or heritable patients with pulmonary arterial hypertension (PAH). MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Bromure d'Ipratropium Product Name: Bromure d'Ipratropium INN or Proposed INN: Bromure d'Ipratropium Trade Name: Salbutamol Product Name: Salbutamol INN or Proposed INN: Salbutamol	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 3	France
154	EUCTR2015-002835-17-DE (EUCTR)	18/01/2016	26/11/2015	RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatment	Investigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III	Pulmonary arterial Hypertension (PAH) MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Adempas® INN or Proposed INN: RIOCIGUAT Trade Name: Opsumit® INN or Proposed INN: MACITENTAN	Justus Liebig Universität Gießen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Germany
155	EUCTR2015-003438-28-AT (EUCTR)	12/01/2016	25/07/2017	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
156	EUCTR2014-003952-29-GB (EUCTR)	25/11/2015	27/07/2015	Riociguat for treatment of PAH in children from 6 to less than 18 years old	Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD	Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 3	United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
157	EUCTR2012-004411-31-GB (EUCTR)	25/11/2015	12/06/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	220	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
158	EUCTR2012-000098-21-FR (EUCTR)	24/11/2015	26/09/2012	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 15.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	858	Phase 3	United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Germany;Netherlands;Sweden;Korea, Republic of
159	NCT02551653 (ClinicalTrials.gov)	November 17, 2015	14/9/2015	Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients	A Microdose Study to Evaluate the Biodistribution of [11C]-GSK2256098 in the Lungs and Heart of Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients Using Positron Emission Tomography (PET)	Hypertension, Pulmonary	Drug: [11C]-GSK2256098 500 MBq	GlaxoSmithKline	NULL	Completed	40 Years	70 Years	All	10	Phase 1	United Kingdom
160	NCT02471183 (ClinicalTrials.gov)	November 4, 2015	11/6/2015	Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension	Multicenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Selexipag	Actelion	NULL	Completed	18 Years	75 Years	All	30	Phase 3	United States
161	NCT02746237 (ClinicalTrials.gov)	November 2015	18/3/2016	Single and Multiple Ascending Doses Clinical Pharmacology Study With KAR5585	A Randomized, Double-blind, Placebo-controlled, Phase 1, First-in-human, Single-center, Safety, Tolerability, Ventricular Repolarization and Pharmacokinetic Study of Single and Multiple Ascending Doses of KAR5585 in Healthy Subjects	Pulmonary Arterial Hypertension	Drug: KAR5585 Capsules;Drug: Placebo Capsules	Karos Pharmaceuticals	NULL	Completed	18 Years	65 Years	Both	120	Phase 1	United States
162	NCT02562235 (ClinicalTrials.gov)	October 29, 2015	28/9/2015	Riociguat in Children With Pulmonary Arterial Hypertension (PAH)	Open-label, Individual Dose Titration Study to Evaluate Safety, Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension (PAH)	Hypertension, Pulmonary	Drug: Riociguat (Adempas, BAY63-2521)	Bayer	Merck Sharp & Dohme LLC	Active, not recruiting	6 Years	17 Years	All	24	Phase 3	Colombia;Germany;Hungary;Italy;Japan;Mexico;Poland;Taiwan;Turkey;Belgium;Brazil;France;Netherlands;Romania;Spain;United Kingdom;United States
163	EUCTR2015-002799-26-GB (EUCTR)	27/10/2015	21/09/2015	A therapeutic trial of blockade of interleukin-6 using the drug Tocilizumab in pulmonary arterial hypertension	TRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension - An open label study of Tocilizumab in PAH	Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: n/a	Papworth Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	26	Phase 2	United Kingdom
164	EUCTR2015-000709-38-AT (EUCTR)	20/10/2015	28/07/2015	Effects of the drug Benzbromaron on the pulmonary vessels	Acute Effects of Benzbromaron on the pulmonary circulation	Pulmonary arterial hypertension MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Benzbromaron AL Product Name: Benzbromaron INN or Proposed INN: BENZBROMARONE	Medical University of Graz	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Austria
165	EUCTR2015-002078-19-FR (EUCTR)	14/10/2015	05/08/2015	Prospective, multicenter, open-label study evaluating the effects of first-line oral combination therapy of macitentan and tadalafil in patients with newly diagnosed pulmonary arterial hypertension	Prospective, multicenter, open-label study evaluating the effects of first-line oral combination therapy of macitentan and tadalafil in patients with newly diagnosed pulmonary arterial hypertension. - OPTIMA	Pulmonary arterial hypertension MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: Opsumit Trade Name: Adcirca Product Name: tadalafil INN or Proposed INN: TADALAFIL Other descriptive name: Adcirca	ACTELION Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France
166	EUCTR2012-004411-31-CZ (EUCTR)	01/10/2015	12/12/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
167	EUCTR2013-004362-34-SE (EUCTR)	26/08/2015	13/03/2014	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3;Phase 4	United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
168	EUCTR2014-003952-29-HU (EUCTR)	25/08/2015	06/07/2015	Riociguat for treatment of PAH in children from 6 to less than 18 years old	Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD	Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 3	United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
169	EUCTR2014-000667-40-PL (EUCTR)	30/07/2015	29/04/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
170	EUCTR2014-002131-34-NL (EUCTR)	29/07/2015	05/03/2015	A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension	A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension	Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;United States;Canada;Spain;Germany;Netherlands;Italy;United Kingdom
171	EUCTR2014-004066-20-DE (EUCTR)	27/07/2015	09/03/2015	A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.	A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right vEntricular remodeling in Pulmonary ArterIal hypeRtension	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;France;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
172	EUCTR2014-003042-27-PL (EUCTR)	23/07/2015	28/05/2015	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
173	NCT02428985 (ClinicalTrials.gov)	June 29, 2015	21/4/2015	Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH)	Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH)	Hypertension, Pulmonary	Drug: Riociguat (ADEMPAS, BAY63-2521)	Bayer	NULL	Recruiting	N/A	N/A	All	600		Japan
174	EUCTR2014-000667-40-ES (EUCTR)	27/05/2015	09/03/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
175	EUCTR2014-002131-34-ES (EUCTR)	18/05/2015	11/03/2015	A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension	A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension	Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
176	EUCTR2014-002131-34-GB (EUCTR)	15/05/2015	15/07/2015	A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension	A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension	Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
177	EUCTR2014-004066-20-GB (EUCTR)	14/05/2015	12/01/2015	A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.	A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right ventricular remodeling in pulmonary arterIal hypertension	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;United States;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom
178	EUCTR2013-004362-34-PT (EUCTR)	08/05/2015	18/02/2015	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3;Phase 4	Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Czechia;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
179	EUCTR2014-002131-34-DE (EUCTR)	07/05/2015	27/02/2015	A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension	A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension	Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
180	EUCTR2014-000667-40-CZ (EUCTR)	23/04/2015	14/01/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
181	EUCTR2013-004362-34-NL (EUCTR)	23/04/2015	29/01/2015	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3;Phase 4	Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
182	EUCTR2014-003042-27-CZ (EUCTR)	23/04/2015	14/01/2015	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Serbia;Czechia;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
183	EUCTR2014-002131-34-IT (EUCTR)	09/04/2015	15/01/2016	A clinical trial with GS-4997 in Subjects with Pulmonary Arterial Hypertension	A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension	Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and toxin use, or human immunodeficiency virus (HIV) infection. MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: GS-4997 2 mg INN or Proposed INN: Not available Product Code: GS-4997 6 mg INN or Proposed INN: Not available Product Code: GS-4997 18 mg INN or Proposed INN: Not available	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;United States;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
184	EUCTR2014-004066-20-NL (EUCTR)	27/03/2015	19/01/2015	A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.	A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right vEntricular remodeling in Pulmonary ArterIal hypeRtension	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;France;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy
185	EUCTR2012-004411-31-GR (EUCTR)	19/03/2015	29/04/2015	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
186	EUCTR2014-000667-40-HU (EUCTR)	17/02/2015	19/01/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
187	EUCTR2014-003042-27-HU (EUCTR)	17/02/2015	19/01/2015	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
188	NCT02276872 (ClinicalTrials.gov)	December 18, 2014	21/10/2014	Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years	A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension	PAH	Drug: oral treprostinil	United Therapeutics	NULL	Completed	7 Years	17 Years	All	32	Phase 2	United States
189	EUCTR2013-004362-34-GR (EUCTR)	21/11/2014	24/11/2014	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Trade Name: Revatio INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 4	United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
190	NCT02234141 (ClinicalTrials.gov)	November 2014	2/9/2014	Selonsertib in Adults With Pulmonary Arterial Hypertension	A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Placebo;Drug: Selonsertib	Gilead Sciences	NULL	Completed	18 Years	75 Years	All	151	Phase 2	United States;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
191	EUCTR2013-004362-34-PL (EUCTR)	22/10/2014	17/07/2014	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Trade Name: Revatio INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3;Phase 4	United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
192	EUCTR2014-001882-28-DE (EUCTR)	13/10/2014	07/08/2014	Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertension	Early Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA	Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Volibris Product Name: Ambrisentan	Thoraxklinik-Heidelberg gGmbH	NULL	Not Recruiting			Female: yes Male: yes	38	Phase 2	Germany
193	EUCTR2013-001759-10-GB (EUCTR)	29/09/2014	27/08/2014	Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)	Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE	Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: Adempas 0.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2;Phase 3	United States;Czech Republic;Canada;Belgium;Germany;Switzerland;United Kingdom
194	NCT02191137 (ClinicalTrials.gov)	September 23, 2014	27/6/2014	Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)	A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment	Hypertension, Pulmonary	Drug: Riociguat (Adempas, BAY63-2521)	Bayer	NULL	Completed	18 Years	80 Years	All	75	Phase 4	United States;Puerto Rico
195	EUCTR2012-003335-33-GR (EUCTR)	22/09/2014	25/06/2014	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
196	JPRN-UMIN000016320	2014/09/18	24/01/2015	Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease	Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease - Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease	Pulmonary arterial hypertension associated with connective tissue disease	Weekly rituximab (375mg/m2) infusion for 4 weeks	The University of Tokyo Hospital	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	6	Not selected	Japan
197	EUCTR2013-004362-34-CZ (EUCTR)	08/09/2014	13/05/2014	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3;Phase 4	United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden
198	EUCTR2014-000091-25-GB (EUCTR)	01/09/2014	11/07/2014	A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome	A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome - Iloprost in patients with Eisenmenger Syndrome	Pulmonary Arterial Hypertension Eisenmenger syndrome MedDRA version: 17.0;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855 MedDRA version: 17.0;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Iloprost Product Name: Ventavis INN or Proposed INN: Iloprost	Royal Brompton and Harefield NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 4	United Kingdom
199	EUCTR2012-000097-26-GR (EUCTR)	05/08/2014	11/06/2014	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy	Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	858	Phase 3	France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden;United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;India
200	EUCTR2012-000098-21-GR (EUCTR)	05/08/2014	10/06/2014	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	858	Phase 3	United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of
201	EUCTR2012-000098-21-DK (EUCTR)	31/07/2014	22/05/2014	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of
202	EUCTR2012-000097-26-DK (EUCTR)	31/07/2014	22/05/2014	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy.	Pulmonary Arterial Hypertension MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of
203	EUCTR2013-004362-34-DE (EUCTR)	30/07/2014	25/03/2014	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3;Phase 4	United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden
204	EUCTR2012-004411-31-RO (EUCTR)	18/07/2014	13/05/2014	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 17.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Italy;Vietnam;India
205	EUCTR2013-004362-34-ES (EUCTR)	30/06/2014	08/05/2014	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Trade Name: Revatio INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 4	Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden;United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark
206	EUCTR2012-000097-26-BE (EUCTR)	18/06/2014	14/04/2014	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy	Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	858	Phase 3	United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden
207	EUCTR2012-000098-21-BE (EUCTR)	18/06/2014	14/04/2014	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	858	Phase 3	United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden
208	EUCTR2013-004362-34-BE (EUCTR)	12/06/2014	17/03/2014	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3	United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
209	EUCTR2012-000097-26-SE (EUCTR)	09/06/2014	10/04/2014	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy.	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
210	NCT02108743 (ClinicalTrials.gov)	June 2014	7/4/2014	Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension	Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension	Idiopathic Pulmonary Arterial Hypertension.	Drug: Albuterol.;Drug: Normal saline placebo	American Medical Association Foundation	NULL	Withdrawn	18 Years	75 Years	Both	0	Phase 2	United States
211	EUCTR2012-000098-21-SE (EUCTR)	15/05/2014	10/04/2014	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	United States;Taiwan;Greece;Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
212	EUCTR2013-004362-34-AT (EUCTR)	12/05/2014	13/03/2014	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION	A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE Product Name: Sildenafil Product Code: UK 092480 INN or Proposed INN: Sildenafil Other descriptive name: SILDENAFIL CITRATE	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	429	Phase 3;Phase 4	United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
213	EUCTR2013-003462-14-ES (EUCTR)	20/02/2014	05/12/2013	Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT.	A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT? - ORCHESTRA	Pulmonary arterial hypertensionHipertensión arterial pulmonar MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 3	Spain
214	EUCTR2013-003489-15-ES (EUCTR)	20/02/2014	27/12/2013	An extension of the ORCHESTRA (AC-055-310) studyExtension del estudio ORCHESTRA (AC-055-310)	An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext.	Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 3	Spain;Italy
215	EUCTR2012-004411-31-HU (EUCTR)	28/01/2014	29/11/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany
216	EUCTR2013-001759-10-CZ (EUCTR)	23/01/2014	24/10/2013	Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)	Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE	Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2;Phase 3	United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
217	NCT02042014 (ClinicalTrials.gov)	January 22, 2014	17/1/2014	Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan	An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment	Severe Pulmonary Arterial Hypertension	Drug: QTI571	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	8	Phase 3	Japan
218	EUCTR2013-001759-10-IT (EUCTR)	14/01/2014	28/10/2013	Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i)	Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE	Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	70	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland;Italy
219	EUCTR2013-002783-12-DE (EUCTR)	07/01/2014	18/09/2013	No	A multi-center, open-label, randomized cross-over study to compare the acute tolerability and pharmacokinetics of BAY Q 6256 (iloprost; Ventavis) inhalation using the I-Neb nebulizer and the FOX nebulizer in patients with pulmonary arterial hypertension - Administration von Iloprost aerosol comparing two nebulizers: Fox and I-Neb	Patients with Pulmonary arterial hypertension, WHO class III, who have been on therpay with Ventavis 10 for at least 4 weeks MedDRA version: 16.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Ventavis 10 Product Name: Ventavis 10 Product Code: Bay Q 6256 INN or Proposed INN: ILOPROST Trade Name: Ilomedin 20 [20 µg / ml] Product Name: Ilomedin 20 Product Code: Bay q 6256 INN or Proposed INN: ILOPROST	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 1;Phase 2	Austria;Germany
220	EUCTR2013-001759-10-FR (EUCTR)	06/01/2014	28/09/2015	Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i)	Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE	Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2;Phase 3	United States;France;Czech Republic;Canada;Belgium;Germany;United Kingdom;Italy;Switzerland
221	EUCTR2013-001759-10-DE (EUCTR)	03/01/2014	15/10/2013	Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)	Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE	Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2;Phase 3	United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
222	JPRN-JapicCTI-142462	01/1/2014	03/03/2014	An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatment	An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatment	pulmonary arterial hypertension	Intervention name : QTI571 INN of the intervention : imatinib Dosage And administration of the intervention : QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day	Novartis Pharma K.K.	NULL				BOTH		Phase 3	NULL
223	EUCTR2013-001759-10-BE (EUCTR)	20/12/2013	20/11/2013	Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)	An open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE	Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2;Phase 3	United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
224	EUCTR2013-003489-15-IT (EUCTR)	10/12/2013	20/11/2013	An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext.	An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext.	Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 3	Spain;Italy
225	EUCTR2013-003462-14-IT (EUCTR)	10/12/2013	20/11/2013	Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT.	A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA	Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 3	Spain;Italy
226	EUCTR2012-003335-33-CZ (EUCTR)	04/12/2013	16/08/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
227	EUCTR2013-002783-12-AT (EUCTR)	02/12/2013	18/10/2013	No	A multi-center, open-label, randomized cross-over study to compare the acute tolerability and pharmacokinetics of BAY Q 6256 (iloprost; Ventavis) inhalation using the I-Neb nebulizer and the FOX nebulizer in patients with pulmonary arterial hypertension - Administration von Iloprost aerosol comparing two nebulizers: Fox and I-Neb	Patients with Pulmonary arterial hypertension, WHO class III, who have been on therpay with Ventavis 10 for at least 4 weeks MedDRA version: 19.0;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Ventavis 10 Product Name: Ventavis 10 Product Code: Bay Q 6256 INN or Proposed INN: ILOPROST Trade Name: Ilomedin 20 [20 µg / ml] Product Name: Ilomedin 20 Product Code: Bay q 6256 INN or Proposed INN: ILOPROST	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 1;Phase 2	Austria;Germany
228	EUCTR2012-003335-33-HU (EUCTR)	26/11/2013	30/04/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany
229	NCT01934647 (ClinicalTrials.gov)	November 22, 2013	30/8/2013	Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003)	A Non-randomized, Single-Panel, Open-Label Trial to Study the Safety, Tolerability and Pharmacodynamics of MK-8892 Acute Dosing in Subjects With Moderate to Severe Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: MK-8892	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	70 Years	All	7	Phase 1	Germany
230	NCT01926509 (ClinicalTrials.gov)	November 14, 2013	19/8/2013	Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005)	A 28-Day Multiple-Dose Titration Study to Assess the Effects of MK-8892 on Safety, Tolerability and Pharmacokinetics in Subjects With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: MK-8892;Drug: Placebo for MK-8892	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	70 Years	All	23	Phase 1	Bulgaria;Germany;Moldova, Republic of
231	EUCTR2013-001100-10-ES (EUCTR)	12/11/2013	12/11/2013	This study is to allow continued access to QTI571 for patients whoreceived QTI571 for pulmonary arterial hypertension in one of thelong-term extension studies (A2301E1, A2102E1 and E2203) andhave been judged by the investigator to benefit from continuedQTI571 treatment.	An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment	Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: GLIVEC 100 mg comprimidos recubiertos con película Product Name: Imatinib mesilate Product Code: QTI571 INN or Proposed INN: IMATINIB MESILATE	Novartis Farmacéutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes	81		United States;Spain;Australia;Switzerland
232	NCT03638908 (ClinicalTrials.gov)	November 2013	12/7/2018	Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial	A Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Fluoxetine	University of Texas Southwestern Medical Center	NULL	Completed	16 Years	80 Years	All	8	Phase 2	United States
233	NCT02000856 (ClinicalTrials.gov)	November 2013	19/11/2013	BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension	BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Dietary Supplement: Beetroot juice	Uppsala University	Karolinska Institutet	Completed	18 Years	N/A	All	15	N/A	Sweden
234	NCT01966302 (ClinicalTrials.gov)	November 2013	15/10/2013	Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)	Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH).	Pulmonary Arterial Hypertension	Drug: BPS-314d-MR	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Lung Biotechnology PBC	Completed	18 Years	75 Years	All	1	Phase 2	United States
235	EUCTR2012-002354-23-NL (EUCTR)	18/10/2013	31/05/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 3	United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Brazil;Belgium;Poland;Romania;Netherlands;Germany;Japan
236	EUCTR2012-004411-31-ES (EUCTR)	07/10/2013	08/10/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 16.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany
237	EUCTR2012-004411-31-DE (EUCTR)	07/10/2013	25/06/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain
238	EUCTR2012-003335-33-NL (EUCTR)	01/10/2013	07/02/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
239	NCT01827059 (ClinicalTrials.gov)	October 2013	5/4/2013	Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE	A Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to Placebo	Pulmonary Arterial Hypertension;Congenital Heart Disease	Drug: Bosentan;Drug: Placebo	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	NULL	Active, not recruiting	18 Years	N/A	All	12	Phase 2	Netherlands
240	NCT01894035 (ClinicalTrials.gov)	September 23, 2013	3/7/2013	Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation	Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.	Pulmonary Hypertension	Drug: Iloprost (Ventavis, BAYQ 6256)	Bayer	NULL	Completed	18 Years	N/A	All	13		Portugal
241	NCT01953965 (ClinicalTrials.gov)	September 2013	26/9/2013	Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.	11C-acetate/18Fluorodeoxyglucose-FDG PET/Cardiac MRI in Pulmonary Hypertension	Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension	Drug: 11C-acetate;Drug: [18F]Fluoro-2-deoxy-2-D-glucose;Drug: MultiHance	Brigham and Women's Hospital	University of Pennsylvania;University of Maryland;Yale University	Terminated	18 Years	72 Years	Both	4	Phase 2	United States
242	EUCTR2012-002354-23-FR (EUCTR)	23/08/2013	24/09/2015	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 3	United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
243	EUCTR2012-002354-23-BE (EUCTR)	19/08/2013	25/02/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 3	United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Netherlands;Japan
244	JPRN-JapicCTI-132155	01/8/2013	11/06/2013	Bosentan extension study for PAH pediatric patients	Open-label, long-term, efficacy, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of Japanese children with pulmonary arterial hypertension who completed the previous study.	Pulmonary arterial hypertension (PAH)	Intervention name : Ro 47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d.	Actelion Pharmaceuticals Japan Ltd.	NULL			14	BOTH	5	Phase 3	NULL
245	EUCTR2012-004411-31-AT (EUCTR)	30/07/2013	01/07/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Philippines;Taiwan;Greece;Serbia;Portugal;United States
246	EUCTR2012-004411-31-BG (EUCTR)	17/07/2013	15/05/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
247	EUCTR2012-004411-31-PT (EUCTR)	03/07/2013	01/07/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 18.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	220	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
248	NCT01897740 (ClinicalTrials.gov)	July 2013	8/7/2013	Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil	A LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, TO PROVIDE SILDENAFIL THERAPY FOR SUBJECTS WHO COMPLETED A1481156 STUDY AND ARE JUDGED BY THE INVESTIGATOR TO DERIVE CLINICAL BENEFIT FROM CONTINUED TREATMENT WITH SILDENAFIL, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATION	Pulmonary Arterial Hypertension	Drug: sildenafil	Pfizer	NULL	No longer available	10 Years	30 Years	All			Russian Federation
249	EUCTR2012-002354-23-DE (EUCTR)	18/06/2013	12/02/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 3	Spain;Turkey;Austria;Israel;United Kingdom;Italy;France;Brazil;Belgium;Poland;Romania;Germany;Netherlands;Japan
250	EUCTR2012-002354-23-ES (EUCTR)	05/06/2013	16/01/2014	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	Lilly S.A.	NULL	Not Recruiting			Female: yes Male: yes	134	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Brazil;Poland;Belgium;Romania;Netherlands;Germany;Japan
251	EUCTR2012-002354-23-AT (EUCTR)	23/05/2013	01/03/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 3	United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Netherlands;Japan
252	EUCTR2012-000097-26-IT (EUCTR)	22/05/2013	19/12/2012	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy	Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	610	Phase 3	United States;Taiwan;Greece;Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of
253	EUCTR2012-003335-33-ES (EUCTR)	12/05/2013	09/04/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Bulgaria;Germany;Israel;Italy;Vietnam;India;France;Malaysia;South Africa
254	JPRN-JapicCTI-132154	01/5/2013		Bosentan for PAH pediatric patients	Open-label, multicenter study to assess the efficacy, safety, tolerability, and pharmacokinetics of bosentan in Japanese children with pulmonary arterial hypertension	Pulmonary arterial hypertension (PAH)	Intervention name : Ro47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d. Control intervention name : null	Actelion Pharmaceuticals Japan Ltd.	NULL			14	BOTH	5	Phase 3	NULL
255	NCT03236818 (ClinicalTrials.gov)	May 2013	18/3/2013	Goal Oriented Strategy to Preserve Ejection Fraction Trial	Raising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction Trial	Pulmonary Arterial Hypertension	Drug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)	VU University Medical Center	NULL	Active, not recruiting	18 Years	80 Years	All	30	Phase 4	Netherlands
256	EUCTR2012-000153-31-CZ (EUCTR)	18/04/2013	20/11/2012	A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United States;France;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
257	EUCTR2012-000166-37-CZ (EUCTR)	18/04/2013	20/11/2012	A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United States;France;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
258	EUCTR2012-000153-31-PL (EUCTR)	17/04/2013	25/01/2013	A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
259	EUCTR2012-000166-37-PL (EUCTR)	17/04/2013	28/01/2013	A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
260	EUCTR2012-002354-23-IT (EUCTR)	12/04/2013	27/02/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 3	United States;Spain;Austria;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
261	EUCTR2012-003335-33-BG (EUCTR)	13/03/2013	14/01/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
262	EUCTR2011-002018-35-IT (EUCTR)	08/03/2013	30/10/2012	SPHERIC-1OE: study of the duration of 12 months for the observation of the use of sildenafil for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease in patients enrolled in the previous study titled SPHERIC-1	SPHERIC-1OE (Sildenafil and Pulmonary HypERtension In COPD – Open Extension) - A multicenter, longitudinal, 12 months open-label study, for the observation of the use of sildenafil in the treatment of patients with pulmonary hypertension associated to chronic obstructive lung disease enrolled in SPHERIC-1 study - SPHERIC-1 OPEN EXTENSION	Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease enrolled in the study SPHERIC-1 MedDRA version: 14.1;Level: LLT;Classification code 10010952;Term: COPD;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	INN or Proposed INN: SILDENAFIL CITRATE	ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI	NULL	Not Recruiting			Female: yes Male: yes			Italy
263	EUCTR2012-000153-31-DE (EUCTR)	05/03/2013	29/11/2012	A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United States;Serbia;France;Hungary;Czech Republic;Poland;Romania;Australia;Bulgaria;Germany;Italy
264	EUCTR2012-000098-21-NL (EUCTR)	05/03/2013	10/08/2012	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Germany;Netherlands;China;Sweden;Korea, Republic of
265	EUCTR2012-000166-37-DE (EUCTR)	05/03/2013	29/11/2012	A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United States;France;Serbia;Hungary;Czech Republic;Poland;Romania;Australia;Bulgaria;Germany;Italy
266	EUCTR2012-003335-33-PT (EUCTR)	01/03/2013	06/02/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 17.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;United States;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
267	EUCTR2012-003335-33-DE (EUCTR)	28/02/2013	31/01/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 19.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
268	EUCTR2012-000153-31-IT (EUCTR)	27/02/2013	13/09/2013	A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 16.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;United States;Serbia;Hungary;Czech Republic;Poland;Australia;Germany;Italy
269	EUCTR2012-003335-33-GB (EUCTR)	27/02/2013	21/11/2012	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 18.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
270	EUCTR2012-003335-33-AT (EUCTR)	19/02/2013	07/02/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
271	EUCTR2012-000097-26-NL (EUCTR)	18/02/2013	29/08/2012	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy.	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Germany;Netherlands;China;Korea, Republic of;Sweden
272	EUCTR2012-003335-33-BE (EUCTR)	07/02/2013	23/01/2013	Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity	Eisenmenger Syndrome MedDRA version: 16.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
273	EUCTR2012-003335-33-IT (EUCTR)	01/02/2013	11/01/2013	Study to evaluate if macitentan is efficient, safe and tolerable to be used for treatment of Eisenmenger Syndrome.	A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO	Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan	ACTELION PHARMACEUTICALS LTD.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Portugal;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;Italy;India;Vietnam;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Bulgaria;Germany
274	EUCTR2012-004411-31-IT (EUCTR)	01/02/2013	11/01/2013	Long-term study to evaluate if macitentan is safe, tolerable and efficient to be used for treatment of Eisenmenger Syndrome.	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome. - MAESTRO-OL	Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: Macitentan	ACTELION PHARMACEUTICALS LTD.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Austria;Russian Federation;Chile;Israel;Italy;Vietnam;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Romania;Bulgaria;South Africa;Germany;China
275	EUCTR2012-000153-31-HU (EUCTR)	22/01/2013	14/11/2012	A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals, Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;United States;Serbia;Czech Republic;Hungary;Poland;Australia;Germany;Italy
276	EUCTR2012-000166-37-HU (EUCTR)	22/01/2013	14/11/2012	A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs	A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: AIR001 Inhalation Solution Product Code: AIR001 INN or Proposed INN: sodium nitrite Other descriptive name: SODIUM NITRITE	Aires Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;United States;Serbia;Czech Republic;Hungary;Poland;Australia;Germany;Italy
277	EUCTR2010-021825-11-BG (EUCTR)	02/01/2013	20/11/2012	A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 3	Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
278	NCT04955990 (ClinicalTrials.gov)	December 9, 2012	29/6/2021	A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants	An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity	Pulmonary Arterial Hypertension	Drug: PAH Therapies	Actelion	NULL	Recruiting	18 Years	N/A	All	3000	Phase 4	United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Colombia;France;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Puerto Rico;Singapore;Spain;Sweden;Turkey;United Kingdom;Russian Federation
279	EUCTR2007-003694-27-BG (EUCTR)	27/11/2012	12/01/2009	Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India
280	EUCTR2012-000098-21-DE (EUCTR)	14/11/2012	01/08/2012	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of
281	NCT01517854 (ClinicalTrials.gov)	November 14, 2012	14/12/2011	Revatio Portal-Pulmonary Arterial Hypertension Trial	Revatio Portal-Pulmonary Arterial Hypertension Trial (RePo1 Trial): A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Evaluate the Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH)	Portopulmonary Hypertension	Drug: Sildenafil;Drug: Placebo	University Health Network, Toronto	NULL	Terminated	18 Years	75 Years	All	12	Phase 2	Canada
282	EUCTR2012-000098-21-GB (EUCTR)	06/11/2012	01/08/2012	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	850	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
283	EUCTR2012-000097-26-GB (EUCTR)	06/11/2012	01/08/2012	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy.	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
284	NCT01725256 (ClinicalTrials.gov)	November 2012	8/11/2012	A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH)	A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension	Drug: AIR001 (sodium nitrite inhalation solution)	Aires Pharmaceuticals, Inc.	NULL	Terminated	18 Years	75 Years	Both	29	Phase 2	United States;Australia;Hungary
285	EUCTR2012-000098-21-AT (EUCTR)	18/10/2012	07/09/2012	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension	An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of
286	EUCTR2012-000097-26-AT (EUCTR)	21/09/2012	07/08/2012	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension receiving background oral monotherapy	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Phase 3	United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
287	EUCTR2012-000097-26-DE (EUCTR)	17/09/2012	02/08/2012	International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receivingbackground oral monotherapy	A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy.	Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	850	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden
288	NCT01649739 (ClinicalTrials.gov)	September 2012	22/7/2012	Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost		Pulmonary Arterial Hypertension	Drug: Levitra	Rabin Medical Center	NULL	Not yet recruiting	18 Years	70 Years	Both	20	Phase 4	Israel
289	EUCTR2011-004106-16-BG (EUCTR)	10/08/2012	11/06/2012	A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound	A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia;Vietnam;India;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
290	EUCTR2012-001675-37-AT (EUCTR)	07/08/2012	14/06/2012	A Study to Investigate the Effects of Lisuride in addition to Conventional Treatment in Patients with Pulmonary Arterial Hypertension	A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial Hypertension - Lis-Safe	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Lisuride INN or Proposed INN: Lisuride	Sinoxa Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	12		Austria;Germany
291	EUCTR2012-001675-37-DE (EUCTR)	24/07/2012	16/05/2012	A Study to Investigate the Effects of Lisuride in addition to Conventional Treatment in Patients with Pulmonary Arterial Hypertension	A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial Hypertension - Lis-Safe	Pulmonary Arterial Hypertension MedDRA version: 16.0;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Lisuride INN or Proposed INN: Lisuride	Sinoxa Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	12		Austria;Germany
292	EUCTR2011-004612-31-PT (EUCTR)	06/07/2012	02/05/2012	A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.	A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	105		Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
293	NCT01645826 (ClinicalTrials.gov)	July 2012	18/10/2011	Efficacy Study of Cardizem in Pulmonary Arterial Hypertension	Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.	Idiopathic Pulmonary Arterial Hypertension;Primary Pulmonary Hypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension	Drug: Diltiazem Hydrochloride;Drug: Sugar Pill	University of South Florida	NULL	Withdrawn	18 Years	N/A	All	0	N/A	United States
294	NCT01469169 (ClinicalTrials.gov)	June 19, 2012	8/11/2011	Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study	A Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH)	Hypertension, Pulmonary	Drug: Iloprost (Ventavis inhaled, BAYQ6256)	Bayer	NULL	Completed	18 Years	75 Years	All	27	Phase 3	Japan
295	EUCTR2011-004106-16-PT (EUCTR)	01/06/2012	28/02/2012	A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound	A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	105		Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
296	EUCTR2011-001873-24-GB (EUCTR)	29/03/2012	24/11/2011	A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body	A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: LY450190 Product Code: LY450190 INN or Proposed INN: TADALAFIL Other descriptive name: LY450190	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 1;Phase 2	United States;France;Canada;Spain;Poland;United Kingdom
297	EUCTR2011-004631-31-DE (EUCTR)	13/03/2012	10/02/2012	16 week study is to assess the safety, tolerability and the effects on the body of a rapid dosing regimen using subcutaneous Remodulin®	A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial Hypertension - RAPID study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Remodulin® (treprostinil) 1 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 2.5 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 5 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 10 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15	United Therapeutics Corp.	NULL	Not Recruiting			Female: yes Male: yes	50		Germany
298	EUCTR2011-001873-24-ES (EUCTR)	13/01/2012	26/10/2011	A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body	A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: LY450190 Product Code: LY450190 INN or Proposed INN: TADALAFIL Other descriptive name: LY450190	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 1;Phase 2	United States;France;Canada;Poland;Spain;United Kingdom
299	EUCTR2010-018320-10-ES (EUCTR)	26/12/2011	21/11/2011	An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)	An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)Extension del estudio AC-066A301, abierta, para investigar la seguridad y la tolerabilidad de ACT-385781A en pacientes con Hipertension Arterial Pulmonar (HAP) - EPITOME-2 Extension	Hipertension Arterial Pulmonar MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM	ACTELION Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40		France;Canada;Belgium;Spain;Netherlands;Italy
300	EUCTR2010-021793-12-NL (EUCTR)	09/11/2011	14/02/2011	A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Czech Republic;Hungary;Spain;Germany;Netherlands;Italy
301	EUCTR2011-002943-92-NL (EUCTR)	07/11/2011	22/08/2011	Study of a new thermostable formulation of Flolan™ to treat Pulmonary Arterial Hypertension (PAH)	A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN™ in Subjects with Pulmonary Arterial Hypertension (PAH)	pulmonary arterial hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: FLOLAN™ and Glycine Diluent Product Name: FLOLAN™ and Glycine Diluent Product Code: 4AU76 INN or Proposed INN: EPOPROSTENOL Trade Name: FLOLAN TM and Glycine Diluent Product Name: FLOLAN™ and Glycine Diluent Product Code: 4AU76 INN or Proposed INN: EPOPROSTENOL	GlaxoSmithKline Research and Development Limited	NULL	Not Recruiting			Female: yes Male: yes	20		United States;Canada;Netherlands
302	EUCTR2010-018320-10-IT (EUCTR)	04/11/2011	01/03/2012	An extension of study AC-066A301 to investigate safety and tolerabilityof the study medication (epoprostenol for injection)	Estensione in aperto dello studio AC-066A301 per valutare la sicurezza e la tollerabilita' dell’ACT-385781A nei pazienti affetti da ipertensione arteriosa polmonare (IAP) - EPITOME-2 Extension	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Epoprostenolo per iniezione INN or Proposed INN: EPOPROSTENOL SODIUM Other descriptive name: NA Trade Name: Epoprostenolo per iniezione INN or Proposed INN: EPOPROSTENOL SODIUM	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	40		Canada;Spain;Belgium;Netherlands;Italy
303	NCT01462565 (ClinicalTrials.gov)	November 1, 2011	13/10/2011	Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)	A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.)	Hypertension, Pulmonary	Drug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodium	GlaxoSmithKline	NULL	Completed	18 Years	75 Years	All	16	Phase 4	United States;Canada;Netherlands
304	NCT01458236 (ClinicalTrials.gov)	November 2011	29/9/2011	A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor	A Multinational, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor	Pulmonary Arterial Hypertension	Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo	Lung Biotechnology Inc.	NULL	Withdrawn	18 Years	80 Years	Both	0	Phase 3	NULL
305	NCT01431326 (ClinicalTrials.gov)	November 2011	17/8/2011	Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care	Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care	Adenovirus;Anesthesia;Anxiety;Anxiolysis;Autism;Autistic Disorder;Bacterial Meningitis;Bacterial Septicemia;Benzodiazepine;Bipolar Disorder;Bone and Joint Infections;Central Nervous System Infections;Convulsions;Cytomegalovirus Retinitis;Early-onset Schizophrenia Spectrum Disorders;Epilepsy;General Anesthesia;Gynecologic Infections;Herpes Simplex Virus;Infantile Hemangioma;Infection;Inflammation;Inflammatory Conditions;Intra-abdominal Infections;Lower Respiratory Tract Infections;Migraines;Pain;Pneumonia;Schizophrenia;Sedation;Seizures;Skeletal Muscle Spasms;Skin and Skin-structure Infections;Treatment-resistant Schizophrenia;Urinary Tract Infections;Withdrawal;Sepsis;Gram-negative Infection;Bradycardia;Cardiac Arrest;Cardiac Arrhythmia;Staphylococcal Infections;Nosocomial Pneumonia;Neuromuscular Blockade;Methicillin Resistant Staphylococcus Aureus;Endocarditis;Neutropenia;Headache;Fibrinolytic Bleeding;Pulmonary Arterial Hypertension;CMV Retinitis;Hypertension;Chronic Kidney Diseases;Hyperaldosteronism;Hypokalemia;Heart Failure;Hemophilia;Heavy Menstrual Bleeding;Insomnia	Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:	Daniel Benjamin	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The Emmes Company, LLC	Completed	N/A	21 Years	All	3520		United States;Canada;Israel;Singapore;United Kingdom;Australia
306	EUCTR2010-019883-36-DE (EUCTR)	13/10/2011	13/05/2011	A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)	A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy. MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Tasigna® 150 mg Product Name: Tasigna Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: Nilotinib 50 mg Product Code: AMN107 INN or Proposed INN: nilotinib	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	55		United States;Hungary;Canada;Singapore;Germany;Switzerland;Italy;Korea, Republic of
307	EUCTR2011-001893-24-DE (EUCTR)	13/10/2011	21/09/2011	To determine oral bioavailability of the oral liquid formulation and potential food effects.	Relative bioavailability and food effect study of two oral liquid formulations in comparison to a 1mg tablet of riociguat to characterize its pharmacokinetic properties in healthy male and female adult subjects in a randomized, open label, 5 fold crossover design	Children with PH due to • Pulmonary arterial hypertension (PAH) • persistent pulmonary hypertension of the newborn (PPHN) MedDRA version: 14.0;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10036727;Term: Primary pulmonary hypertension;Classification code 10053592;Term: Newborn persistent pulmonary hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders	Product Name: BAY 63-2521 0.3 % Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Product Name: BAY 63-2521 0.06 % Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Product Name: BAY 63-2521 IR tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	30		Germany
308	EUCTR2010-021572-29-IT (EUCTR)	19/09/2011	07/02/2011	An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588	An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064908 MedDRA version: 9.1;Classification code 10064910 MedDRA version: 9.1;Classification code 10064909	Trade Name: VOLIBRIS INN or Proposed INN: ambrisentan Trade Name: VOLIBRIS INN or Proposed INN: ambrisentan INN or Proposed INN: Ambrisentan	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66		Hungary;Greece;Spain;Netherlands;Germany;Italy
309	NCT01582438 (ClinicalTrials.gov)	August 17, 2011	19/4/2012	An Open Label Access Study For Subjects Who Completed A1481156	A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In India	Pulmonary Arterial Hypertension	Drug: Access program - sildenafil citrate, Viagra, Revatio	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	NULL	No longer available	12 Years	30 Years	All			India
310	JPRN-UMIN000005973	2011/08/01	01/08/2011	Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics	Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics - Tadalafil study for pediatric PAH	pediatric pulmonary arterial hypertension	single oral administration of tadalafil 1mg/kg	National Cerebral and Cardiovascular Center	NULL	Complete: follow-up complete	Not applicable	18years-old	Male and Female	10	Not applicable	Japan
311	EUCTR2010-018863-40-ES (EUCTR)	29/07/2011	20/06/2011	Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	Pulmonary arterial hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 0.5 mg Product Code: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Poland;Spain;Austria;Germany;United Kingdom;Italy
312	EUCTR2010-018320-10-NL (EUCTR)	11/07/2011	12/05/2011	An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)	An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM	ACTELION Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40		France;Canada;Belgium;Spain;Netherlands;Italy
313	EUCTR2010-018322-40-NL (EUCTR)	11/07/2011	19/07/2011	A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2	A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2	Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM	ACTELION Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 3	Netherlands;Belgium;France;Spain;Italy
314	EUCTR2010-018863-40-GB (EUCTR)	24/06/2011	24/03/2011	Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	Pulmonary arterial hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	18	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Spain;Poland;Austria;Germany;Italy;United Kingdom
315	EUCTR2011-001312-59-GB (EUCTR)	24/06/2011	15/04/2011	A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension	A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension	Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the arteries to the lungs, rapidly evolving in a clinical syndrome of dyspnoea and fatigue and eventually leading to right ventricular failure and death. MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Qutenza Product Name: Qutenza INN or Proposed INN: Capsaicin	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	0		United Kingdom
316	EUCTR2010-018322-40-ES (EUCTR)	17/06/2011	03/11/2011	Estudio de investigación clínica para evaluar la seguridad de cambiar el Flolan por un nuevo fármaco llamado Epoprostenol-Actelion en pacientes que padecen hipertensión arterial pulmonar	Estudio de fase 3b multicéntrico, de una única rama, abierto para evaluar los efectos de cambiar de Flolan® a ACT-385781A en pacientes con hipertensión arterial pulmonar // A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2	Hipertensión Arterial Pulmonar (HAP) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODICO Other descriptive name: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODICO Other descriptive name: EPOPROSTENOL SODIUM	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 3	France;Canada;Belgium;Spain;Netherlands;Italy
317	NCT01392495 (ClinicalTrials.gov)	June 2011	11/7/2011	Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)	An Open-label Extension Study to CQTI571A2102 to Evaluate the Long-term Safety, Tolerability and Efficacy of QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Imatinib	Novartis Pharmaceuticals	NULL	Terminated	N/A	N/A	All	17	Phase 3	United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Turkey
318	EUCTR2010-018322-40-IT (EUCTR)	04/05/2011	05/01/2012	A clinical research study to evaluate the safety of changing from Flolanto a new drug called Epoprostenol-Actelion in patients suffering frompulmonary arterial hypertension	Uno studio multicentrico, a braccio singolo, in aperto, di fase 3b, per valutare gli effetti del passaggio da Flolan ad ACT 385781A nei pazienti con ipertensione arteriosa polmonare - EPITOME-2	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Epoprostenolo per iniezione INN or Proposed INN: Epoprostenol Trade Name: Epoprostenol for injection INN or Proposed INN: Epoprostenol	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	40		Canada;Netherlands;Belgium;France;Spain;Italy
319	EUCTR2010-021793-12-ES (EUCTR)	28/04/2011	03/03/2011	Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar	Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar	Hipertensión arterial pulmonar (PAH) en niños. MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película INN or Proposed INN: BOSENTAN MONOHIDRATO Other descriptive name: BOSENTAN MONOHIDRATO	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
320	EUCTR2010-021825-11-NL (EUCTR)	28/04/2011	03/11/2010	A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China
321	NCT01392469 (ClinicalTrials.gov)	April 20, 2011	10/5/2011	Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants	A Non-Randomized, Multiple Dose, Three Treatment Period, Open-Label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) Patients	Pulmonary Arterial Hypertension	Drug: Imatinib;Drug: Sildenafil;Drug: Bosentan	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	21	Phase 3	United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey
322	EUCTR2010-021793-12-IT (EUCTR)	10/04/2011	16/05/2011	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Study Extension	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Study Extension	Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 13.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: TRACLEER INN or Proposed INN: Bosentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
323	EUCTR2010-021960-14-DE (EUCTR)	08/04/2011	03/03/2011	An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension	An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension	Pulmonary arterial hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESILATE Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESILATE	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	20		Germany;Italy
324	EUCTR2010-021793-12-DE (EUCTR)	04/04/2011	01/02/2011	A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;South Africa;Germany;Netherlands;China
325	JPRN-UMIN000005464	2011/04/01	19/04/2011	Drug interactions and effects of combination therapy for pulmonary arterial hypertension	Drug interactions and effects of combination therapy for pulmonary arterial hypertension - Drug interactions and effects of PAH combination therapy	pulmonary arterial hypertension	phase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks phase 2: sildenafil(60mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks	Hamamatsu University School of Medicine	University of Shizuoka	Recruiting	20years-old	Not applicable	Male and Female	15	Not applicable	Japan
326	JPRN-UMIN000005438	2011/04/01	14/04/2011	prospective intervention study of prevention of infections by chlorhexidine-impregnated sponge dressings for patients with tunneled central venous catheters	prospective intervention study of prevention of infections by chlorhexidine-impregnated sponge dressings for patients with tunneled central venous catheters - prospective study of prevention of infections for patients with tunneled central venous catheters	patients with pulmonary arterial hypertension	Use of chlorhexidine-impregnated sponge dressing during former 6 months Use of chlorhexidine-impregnated sponge dressing during latter 6 months	Department of cardiology, Keio University School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	30	Not selected	Japan
327	EUCTR2010-024585-22-GB (EUCTR)	25/03/2011	25/02/2011	What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?	What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients	Idiopathic or familial pulmonary arterial hypertension MedDRA version: 18.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Ferinject Product Name: Ferinject INN or Proposed INN: Ferric carboxymaltose	Imperial College Academic Healthsciences Centre	NULL	Not Recruiting			Female: yes Male: yes		Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Germany;United Kingdom
328	EUCTR2010-021960-14-IT (EUCTR)	11/03/2011	26/05/2011	An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy ofQTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - ND	An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy ofQTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - ND	Pulmonary arterial hypertension (PAH) MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: GLIVEC INN or Proposed INN: IMATINIB MESYLATE	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	20		Germany;Italy
329	EUCTR2010-021793-12-CZ (EUCTR)	09/03/2011	04/02/2011	A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China
330	EUCTR2010-021793-12-HU (EUCTR)	28/02/2011	02/02/2011	A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia
331	EUCTR2009-014992-31-NL (EUCTR)	16/02/2011	18/02/2011	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Austria;United Kingdom;United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
332	EUCTR2009-014490-41-NL (EUCTR)	16/02/2011	18/02/2011	Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Peru;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
333	EUCTR2009-014992-31-SK (EUCTR)	09/02/2011	09/06/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
334	EUCTR2009-014490-41-SK (EUCTR)	09/02/2011	09/06/2010	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
335	NCT01246037 (ClinicalTrials.gov)	February 2011	18/11/2010	Beta-blockers in i-PAH	Beta-blocker Therapy in Idiopathic Pulmonary Arterial Hypertension	Idiopathic Pulmonary Arterial Hypertension	Drug: Bisoprolol	VU University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development	Active, not recruiting	18 Years	N/A	Both	30	Phase 1/Phase 2	Netherlands
336	EUCTR2010-021344-17-IT (EUCTR)	28/01/2011	07/02/2011	A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND	A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND	Pulmonary arterial hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911	Trade Name: GLIVEC INN or Proposed INN: IMATINIB MESYLATE Trade Name: REVATIO INN or Proposed INN: Sildenafil Trade Name: TRACLEER INN or Proposed INN: Bosentan	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	24		Italy
337	EUCTR2010-018863-40-PL (EUCTR)	25/01/2011	07/06/2010	Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	Pulmonary arterial hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
338	EUCTR2010-021572-29-ES (EUCTR)	19/01/2011	17/11/2010	Estudio de extensión abierto y a largo plazo sobre el tratamiento de la hipertensión arterial pulmonar en pacientes pediátricos de 8 a 18 años de edad que han participado en el estudio AMB112529 y para los que se desea tratamiento continuo con ambrisentan.An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired.	Estudio de extensión abierto y a largo plazo sobre el tratamiento de la hipertensión arterial pulmonar en pacientes pediátricos de 8 a 18 años de edad que han participado en el estudio AMB112529 y para los que se desea tratamiento continuo con ambrisentan.An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired.	Hipertensión Arterial PulmonarPulmonary Arterial Hypertension MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 13;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar MedDRA version: 13;Level: PT;Term: Hipertensión arterial pulmonar	Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan	GlaxoSmithKline, S.A	NULL	Not Recruiting			Female: yes Male: yes	66		Hungary;Greece;Spain;Netherlands;Germany;Italy
339	EUCTR2010-021825-11-IT (EUCTR)	17/01/2011	08/02/2011	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE-3	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE-3	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064908 MedDRA version: 9.1;Classification code 10064909 MedDRA version: 9.1;Classification code 10064910	Trade Name: TRACLEER INN or Proposed INN: Bosentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
340	EUCTR2010-021572-29-DE (EUCTR)	11/01/2011	10/11/2010	An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired	An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired	Pulmonary Arterial Hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.0;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 3	France;Hungary;Greece;Spain;Netherlands;Germany;Italy
341	EUCTR2010-018863-40-AT (EUCTR)	05/01/2011	20/07/2010	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	Pulmonary arterial hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo	Bayer Health Care AG	NULL	Not Recruiting			Female: yes Male: yes	36		United Kingdom;Czech Republic;Germany;Spain;Italy;Poland;Austria
342	JPRN-UMIN000004369	2011/01/01	01/01/2011	Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease	Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease - Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease	Connective Tissue Disease	Bosentan	Tokushima University	NULL	Complete: follow-up complete	18years-old	85years-old	Male and Female	20	Not selected	Japan
343	EUCTR2010-021825-11-ES (EUCTR)	22/12/2010	12/11/2010	Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3	Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3	Hpertensión arterial pulmonar (PAH) en niños MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película INN or Proposed INN: BOSENTAN MONOHIDRATO Other descriptive name: BOSENTAN MONOHIDRATO	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 3	Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
344	EUCTR2010-021825-11-HU (EUCTR)	08/12/2010	04/11/2010	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
345	EUCTR2010-021825-11-CZ (EUCTR)	03/12/2010	03/12/2010	A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
346	EUCTR2010-019547-19-IT (EUCTR)	30/11/2010	14/12/2010	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529	pulmonary arterial hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911 MedDRA version: 9.1;Classification code 10065150 MedDRA version: 9.1;Classification code 10065151 MedDRA version: 9.1;Classification code 10065152	Trade Name: VOLIBRIS INN or Proposed INN: AMBRISENTAN Trade Name: VOLIBRIS INN or Proposed INN: AMBRISENTAN Product Name: AMBRISENTAN Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66		France;Hungary;Greece;Spain;Germany;Netherlands;Italy
347	EUCTR2010-021825-11-DE (EUCTR)	26/11/2010	08/11/2010	A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
348	EUCTR2010-021572-29-GR (EUCTR)	23/11/2010	26/10/2010	An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired	An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired	Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension	Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66		Hungary;Germany;Netherlands;Spain;Italy;Greece
349	EUCTR2009-014992-31-IE (EUCTR)	16/11/2010	15/04/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
350	EUCTR2009-011150-17-BE (EUCTR)	15/11/2010	14/06/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	614		United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
351	EUCTR2009-014490-41-IE (EUCTR)	15/11/2010	14/04/2010	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
352	EUCTR2010-019547-19-FR (EUCTR)	12/11/2010	23/08/2010	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension	Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Hungary;Greece;Spain;Germany;Netherlands;Italy
353	EUCTR2009-014992-31-GR (EUCTR)	09/11/2010	09/11/2010	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
354	EUCTR2010-019547-19-NL (EUCTR)	05/11/2010	01/07/2010	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension	Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	France;Hungary;Greece;Spain;Germany;Netherlands;Italy
355	EUCTR2009-018167-26-FR (EUCTR)	04/11/2010	13/09/2010	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	140		France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
356	NCT01244620 (ClinicalTrials.gov)	November 2010	15/11/2010	A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses	A Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy Subjects	Pulmonary Arterial Hypertension	Drug: sitaxentan;Drug: tadalafil;Drug: sitaxsentan;Drug: sildenafil	Pfizer	NULL	Terminated	21 Years	55 Years	All	16	Phase 1	Singapore
357	NCT01260454 (ClinicalTrials.gov)	November 2010	9/12/2010	The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain	The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain	Pulmonary Hypertension;Pulmonary Arterial Hypertension	Drug: Qutenza (8% capsaicin)	University of Rochester	United Therapeutics	Completed	15 Years	80 Years	All	6	Phase 2	United States
358	NCT01210443 (ClinicalTrials.gov)	November 2010	11/8/2010	Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients	A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension	Hypertension, Pulmonary	Drug: Sitaxentan	Pfizer	NULL	Terminated	16 Years	80 Years	All	2	Phase 3	Japan
359	EUCTR2009-014992-31-PL (EUCTR)	19/10/2010	20/05/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
360	EUCTR2010-019547-19-HU (EUCTR)	15/10/2010	12/07/2010	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension	Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Product Name: ambrisentan Product Code: GSK1325760	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	France;Hungary;Greece;Spain;Germany;Netherlands;Italy
361	EUCTR2009-014490-41-GR (EUCTR)	11/10/2010	04/10/2010	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
362	EUCTR2010-019547-19-ES (EUCTR)	06/10/2010	15/07/2010	Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	Hipertensión arterial pulmonar MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 13;Level: PT;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar	Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN	GlaxoSmithKline, S.A.	NULL	Not Recruiting			Female: yes Male: yes	66	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Hungary;Greece;Spain;Germany;Netherlands;Italy
363	EUCTR2010-019547-19-DE (EUCTR)	05/10/2010	14/07/2010	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	France;Hungary;Greece;Spain;Netherlands;Germany;Italy
364	EUCTR2007-003975-38-AT (EUCTR)	03/10/2010	28/08/2007	Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH	Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH	Pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension	Product Name: Terguride 0.5 mg tablet INN or Proposed INN: Terguride Other descriptive name: Transdihydrolisuride	Ergonex Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	99	Phase 2	Czech Republic;Germany;Netherlands;Austria
365	JPRN-UMIN000012669	2010/10/01	01/10/2015	Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management-	Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management- - Sildenafil for pulmonary arterial hypertension after pediatric cardiac surgery	pulmonary hypertension	Sildenafil will be administered via a nasogastric tube or orally at a dose of 0.5 mg/kg. If the investigator note there is no effect of sildenafil on any parameters and clinical conditions, a repeat dose of sildenafil (0.5 or 1.0 mg/kg) can be given 4 hours after the initial administration by the investigators judgment. Sildenafil will be gradually weaned off for 5 to 7 days.	Osaka Medical College	NULL	Complete: follow-up complete	Not applicable	24months-old	Male and Female	20	Not applicable	Japan
366	EUCTR2009-011150-17-FR (EUCTR)	24/09/2010	13/08/2010	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	352	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
367	EUCTR2010-019883-36-IT (EUCTR)	20/09/2010	24/09/2010	ND	A 24 week, randomized, double blind, multicenter, placebocontrolled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: TASIGNA INN or Proposed INN: nilotinib Trade Name: TASIGNA INN or Proposed INN: nilotinib Trade Name: TASIGNA INN or Proposed INN: nilotinib	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	55		United States;Hungary;Canada;Singapore;Germany;Italy;Korea, Republic of
368	EUCTR2009-018167-26-IT (EUCTR)	20/09/2010	14/07/2010	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension: IMPRES Extension - ND	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension: IMPRES Extension - ND	pulmonary arterial hypertension MedDRA version: 9.1;Level: PT;Classification code 10037400	Trade Name: GLIVEC INN or Proposed INN: IMATINIB	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	140		France;Belgium;Spain;Austria;Germany;United Kingdom;Italy
369	EUCTR2009-018167-26-GB (EUCTR)	07/09/2010	21/06/2010	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	140	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
370	NCT01165047 (ClinicalTrials.gov)	September 2010	16/7/2010	Nitric Oxide, GeNO Nitrosyl Delivery System	An Open Label, Non-Randomized Pilot Study to Evaluate the Safety and Performance of the GeNO Nitrosyl Delivery System in Subjects Being Evaluated for Orthotopic Heart Transplantation (OHT), or Left Ventricular Assist Device (LVAD) Implantation	Pulmonary Arterial Hypertension	Drug: Nitric Oxide	Aurora Health Care	NULL	Completed	18 Years	N/A	All	10	Phase 2	United States
371	EUCTR2010-019883-36-HU (EUCTR)	31/08/2010	08/07/2010	A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)	A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy. MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tasigna® Product Name: Tasigna Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: nilotinib Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: Nilotinib Product Code: AMN107 INN or Proposed INN: nilotinib	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	66		Hungary;Germany
372	EUCTR2009-018167-26-BE (EUCTR)	31/08/2010	18/05/2010	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 3	France;Spain;Belgium;Austria;Germany;Italy;United Kingdom
373	EUCTR2009-011150-17-NL (EUCTR)	26/08/2010	26/05/2010	Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	545	Phase 4	France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden
374	EUCTR2009-014490-41-DE (EUCTR)	24/08/2010	10/06/2010	Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
375	EUCTR2009-014992-31-DE (EUCTR)	24/08/2010	08/06/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
376	EUCTR2009-014992-31-CZ (EUCTR)	20/08/2010	19/08/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
377	EUCTR2009-011150-17-DE (EUCTR)	16/08/2010	03/08/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	614		United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden
378	EUCTR2009-011150-17-GB (EUCTR)	11/08/2010	22/06/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	545	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
379	EUCTR2009-014490-41-IT (EUCTR)	06/08/2010	28/12/2011	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate the efficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Belarus;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Singapore;Germany;Sweden
380	EUCTR2009-014992-31-IT (EUCTR)	06/08/2010	28/12/2011	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term, single-arm, open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON-OL	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Belarus;United States;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Germany;Sweden
381	EUCTR2009-011150-17-IT (EUCTR)	06/08/2010	09/08/2010	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911	Trade Name: VOLIBRIS Trade Name: CIALIS INN or Proposed INN: Tadalafil	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	352		France;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
382	EUCTR2009-011150-17-AT (EUCTR)	03/08/2010	22/06/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
383	NCT01077297 (ClinicalTrials.gov)	August 2010	25/2/2010	Tezosentan in Pulmonary Arterial Hypertension	Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines	Pulmonary Arterial Hypertension	Drug: Tezosentan	Idorsia Pharmaceuticals Ltd.	NULL	Terminated	18 Years	N/A	All	3	Phase 2	United States;France;Switzerland
384	EUCTR2009-014490-41-AT (EUCTR)	28/07/2010	28/05/2010	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessing the safety and efficacy of selexipag on morbidity and mortality in patients with pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
385	EUCTR2009-014992-31-AT (EUCTR)	28/07/2010	28/05/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
386	EUCTR2009-014490-41-HU (EUCTR)	27/07/2010	18/05/2010	Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
387	EUCTR2009-014992-31-HU (EUCTR)	27/07/2010	01/06/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
388	EUCTR2010-018863-40-CZ (EUCTR)	22/07/2010	02/06/2010	Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	Pulmonary arterial hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 0.5 mg Product Code: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
389	EUCTR2010-018863-40-IT (EUCTR)	20/07/2010	20/08/2010	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	Pulmonary arterial hypertension. MedDRA version: 9.1;Level: LLT;Classification code 10064911	Product Name: Riociguat Product Name: Riociguat Product Name: Riociguat Product Name: Riociguat	Bayer Health Care AG	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
390	EUCTR2009-011150-17-GR (EUCTR)	16/07/2010	14/07/2010	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	352		France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
391	EUCTR2010-018863-40-DE (EUCTR)	16/07/2010	26/04/2010	Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters	An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS	Pulmonary arterial hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR tablets 0.5 mg Product Code: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	18		Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
392	EUCTR2010-019547-19-GR (EUCTR)	16/07/2010	30/06/2010	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.	Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension	Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan	GlaxoSmithKline Research & Development, Ltd	NULL	Not Recruiting			Female: yes Male: yes	66		Hungary;Germany;Netherlands;France;Spain;Italy;Greece
393	EUCTR2009-014453-32-CZ (EUCTR)	15/07/2010	11/02/2010	NA	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Belgium;Ireland;Germany
394	EUCTR2009-011150-17-SE (EUCTR)	14/07/2010	18/06/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
395	EUCTR2009-011150-17-ES (EUCTR)	13/07/2010	02/06/2010	AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Hipertensión arterial pulmonar MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar	Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Trade Name: CIALIS 20 mg comprimidos recubiertos con película INN or Proposed INN: TADALAFILO Other descriptive name: TADALAFIL	GlaxoSmithKline,S.A.	NULL	Not Recruiting			Female: yes Male: yes	352		France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
396	EUCTR2010-018322-40-BE (EUCTR)	02/07/2010	07/04/2010	A clinical research study to evaluate the safety of changing from Flolan to a new drug called Epoprostenol-Actelion in patients suffering from pulmonary arterial hypertension	A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM	ACTELION Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	France;Canada;Spain;Belgium;Netherlands;Italy
397	EUCTR2010-018320-10-BE (EUCTR)	02/07/2010	13/04/2010	An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)	An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM	ACTELION Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40		France;Canada;Spain;Belgium;Netherlands;Italy
398	EUCTR2006-000804-18-PT (EUCTR)	02/07/2010	25/01/2010	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	France;Portugal;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
399	NCT01179737 (ClinicalTrials.gov)	July 2010	3/8/2010	Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)	A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension	Drug: Nilotinib;Drug: Placebo to nilotinib	Novartis Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	23	Phase 2	United States;Canada;Germany;Korea, Republic of;Singapore;Switzerland;Hungary;Italy
400	NCT01305252 (ClinicalTrials.gov)	July 2010	2/11/2010	A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).	CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on Tadalafil	Hypertension, Pulmonary	Drug: treprostinil inhalations;Drug: tadalafil	Stanford University	Northwestern University	Completed	18 Years	69 Years	All	21	Phase 4	United States
401	EUCTR2010-020917-97-IT (EUCTR)	23/06/2010	28/12/2011	SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1	SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1	Moderate to severe pulmonary hypertension associated to moderate to mild COPD. MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10010952;Term: COPD;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	INN or Proposed INN: Sildenafil	ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI	NULL	Not Recruiting			Female: yes Male: yes			Italy
402	EUCTR2008-003610-94-GR (EUCTR)	15/06/2010	11/01/2010	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
403	EUCTR2008-003482-68-GR (EUCTR)	15/06/2010	09/11/2009	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study, amend 4	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study, amend 4	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462		Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
404	NCT01174173 (ClinicalTrials.gov)	June 2010	23/7/2010	Ranolazine and Pulmonary Hypertension	Effects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial Hypertension	Angina;Pulmonary Arterial Hypertension	Drug: Ranolazine	Northwestern University	Gilead Sciences	Completed	18 Years	80 Years	All	11	Phase 3	United States
405	EUCTR2010-018322-40-FR (EUCTR)	20/05/2010	29/03/2010	A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2	A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2	Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Epoprostenol-Actelion Product Name: Epoprostenol-Actelion Product Code: ACT-385781A INN or Proposed INN: EPOPROSTENOL SODIUM	ACTELION Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 3	France;Spain;Belgium;Netherlands;Italy
406	EUCTR2009-018167-26-DE (EUCTR)	04/05/2010	11/03/2010	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	140		France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
407	EUCTR2009-018167-26-AT (EUCTR)	15/04/2010	16/02/2010	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension	Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	140		France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
408	EUCTR2009-014246-29-DE (EUCTR)	08/04/2010	16/11/2009	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium	Lung Rx	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Czech Republic;Belgium;Ireland;Germany
409	NCT01117987 (ClinicalTrials.gov)	April 2010	3/5/2010	Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)	An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension	Pulmonary Arterial Hypertension	Drug: Imatinib;Drug: Placebo	Novartis Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	144	Phase 3	United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Switzerland;United Kingdom;Sweden
410	NCT00995566 (ClinicalTrials.gov)	April 2010	17/9/2009	A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin	Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin	Pulmonary Arterial Hypertension	Drug: Sitaxentan sodium	Pfizer	NULL	Terminated	18 Years	N/A	All	54	N/A	Belgium;France;Germany;Sweden
411	EUCTR2009-014490-41-GB (EUCTR)	23/03/2010	17/03/2010	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
412	EUCTR2009-009366-13-PT (EUCTR)	05/03/2010	03/11/2009	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
413	EUCTR2009-014490-41-BE (EUCTR)	22/02/2010	23/11/2009	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
414	EUCTR2009-014992-31-BE (EUCTR)	22/02/2010	23/11/2009	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
415	EUCTR2009-014246-29-CZ (EUCTR)	18/02/2010	07/12/2009	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung Rx Inc	NULL	Not Recruiting			Female: yes Male: yes	36		Germany;Czech Republic;Belgium;Ireland
416	EUCTR2009-014490-41-FR (EUCTR)	12/02/2010	26/11/2009	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON 2	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON 2	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	272	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
417	EUCTR2009-014490-41-SE (EUCTR)	06/02/2010	14/12/2009	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of
418	EUCTR2009-014992-31-SE (EUCTR)	06/02/2010	14/12/2009	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
419	EUCTR2009-014992-31-DK (EUCTR)	05/02/2010	17/12/2009	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
420	EUCTR2009-014246-29-IE (EUCTR)	01/02/2010	06/11/2009	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium	Lung Rx	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Germany;Belgium;Ireland
421	EUCTR2009-014453-32-IE (EUCTR)	01/02/2010	09/11/2009	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC Inc	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Belgium;Ireland;Germany
422	EUCTR2006-000804-18-SE (EUCTR)	28/01/2010	03/12/2009	An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
423	EUCTR2009-014992-31-FR (EUCTR)	27/01/2010	26/11/2009	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	544	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
424	EUCTR2009-014490-41-ES (EUCTR)	22/01/2010	02/12/2009	Estudio en fase III, multicéntrico, a doble ciego y controlado con placebo, para demostrar la eficacia y seguridad de ACT-293987 en pacientes con hipertensión arterial pulmonar (PAH) - GRIPHON 2	Estudio en fase III, multicéntrico, a doble ciego y controlado con placebo, para demostrar la eficacia y seguridad de ACT-293987 en pacientes con hipertensión arterial pulmonar (PAH) - GRIPHON 2	Hipertensión Arterial Pulmonar MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	272		Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
425	EUCTR2009-014992-31-ES (EUCTR)	22/01/2010	02/12/2009	Estudio de extensión abierta, de grupo único de tratamiento y a largo plazo, para evaluar la seguridad y tolerabilidad de ACT-293987 en pacientes con hipertensión arterial pulmonar - GRIPHON OL	Estudio de extensión abierta, de grupo único de tratamiento y a largo plazo, para evaluar la seguridad y tolerabilidad de ACT-293987 en pacientes con hipertensión arterial pulmonar - GRIPHON OL	Hipertensión Arterial Pulmonar MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	544	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
426	EUCTR2008-007455-26-AT (EUCTR)	21/01/2010	10/03/2009	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension	Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries. MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Cicletanine hydrochloride Product Code: NA Product Name: Cicletanine hydrochloride Product Code: NA	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United Kingdom;Germany;Belgium;Spain;Austria
427	EUCTR2008-005886-78-CZ (EUCTR)	12/01/2010	10/12/2008	A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	PULMONARY ARTERIAL HYPERTENSION MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions	Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil citrate	Pfizer Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
428	EUCTR2008-005885-30-CZ (EUCTR)	12/01/2010	10/12/2008	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	Pulmonary arterial hypertension MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions	Trade Name: Thelin INN or Proposed INN: SITAXSENTAN SODIUM	Pfizer Ltd	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
429	EUCTR2008-005887-14-CZ (EUCTR)	12/01/2010	10/12/2008	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil Citrate	Pfizer Ltd.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
430	EUCTR2009-014453-32-BE (EUCTR)	11/01/2010	09/11/2009	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	United States;Czech Republic;Belgium;Ireland;Romania;Germany
431	EUCTR2009-012057-38-NL (EUCTR)	05/01/2010	23/11/2009	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	200		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
432	NCT01148836 (ClinicalTrials.gov)	January 2010	19/3/2010	Coenzyme Q-10 and Pulmonary Arterial Hypertension	Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Dietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects;Dietary Supplement: Coenzyme Q-10 in Normal Control subjects	The Cleveland Clinic	NULL	Completed	18 Years	55 Years	All	18	N/A	United States
433	NCT01066845 (ClinicalTrials.gov)	January 2010	3/2/2010	Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension	Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan	Pulmonary Arterial Hypertension	Drug: tadalafil	Eli Lilly and Company	NULL	Completed	15 Years	N/A	Both	1809	N/A	NULL
434	EUCTR2008-007455-26-GB (EUCTR)	31/12/2009	14/04/2009	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension	Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries. MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Cicletanine hydrochloride Product Code: Not applicable Product Name: Cicletanine hydrochloride Product Code: Not applicable	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Spain;Belgium;Austria;Germany;United Kingdom
435	EUCTR2009-009366-13-SE (EUCTR)	17/12/2009	22/10/2009	A study to assess how safe and effective an oral UT-15C tablet is when given to subjects with high blood pressure in the artery that carries blood to the lungs	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Germany;Netherlands;France;Italy;Austria;Sweden;Israel;United Kingdom;Mexico;Belgium;Puerto Rico;Spain
436	EUCTR2009-014246-29-BE (EUCTR)	09/12/2009	09/11/2009	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung Rx Inc	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Czech Republic;Belgium;Ireland;Germany
437	EUCTR2009-014490-41-DK (EUCTR)	08/12/2009	23/11/2009	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
438	NCT01445873 (ClinicalTrials.gov)	December 1, 2009	30/9/2011	Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)	NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)	Pulmonary Arterial Hypertension	Drug: Sitaxentan sodium	Pfizer	NULL	Completed	18 Years	N/A	All	36		NULL
439	NCT00990314 (ClinicalTrials.gov)	November 30, 2009	5/10/2009	Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients	An Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients	Pulmonary Arterial Hypertension	Drug: Beraprost Sodium Modified Release	Lung Biotechnology PBC	NULL	Completed	18 Years	75 Years	All	31	Phase 2	United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
440	EUCTR2009-009366-13-FR (EUCTR)	26/11/2009	06/11/2009	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Portugal;France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
441	EUCTR2008-003572-21-SE (EUCTR)	19/11/2009	25/08/2008	A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION	A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION	Pulmonary arterial hypertension. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: PF-00489791 Product Name: PF-00489791 Product Name: PF-00489791 Trade Name: Revatio	Pfizer Ltd,Ramsgate Road,Sandwich,Kent CT13 9NJ	NULL	Not Recruiting			Female: yes Male: yes	79	Phase 2	Germany;Belgium;Spain;Sweden
442	EUCTR2009-009366-13-ES (EUCTR)	18/11/2009	24/09/2009	Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Estudio internacional, multicéntrico, aleatorizado, doble ciego y controlado con placebo de 16 semanas de duración sobre la eficacia y la seguridad de UT-15C por vía oral en comprimidos de liberación lenta en pacientes con hipertensión arterial pulmonarA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Hipertensión Arterial PulmonarPulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: treprostinil dietanolamina Product Code: UT-15C SR INN or Proposed INN: treprostinil dietanolamina Product Name: treprostinil dietanolamina Product Code: UT-15C INN or Proposed INN: treprostinil dietanolamina Product Name: treprostinil dietanolamina Product Code: UT-15C INN or Proposed INN: treprostinil dietanolamina	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;Portugal;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
443	EUCTR2009-009366-13-IT (EUCTR)	17/11/2009	11/12/2009	A 16-Week, International, Multicenter, Double-Blind, Randomized,Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C SustainedRelease Tablets in Subjects with Pulmonary ArterialHypertension - Freedom C	A 16-Week, International, Multicenter, Double-Blind, Randomized,Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C SustainedRelease Tablets in Subjects with Pulmonary ArterialHypertension - Freedom C	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil	UNITED THERAPEUTICS	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
444	EUCTR2009-012057-38-IT (EUCTR)	06/11/2009	30/10/2009	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study (IMPRES) - ND	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study (IMPRES) - ND	Pulmonary arterial hypertension, MedDRA version: 9.1;Level: PT;Classification code 10037400	Trade Name: GLIVEC INN or Proposed INN: Imatinib	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	200		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
445	EUCTR2008-003482-68-PT (EUCTR)	04/11/2009	22/09/2009	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462		United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Germany;Japan;New Zealand;Sweden
446	EUCTR2009-009366-13-NL (EUCTR)	04/11/2009	18/08/2009	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
447	EUCTR2008-003610-94-PT (EUCTR)	04/11/2009	22/09/2009	Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Singapore;Poland;Belgium;Brazil;Germany;New Zealand;Japan;Sweden
448	EUCTR2007-003694-27-DK (EUCTR)	30/10/2009	10/03/2008	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands;Sweden
449	EUCTR2005-005068-97-BE (EUCTR)	29/10/2009	10/06/2009	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden
450	EUCTR2009-009366-13-BE (EUCTR)	23/10/2009	04/09/2009	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		France;Portugal;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
451	EUCTR2009-009366-13-AT (EUCTR)	22/10/2009	23/09/2009	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
452	EUCTR2009-012450-20-FR (EUCTR)	15/10/2009	07/09/2009	Multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines	Multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines	Pulmonary arterial hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Tezosentan Product Code: ACT-050089 (Ro 61-0612) INN or Proposed INN: tezosentan Other descriptive name: Tezosentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	13	Phase 2	France
453	EUCTR2009-012057-38-ES (EUCTR)	02/10/2009	02/07/2009	Ensayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRES	Ensayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRES	Pacientes con Hipertensión Arterial Pulmonar (HAP) que tienen una RVP>1000 dynes.sec.cm-5 a pesar de estar en tratamiento con dos o mas terapias específicas para la HAP. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: GLIVEC 100 mg comprimidos recubiertos con película INN or Proposed INN: IMATINIB Other descriptive name: IMATINIB	Novartis Farmacéutica SA	NULL	Not Recruiting			Female: yes Male: yes	200		France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
454	EUCTR2008-007455-26-ES (EUCTR)	28/09/2009	23/04/2009	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensionEstudio en fase II , de asignación aleatoria, doblemente ciego, controlado con placebo y multicéntrico. Estudio de búsqueda de dosis con cicletanina en sujetos con hipertensión arterial pulmonar	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensionEstudio en fase II , de asignación aleatoria, doblemente ciego, controlado con placebo y multicéntrico. Estudio de búsqueda de dosis con cicletanina en sujetos con hipertensión arterial pulmonar	Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries.La hipertensión pulmonar (PH) es una enfermedad grave y potencialmente mortal de la vasculatura pulmonar, caracterizada por una vasoconstricción profunda y una proliferación anómala de células musculares lisas en las paredes de las arterías pulmonares MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Cicletanine hydrochloride Product Name: Cicletanine hydrochloride	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United Kingdom;Germany;Belgium;Spain;Austria
455	EUCTR2009-012057-38-FR (EUCTR)	21/09/2009	07/07/2009	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	200		France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
456	EUCTR2009-012057-38-BE (EUCTR)	18/09/2009	22/07/2009	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
457	EUCTR2009-009366-13-GB (EUCTR)	02/09/2009	07/08/2009	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
458	NCT00902174 (ClinicalTrials.gov)	September 2009	13/5/2009	Imatinib (QTI571) in Pulmonary Arterial Hypertension	A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES)	Pulmonary Arterial Hypertension	Drug: imatinib mesylate;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	202	Phase 3	United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Switzerland;United Kingdom
459	EUCTR2009-012057-38-GB (EUCTR)	18/08/2009	15/07/2010	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
460	EUCTR2009-012057-38-DE (EUCTR)	13/08/2009	10/06/2009	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	Pulmonary arterial hypertension (PAH) patients who have a PVR =800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® 100 mg Filmtabletten Product Code: QTI571 INN or Proposed INN: Imatinib mesilate	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
461	EUCTR2008-007455-26-DE (EUCTR)	13/08/2009	23/03/2009	Cicletanine Phase II for Pulmonary Arterial Hypertension	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension	Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries. MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Cicletanine hydrochloride Product Name: Cicletanine hydrochloride	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Mexico;Canada;Spain;Belgium;Austria;Australia;Israel;Germany;United Kingdom
462	EUCTR2009-012057-38-SE (EUCTR)	12/08/2009	08/07/2009	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
463	EUCTR2009-012057-38-AT (EUCTR)	17/07/2009	15/06/2009	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES	Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Glivec® Product Code: QTI571 INN or Proposed INN: IMATINIB MESYLATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	200		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
464	EUCTR2008-003290-41-IE (EUCTR)	29/06/2009	11/12/2008	A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients	A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	LungRx	NULL	Not Recruiting			Female: yes Male: yes	10		Belgium;Ireland
465	EUCTR2008-006833-29-IE (EUCTR)	29/06/2009	11/12/2008	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC	NULL	Not Recruiting			Female: yes Male: yes	19		Belgium;Ireland
466	EUCTR2008-005886-78-BG (EUCTR)	25/06/2009	19/06/2009	A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	PULMONARY ARTERIAL HYPERTENSION MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions	Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil citrate	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
467	EUCTR2008-005887-14-BG (EUCTR)	25/06/2009	19/06/2009	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil Citrate	Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
468	EUCTR2008-005885-30-BG (EUCTR)	25/06/2009	19/06/2009	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	Pulmonary arterial hypertension MedDRA version: 13.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Thelin INN or Proposed INN: SITAXSENTAN SODIUM	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
469	EUCTR2005-005068-97-CZ (EUCTR)	16/06/2009	11/06/2009	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
470	EUCTR2009-010703-80-DE (EUCTR)	11/06/2009	17/04/2009		A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15	Indication: Symptomatic Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Ventavis Product Name: Iloprost INN or Proposed INN: Iloprost	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	63		Germany;Austria
471	EUCTR2008-007455-26-BE (EUCTR)	08/06/2009	30/03/2009	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial Hypertension	Pulmonary hypertension (PH) is a serious and life-threatening disease of the pulmonary vasculature, characterized by profound vasoconstriction and an abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries. MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Cicletanine hydrochloride Product Name: Cicletanine hydrochloride	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Spain;Belgium;Austria;Germany;United Kingdom
472	EUCTR2008-003482-68-ES (EUCTR)	08/06/2009	24/10/2008	Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg ,tid )administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática-Estudio PATENT -1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Hipertensión Arterial Pulmonar (HAP) Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
473	EUCTR2009-010703-80-AT (EUCTR)	03/06/2009	04/05/2009		A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15	Indication: Symptomatic Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Ventavis Product Name: Iloprost INN or Proposed INN: Iloprost	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	63		Germany;Austria
474	EUCTR2009-011013-24-AT (EUCTR)	03/06/2009	30/04/2009	A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extension	A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extension	Indication: Symptomatic Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Ventavis Product Name: Iloprost INN or Proposed INN: Iloprost	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	63		Austria
475	NCT00887978 (ClinicalTrials.gov)	June 2009	23/4/2009	Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension	Pulmonary Hypertension	Drug: UT-15C SR;Drug: Placebo	United Therapeutics	NULL	Completed	18 Years	75 Years	All	310	Phase 3	United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Portugal;Spain;Sweden;United Kingdom;Ireland;Norway
476	EUCTR2008-003610-94-GB (EUCTR)	20/05/2009	27/11/2008	Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 at different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: R	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	462	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden
477	EUCTR2007-003975-38-CZ (EUCTR)	19/05/2009	13/02/2009	Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH	Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH	Pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension	Product Name: Terguride 0.5 mg tablet INN or Proposed INN: Terguride Other descriptive name: Transdihydrolisuride	Ergonex Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	84	Phase 2	Germany;Czech Republic;Netherlands;Austria
478	EUCTR2008-003610-94-DK (EUCTR)	24/04/2009	12/03/2009	Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Germany;New Zealand;Japan;Sweden
479	EUCTR2008-003610-94-IE (EUCTR)	06/04/2009	09/01/2009	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462		Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece
480	EUCTR2008-005886-78-SK (EUCTR)	06/04/2009	20/02/2009	A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	PULMONARY ARTERIAL HYPERTENSION MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions	Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil citrate	Pfizer Limited, Ramsgate Road, Sandwich, Kent UK	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Slovakia;Bulgaria
481	EUCTR2008-005885-30-SK (EUCTR)	06/04/2009	20/02/2009	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	Pulmonary arterial hypertension MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions	Trade Name: Thelin INN or Proposed INN: SITAXSENTAN SODIUM	Pfizer Limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Slovakia;Bulgaria
482	EUCTR2007-003328-39-AT (EUCTR)	02/04/2009	18/01/2008	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: NS-304 INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Nippon Shinyaku Co., LTD	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
483	EUCTR2008-005887-14-SK (EUCTR)	01/04/2009	20/02/2009	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil Citrate	Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Slovakia;Bulgaria
484	NCT00864201 (ClinicalTrials.gov)	April 2009	17/3/2009	A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease	A Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease	Hypertension, Pulmonary;Connective Tissue Disease	Drug: bosentan	Hamilton Health Sciences Corporation	Actelion	Not yet recruiting	18 Years	N/A	Both	10	Phase 3	Canada
485	NCT00878943 (ClinicalTrials.gov)	March 31, 2009	8/4/2009	Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study	A Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.	Pulmonary Arterial Hypertension	Drug: Sildenafil citrate	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	NULL	No longer available	18 Years	N/A	All			India
486	EUCTR2007-003621-24-AT (EUCTR)	30/03/2009	23/04/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
487	EUCTR2008-003572-21-BE (EUCTR)	20/03/2009	08/09/2008	A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION	A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION	Pulmonary arterial hypertension. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: PF-00489791 Product Name: PF-00489791 Product Name: PF-00489791 Trade Name: Revatio Product Name: REVATIO INN or Proposed INN: Sildenafil Citrate	Pfizer Ltd,Ramsgate Road,Sandwich,Kent CT13 9NJ	NULL	Not Recruiting			Female: yes Male: yes	79	Phase 2	Germany;Belgium;Spain;Sweden
488	EUCTR2007-006453-12-AT (EUCTR)	19/03/2009	23/06/2008	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension	A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02)	Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: Selexipag, ACT-293987 (NS-304) INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
489	EUCTR2008-003482-68-DK (EUCTR)	16/03/2009	02/02/2009	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG, D-51368 Leverkusen	NULL	Not Recruiting			Female: yes Male: yes	462		Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
490	EUCTR2008-003482-68-AT (EUCTR)	13/03/2009	21/10/2008	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
491	EUCTR2008-003610-94-AT (EUCTR)	13/03/2009	18/11/2008	Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden
492	EUCTR2008-003482-68-GB (EUCTR)	09/03/2009	07/01/2009	Study to evaluate the efficacy and safety of different doses of Bay 63-2521 in patients with pulmonary arterial hypertension.	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG, D-51368 Leverkusen	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Germany;New Zealand;Japan;Sweden
493	EUCTR2008-003610-94-BE (EUCTR)	05/03/2009	23/01/2009	Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden
494	EUCTR2008-003610-94-IT (EUCTR)	05/03/2009	17/03/2009	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH - PATENT 2	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH - PATENT 2	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462		United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden;Portugal;Greece;Spain;Ireland;Austria;Italy
495	EUCTR2008-003482-68-IT (EUCTR)	17/02/2009	17/03/2009	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH) - PATENT 1	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH) - PATENT 1	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat	Bayer Healthcare AG	NULL	Not Recruiting			Female: yes Male: yes	462		Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
496	EUCTR2008-003482-68-NL (EUCTR)	13/02/2009	30/10/2008	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462		Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
497	EUCTR2008-003610-94-NL (EUCTR)	13/02/2009	28/04/2009	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Netherlands;Germany;Sweden
498	EUCTR2008-003610-94-CZ (EUCTR)	12/02/2009	02/02/2009	Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Germany;New Zealand;Japan;Sweden
499	EUCTR2008-003290-41-BE (EUCTR)	04/02/2009	09/12/2008	A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients	A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung Rx	NULL	Not Recruiting			Female: yes Male: yes	20		Belgium;Ireland
500	EUCTR2008-006833-29-BE (EUCTR)	04/02/2009	16/12/2008	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC	NULL	Not Recruiting			Female: yes Male: yes	19	Phase 2	United States;Belgium;Ireland
501	JPRN-UMIN000001709	2009/02/01	16/02/2009	Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension	Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension - Multikinase Inhibitor for Pulmonary Arterial Hypertension	pulmonary arterial hypertension	administration of sorafenib, which is the multikinase inhibitor (tyrosine and serine/threonine kinase inhibitor)	Medical Education Center, School of Medicine, Keio University	NULL	Pending	20years-old	Not applicable	Male and Female	10	Not selected	Japan
502	EUCTR2008-003572-21-DE (EUCTR)	30/01/2009	24/09/2008	A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OF PF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHIC AND FAMILIAL PULMONARY ARTERIAL HYPERTENSION	A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OF PF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHIC AND FAMILIAL PULMONARY ARTERIAL HYPERTENSION	Pulmonary arterial hypertension. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: PF-00489791 Product Name: PF-00489791 Product Name: PF-00489791 Trade Name: Revatio 20 mg Filmtabletten Product Name: Sildenafil Filmtabletten INN or Proposed INN: Sildenafil	Pfizer Ltd.	NULL	Not Recruiting			Female: yes Male: yes	79	Phase 2	Spain;Belgium;Germany;Sweden
503	EUCTR2006-006748-76-BG (EUCTR)	30/01/2009	06/01/2009	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	Pulmonary arterial hypertension (PAH)	Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate	Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	219		United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
504	EUCTR2008-003482-68-CZ (EUCTR)	23/01/2009	23/01/2009	Study to assess the efficacy and safety of different doses of a new drug (BAY 63 2521), given orally to patients with Pulmonary Arterial Hypertension.	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462		Germany;France;Ireland;Singapore;Austria;Sweden;Brazil;Australia;Czech Republic;Canada;New Zealand;Belgium;Korea, Republic of;United States;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Israel;United Kingdom;Russian Federation;Taiwan;Denmark;Argentina;Mexico;China;Thailand;Spain;Japan
505	EUCTR2008-003572-21-ES (EUCTR)	15/01/2009	15/10/2008	Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION	Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION	Hipertensión arterial pulmonarPulmonary arterial hypertension. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: PF-00489791 Product Name: PF-00489791 Product Name: PF-00489791 Trade Name: REVATIO 20 mg, comprimidos recubiertos con película INN or Proposed INN: SILDENAFILO Other descriptive name: SILDENAFIL	Pfizer, S.A.	NULL	Not Recruiting			Female: yes Male: yes	79	Phase 2	Belgium;Spain;Germany;Sweden
506	EUCTR2008-003482-68-BE (EUCTR)	14/01/2009	13/02/2009	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG, D-51368 Leverkusen	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
507	EUCTR2008-003610-94-FR (EUCTR)	14/01/2009	07/11/2008	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
508	EUCTR2008-003482-68-IE (EUCTR)	13/01/2009	10/10/2008	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
509	EUCTR2008-003482-68-FR (EUCTR)	27/12/2008	06/11/2008	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
510	EUCTR2008-003610-94-SE (EUCTR)	08/12/2008	14/11/2008	Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden
511	EUCTR2008-003482-68-SE (EUCTR)	05/12/2008	07/11/2008	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG, D-51368 Leverkusen	NULL	Not Recruiting			Female: yes Male: yes	462		Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
512	EUCTR2007-003621-24-GB (EUCTR)	02/12/2008	14/07/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
513	JPRN-UMIN000001578	2008/12/01	16/12/2008	Tyrosine Kinase Inhibitor for the Treatment of Severe Pulmonary Arterial Hypertension	Tyrosine Kinase Inhibitor for the Treatment of Severe Pulmonary Arterial Hypertension - Tyrosine Kinase Inhibitor for Pulmonary Arterial Hypertension	pulmonary arterial hypertension	administration of tyrosine kinase inhibitor (imatinib)	Medical Education Center	NULL		20years-old	Not applicable	Male and Female	10	Not selected	Japan
514	NCT00814645 (ClinicalTrials.gov)	December 2008	22/12/2008	Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers	A Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy Volunteers	Pulmonary Arterial Hypertension	Drug: Sodium Nitrite Inhalation Solution;Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)	Aires Pharmaceuticals, Inc.	NULL	Completed	18 Years	55 Years	Both	25	Phase 1	United States
515	EUCTR2008-003482-68-DE (EUCTR)	26/11/2008	02/10/2008	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462		Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
516	EUCTR2008-003610-94-DE (EUCTR)	26/11/2008	31/10/2008	Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study	Pulmonary Arterial Hypertension (PAH) MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden
517	EUCTR2007-003328-39-GB (EUCTR)	05/11/2008	19/03/2008	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;Germany;United Kingdom;Belgium;France;Italy;Austria
518	EUCTR2006-001464-23-GR (EUCTR)	04/11/2008	30/01/2009	A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A	A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil	Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ	NULL	Not Recruiting			Female: yes Male: yes	106		Czech Republic;Greece;Germany;Italy;United Kingdom
519	EUCTR2007-003694-27-DE (EUCTR)	28/10/2008	12/12/2007	Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
520	EUCTR2006-006748-76-LV (EUCTR)	22/10/2008	10/06/2008	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	Pulmonary arterial hypertension (PAH)	Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate	Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	219		United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
521	NCT00667823 (ClinicalTrials.gov)	October 17, 2008	24/4/2008	Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension	Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Macitentan	Actelion	NULL	Completed	12 Years	N/A	All	550	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;Finland;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Japan;Korea, Republic of;Norway;Portugal;Spain
522	EUCTR2006-006748-76-GB (EUCTR)	15/10/2008	02/09/2008	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	Pulmonary arterial hypertension (PAH)	Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate	Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	219	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Italy;United Kingdom
523	EUCTR2007-002440-14-DK (EUCTR)	14/10/2008	06/03/2008	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;France;Finland;Belgium;Austria;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden
524	EUCTR2007-002440-14-BG (EUCTR)	10/10/2008	13/10/2008	A study to assess the effects of macitentan on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Norway;Sweden
525	EUCTR2007-006453-12-BE (EUCTR)	03/10/2008	07/07/2008	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension	A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT 293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02)	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: Selexipag, ACT-293987 (NS-304) INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
526	NCT00866983 (ClinicalTrials.gov)	October 2008	20/3/2009	Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil	A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.	Pulmonary Arterial Hypertension	Drug: sildenafil (Revatio) 20 mg TID	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	NULL	No longer available	18 Years	N/A	All			Brazil
527	EUCTR2005-005068-97-GR (EUCTR)	23/09/2008	20/02/2009	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
528	EUCTR2007-006453-12-DE (EUCTR)	12/09/2008	19/12/2008	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension	A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)	Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: Selexipag, ACT-293987 (NS-304) INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
529	EUCTR2007-002440-14-PT (EUCTR)	05/09/2008	05/05/2008	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	France;Portugal;Finland;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden
530	JPRN-UMIN000001350	2008/09/01	01/10/2008	Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases	Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases - Keio university clinical trial for early pulmonary arterial hypertension with connective tissue diseases (KEEP-ACTIVE study)	Pulmonary arterial hypertension (PAH) associated with connective tissue disease	Beraprost sodium Beraprost sodium and Sildenafil citrate	Keio University	NULL	Complete: follow-up complete	18years-old	80years-old	Male and Female	70	Not selected	Japan
531	EUCTR2007-006453-12-FR (EUCTR)	20/08/2008	30/06/2008	A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)	A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension	Product Code: NS-304 INN or Proposed INN: 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide	Nippon Shinyaku Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
532	NCT00705588 (ClinicalTrials.gov)	August 2008	25/6/2008	Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.		Pulmonary Arterial Hypertension	Drug: Tadalafil;Drug: Vardenafil	Rabin Medical Center	NULL	Not yet recruiting	18 Years	N/A	Both	30	Phase 4	Israel
533	EUCTR2007-006453-12-GB (EUCTR)	31/07/2008	15/07/2008	A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)	A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
534	EUCTR2007-003694-27-PT (EUCTR)	24/07/2008	05/05/2008	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands;Sweden
535	EUCTR2007-003621-24-NL (EUCTR)	23/07/2008	13/03/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
536	EUCTR2007-003621-24-IT (EUCTR)	15/07/2008	17/11/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil	MONDOGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
537	EUCTR2007-006453-12-IT (EUCTR)	15/07/2008	21/07/2008	A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open extension study to NS 304/-02) - ND	A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open extension study to NS 304/-02) - ND	Pulmonary Arterial Hypertension (PHA) (idiopatic PAH, familiar PHA, and associated with collagen disease, corrected congenital vitium or anorexigen) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Code: NS-304	NIPPON SHINYAKU CO., LTD.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	France;Hungary;Belgium;Austria;Germany;United Kingdom;Italy
538	EUCTR2007-003621-24-ES (EUCTR)	07/07/2008	12/05/2008	Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar.	Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar.	Hipertensión arterial pulmonar (HAP) debida a hipertensión arterial pulmonar idiopática (HAPI), HAP familiar o HAP asociada con enfermedades del tejido conjuntivo (ETC) (p. ej. esclerosis sistémica, lupus eritematoso sistémico) o con defectos cardiacos congénitos reparados(DCCR). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
539	EUCTR2007-003694-27-NL (EUCTR)	04/07/2008	08/01/2008	Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
540	EUCTR2007-002440-14-NL (EUCTR)	03/07/2008	08/01/2008	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
541	EUCTR2007-001643-21-GB (EUCTR)	26/06/2008	10/10/2007	Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension	Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension	Pulmonary hypertension in patients with interstitial lung disease. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: Bosentan	Royal Brompton and Harefield NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
542	EUCTR2006-006748-76-GR (EUCTR)	24/06/2008	14/03/2008	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	Pulmonary arterial hypertension (PAH). MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480	Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UK	NULL	Not Recruiting			Female: yes Male: yes	284		United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
543	EUCTR2007-003621-24-BE (EUCTR)	20/06/2008	08/01/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
544	EUCTR2007-003694-27-IT (EUCTR)	14/06/2008	16/05/2008	Long-term, single-arm, open label extension study of the SERAPHIN study to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension. - SERAPHIN OL	Long-term, single-arm, open label extension study of the SERAPHIN study to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension. - SERAPHIN OL	Pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary	Product Name: ACT-064992 Product Code: ACT-064992	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Slovakia;Finland;Austria;Italy;United Kingdom;France;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands;Sweden
545	EUCTR2006-006748-76-BE (EUCTR)	10/06/2008	29/01/2008	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	Pulmonary arterial hypertension (PAH)	INN or Proposed INN: Sildenafil citrate INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate	Pfizer Ltd, Ramsgate Road, Sandwich, Kent UK	NULL	Not Recruiting			Female: yes Male: yes	219		United Kingdom;Netherlands;Denmark;Belgium;Bulgaria;Italy;Greece;Latvia
546	EUCTR2005-005068-97-PT (EUCTR)	06/06/2008	11/03/2008	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term:	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
547	EUCTR2007-002440-14-FR (EUCTR)	03/06/2008	06/02/2008	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Denmark;Bulgaria;Germany;Netherlands;Sweden
548	EUCTR2007-003694-27-FR (EUCTR)	03/06/2008	06/02/2008	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands;Sweden
549	EUCTR2007-002440-14-DE (EUCTR)	29/05/2008	20/12/2007	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;France;Finland;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden
550	EUCTR2007-003621-24-FR (EUCTR)	29/05/2008	27/12/2007	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
551	EUCTR2007-002440-14-SK (EUCTR)	16/05/2008	18/04/2008	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Denmark;Bulgaria;Germany;Netherlands;Sweden
552	EUCTR2007-003694-27-SK (EUCTR)	16/05/2008	18/04/2008	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands;Sweden
553	EUCTR2007-002440-14-GB (EUCTR)	15/05/2008	26/11/2007	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Denmark;Bulgaria;Germany;Netherlands;Sweden
554	EUCTR2005-005068-97-ES (EUCTR)	11/05/2008	03/03/2008	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2	Hipertensión Arterial PulmonarPatients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term:	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Portugal;Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
555	NCT00660179 (ClinicalTrials.gov)	May 2008	14/4/2008	Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension	A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: macitentan (ACT-064992);Drug: placebo	Actelion	NULL	Completed	12 Years	N/A	All	742	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Norway;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Finland;Former Serbia and Montenegro;Portugal
556	EUCTR2007-003328-39-HU (EUCTR)	25/04/2008	18/01/2008	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
557	EUCTR2007-003328-39-BE (EUCTR)	25/04/2008	27/11/2007	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
558	EUCTR2006-006748-76-NL (EUCTR)	23/04/2008	01/11/2007	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	Pulmonary arterial hypertension (PAH). MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480	Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UK	NULL	Not Recruiting			Female: yes Male: yes	284		United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
559	EUCTR2006-006748-76-IT (EUCTR)	21/04/2008	21/02/2008	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - ND	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - ND	Pulmonary arterial hypertension (PAH). MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Trade Name: Revatio INN or Proposed INN: Sildenafil Trade Name: Revatio INN or Proposed INN: Sildenafil Trade Name: Revatio INN or Proposed INN: Sildenafil	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	284		United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
560	EUCTR2007-002440-14-AT (EUCTR)	18/04/2008	19/02/2008	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
561	EUCTR2007-003694-27-AT (EUCTR)	18/04/2008	19/02/2008	Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
562	EUCTR2007-003328-39-IT (EUCTR)	11/04/2008	02/07/2008	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over. - ND	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over. - ND	pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: NS-304 Product Code: NS-304 INN or Proposed INN: : 2-{4-[(5,6-difenilpirazin-2-yl)(isopropil)amino]butoxi}-N-	NIPPON SHINYAKU CO., LTD.	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
563	EUCTR2006-000804-18-DE (EUCTR)	10/04/2008	12/12/2007	An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungs	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Germany;Netherlands;Sweden
564	EUCTR2007-002440-14-SE (EUCTR)	04/04/2008	11/02/2008	A study to assess the effects of macitentan on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
565	EUCTR2006-000800-17-DE (EUCTR)	02/04/2008	19/05/2008	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
566	EUCTR2007-003694-27-BE (EUCTR)	01/04/2008	26/02/2008	Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
567	EUCTR2007-002440-14-BE (EUCTR)	01/04/2008	18/12/2007	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Denmark;Bulgaria;Germany;Netherlands;Sweden
568	EUCTR2007-002440-14-IT (EUCTR)	27/03/2008	15/07/2008	A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group, Event driven, Phase III study to assess the effects of ACT-064992 on Morbidity and Mortality in patients with Symptomatic Pulmonary Arterial Hypertension - SERAPHIN	A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group, Event driven, Phase III study to assess the effects of ACT-064992 on Morbidity and Mortality in patients with Symptomatic Pulmonary Arterial Hypertension - SERAPHIN	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary	Product Name: ACT - 064992 Product Code: ACT - 064992 Product Name: ACT - 064992 Product Code: ACT - 064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
569	EUCTR2007-003621-24-DE (EUCTR)	20/03/2008	13/02/2009	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria
570	EUCTR2007-002440-14-FI (EUCTR)	10/03/2008	11/02/2008	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN	To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
571	EUCTR2007-003694-27-FI (EUCTR)	10/03/2008	11/02/2008	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands;Sweden
572	EUCTR2007-003694-27-SE (EUCTR)	07/03/2008	11/02/2008	Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
573	EUCTR2005-005068-97-SK (EUCTR)	06/03/2008	06/07/2010	A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its own	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden
574	EUCTR2007-002803-42-AT (EUCTR)	05/03/2008	20/02/2008	Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial	Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial	Pulmonary arterial hypertension (PAH) is associated with poor prognosis.The most common cause of death is right heart failure. The fact that right heart failure is associated with low systemic perfusion pressures limits the systemic use of potent vasodilators in this patient population. As a consequence, no therapeutic recommendations exist for patients experiencing right heart failure in the course of PAH.	Trade Name: Ventavis(Iloprost) Product Name: Ventavis(Iloprost)	Univ.Clinic of Internal Medicine II, Department of Cardiology, Medical University of Vienna, Austria	NULL	Not Recruiting			Female: yes Male: yes	8		Austria
575	EUCTR2007-003975-38-NL (EUCTR)	18/02/2008	17/10/2007	Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH	Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH	Pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension	Product Name: Terguride 0,5mg tablet INN or Proposed INN: Terguride Other descriptive name: Transdihydrolisuride	Ergonex Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	84	Phase 2	Czech Republic;Germany;Netherlands;Austria
576	EUCTR2007-003328-39-DE (EUCTR)	13/02/2008	07/12/2007	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
577	EUCTR2007-003328-39-FR (EUCTR)	23/01/2008	29/11/2007	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: NS-304 INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Nippon Shinyaku Co., LTD	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
578	EUCTR2006-006748-76-DK (EUCTR)	21/01/2008	09/01/2008	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A	Pulmonary arterial hypertension (PAH)	Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate Trade Name: Revatio INN or Proposed INN: Sildenafil citrate	Pfizer Ltd, Ramsgate Road, Sandwich, Kent UK	NULL	Not Recruiting			Female: yes Male: yes	219		Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;United Kingdom;Italy
579	EUCTR2007-001645-17-GB (EUCTR)	04/12/2007	10/10/2007	Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease	Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease	Pulmonary hypertension in patients with interstitial lung disease. Specifically this trial looks at patients who have mild pulmonary hypertension, or are in an at-risk group to developing pulmonary hypertension, in the context of their interstitial lung disease. The interstitial lung diseases addressed include idiopathic pulmonary fibrosis and non-specific interstitial pneumonitis. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: Tracleer	Royal Brompton and Harefield NHS Trust	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
580	EUCTR2007-002774-64-DE (EUCTR)	04/12/2007	20/08/2007	Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil	Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil	Patients with pre-existing congenital heart disease may develop Eisenmenger physiology (EP), characterized by development of pulmonary arterial hypertension and intracardiac right to left shunt. This Patients suffer from cyanosis and reduced quality of life. While EP has been regarded as not amenable to conventional treatments, new oral drugs as Sildenafil have been used successfully to improve primary arterial hypertension. Thus may be an important treatment option for patients with EP, too.	Trade Name: Revatio INN or Proposed INN: SILDENAFIL	Deutsches Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler	NULL	Not Recruiting			Female: yes Male: yes	80		Germany
581	EUCTR2007-003975-38-DE (EUCTR)	22/11/2007	28/08/2007	Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH	Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH	Pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension	Product Name: Terguride 0,5mg tablet INN or Proposed INN: Terguride Other descriptive name: Transdihydrolisuride	Ergonex Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	99	Phase 2	Czech Republic;Austria;Netherlands;Germany
582	EUCTR2005-005068-97-GB (EUCTR)	30/10/2007	14/06/2007	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
583	EUCTR2005-005068-97-DK (EUCTR)	12/09/2007	11/05/2007	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
584	EUCTR2006-000800-17-IT (EUCTR)	27/08/2007	10/05/2007	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine	UNITED THERAPEUTICS	NULL	Not Recruiting			Female: yes Male: yes	300		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
585	EUCTR2006-000804-18-IT (EUCTR)	27/08/2007	03/04/2007	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Pulmonary Arterial Hypertension PAH MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Product Code: UT-15C SR Product Code: UT-15C SR Product Code: UT-15C SR Product Name: UT-15C SR	UNITED THERAPEUTICS	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
586	EUCTR2006-000801-50-NL (EUCTR)	03/07/2007	02/04/2007	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	France;Belgium;Austria;Netherlands;Italy
587	EUCTR2006-000804-18-NL (EUCTR)	19/06/2007	01/12/2006	An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 16.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
588	EUCTR2006-000800-17-NL (EUCTR)	19/06/2007	01/12/2006	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
589	EUCTR2005-005068-97-SE (EUCTR)	18/06/2007	02/04/2007	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
590	EUCTR2006-000801-50-IT (EUCTR)	12/06/2007	21/06/2007	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	Pulmonary Arterial Hypertension (PAH) MedDRA version: 6.1;Level: PT;Classification code 10037400	Product Name: treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	UNITED THERAPEUTICS	NULL	Not Recruiting			Female: yes Male: yes	150		Netherlands;Belgium;France;Italy;Austria
591	EUCTR2006-000804-18-FR (EUCTR)	11/06/2007	19/01/2007	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
592	EUCTR2006-000800-17-ES (EUCTR)	29/05/2007	02/03/2010	Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Corticircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
593	EUCTR2006-000804-18-ES (EUCTR)	29/05/2007	02/03/2010	Estudio abierto de ampliación con UT-15C LP en sujetos con hipertensión arterial pulmonarAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Estudio abierto de ampliación con UT-15C LP en sujetos con hipertensión arterial pulmonarAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Cortocircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) VIH. MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo Product Name: Dietanolamina de treprostinilo Product Code: UT-15C LP INN or Proposed INN: Dietanolamina de treprostinilo	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	450		Portugal;France;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
594	EUCTR2006-000800-17-FR (EUCTR)	21/05/2007	19/01/2007	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
595	EUCTR2006-000801-50-FR (EUCTR)	21/05/2007	19/01/2007	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	France;Belgium;Austria;Netherlands;Italy
596	EUCTR2006-004705-26-GB (EUCTR)	10/05/2007	17/04/2007	Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology	Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology	Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease) MedDRA version: 8.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome	Trade Name: Revatio ® 20 mg film-coated tablets Product Name: Sildenafil INN or Proposed INN: Sildenafil (REVATIO)	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 4	United Kingdom
597	EUCTR2006-000804-18-GB (EUCTR)	04/05/2007	22/11/2006	An extension study of UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungs	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
598	EUCTR2005-006192-13-PT (EUCTR)	26/04/2007	30/11/2006	A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the addition of inhaled iloprost in patients with pulmonary arterial hypertension (PAH) receiving oral sildenafil - VISION	A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the addition of inhaled iloprost in patients with pulmonary arterial hypertension (PAH) receiving oral sildenafil - VISION	Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Trade Name: Ventavis Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost	CoTherix, Inc	NULL	Not Recruiting			Female: yes Male: yes	180		Portugal;Germany;United Kingdom;Spain;Italy;Austria
599	EUCTR2006-000801-50-BE (EUCTR)	23/04/2007	25/01/2007	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	150		France;Belgium;Austria;Netherlands;Italy
600	EUCTR2006-000800-17-BE (EUCTR)	23/04/2007	25/01/2007	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Product Code: UT-15C SR INN or Proposed INN: Treprostinil	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
601	EUCTR2006-000804-18-BE (EUCTR)	23/04/2007	25/01/2007	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
602	EUCTR2005-000963-25-SK (EUCTR)	20/04/2007	20/03/2007	A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A	A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A	Pulmonary Arterial Hypertension MedDRA version: 8.1;Level: LLT;Classification code 10064911	INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480	Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK	NULL	Not Recruiting			Female: yes Male: yes	185	Phase 3	Slovakia;Finland;United Kingdom;Sweden
603	EUCTR2005-000963-25-FI (EUCTR)	28/03/2007	09/01/2007	A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A	A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A	Pulmonary Arterial Hypertension MedDRA version: 8.1;Level: LLT;Classification code 10064911	INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480	Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK	NULL	Not Recruiting			Female: yes Male: yes	185		Finland;United Kingdom;Sweden
604	EUCTR2006-002235-25-FI (EUCTR)	28/03/2007	09/01/2007	A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A	A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A	Pulmonary Arterial Hypertension MedDRA version: 9.0;Level: LLT;Classification code 10064911	INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480	Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	204		Finland;United Kingdom
605	EUCTR2006-002235-25-SK (EUCTR)	22/03/2007	13/02/2007	A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A	A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A	Pulmonary Arterial Hypertension MedDRA version: 9.0;Level: LLT;Classification code 10064911	INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480	Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 3	Slovakia;Finland;United Kingdom
606	EUCTR2006-000801-50-AT (EUCTR)	19/02/2007	17/01/2007	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	150		Netherlands;Belgium;France;Italy;Austria
607	EUCTR2006-000804-18-AT (EUCTR)	19/02/2007	17/01/2007	An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungs	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV) MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
608	EUCTR2006-000804-18-IE (EUCTR)	15/02/2007	09/11/2006	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT	Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
609	EUCTR2006-000800-17-IE (EUCTR)	15/02/2007	13/11/2006	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
610	EUCTR2004-003236-59-ES (EUCTR)	14/02/2007	05/05/2010		Investigación clínica doble ciego controlada con placebo sobre la efficacia y la tolerabilidad de Treprostinil sódico inhaldo en pacientes con Hipertensión Pulmonar Graves.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. -	Hipertensión Arterial Pulmonar Grave de clase III y IV de la NYHANYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)	Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	220		Germany;United Kingdom;Ireland;Spain;Italy
611	EUCTR2006-000800-17-AT (EUCTR)	19/01/2007	17/01/2007	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
612	EUCTR2006-000800-17-GB (EUCTR)	18/01/2007	22/11/2006	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C	Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or 3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension	Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprosinil Diethanolamine Product Code: UT-15C-SR INN or Proposed INN: Treprostinil diethanolamine Product Name: Treprosinil Diethanolamine Product Code: UT-15C-SR INN or Proposed INN: Treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom
613	EUCTR2006-002235-25-GB (EUCTR)	14/12/2006	18/09/2006	A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A	A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A	Pulmonary Arterial Hypertension MedDRA version: 9.0;Level: LLT;Classification code 10064911	INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480	Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Slovakia;Finland;United Kingdom
614	EUCTR2006-001464-23-IT (EUCTR)	03/11/2006	19/02/2007	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL SILDENAFIL 20MG TID OR PLACEBO WHEN ADDED TO BOSENTAN IN THE TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND	A MULTINATIONAL, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL SILDENAFIL 20MG TID OR PLACEBO WHEN ADDED TO BOSENTAN IN THE TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND	Pulmonary Arterial Hypertension PAH . MedDRA version: 6.1;Level: PT;Classification code 10037400	Trade Name: G04BE03- Sildenafil - sildenafil (citrato) Product Name: Sildenafil INN or Proposed INN: Sildenafil	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	106		Czech Republic;Greece;Germany;United Kingdom;Italy
615	NCT00403650 (ClinicalTrials.gov)	November 2006	24/11/2006	Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension	Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension	Sarcoidosis;Pulmonary Arterial Hypertension	Drug: Iloprost	University of Cincinnati	NULL	Completed	18 Years	90 Years	Both	20	Phase 4	United States
616	EUCTR2006-003520-10-DE (EUCTR)	20/10/2006	23/08/2006	Long-term study to collect additional information to evaluate the saftey and tolerability of BAY 63-2521 in different doses	A multicenter, non-randomized, non-blinded, non-controlled study to investigate the impact of multiple doses of BAY 63 2521 on safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with pulmonary hypertension in a 12 week 3 times a day individual dose titration scheme	Subjects with PH due to• Pulmonary arterial hypertension (PAH) [Venice protocol] or• Chronic thrombembolic PH (CTEPH) MedDRA version: 19.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	0	Phase 1;Phase 2	Germany
617	EUCTR2006-001464-23-GB (EUCTR)	18/10/2006	11/06/2006	A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A	A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A	Pulmonary Arterial Hypertension MedDRA version: 8.0;Level: LLT;Classification code 10064911	Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil	Pfizer Ltd	NULL	Not Recruiting			Female: yes Male: yes	106	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes	Czech Republic;Greece;Germany;Italy;United Kingdom
618	EUCTR2004-000745-37-GB (EUCTR)	10/10/2006	23/02/2005	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension	Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	50		Spain;Italy;United Kingdom
619	EUCTR2005-004863-41-DE (EUCTR)	04/10/2006	25/07/2006	Clinical investigation into efficacy, hemodynamics and tolerability of simvastatin vs placebo in patients with pulmonary arterial hypertension(Shorttitle: SIPHT)Double-blind, randomized, prospective Phase III-b study for 6 months with adjusting doses of simvastatin (40/80 mg daily) or placebo followed by an open-label period with a final dose of simvastatin 80 mg daily for another 6 months - SIPHT	Clinical investigation into efficacy, hemodynamics and tolerability of simvastatin vs placebo in patients with pulmonary arterial hypertension(Shorttitle: SIPHT)Double-blind, randomized, prospective Phase III-b study for 6 months with adjusting doses of simvastatin (40/80 mg daily) or placebo followed by an open-label period with a final dose of simvastatin 80 mg daily for another 6 months - SIPHT	Modified NYHA class II or III patients with Pulmonary Hypertension (PH), ICD: 416.9 MedDRA version: 8.1;Level: LLT;Classification code 10020787;Term: Hypertension pulmonary	Trade Name: simvastatin 40 mg tablets Product Name: simvastatin Product Name: simvastatin 40 mg Product Code: simvastatin 40 mg INN or Proposed INN: simvastatin	Dept. of Internal Medicine II, University Hospital Giessen	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Germany
620	EUCTR2005-006192-13-IT (EUCTR)	19/09/2006	12/04/2007	A Randomized, Double-blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil - VISION	A Randomized, Double-blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil - VISION	primary pulmonary hypertension ICD IX 416.8 MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Trade Name: ventavis INN or Proposed INN: Iloprost	COTHERIX, INC.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Portugal;Spain;Austria;Germany;United Kingdom;Italy
621	EUCTR2005-000963-25-GB (EUCTR)	13/09/2006	19/09/2006	A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A	A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A	Pulmonary Arterial Hypertension MedDRA version: 8.1;Level: LLT;Classification code 10064911	INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480	Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Slovakia;Finland;United Kingdom;Sweden
622	EUCTR2005-005569-12-AT (EUCTR)	11/08/2006	13/07/2006	A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.	A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.	pulmonary arterial hypertension	Product Name: Glivec Product Code: STI571 INN or Proposed INN: Imatinib	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes			Austria;Germany;United Kingdom
623	EUCTR2005-006192-13-DE (EUCTR)	06/07/2006	03/05/2006	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION	Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Trade Name: Ventavis Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost	Actelion Pharmaceuticals US, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180		Portugal;United Kingdom;Germany;Spain;Italy;Austria
624	EUCTR2006-001464-23-DE (EUCTR)	04/07/2006	05/05/2006	A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg three times daily or placebo when added to bosentan in the treatment of adult subjects, withpulmonary arterial hypertension.	A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil Other descriptive name: n/a	Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	106		France;Czech Republic;Taiwan;Greece;Belgium;Australia;Israel;Germany;Italy;United Kingdom
625	EUCTR2005-006192-13-GB (EUCTR)	22/06/2006	21/03/2006	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION	Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Trade Name: Ventavis Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost	Actelion Pharmaceuticals US, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180		Portugal;Germany;United Kingdom;Spain;Italy;Austria
626	EUCTR2005-005066-37-DE (EUCTR)	09/06/2006	06/11/2006	COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1	COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1	Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.	Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 2	United Kingdom;Germany;Italy
627	EUCTR2005-006192-13-ES (EUCTR)	09/06/2006	12/05/2006	Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION	Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION	Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Classification code 10037400	Trade Name: **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter. Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost	CoTherix, Inc	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Portugal;Spain;Austria;Germany;Italy;United Kingdom
628	EUCTR2006-001464-23-CZ (EUCTR)	08/06/2006	21/04/2006	A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A	A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil	Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ	NULL	Not Recruiting			Female: yes Male: yes	106		Czech Republic;Greece;Germany;Italy;United Kingdom
629	EUCTR2005-005569-12-DE (EUCTR)	24/05/2006	27/03/2006	A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.	A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.	pulmonary arterial hypertension	Trade Name: Glivec 100 mg Hartkapsel Product Name: Glivec Product Code: STI571 INN or Proposed INN: Imatinib Trade Name: Glivec 100 mg Filmtabletten Product Name: Glivec Product Code: STI571 INN or Proposed INN: Imatinib	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60		Austria;Germany;United Kingdom
630	EUCTR2005-006192-13-AT (EUCTR)	15/05/2006	05/05/2006	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION	Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension	Trade Name: Ventavis Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost	Actelion Pharmaceuticals US, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180		Portugal;Germany;United Kingdom;Spain;Italy;Austria
631	NCT00469027 (ClinicalTrials.gov)	May 2006	2/5/2007	Pulmonary Hypertension: Assessment of Cell Therapy	Phase I Trial to Establish Safety of Autologous Progenitor Cell-based Gene Therapy Delivery of heNOS in Patients With Severe Pulmonary Arterial Hypertension(PAH)Refractory to Conventional Treatment	Hypertension, Pulmonary	Biological: eNOS transfected EPCs will be delivered via a PA line	Northern Therapeutics	St. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General Hospital;St. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General Hospital	Completed	18 Years	80 Years	Both	7	Phase 1	Canada
632	NCT00595049 (ClinicalTrials.gov)	May 2006	7/1/2008	Pulmonary Artery Remodelling With Bosentan	Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).	Hypertension, Pulmonary	Drug: bosentan	Actelion	NULL	Completed	18 Years	N/A	Both	11	Phase 4	Australia;United States
633	NCT01027949 (ClinicalTrials.gov)	May 2006	4/12/2009	An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension	An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Treprostinil diethanolamine	United Therapeutics	NULL	Active, not recruiting	12 Years	N/A	All	900	Phase 3	United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic
634	EUCTR2005-005066-37-BE (EUCTR)	21/04/2006	15/02/2006	COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1	COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1	Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.	Trade Name: viagra Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 2	Belgium;Germany;Italy;United Kingdom
635	EUCTR2005-002844-24-GB (EUCTR)	10/04/2006	12/09/2005	A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	350	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Spain;Belgium;Ireland;Germany;Italy;United Kingdom
636	EUCTR2005-002692-33-GB (EUCTR)	10/04/2006	12/09/2005	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Spain;Belgium;Ireland;Germany;Italy;United Kingdom
637	NCT00477269 (ClinicalTrials.gov)	April 2006	22/5/2007	Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension	A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension	Drug: Imatinib mesylate;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	59	Phase 2/Phase 3	United States;Austria;Germany;United Kingdom
638	EUCTR2005-002844-24-ES (EUCTR)	22/03/2006	12/12/2005	- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerte	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;United Kingdom;Ireland;Spain;Italy
639	EUCTR2005-005066-37-IT (EUCTR)	21/03/2006	05/06/2006	Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1	Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1	Patients suffering from pulmonary arterial hypertension PAH MedDRA version: 6.1;Level: PT;Classification code 10037400	INN or Proposed INN: Sildenafil	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 2	Germany;United Kingdom;Italy
640	EUCTR2005-005066-37-GB (EUCTR)	15/03/2006	13/02/2006	COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1	COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1	Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks.	Trade Name: viagra Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	44	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Belgium;Germany;Italy;United Kingdom
641	EUCTR2006-000021-57-DK (EUCTR)	10/03/2006	24/02/2006	Bosentan and Sildenfil for patients with Eisenmenger syndrome	Bosentan and Sildenfil for patients with Eisenmenger syndrome	Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).	Trade Name: Tracleer Product Name: Tracleer Other descriptive name: Bosentan monohydrat Trade Name: VIAGRA Product Name: Viagra Other descriptive name: sildenafil	Rigshospitalet	NULL	Not Recruiting			Female: yes Male: yes	20		Denmark
642	EUCTR2005-002692-33-IE (EUCTR)	23/02/2006	12/10/2005	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Spain;Belgium;Ireland;Germany;Italy;United Kingdom
643	EUCTR2005-002844-24-IE (EUCTR)	23/02/2006	12/10/2005	A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;United Kingdom;Spain;Ireland;Italy
644	EUCTR2005-002692-33-DE (EUCTR)	17/02/2006	21/10/2005	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Product Name: Cialis INN or Proposed INN: Tadalafil Product Name: Cialis INN or Proposed INN: Tadalafil Product Name: Tadalafil INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Spain;Ireland;Germany;Italy;United Kingdom
645	EUCTR2005-002692-33-IT (EUCTR)	16/02/2006	23/06/2006	A randomized, Double blind, Placebo controlled phase 3 Study of the phosphodiesterae Type 5 PDE Inhibiotr Tadalafil in the Treatment of patients with Pulomanry Arterial Hypertension.	A randomized, Double blind, Placebo controlled phase 3 Study of the phosphodiesterae Type 5 PDE Inhibiotr Tadalafil in the Treatment of patients with Pulomanry Arterial Hypertension.	Pulmonary Arterial Hypertension MedDRA version: 6.1;Level: PT;Classification code 10037405	INN or Proposed INN: Tadalafil	ELI LILLY	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Germany;United Kingdom;Spain;Ireland;Italy
646	EUCTR2005-002844-24-IT (EUCTR)	07/02/2006	12/09/2007	A double blind, Extension Study to evaluate the Long-term safety and Efficacy of the phsphodiesterase Type 5 (PDE5) inhibitor Tadalafil in the Treatment of patients with Pulmonary Arterial Hypertension.	A double blind, Extension Study to evaluate the Long-term safety and Efficacy of the phsphodiesterase Type 5 (PDE5) inhibitor Tadalafil in the Treatment of patients with Pulmonary Arterial Hypertension.	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	INN or Proposed INN: Tadalafil	ELI LILLY	NULL	Not Recruiting			Female: yes Male: yes	350		Spain;Ireland;Germany;United Kingdom;Italy
647	EUCTR2005-002692-33-ES (EUCTR)	02/02/2006	12/12/2005	Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerte	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Belgium;Spain;Ireland;Germany;Italy;United Kingdom
648	EUCTR2005-005569-12-GB (EUCTR)	26/01/2006	02/12/2005	A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.	A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.	pulmonary arterial hypertension	Trade Name: Glivec Product Name: Glivec Product Code: STI571 INN or Proposed INN: Imatinib Product Code: STI571 INN or Proposed INN: Imatinib	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60		Austria;Germany;United Kingdom
649	EUCTR2005-002844-24-BE (EUCTR)	25/01/2006	26/10/2005	An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Eli Lilly and Company Limited	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3;Phase 4	Spain;Belgium;Ireland;Germany;Italy;United Kingdom
650	EUCTR2005-002692-33-BE (EUCTR)	25/01/2006	26/10/2005	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Spain;Belgium;Ireland;Germany;Italy;United Kingdom
651	EUCTR2004-004391-36-CZ (EUCTR)	20/01/2006	05/01/2006	A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension	A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension	Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: no Male: yes	23		Hungary;Czech Republic
652	EUCTR2005-002844-24-DE (EUCTR)	17/01/2006	11/10/2005	An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	350		Spain;Ireland;Germany;Italy;United Kingdom
653	EUCTR2005-000812-29-IT (EUCTR)	15/11/2005	15/02/2006	ARIES-1 - Ambrisentan in PAH A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension	ARIES-1 - Ambrisentan in PAH A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension	PULMONARY ARTERIAL HYPERTENSION MedDRA version: 6.1;Level: PT;Classification code 10037400	Product Name: Ambrisentan	MYOGEN INC.	NULL	Not Recruiting			Female: yes Male: yes	186	Phase 3	Hungary;Germany;Belgium;Spain;Italy
654	EUCTR2005-001193-28-AT (EUCTR)	08/11/2005	04/10/2005	ARIES-320/321-E A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-E	ARIES-320/321-E A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-E	Pulmonary Arterial Hypertension	Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan	Myogen, Inc	NULL	Not Recruiting			Female: yes Male: yes	372		Austria
655	EUCTR2005-000812-29-AT (EUCTR)	08/11/2005	04/10/2005	ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1	ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1	Pulmonary Arterial Hypertension	Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan	Myogen, Inc	NULL	Not Recruiting			Female: yes Male: yes	186	Phase 3	Hungary;Belgium;Spain;Austria;Germany;Italy
656	EUCTR2005-000812-29-DE (EUCTR)	07/11/2005	02/03/2007	ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1	ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1	Pulmonary Arterial Hypertension	Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan	Myogen, Inc	NULL	Not Recruiting			Female: yes Male: yes	186	Phase 3	Hungary;Germany;Belgium;Spain;Italy
657	EUCTR2005-000812-29-ES (EUCTR)	21/10/2005	19/09/2005	ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1	ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1	Pulmonary Arterial Hypertension	Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan	Myogen, Inc	NULL	Not Recruiting			Female: yes Male: yes	186	Phase 3	Hungary;Belgium;Spain;Austria;Germany;Italy
658	EUCTR2005-001967-70-IT (EUCTR)	20/10/2005	19/01/2007	An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1	An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1	Treatment of pulmonary arterial hypertension in children MedDRA version: 14.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: Bosentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	35		Germany;United Kingdom;Italy
659	EUCTR2005-001967-70-GB (EUCTR)	13/10/2005	25/08/2005	An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2	An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2	Idiopathic or familial pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Germany;Italy;United Kingdom
660	EUCTR2005-001564-31-DE (EUCTR)	07/10/2005	08/07/2005	A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA	A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA	Pulmonary Arterial Hypertension MedDRA version: 7.0;Level: low;Classification code 10037400	Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan	Myogen Inc.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Belgium;Germany
661	EUCTR2005-000812-29-HU (EUCTR)	21/09/2005	11/08/2005	Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1	Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1	Pulmonary Arterial Hypertension MedDRA version: 7.0;Level: low;Classification code 10037400	Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan	Myogen, Inc.	NULL	Not Recruiting			Female: yes Male: yes	186	Phase 3	Hungary;Belgium;Spain;Austria;Germany;Italy
662	EUCTR2005-000812-29-BE (EUCTR)	16/09/2005	08/02/2006	ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1	ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1	Pulmonary Arterial Hypertension	Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan	Myogen, Inc	NULL	Not Recruiting			Female: yes Male: yes	186	Phase 3	Hungary;Germany;Belgium;Spain;Italy
663	EUCTR2004-003236-59-IE (EUCTR)	09/09/2005	06/07/2005		Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. -	NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)	Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840	Lung Rx Inc.	NULL	Not Recruiting			Female: yes Male: yes	165		Germany;United Kingdom;Spain;Ireland;Italy
664	EUCTR2004-003236-59-AT (EUCTR)	24/08/2005	20/07/2005	Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.	Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.	NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)	Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	220		Spain;Ireland;Austria;Germany;Italy;United Kingdom
665	EUCTR2004-003236-59-BE (EUCTR)	20/08/2005	15/12/2005	Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.	Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.	NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)	Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
666	EUCTR2005-001564-31-BE (EUCTR)	16/08/2005	15/12/2005	A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA	A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA	Pulmonary Arterial Hypertension MedDRA version: 7.0;Level: low;Classification code 10037400	Product Name: Ambrisentan Product Code: BSF 208075 or LU 208075 INN or Proposed INN: Ambrisentan INN or Proposed INN: Ambrisentan INN or Proposed INN: Ambrisentan	Myogen Inc.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Belgium;Germany
667	NCT00593905 (ClinicalTrials.gov)	July 2005	3/1/2008	Pharmacogenomics in Pulmonary Arterial Hypertension	Pharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific Genes	Pulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group I	Drug: Sitaxsentan;Drug: Bosentan, Ambrisentan	West Penn Allegheny Health System	National Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland, College Park;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospitals Cleveland Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh Medical Center;University of Southern California;The University of Texas Medical Branch, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest Physicians	Withdrawn	N/A	N/A	All	0		United States
668	EUCTR2004-003236-59-GB (EUCTR)	30/06/2005	13/06/2005	Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.	Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.	NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)	Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	220	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
669	EUCTR2004-005157-63-IT (EUCTR)	15/06/2005	15/02/2006	An open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAH	An open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAH	Treatment of pulmonary arterial hypertension in children. MedDRA version: 6.1;Level: PT;Classification code 10037405	Trade Name: TRACLEER 62,5MG 56CPR RIV. INN or Proposed INN: Bosentan	ACTELION PHARMACEUTICALS ITALIA	NULL	Not Recruiting			Female: yes Male: yes	35		United Kingdom;Italy
670	EUCTR2004-005157-63-GB (EUCTR)	15/06/2005	19/04/2005	An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1	An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1	Idiopathic or familial PAH	Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	33	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Italy;United Kingdom
671	EUCTR2004-003236-59-IT (EUCTR)	30/05/2005	09/11/2009	Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension	Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension	NYHA Class III and IV patients with severe Pulmonary Arterial Hypertensio MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Treprostinil Sodium Solution for Inhalation Product Code: TRE INN or Proposed INN: Treprostinil Sodium Solution for Inhalation	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	220		Spain;Ireland;Germany;United Kingdom;Italy
672	EUCTR2005-000963-25-SE (EUCTR)	30/05/2005	06/04/2005	Oral Revatio in Pediatric PAH- Long term follow on study to A1481131	A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480	Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK	NULL	Not Recruiting			Female: yes Male: yes	200		Taiwan;Finland;Thailand;Costa Rica;Guatemala;Chile;Russian Federation;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Brazil;Malaysia;Poland;Sweden
673	EUCTR2004-004391-36-HU (EUCTR)	23/05/2005	23/02/2005	A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension	A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension	Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: no Male: yes	23		Hungary;Czech Republic
674	EUCTR2004-000745-37-IT (EUCTR)	15/03/2005	21/06/2005	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension)	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension)	No modification of the label due to the fact that is an open label extension of a phase IV trial. MedDRA version: 6.1;Level: PT;Classification code 10037406	Trade Name: TRACLEER*125MG 56CPR RIV. INN or Proposed INN: Bosentan	ACTELION PHARMACEUTICALS ITALIA	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom;Spain;Italy
675	EUCTR2004-000478-30-ES (EUCTR)	10/02/2005	03/11/2004	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients.	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 3	Czech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden
676	EUCTR2004-003847-37-IT (EUCTR)	21/12/2004	16/02/2006	An Open label uncontrolled study of the safety and efficacy of chronic intravenous Remodulin in patients with pulmonary Arterial Hypertension	An Open label uncontrolled study of the safety and efficacy of chronic intravenous Remodulin in patients with pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 6.1;Level: PT;Classification code 10037400		BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes			Italy
677	EUCTR2004-000478-30-BE (EUCTR)	14/12/2004	24/08/2005	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		Czech Republic;Spain;Belgium;Denmark;Austria;Italy;United Kingdom;Sweden
678	EUCTR2004-000478-30-AT (EUCTR)	08/12/2004	03/11/2004	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden
679	EUCTR2004-000478-30-CZ (EUCTR)	26/11/2004	26/11/2004	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
680	EUCTR2004-000478-30-SE (EUCTR)	28/10/2004	20/07/2004	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
681	EUCTR2004-000745-37-ES (EUCTR)	11/10/2004	07/10/2004	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension	Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 4	Spain;Italy;United Kingdom
682	EUCTR2004-000478-30-DK (EUCTR)	10/09/2004	10/01/2007	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
683	EUCTR2004-000478-30-IT (EUCTR)	09/09/2004	11/07/2007	A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Treatment of pulmonary arterial hypertension (PAH) in patients with grade II modified NYHA MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: TRACLEER*56CPR RIV 125MG INN or Proposed INN: Bosentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	170		Czech Republic;Spain;Denmark;United Kingdom;Italy;Sweden
684	EUCTR2004-000478-30-GB (EUCTR)	15/07/2004	21/06/2005	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients.	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden
685	NCT00644605 (ClinicalTrials.gov)	October 2002	20/3/2008	A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension	A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over	Hypertension, Pulmonary	Drug: sildenafil;Drug: placebo	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	NULL	Completed	18 Years	N/A	All	275	Phase 3	United States;Australia;Belgium;Brazil;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom;Czech Republic
686	NCT00034307 (ClinicalTrials.gov)	February 2002	24/4/2002	Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension	A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension	Pulmonary Hypertension	Drug: sitaxsentan sodium	ICOS-Texas Biotechnology	ICOS Corporation;Texas Biotechnology Corporation	Active, not recruiting	16 Years	75 Years	Both	180	Phase 2/Phase 3	United States;Canada
687	NCT02784808 (ClinicalTrials.gov)	January 2000	25/5/2016	Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs)		Juvenile Idiopathic Arthritis	Drug: Biological DMARDs;Drug: Non-Biologic DMARDs	Hoffmann-La Roche	NULL	Completed	N/A	18 Years	Both	4557	N/A	NULL
688	JPRN-UMIN000020386	1999/04/01	28/12/2015	Acute Vasoreactivity Testing with Nicardipine in Patients with Pulmonary Arterial Hypertension	Acute Vasoreactivity Testing with Nicardipine in Patients with Pulmonary Arterial Hypertension - Acute Vasoreactivity Testing with Nicardipine in Patients with Pulmonary Arterial Hypertension	plumonary arterial hypertension	Nicardipine was administered by short-time continuous infusion (1 microg/kg/min for 5 min and 2 microg/kg/min for 5 min) followed by bolus injection (5 microg/kg). Hemodynamic responses were continuously measured using a right heart catheter.Hemodynamic responses were continuously measured before, during and after administration of nicardipine using an RHC. SaO2 (saturation of arterial blood) and SPAO2 (saturation of pulmonary arterial blood) were measured to calculate cardiac output every 5 minutes.	Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences	National Hospital Organization, Okayama Medical Center	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	100	Not applicable	Japan
689	EUCTR2009-009366-13-DE (EUCTR)		23/09/2009	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	300		France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
690	EUCTR2012-002354-23-PL (EUCTR)		17/06/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 3	United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Brazil;Belgium;Romania;Germany;Netherlands;Japan
691	EUCTR2016-001062-28-FR (EUCTR)		03/07/2018	A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)	A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	ACTELION Pharmaceuticals Ltd	NULL	NA			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Australia;South Africa;Germany;China;Korea, Republic of
692	EUCTR2011-001873-24-PL (EUCTR)		09/12/2011	A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body	A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: LY450190 Product Code: LY450190 INN or Proposed INN: TADALAFIL Other descriptive name: LY450190	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 1;Phase 2	France;United States;Canada;Spain;Poland;United Kingdom
693	EUCTR2005-005068-97-DE (EUCTR)		13/02/2006	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate)	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
694	EUCTR2012-002354-23-GB (EUCTR)		16/01/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 3	United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
695	EUCTR2009-014453-32-DE (EUCTR)		11/12/2009	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung RX	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Czech Republic;Belgium;Ireland;Germany
696	EUCTR2012-004411-31-PL (EUCTR)		29/08/2014	Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome	Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label)	Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	France;Malaysia;South Africa;Netherlands;China;Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
697	EUCTR2010-021572-29-FR (EUCTR)		11/10/2011	Testing medicines to treat children with pulmonary arterial hypertension (PAH)Testing medicines to treat teens with pulmonary arterial hypertension (PAH)	An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - Safety FU Study of Amb in 8-17yr olds	Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: VOLIBRIS® (ambrisentan) Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Trade Name: VOLIBRIS® (ambrisentan) Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	United States;France;Hungary;Greece;Spain;Netherlands;Germany;Italy;Japan
698	EUCTR2011-004612-31-FR (EUCTR)		27/08/2012	A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.	A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6	Pulmonary arterial hypertension (PAH) in children MedDRA version: 15.0;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 15.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	NA			Female: yes Male: yes	105	Phase 3	Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
699	EUCTR2004-003236-59-DE (EUCTR)		16/05/2006	Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.	Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.	NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)	Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A INN or Proposed INN: N/A Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	220		Spain;Ireland;Germany;Italy;United Kingdom
700	EUCTR2010-021793-12-PL (EUCTR)		25/07/2011	A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a day	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 3	Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China
701	EUCTR2018-000145-39-PL (EUCTR)		02/04/2019	A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension	A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	55	Phase 2	Canada;Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Vietnam;France;Hungary;Malaysia;Poland;Singapore;Romania;Netherlands;Germany;China
702	EUCTR2007-003694-27-PL (EUCTR)		26/05/2008	Clinical research to assess the long-term safety and tolerability of ACT- 064992 in patients with Pulmonary Arterial Hypertension	SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL	symptomatic pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Croatia;Romania;Bulgaria;Germany;Sweden;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia
703	EUCTR2011-004612-31-NL (EUCTR)		07/05/2012	A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.	A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	NA			Female: yes Male: yes	105	Phase 3	Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
704	EUCTR2019-002817-21-FR (EUCTR)		14/10/2019	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	NA			Female: yes Male: yes	237	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
705	EUCTR2014-004167-20-Outside-EU/EEA (EUCTR)		24/03/2015	Open Label Study of Sildenafil in Subjects With Pulmonary Arterial Hypertension	A Phase 3, Multi-Center, Open-Label Study To Confirm Safety, Efficacy And Tolerability Of Sildenafil Citrate 20 Mg Three Times a Day (TID) In Subjects With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 17.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;System Organ Class: 100000004855;Therapeutic area: Not possible to specify	Trade Name: Revatio Product Name: SILDENAFIL CITRATE INN or Proposed INN: SILDENAFIL CITRATE Other descriptive name: SILDENAFIL CITRATE Trade Name: Revatio Product Name: SILDENAFIL CITRATE INN or Proposed INN: SILDENAFIL CITRATE Other descriptive name: SILDENAFIL CITRATE	Pfizer Japan Inc	NULL	NA			Female: yes Male: yes	44	Phase 3	Japan
706	EUCTR2005-001967-70-DE (EUCTR)		30/08/2005	An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2	An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2	Idiopathic or familial pulmonary arterial hypertension	Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	30		United Kingdom;Germany;Italy

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97. 潰瘍性大腸炎

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臨床試験数 : 2,630 /  薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05442567 (ClinicalTrials.gov)	May 2, 2023	30/6/2022	A Study of Vedolizumab in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)	A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab IV;Other: No Intervention	Takeda	NULL	Not yet recruiting	3 Years	17 Years	All	240	Phase 3	NULL
2	NCT05370885 (ClinicalTrials.gov)	May 2023	30/3/2022	VE202 in Patients With Mild-to-Moderate Ulcerative Colitis	Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis	Ulcerative Colitis;Colitis, Ulcerative	Biological: VE202;Drug: Vancomycin Oral Capsule;Other: VE202 Placebo;Other: Vancomycin Placebo	Vedanta Biosciences, Inc.	NULL	Not yet recruiting	18 Years	75 Years	All	100	Phase 2	NULL
3	NCT05771155 (ClinicalTrials.gov)	May 2023	1/3/2023	Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®	A Randomized, Double-blind, Multicenter Phase 3 Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC) to Compare the Efficacy, Safety and Immunogenicity of PB016 and Entyvio® for the Induction and Maintenance of Clinical Response and Remission	Ulcerative Colitis	Biological: Intravenous (IV) infusions	Polpharma Biologics S.A.	NULL	Not yet recruiting	18 Years	75 Years	All	750	Phase 3	NULL
4	NCT05117749 (ClinicalTrials.gov)	May 2023	21/10/2021	Saffron and Ulcerative Colitis	The Effect of Saffron in Patients With Ulcerative Colitis: A Randomized Double-blind Clinical Trial	Ulcerative Colitis	Drug: Saffron 100;Drug: Saffron 50;Drug: Placebo	Shiraz University of Medical Sciences	NULL	Not yet recruiting	18 Years	80 Years	All	60	Phase 2	NULL
5	NCT05672199 (ClinicalTrials.gov)	April 26, 2023	3/1/2023	Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Efavaleukin alfa;Drug: Placebo	Amgen	NULL	Not yet recruiting	18 Years	80 Years	All	200	Phase 2	NULL
6	NCT05767021 (ClinicalTrials.gov)	April 21, 2023	8/2/2023	A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab	Ulcerative Colitis Chronic;Ulcerative Colitis	Drug: Mirikizumab	Eli Lilly and Company	NULL	Not yet recruiting	18 Years	N/A	All	160	Phase 3	NULL
7	NCT05702879 (ClinicalTrials.gov)	April 1, 2023	18/1/2023	Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success	An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy	Ulcerative Colitis	Drug: Ozanimod;Drug: TNF Inhibitor;Drug: Steroids;Drug: Vedolizumab;Drug: Ustekinumab	University Hospital Inselspital, Berne	Bristol-Myers Squibb	Not yet recruiting	18 Years	80 Years	All	240		NULL
8	NCT05715099 (ClinicalTrials.gov)	March 30, 2023	19/1/2023	Saffron as Anti Inflammatory In Patients With Inflammatory Bowel Disease	Efficacy of Nutritional Saffron Supplement as an Anti-inflammatory Agent in Egyptian Patients With Inflammatory Bowel Disease	Ulcerative Colitis	Drug: Saffron;Drug: Placebo	Minia University	NULL	Not yet recruiting	18 Years	60 Years	All	90	Phase 4	Egypt
9	NCT05770609 (ClinicalTrials.gov)	March 15, 2023	5/3/2023	A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis	Drug: SPH3127 Tablets with Dose A;Drug: SPH3127 Tablets with Dose B;Drug: SPH3127 Tablets placebo	Shanghai Pharmaceuticals Holding Co., Ltd	NULL	Not yet recruiting	18 Years	75 Years	All	108	Phase 2	China
10	NCT05202990 (ClinicalTrials.gov)	March 2023	10/1/2022	Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis	Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.	Pediatric Ulcerative Colitis in Remission	Drug: Fecal Microbiota Transplantation by Stool capsules;Drug: Fecal Microbiota Transplantation by Intra-rectal enemas	Assistance Publique - Hôpitaux de Paris	MRSU 938 - Research Center of Saint Antoine	Not yet recruiting	8 Years	17 Years	All	26	Phase 2	France
11	NCT04314375 (ClinicalTrials.gov)	March 2023	17/3/2020	Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	Ulcerative Colitis	Drug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: Placebo	Bausch Health Americas, Inc.	NULL	Not yet recruiting	5 Years	17 Years	All	70	Phase 4	NULL
12	NCT05684484 (ClinicalTrials.gov)	February 1, 2023	26/12/2022	Role of Roflumilast in Ulcerative Colitis	Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.	Ulcerative Colitis	Drug: Roflumilast 500 Ug ORAL TABLET [Daliresp];Drug: corticosteroids +immune suppressive +amino salicylic acid	Tanta University	NULL	Not yet recruiting	15 Years	80 Years	All	52	Phase 4	NULL
13	NCT05567068 (ClinicalTrials.gov)	February 1, 2023	1/10/2022	Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis	Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.	Inflammatory Bowel Diseases	Drug: Atorvastatin 80mg;Drug: Mesalamine	Tanta University	NULL	Not yet recruiting	18 Years	75 Years	All	44	Phase 2	NULL
14	NCT05743374 (ClinicalTrials.gov)	February 2023	14/2/2023	Micronutrient and Additive Modifications May Optimize Diet To Health	Micronutrient and Additive Modifications May Optimize Diet To Health	Ulcerative Colitis;Diet Habit;Microbial Colonization	Other: Normal diet;Dietary Supplement: E400 elimination	Region Skane	NULL	Not yet recruiting	18 Years	N/A	All	70	N/A	Sweden
15	NCT05743010 (ClinicalTrials.gov)	February 2023	15/11/2022	A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Randomized, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: APL-1401;Drug: Placebo	Jiangsu Yahong Meditech Co., Ltd aka Asieris	NULL	Not yet recruiting	18 Years	65 Years	All	36	Phase 1	United States
16	NCT05507931 (ClinicalTrials.gov)	February 2023	17/8/2022	Broccoli Sprouts for Mild Ulcerative Colitis	A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis	Ulcerative Colitis;Ulcerative Colitis Chronic Mild	Dietary Supplement: 1 Serving of broccoli sprouts;Dietary Supplement: 3 Servings of broccoli sprouts	University of Michigan	University of Maine	Not yet recruiting	18 Years	N/A	All	40	N/A	United States
17	EUCTR2022-002593-89-CZ (EUCTR)	23/01/2023	28/12/2022	A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease	A 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability ofTEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study - RELIEVE UCCD LTE	Moderate to severe Ulcerative colitis or moderate to severe Crohn'sdisease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TEV-48574 Product Code: TEV-48574 INN or Proposed INN: TEV-48574 Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A	Teva Branded Pharmaceutical Products R&D, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	128	Phase 2	United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Norway;Germany
18	EUCTR2021-006881-19-CZ (EUCTR)	06/01/2023	06/01/2023	A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease	A 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD) - RELIEVE UCCD	Moderate to severe Ulcerative colitis or moderate to severe Crohn's disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TEV-48574 Product Code: TEV-48574 INN or Proposed INN: TEV-48574 Other descriptive name: Fully human IgG1 monoclonal antibody specific for TL1A	Teva Branded Pharmaceutical Products R&D, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	United States;Czechia;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;Norway;Germany;Japan
19	NCT05561738 (ClinicalTrials.gov)	January 1, 2023	13/9/2022	Nicotinamide Riboside in Ulcerative Colitis	Nicotinamide Riboside in Ulcerative Colitis	Ulcerative Colitis	Dietary Supplement: Nicotinamide Riboside Chloride;Dietary Supplement: Placebo;Other: Standard of Care	University of Pittsburgh	Crohn's and Colitis Foundation	Not yet recruiting	N/A	18 Years	All	40	N/A	United States
20	NCT05112263 (ClinicalTrials.gov)	January 1, 2023	26/10/2021	Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis	Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized Study	Ulcerative Colitis	Drug: Tofacitinib;Drug: Cyclosporine	Postgraduate Institute of Medical Education and Research	All India Institute of Medical Sciences, New Delhi	Not yet recruiting	18 Years	65 Years	All	96	N/A	NULL
21	NCT05316220 (ClinicalTrials.gov)	December 31, 2022	31/3/2022	A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis	A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: Mesalamine;Drug: Placebo	AbbVie	NULL	Not yet recruiting	5 Years	17 Years	All	80	Phase 3	United States;Puerto Rico
22	EUCTR2021-005528-39-NL (EUCTR)	14/12/2022	12/09/2022	Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-78934804 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab INN or Proposed INN: Golimumab Other descriptive name: Golimumab Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Other descriptive name: Guselkumab Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Golimumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 2	Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;India;France;Jordan;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Switzerland;Malaysia;Australia;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Bulgaria;Georgia;Germany;Norway;New Zealand;Japan
23	NCT05561062 (ClinicalTrials.gov)	December 1, 2022	27/9/2022	Atorvastatin in Patients With Ulcerative Colitis	Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis	Inflammatory Bowel Diseases	Drug: Atorvastatin 80mg	Tanta University	NULL	Not yet recruiting	18 Years	75 Years	All	50	Phase 2	NULL
24	NCT05610956 (ClinicalTrials.gov)	December 1, 2022	31/10/2022	Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis	Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis	Ulcerative Colitis	Drug: Empagliflozin;Drug: conventional treatment	Tanta University	NULL	Not yet recruiting	18 Years	70 Years	All	60	Early Phase 1	NULL
25	NCT05579483 (ClinicalTrials.gov)	December 2022	4/10/2022	Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures	Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures	Ulcerative Colitis	Dietary Supplement: Prebiotics;Dietary Supplement: Placebo	Wageningen University	Winclove Probiotics B.V.;China Scholarship Council	Not yet recruiting	18 Years	65 Years	All	60	N/A	Netherlands
26	NCT05588843 (ClinicalTrials.gov)	November 25, 2022	17/10/2022	Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis	A Randomized, Double-blind, Placebo Controlled, Dose-finding Study to Assess the Efficacy and Safety of SAR443122 in Adult Patients With Moderate to Severe Ulcerative Colitis	Colitis Ulcerative	Drug: SAR443122;Drug: Placebo	Sanofi	NULL	Recruiting	18 Years	75 Years	All	182	Phase 2	United States;Argentina;Chile;United Kingdom
27	NCT05549323 (ClinicalTrials.gov)	November 7, 2022	17/9/2022	A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis	A PHASE 1B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ORAL PF-07054894 IN ADULT PARTICIPANTS AGED 18-75 YEARS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative Colitis	Drug: PF-07054894;Drug: Placebo	Pfizer	NULL	Recruiting	18 Years	75 Years	All	27	Phase 1	United States
28	JPRN-jRCT2031220308	01/11/2022	01/09/2022	A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC	Colitis, Ulcerative	Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip	Nishikawa Kazuko	NULL	Pending	>= 18age old	<= 65age old	Both	550	Phase 2	Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;NewZealand;Poland;Portugal;Serbia;Japan
29	NCT05553704 (ClinicalTrials.gov)	November 1, 2022	20/9/2022	Metformin in Patients With Ulcerative Colitis Treated With Mesalamine	Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine	Inflammatory Bowel Diseases	Drug: Metformin	Tanta University	NULL	Recruiting	18 Years	75 Years	All	52	Phase 2	Egypt
30	NCT05570006 (ClinicalTrials.gov)	November 1, 2022	5/10/2022	Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis	A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: ABBV-668	AbbVie	NULL	Not yet recruiting	18 Years	N/A	All	40	Phase 2	United States;Belgium
31	NCT05626166 (ClinicalTrials.gov)	November 2022	9/11/2022	the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis	Clinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With Mesalamine	Ulcerative Colitis	Drug: Placebo;Drug: Diosmin	Tanta University	NULL	Not yet recruiting	18 Years	N/A	All	60	Phase 3	NULL
32	NCT05242484 (ClinicalTrials.gov)	September 19, 2022	15/2/2022	A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804;Drug: Placebo	Janssen Research & Development, LLC	NULL	Recruiting	18 Years	65 Years	All	550	Phase 2	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Jordan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Lithuania
33	NCT05539625 (ClinicalTrials.gov)	September 2022	4/8/2022	Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis	Mitochondrial Antioxidant Therapy to Resolve Inflammation in Ulcerative Colitis (Mini-MARVEL): A Phase 2b Feasibility Randomised Placebo Controlled Trial of Oral MitoQ in Mild-tomoderately Active Paediatric UC	Ulcerative Colitis	Dietary Supplement: MitoQ;Other: Placebo	University of Edinburgh	The Jon Moulton Charity Trust;MitoQ	Not yet recruiting	6 Years	17 Years	All	120	Phase 2	NULL
34	JPRN-jRCT2011210047	09/08/2022	29/10/2021	Open-label Extension Study of Brazikumab in Ulcerative Colitis	A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis - EXPEDITION OLE	Ulcerative Colitis	Completers in the lead-in study will receive a maintenance dose of brazikumab 240 mg administered SC every 4 weeks (Group A). The 240 mg SC dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered. Participants in the lead-in study who have not responded to treatment and have met criteria for rescue treatment are considered inadequate/non-responders (Group B). In these eligible participants, IV induction dosing with 1440 mg of brazikumab at Week 0, Week 4, and Week 8 will be administered, followed by brazikumab 240 mg SC-administered every 4 weeks thereafter (up to Week 52).	Ageishi Yuji	NULL	Recruiting	>= 18age old	<= 80age old	Both	21	Phase 2	India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan
35	EUCTR2021-002549-13-PT (EUCTR)	02/08/2022	27/10/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Serbia;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
36	NCT05218850 (ClinicalTrials.gov)	July 1, 2022	20/1/2022	The Use of Butyrate Therapy in Pediatric Ulcerative Colitis	Butyrate Therapy in Pediatric Ulcerative Colitis	Ulcerative Colitis	Drug: Butyrate	Children's Hospital Los Angeles	NULL	Not yet recruiting	7 Years	21 Years	All	10	Phase 1	United States
37	NCT05119140 (ClinicalTrials.gov)	June 10, 2022	20/10/2021	HCQ for Non Europeans With Mild to Severe UC	Administration of Hydroxychloroquine (Plaquenil) to Individuals of Non-European Ancestry for the Treatment of Mild to Severe Ulcerative Colitis.	Ulcerative Colitis (Disorder)	Drug: Hydroxychloroquine;Drug: Mesalamine	Icahn School of Medicine at Mount Sinai	Crohn's and Colitis Foundation	Recruiting	18 Years	N/A	All	20	Phase 1/Phase 2	United States
38	ITMCTR2200006063	2022-06-05	2022-06-05	A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative colitis	A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative colitis	Ulcerative colitis	No intervention:No intervention;Pure western medicine intervention:Mesalazine ;Intervention of integrated Chinese and Western medicine:Mesalazine + invigorating spleen and removing dampness;Simple Chinese medicine intervention:Shenling Baizhu powder + special prescription;	Guangdong Provincial Hospital of Chinese Medicine	NULL	Pending	18	75	Both	No intervention:25;Pure western medicine intervention:25;Intervention of integrated Chinese and Western medicine:25;Simple Chinese medicine intervention:25;	Phase 1	China
39	NCT05341401 (ClinicalTrials.gov)	June 2022	21/3/2022	Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis	Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis	Ulcerative Colitis Chronic	Drug: Budesonide MMX;Drug: Prednisolone	Assiut University	NULL	Not yet recruiting	18 Years	60 Years	All	100	Phase 2/Phase 3	NULL
40	NCT04276740 (ClinicalTrials.gov)	May 31, 2022	12/2/2020	MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis	Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC	Ulcerative Colitis Flare	Dietary Supplement: MitoQ;Other: Placebo	University of Edinburgh	JP Moulton Charitable Foundation;MitoQ	Not yet recruiting	18 Years	N/A	All	206	Phase 2	NULL
41	EUCTR2021-003702-42-ES (EUCTR)	17/05/2022	12/05/2022	A Phase 3 Placebo-controlled Efficacy and Safety Study with Ritlecitinib (PF-06651600) in Adults with Moderately to Severely Active UC	AN INTERVENTIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Moderate to Severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ritlecitinib Product Code: PF-06651600 INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 Product Name: Ritlecitinib Product Code: PF-06651600 INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	432	Phase 3	Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Norway;Germany;Japan;Sweden
42	EUCTR2021-002549-13-DK (EUCTR)	21/04/2022	24/01/2022	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;New Zealand;Sweden
43	EUCTR2021-002549-13-AT (EUCTR)	31/03/2022	25/10/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden;United States;Taiwan;Portugal;Serbia
44	JPRN-jRCTs021210073	08/03/2022	08/03/2022	Ustekinumab withdrawal for UC in remission	Ustekinumab withdrawal for ulcerative colitis in remission	Ulcerative colitis	No maintenance subcutaneous Ustekinumab therapy for UC patients in remission with Ustekinumab.	Shimodaira Yosuke	NULL	Recruiting	>= 15age old	< 75age old	Both	30	Phase 4	Japan
45	EUCTR2021-002549-13-NO (EUCTR)	07/03/2022	24/11/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	United States;Portugal;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
46	JPRN-jRCTs031210326	28/02/2022	21/09/2021	Evaluation of biomarkers in BF treatment	A multicenter study to evaluate the effectiveness of budesonide enema foam treatment and the usefulness ofserum biomarker measurement for active ulcerative colitis - BF-LRG	Ulcerative colitis Ulcerative colitis	Budesonide foam was administered as a study drug	Matsuoka Katsuyoshi	EA Pharma Co., Ltd.	Recruiting	>= 16age old	Not applicable	Both	20	N/A	Japan
47	EUCTR2021-002549-13-HR (EUCTR)	24/02/2022	28/02/2022	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
48	NCT05180175 (ClinicalTrials.gov)	February 7, 2022	17/12/2021	The Nordic IBD Treatment Strategy Trial	The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease	Drug: Top down treatment if patient at high risk	Region Örebro County	NULL	Recruiting	18 Years	70 Years	All	250	Phase 4	Denmark;Iceland;Norway;Sweden
49	EUCTR2021-003050-23-LT (EUCTR)	25/01/2022	11/10/2021	VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis	A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic	Oppilan Pharma Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany
50	EUCTR2021-003050-23-PL (EUCTR)	02/01/2022	29/09/2021	VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis	A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002	Oppilan Pharma Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	United States;Belarus;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany
51	NCT04924270 (ClinicalTrials.gov)	January 2022	7/6/2021	Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases	Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial	Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis	Biological: Faecal microbiota transplantation;Other: Placebo	Torkell Ellingsen	Region of Southern Denmark;University of Southern Denmark	Not yet recruiting	18 Years	70 Years	All	200	Phase 2	NULL
52	NCT04804540 (ClinicalTrials.gov)	December 29, 2021	15/3/2021	A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease	A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease	Ulcerative Colitis;Crohn Disease	Drug: Vedolizumab IV	Takeda	NULL	Active, not recruiting	18 Years	65 Years	All	150	Phase 4	India
53	JPRN-jRCT1051210145	28/12/2021	28/12/2021	Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial	Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial	ulcerative colitis ulcerative colitis;D003093	Administration of vedolizumab 300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 weeks	ooi makoto	NULL	Recruiting	>= 18age old	<= 80age old	Both	150	Phase 3	Japan
54	EUCTR2021-000091-11-BE (EUCTR)	09/12/2021	27/07/2021	A study of PRA023 in patients with Ulcerative Colitis	A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023	Prometheus Biosciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2	United States;Czechia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Georgia
55	EUCTR2021-001280-24-LT (EUCTR)	07/12/2021	19/08/2021	Study of VE202 in Patients with Ulcerative Colitis	Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis	Mild-to-moderate ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VE202 Product Code: VE202 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841829 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841842 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841855 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841894 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841907 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841920 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841933 INN or Proposed INN: Not applicable Other descriptive name: JNJ-64841946	Vedanta Biosciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	Serbia;United States;Czechia;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Netherlands;United Kingdom
56	EUCTR2021-002549-13-LT (EUCTR)	02/12/2021	06/09/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
57	EUCTR2021-002549-13-SK (EUCTR)	02/12/2021	24/08/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
58	NCT05084261 (ClinicalTrials.gov)	November 30, 2021	20/9/2021	An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)	A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)	Ulcerative Colitis	Drug: BT051 200 mg;Drug: BT051 800 mg;Drug: BT051 3200 mg;Drug: Matching Placebo	Adiso Therapeutics	NULL	Completed	18 Years	75 Years	All	24	Phase 1	United States;Georgia;Moldova, Republic of;Poland;Ukraine
59	NCT05156125 (ClinicalTrials.gov)	November 30, 2021	1/12/2021	VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: VTX002;Drug: Placebo	Oppilan Pharma Ltd	NULL	Recruiting	18 Years	80 Years	All	180	Phase 2	United States;Bulgaria;Czechia;France;Georgia;Germany;Hungary;Italy;Lithuania;Poland;Serbia;Slovakia;Ukraine
60	NCT04985968 (ClinicalTrials.gov)	November 24, 2021	22/7/2021	The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis	Ulcerative Colitis	Drug: Cobitolimod 250 mg;Drug: Cobitolimod 500 mg;Drug: Placebo	InDex Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	440	Phase 3	United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Croatia;Denmark;France;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Serbia;Slovakia;Sweden;Turkey;United Kingdom;Korea, Democratic People's Republic of
61	NCT05404074 (ClinicalTrials.gov)	November 22, 2021	17/5/2022	Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis	Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis	Ulcerative Colitis	Drug: Cobitolimod 500mg	InDex Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	6	Phase 1	Sweden
62	EUCTR2021-002549-13-IT (EUCTR)	22/11/2021	19/10/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: [-] INN or Proposed INN: Cobitolimod Product Name: Cobitolimod Product Code: [-] INN or Proposed INN: Cobitolimod	INDEX PHARMACEUTICALS AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
63	EUCTR2021-003050-23-HU (EUCTR)	22/11/2021	01/10/2021	VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis	A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic	Oppilan Pharma Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Hungary;Czech Republic;Poland;Georgia;Germany
64	NCT05088369 (ClinicalTrials.gov)	November 11, 2021	12/10/2021	Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201	A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults)	Ulcerative Colitis;Crohn's Disease	Drug: HM201;Drug: Placebo	Syneos Health	Himuka AM Pharma Corp.	Completed	18 Years	55 Years	All	53	Phase 1	Australia
65	NCT04968951 (ClinicalTrials.gov)	November 10, 2021	9/7/2021	Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)	REFOCUS: Refined Fecal Microbiota Transplantation (FMT) Delivered by Oral Capsules for Induction of Remission in Mild to Moderate Ulcerative Colitis - a Phase I Study	Ulcerative Colitis;FMT;Fecal Microbiota Transplant	Drug: Metronidazole;Drug: Placebo;Drug: Vancomycin;Biological: Fecal Microbiota Transplantation	Ari M Grinspan	NULL	Recruiting	18 Years	75 Years	All	20	Early Phase 1	United States
66	NCT05181137 (ClinicalTrials.gov)	November 5, 2021	10/12/2021	A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis	A Phase 3 Study to Evaluate the Efficacy and Long-term Safety of SHR0302 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: SHR0302;Drug: Placebo	Reistone Biopharma Company Limited	NULL	Recruiting	18 Years	75 Years	All	368	Phase 3	United States;China;Georgia;Poland;Ukraine
67	NCT04855799 (ClinicalTrials.gov)	November 2, 2021	20/4/2021	GI Permeability Change in Response to Aquamin®	Direct Measurement of Gastrointestinal Permeability Change in Response to Aquamin®	Ulcerative Colitis;Healthy;Irritable Bowel Syndrome With Diarrhea	Drug: Aquamin	James Varani	NULL	Recruiting	18 Years	80 Years	All	30	Phase 2	United States
68	NCT04999228 (ClinicalTrials.gov)	November 1, 2021	5/8/2021	Top Down Versus Step up in Pediatric Ulcerative Colitis	First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis	Ulcerative Colitis;Infliximab;Children	Drug: Infliximab;Drug: Corticosteroids	Children's Hospital of Fudan University	NULL	Recruiting	6 Years	18 Years	All	40	Phase 4	China
69	JPRN-jRCT2041200098	28/10/2021	02/02/2021	A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC)	A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	-Ustekinumab Dose Based on BSA and Body Weight As per BSA and body weight Ustekinumab will be administered SC and IV. Induction Period (I):Ustekinumab Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) Maintenance (M) Period: Ustekinumab once every 12 Week (q12w) -Matching Placebo Placebo will be administered subcutaneously. Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)	Nishikawa Kazuko	NULL	Recruiting	>= 2age old	< 18age old	Both	100	Phase 3	United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan
70	EUCTR2021-003050-23-CZ (EUCTR)	25/10/2021	18/08/2021	VTX002 versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis	A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic Product Code: VTX002 INN or Proposed INN: not yet available Other descriptive name: VTX002 is not biologic	Oppilan Pharma Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	Belarus;United States;Czechia;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Hungary;Poland;Georgia;Germany
71	EUCTR2021-002549-13-DE (EUCTR)	20/10/2021	28/06/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;New Zealand;Sweden
72	EUCTR2021-000091-11-CZ (EUCTR)	20/10/2021	22/04/2021	A study of PRA023 in patients with Ulcerative Colitis	A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023	Prometheus Biosciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2	United States;Czechia;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Georgia
73	EUCTR2021-001280-24-HU (EUCTR)	13/10/2021	18/08/2021	Study of VE202 in Patients with Ulcerative Colitis	Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis	Mild-to-moderate ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VE202 Product Code: VE202 INN or Proposed INN: Not applicable Other descriptive name: JNJ-72537634	Vedanta Biosciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	United States;Czechia;Hungary;Poland;Ukraine;Lithuania;Russian Federation;Netherlands
74	NCT03843385 (ClinicalTrials.gov)	October 2021	14/2/2019	Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis	Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Drug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: Placebo	Jena University Hospital	German Federal Ministry of Education and Research	Not yet recruiting	18 Years	75 Years	All	174	Phase 2/Phase 3	NULL
75	EUCTR2021-002549-13-HU (EUCTR)	24/09/2021	23/07/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
76	EUCTR2021-000091-11-HU (EUCTR)	13/09/2021	17/04/2021	A study of PRA023 in patients with Ulcerative Colitis	A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023	Prometheus Biosciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2	Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Georgia
77	EUCTR2021-002549-13-SE (EUCTR)	07/09/2021	16/06/2021	A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis	A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD Product Name: Cobitolimod INN or Proposed INN: COBITOLIMOD	InDex Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
78	EUCTR2018-003524-36-NO (EUCTR)	06/09/2021	16/06/2021	Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.	Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Trade Name: Metoject Trade Name: Puri-Nethol Trade Name: Remsima Trade Name: Inflectra	UMC Amsterdam location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	124	Phase 4	France;Ireland;Netherlands;Norway;United Kingdom
79	JPRN-jRCT2031210210	16/08/2021	28/07/2021	A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease	A master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's Disease - I6T-MC-AMAZ	Ulcerative Colitis / Crohn's Disease -	Drug: Mirikizumab Administered SC Other Name: LY3074828	Yoshimoto Yusuke	NULL	Recruiting	Not applicable	Not applicable	Both	5	Phase 3	United States;Japan
80	JPRN-jRCT2071210075	12/08/2021	07/10/2021	Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis	OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis	Drug: tofacitinib Open label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID.	Kawai Norisuke	NULL	Recruiting	>= 2age old	<= 17age old	Both	120	Phase 3	Australia;Canada;United States;Japan
81	EUCTR2021-000091-11-PL (EUCTR)	06/08/2021	20/05/2021	A study of PRA023 in patients with Ulcerative Colitis	A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023	Prometheus Biosciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170	Phase 2	United States;Czechia;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Georgia
82	EUCTR2018-002135-19-FR (EUCTR)	16/07/2021	02/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Democratic People's Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
83	NCT04996797 (ClinicalTrials.gov)	July 14, 2021	2/8/2021	A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis	A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: PRA023 IV;Device: Companion Diagnostic (CDx) Testing;Other: Placebo	Prometheus Biosciences, Inc.	NULL	Active, not recruiting	18 Years	N/A	All	170	Phase 2	United States;Australia;Belgium;Canada;Czechia;France;Georgia;Hungary;Israel;Italy;Poland;United Kingdom
84	EUCTR2019-003596-19-RO (EUCTR)	07/07/2021	21/04/2022	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa	Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE	Cristcot HCA LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	618	Phase 3	United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India
85	EUCTR2019-003113-34-SK (EUCTR)	29/06/2021	27/04/2021	Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Czechia;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Norway;Germany
86	NCT04919252 (ClinicalTrials.gov)	June 1, 2021	6/4/2021	Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease	Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease	Crohn's Disease and Ulcerative Colitis	Drug: Vedolizumab	Yonsei University	NULL	Not yet recruiting	19 Years	70 Years	All	60	Phase 3	Korea, Republic of
87	EUCTR2020-003017-35-SK (EUCTR)	26/05/2021	28/12/2020	A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)	An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Czechia;Slovakia;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Romania;Australia;Georgia;Germany;Latvia;China;Japan;Korea, Republic of
88	EUCTR2019-003334-16-LV (EUCTR)	29/04/2021	14/01/2021	Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis	Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis	acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 3	Belarus;Poland;Ukraine;Bulgaria;Russian Federation;Germany;Latvia
89	EUCTR2020-003556-33-PL (EUCTR)	19/04/2021	17/02/2021	A Placebo-controlled Study of BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis	A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase	Moderate to severe ulcerative colitis. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BBT-401-1S Product Code: BBT-401-1S INN or Proposed INN: None Other descriptive name: Sodium (S)-3-(4-hydroxyphenyl)-2-(2-((S)-1-((S)-1-palmitoylpyrrolidine-2-carbonyl)pyrrolidine-2-carboxamido)acetamido)propanoate	Bridge Biotherapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36	Phase 2	United States;Poland;Ukraine;New Zealand;Korea, Republic of
90	EUCTR2020-003017-35-BE (EUCTR)	15/04/2021	05/02/2021	A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)	An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Czechia;Slovakia;Ukraine;Israel;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;China;Japan;Korea, Republic of
91	JPRN-jRCTs011200009	08/04/2021	06/11/2020	vedolizumab-4026	A study to evaluate the relationship between the pharmacokinetics of vedolizumab in the colon tissue and in the serum concentrations, alpha4beta7 integrin receptor occupancy and the efficacy in subjects with moderately to severely active ulcerative colitis and treated by vedolizumab IV - vedolizumab-4026	Subjects with UC	Vedolizumab 300 mg is administered at Week 0, 2, 6 and every 8 weeks thereafter. Treatment duration is 46 weeks.	Fujiya Mikihiro	Takeda Pharmaceutical Company Limited (Takeda)	Not Recruiting	>= 20age old	<= 80age old	Both	30	Phase 4	Japan
92	NCT04818788 (ClinicalTrials.gov)	April 1, 2021	20/3/2021	Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis	Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy	Ulcerative Colitis	Drug: Biological Drug	Assiut University	NULL	Not yet recruiting	18 Years	55 Years	All	24		NULL
93	NCT04613518 (ClinicalTrials.gov)	March 15, 2021	28/10/2020	A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis	Colitis, Ulcerative	Drug: BMS-986165;Other: Placebo Comparator	Bristol-Myers Squibb	NULL	Active, not recruiting	18 Years	65 Years	All	50	Phase 2	United States;Australia;Canada;Germany;Netherlands;Poland;Puerto Rico;United Kingdom
94	EUCTR2020-000047-31-PL (EUCTR)	13/03/2021	15/07/2021	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	Belarus;Serbia;United States;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;Moldova, Republic of
95	EUCTR2019-002942-19-DK (EUCTR)	12/03/2021	05/11/2020	Nordic study of treatment strategy in inflammatory bowel disease	NORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile	Crohn's disease and Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Imurel INN or Proposed INN: Azathioprine Trade Name: Puri-nethol INN or Proposed INN: MERCAPTOPURINE	Region Örebro län	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 4	Denmark
96	EUCTR2019-003334-16-BG (EUCTR)	11/03/2021	02/12/2020	Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis	Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis	acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Germany;Latvia
97	EUCTR2016-004676-22-FR (EUCTR)	09/03/2021	26/01/2021	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	942	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
98	EUCTR2020-003017-35-CZ (EUCTR)	04/03/2021	29/12/2020	A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)	An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Czechia;Slovakia;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Georgia;Latvia;Germany;Japan;China;Korea, Republic of
99	EUCTR2019-001653-99-BE (EUCTR)	26/02/2021	26/02/2021	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Portugal;Serbia;United States;Slovakia
100	EUCTR2020-002833-13-PL (EUCTR)	24/02/2021	19/11/2020	A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: HUMIRA	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Poland;Ukraine;Georgia;Netherlands
101	EUCTR2020-003017-35-HU (EUCTR)	17/02/2021	29/12/2020	A study of LY3471851 in adult participants with moderately to severely active ulcerative colitis (UC)	An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: LY3471851	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	United States;Czechia;Slovakia;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Romania;Australia;Georgia;Germany;Latvia;China;Japan;Korea, Republic of
102	EUCTR2020-000047-31-DE (EUCTR)	11/02/2021	17/08/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	Serbia;United States;Belarus;Ukraine;Russian Federation;United Kingdom;Italy;Switzerland;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Germany;Netherlands;Moldova, Republic of
103	NCT04750135 (ClinicalTrials.gov)	February 7, 2021	7/2/2021	Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis	Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Drug: metformin 500 mg TID Oral Tablet;Drug: Placebo	National Hepatology & Tropical Medicine Research Institute	NULL	Not yet recruiting	18 Years	65 Years	All	40	Phase 2	Egypt
104	EUCTR2020-002833-13-NL (EUCTR)	05/02/2021	29/10/2020	A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101 Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: HUMIRA	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 2	Poland;Ukraine;Georgia;Netherlands
105	JPRN-UMIN000043165	2021/02/01	31/01/2021	Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease	Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease	Crohn's disease, Ulcerative colitis, IBDU	witching from originator infliximab to infliximab biosimilar CT-P13	Fukuoka University Chikushi Hospital	NULL	Pending	Not applicable	Not applicable	Male and Female	220	Not selected	Japan
106	EUCTR2019-001653-99-LT (EUCTR)	01/02/2021	23/09/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland
107	JPRN-jRCT1031200329	28/01/2021	28/01/2021	UC Bio Study	Open-ravel randomized control trial to evaluate the efficacy of biologics for ulcerative colitis with treatment-refractoriness	Ulcerative colitis Biologics;D003093	Infliximab:Infliximab (5 mg / kg / body weight) is infused intravenously at 0, 2, 6, 14, and 22 weeks. Vedolizumab:Intravenous infusion of vedolizumab 300 mg at 0, 2, 6, 14, and 22 weeks Ustekinumab: a single intravenous infusion of the dose shown below is given at the first induction therapy. Body weight dose 55kg or less 260mg 55-85kg 390mg 85kg or more 520mg After 8_weeks of intravenous drip infusion, 90 mg of ustekinumab is usually subcutaneously administered to adults, and 90 mg is subcutaneously administered at 12-week intervals thereafter. If the effect is diminished, the dosing interval can be shortened to 8 weeks.	Naganuma Makoto	NULL	Recruiting	>= 16age old	Not applicable	Both	231	N/A	Japan
108	EUCTR2019-001653-99-LV (EUCTR)	18/01/2021	26/10/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
109	EUCTR2019-001653-99-AT (EUCTR)	12/01/2021	24/11/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
110	JPRN-jRCT2071200081	12/01/2021	13/01/2021	ELEVATE UC OLE: An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis	Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant s country, whichever comes first	IQVIA Services Japan K.K. ICCC:	NULL	Not Recruiting	>= 16age old	<= 80age old	Both	35	Phase 3	Croatia;Czech Republic;Denmark;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Egypt;Estonia;France;Germany;Hungary;India;Israel;Italy;Korea;Lebanon;Mexico;Moldova;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Japan
111	EUCTR2020-002306-12-PL (EUCTR)	12/01/2021	08/09/2020	GB004 in adult subjects with active ulcerative colitis	A Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate GB004 in adult subjects with mild-to-moderate active ulcerative colitis	Mild-to-moderate active ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GB004 INN or Proposed INN: Not applicable Other descriptive name: GB004-HCl Product Code: GB004 INN or Proposed INN: Not applicable Other descriptive name: GB004-HCl	GB004, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Poland;Ukraine;Romania;Australia;Russian Federation;Georgia;Italy;Moldova, Republic of;Korea, Republic of
112	EUCTR2019-001653-99-DE (EUCTR)	08/01/2021	05/10/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Portugal;Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
113	JPRN-jRCT2071200080	25/12/2020	13/01/2021	ELEVATE UC 40 JAPAN: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Japanese Subjects	A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis	The investigational drug and the placebo are an oral tablet. The investigational drug is APD334 (etrasimod).	IQVIA Services Japan K.K. ICCC:	NULL	Not Recruiting	>= 16age old	<= 80age old	Both	35	Phase 3	Japan
114	NCT03414788 (ClinicalTrials.gov)	December 7, 2020	8/1/2018	Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease	PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS	Inflammatory Bowel Disease	Biological: PF 06687234;Biological: [124I]IB PF 06687234	Pfizer	NULL	Withdrawn	18 Years	75 Years	All	0	Phase 1	United States
115	EUCTR2019-001653-99-FR (EUCTR)	26/11/2020	12/10/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Malaysia;Denmark;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
116	EUCTR2020-000047-31-BG (EUCTR)	25/11/2020	08/10/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101	Applied Molecular Transport Inc.	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 2	Serbia;United States;Belarus;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of
117	EUCTR2018-002135-19-RO (EUCTR)	19/11/2020	01/04/2022	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
118	NCT04505410 (ClinicalTrials.gov)	November 18, 2020	5/8/2020	Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis	A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Second Line Induction With Biological Medications Tofacitinib, Ustekinumab or Vedolizumab	Ulcerative Colitis	Drug: Tofacitinib;Other: Fast Mimicking Diet;Drug: Ustekinumab induction;Drug: Infliximab induction	University of Miami	Pfizer	Recruiting	18 Years	N/A	All	76	Phase 3	United States
119	NCT04312113 (ClinicalTrials.gov)	November 16, 2020	14/3/2020	Angiographic Delivery of AD-MSC for Ulcerative Colitis	A Phase I Single Site Open Label Study of Intra-arterial Delivery of Mesenchymal Stem Cells for Luminal Ulcerative Colitis	Ulcerative Colitis	Drug: Adipose derived, autologous mesenchymal stem cells	Mayo Clinic	NULL	Recruiting	18 Years	65 Years	All	20	Phase 1	United States
120	NCT04543994 (ClinicalTrials.gov)	November 10, 2020	3/9/2020	Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)	A Phase IB/IIA Study of Remestemcel-L, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product, for the Treatment of Medically Refractory Ulcerative Colitis	Ulcerative Colitis	Drug: Remestemcel-L;Other: Placebo	The Cleveland Clinic	Mesoblast, Inc.	Recruiting	18 Years	75 Years	All	24	Phase 1/Phase 2	United States
121	EUCTR2018-005086-39-BG (EUCTR)	27/10/2020	25/06/2020	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
122	JPRN-UMIN000046650	2020/10/08	18/01/2022	exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis	exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis - exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis	ulcerative colitis	Endoscopy was performed 28 to 32 weeks after the administration of ustekinumab	JUNTENDO UNIVERSITY NERIMA HOSPITAL	NULL	Recruiting	20years-old	100years-old	Male and Female	30	Not selected	Japan
123	EUCTR2020-000047-31-FR (EUCTR)	07/10/2020	13/05/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of
124	JPRN-UMIN000041972	2020/10/01	01/10/2020	Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis.	Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis. - BS-UC-2020	ulcerative colitis	Broccoli Sprouts (20 g/day, 8 weeks) Alfalfa Sprouts (20 g/day, 8 weeks)	University of Tsukuba	NULL	Recruiting	20years-old	Not applicable	Male and Female	50	Not selected	Japan
125	EUCTR2020-000659-11-PL (EUCTR)	10/09/2020	23/07/2020	A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with ulcerative colitis	A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Poland;Ukraine;Georgia;Moldova, Republic of
126	EUCTR2020-000047-31-HU (EUCTR)	09/09/2020	07/07/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	Belarus;Serbia;United States;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Georgia;Bulgaria;Netherlands;Germany;Moldova, Republic of
127	NCT04205643 (ClinicalTrials.gov)	September 2, 2020	18/12/2019	CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Biological: CT-P13 SC (Infliximab);Other: Placebo SC	Celltrion	NULL	Active, not recruiting	18 Years	75 Years	All	548	Phase 3	Poland
128	NCT04109300 (ClinicalTrials.gov)	September 1, 2020	27/9/2019	Preemptive HLA Genotyping for the Safe Use of Infliximab-combination Therapy in Inflammatory Bowel Disease	Pharmacogenomic Strategies in Inflammatory Bowel Disease: Evaluating the Role of Pre-emptive HLADQA1 Genotyping for the Application of Targeted Infliximab-based Combination Therapy (INHERIT)	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease	Genetic: HLADQA1*05A>G screening;Other: Standard of Care	Western University, Canada	NULL	Not yet recruiting	18 Years	85 Years	All	162	N/A	Canada
129	JPRN-jRCTs031200103	01/09/2020	01/09/2020	Alginate combined fecal microbiota transplantation for ulcerative colitis	Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis	Ulcerative colitis Ulcerative colitis	A-FMT plus algin acid therapy arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take algin acid two times a day every single day. A-FMT plus placebo arm Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take Placebo two times a day every single day.	Ishikawa Dai	NULL	Recruiting	>= 20age old	Not applicable	Both	60	N/A	Japan
130	NCT04583358 (ClinicalTrials.gov)	August 26, 2020	16/9/2020	Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD)	Ulcerative Colitis	Drug: AMT-101 (oral);Other: Placebo (oral)	Applied Molecular Transport	NULL	Active, not recruiting	18 Years	80 Years	All	105	Phase 2	United States;Belarus;Bulgaria;Canada;France;Georgia;Germany;Hungary;Moldova, Republic of;Poland;Russian Federation;Switzerland;Ukraine;United Kingdom
131	EUCTR2018-000930-37-HU (EUCTR)	17/08/2020	24/06/2020	A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Ravagalimab Product Code: ABBV-323 Other descriptive name: ABBV-323	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
132	EUCTR2019-003999-39-NO (EUCTR)	17/08/2020	29/04/2020	A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06826647 Product Code: PF-06826647 INN or Proposed INN: PF-06826647	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	202	Phase 2	United States;United Arab Emirates;Qatar;Saudi Arabia;Hong Kong;Slovakia;Morocco;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Puerto Rico;Jordan;Malaysia;Australia;Tunisia;China;Bosnia and Herzegovina;Oman;Turkey;United Kingdom;Czech Republic;Armenia;Mexico;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Norway
133	JPRN-UMIN000042017	2020/08/13	05/10/2020	Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis	Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis - Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis	Ulcerative colitis	hydrogen gas 8 weeks inhalation the inhalation for 4 hours per day 12 weeks observation after the inhalation placebo gas 8 weeks inhalation the inhalation for 4 hours per day 12 weeks observation after the inhalation	Juntendo University Hospital	NULL	Suspended	20years-old	Not applicable	Male and Female	20	Not selected	Japan
134	EUCTR2019-004469-41-BG (EUCTR)	11/08/2020	27/04/2020	A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis	Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	169	Phase 2	Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
135	NCT04504383 (ClinicalTrials.gov)	August 5, 2020	5/8/2020	PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis	Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe	Drug: PN-943;Drug: Placebo	Protagonist Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	75 Years	All	150	Phase 2	United States;Austria;Bulgaria;Canada;Georgia;Germany;Hungary;Italy;Korea, Republic of;Poland;Russian Federation;Serbia;Ukraine
136	EUCTR2020-000047-31-GB (EUCTR)	03/08/2020	20/04/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT-101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT-101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of
137	EUCTR2019-003596-19-DE (EUCTR)	29/07/2020	29/07/2020	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa	Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE	Cristcot HCA LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	618	Phase 3	United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India
138	EUCTR2018-002136-24-RO (EUCTR)	13/07/2020	30/03/2022	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
139	EUCTR2018-003986-33-PT (EUCTR)	06/07/2020	28/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
140	EUCTR2018-004694-27-FR (EUCTR)	06/07/2020	10/04/2020	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Poland;Australia;Germany;Japan;Korea, Republic of;United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium
141	EUCTR2019-003334-16-DE (EUCTR)	26/06/2020	05/05/2020	Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis	Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis	acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 3	Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany
142	EUCTR2019-003596-19-IT (EUCTR)	26/06/2020	17/06/2021	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum.	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects withUlcerative Colitis of the Rectum. - CESSA	Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 90 mg idrocortisone acetato in supposta con applicatore per supposte Sephure Product Code: [90 mg idrocortisone acetato in supposta con appli INN or Proposed INN: IDROCORTISONE ACETATO	Cristcot HCA LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	618	Phase 3	United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Russian Federation;Germany;Italy;India
143	EUCTR2019-001430-33-DE (EUCTR)	18/06/2020	25/02/2020	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis	ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-4875 Product Code: GS-4875	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany
144	NCT04188990 (ClinicalTrials.gov)	June 15, 2020	2/12/2019	Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition	Evaluation of the Effectiveness and Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition	Pancreatitis, Acute;Crohn Disease;Ulcerative Colitis;Inflammatory Bowel Diseases;Pancreatic Cancer;Esophagus Cancer;Gastric Cancer;Colorectal Cancer	Dietary Supplement: Nutritional dietary intervention;Dietary Supplement: By demand;Dietary Supplement: Usual current care	Hospital Galdakao-Usansolo	NULL	Active, not recruiting	18 Years	N/A	All	900	N/A	Spain
145	NCT04259060 (ClinicalTrials.gov)	June 2020	27/1/2020	Hydroxocobalamin Approach to Reduction of Calprotectin With Butyrate for Ulcerative Colitis Research	Hydroxocobalamin Approach to Reduction of Nitrite With Butyrate for Ulcerative Colitis	Ulcerative Colitis	Drug: Hydroxocobalamin with Butyrate;Drug: Placebo with Butyrate	Joshua Korzenik	NULL	Not yet recruiting	18 Years	75 Years	All	42	Phase 2	United States
146	JPRN-JapicCTI-194980	22/5/2020	30/09/2019	A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Induction Study 1: Guselkumab Dose 1, Induction Study 1: Guselkumab Dose 2, Induction Study 1: Guselkumab Dose 3, Induction Study 2: Guselkumab IV; Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab IV or SC. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Study 1: Placebo IV Induction, Study 2: Placebo IV Maintenance Study: Placebo SC; Participants will receive matching placebo IV or SC.	Janssen Pharmaceutical K.K.	NULL	recruiting	18		BOTH	1000	Phase 2-3	Japan, Asia except Japan, North America, Europe
147	EUCTR2019-001430-33-PL (EUCTR)	20/05/2020	28/02/2020	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis	ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-4875 Product Code: GS-4875	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany
148	EUCTR2019-001430-33-AT (EUCTR)	15/05/2020	31/01/2020	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis	Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-4875 Product Code: GS-4875	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany
149	EUCTR2019-003849-15-ES (EUCTR)	12/05/2020	28/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
150	EUCTR2019-001430-33-IT (EUCTR)	05/05/2020	27/01/2021	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis - FALCON	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GS-4875 Product Code: [GS-4875] Product Name: GS-4875 Product Code: [GS-4875]	GILEAD SCIENCES INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	United States;Czechia;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany
151	EUCTR2019-003113-34-NO (EUCTR)	04/05/2020	21/01/2020	Ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Czechia;Hungary;Slovakia;Poland;Russian Federation;Bulgaria;Germany;Norway
152	EUCTR2019-003780-21-NL (EUCTR)	04/05/2020	21/02/2020	Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study)	Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Janus kinase Inhibitor INN or Proposed INN: Janus kinase Inhibitor	Alimentiv Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	United States;Canada;Spain;Belgium;Netherlands;Italy
153	NCT04156984 (ClinicalTrials.gov)	May 2020	24/10/2019	Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis	Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens	Ulcerative Colitis	Drug: Golimumab Prefilled Syringe	David Drobne	NULL	Not yet recruiting	18 Years	65 Years	All	30	Phase 4	Slovenia
154	EUCTR2018-003278-28-BG (EUCTR)	22/04/2020	23/05/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of
155	EUCTR2018-003987-29-AT (EUCTR)	15/04/2020	09/10/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	912	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
156	EUCTR2017-003703-22-BG (EUCTR)	07/04/2020	06/02/2020	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
157	EUCTR2018-003986-33-AT (EUCTR)	07/04/2020	20/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
158	EUCTR2019-003849-15-GR (EUCTR)	03/04/2020	02/04/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
159	EUCTR2019-003849-15-FR (EUCTR)	03/04/2020	03/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
160	EUCTR2019-001430-33-FR (EUCTR)	02/04/2020	20/02/2020	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis	ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-4875 Product Code: GS-4875	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany
161	NCT04332328 (ClinicalTrials.gov)	April 1, 2020	31/3/2020	Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt	Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt	Diet in Ulcerative Colitis Patients	Dietary Supplement: Diet	Assiut University	NULL	Not yet recruiting	N/A	N/A	All	50		NULL
162	EUCTR2019-002698-74-BG (EUCTR)	27/03/2020	31/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
163	EUCTR2019-002698-74-PL (EUCTR)	24/03/2020	11/02/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan
164	EUCTR2019-003849-15-AT (EUCTR)	20/03/2020	06/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
165	EUCTR2016-000642-62-SE (EUCTR)	18/03/2020	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden;Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic
166	EUCTR2016-000642-62-FR (EUCTR)	10/03/2020	30/07/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
167	EUCTR2017-003703-22-PT (EUCTR)	02/03/2020	18/12/2019	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;Portugal;United States;Belarus;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Netherlands;Germany;Bosnia and Herzegovina
168	NCT04309058 (ClinicalTrials.gov)	March 2020	24/2/2020	Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism	Observation of the Effect of Vitamin D Supplementation on Chronic Course of Patients With Ulcerative Colitis Based on Vitamin D Receptor Fok I Gene Polymorphism,a Prospective Cohort Study	Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement	Drug: Vitamin D drops	Second Affiliated Hospital of Wenzhou Medical University	NULL	Not yet recruiting	N/A	N/A	All	100	Early Phase 1	China
169	EUCTR2018-004002-25-ES (EUCTR)	28/02/2020	04/09/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkum	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
170	EUCTR2018-003986-33-DK (EUCTR)	28/02/2020	02/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
171	NCT04241029 (ClinicalTrials.gov)	February 25, 2020	17/1/2020	Boosting Biologics in UC	Boosting Biologics in Ulcerative Colitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Dietary Supplement: IDOFORM®Travel	Oslo University Hospital	Helse Sor-Ost	Recruiting	18 Years	75 Years	All	20	Phase 1	Norway
172	EUCTR2019-003113-34-HU (EUCTR)	25/02/2020	09/01/2020	Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	Czech Republic;Russian Federation;Hungary;Norway;United States;Poland;Slovakia;Bulgaria;Germany
173	EUCTR2019-003113-34-DE (EUCTR)	19/02/2020	08/11/2019	Ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Hungary;Czech Republic;Norway;Germany
174	EUCTR2018-003986-33-BG (EUCTR)	11/02/2020	23/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
175	EUCTR2019-004090-50-ES (EUCTR)	07/02/2020	11/11/2019	Clinical Trial to evaluate the safety and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis	A Phase Ib/IIa, randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety, pharmacokinetics and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis	Moderate to severe ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OST-122 INN or Proposed INN: Not available yet Other descriptive name: OST-122 Product Name: OST-122 INN or Proposed INN: Not available yet Other descriptive name: OST-122	ONCOSTELLAE S.L.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	32	Phase 1;Phase 2	Spain
176	NCT04074590 (ClinicalTrials.gov)	February 3, 2020	29/8/2019	Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis	A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis	Colitis, Ulcerative	Drug: LYS006;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	23	Phase 2	Bulgaria;Czechia;Germany;Poland;Russian Federation;Slovakia;Hungary;Norway;United Kingdom;United States
177	NCT04202211 (ClinicalTrials.gov)	February 2020	13/12/2019	FMT for Remission of Active Ulcerative Colitis in Adults	A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Biological: FMT oral;Biological: FMT enema;Other: Placebo oral;Other: Placebo enema	University of British Columbia	Crohn's and Colitis Canada;Vancouver Island Health Authority	Not yet recruiting	18 Years	N/A	All	145	Phase 2	Canada
178	EUCTR2018-002135-19-IT (EUCTR)	30/01/2020	17/06/2021	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473]	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
179	EUCTR2018-004491-35-RO (EUCTR)	30/01/2020	18/03/2022	A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis	A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Itacitinib Product Code: INCB039110 INN or Proposed INN: ITACITINIB ADIPATE Other descriptive name: ITACITINIB ADIPATE	Incyte Corporation	NULL	Not Recruiting			Female: yes Male: yes	206	Phase 2	United States;Czechia;Poland;Romania;Germany
180	EUCTR2018-003986-33-LV (EUCTR)	24/01/2020	01/11/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
181	EUCTR2018-003985-15-AT (EUCTR)	21/01/2020	08/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
182	EUCTR2018-003985-15-FR (EUCTR)	20/01/2020	12/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
183	EUCTR2018-003986-33-FR (EUCTR)	14/01/2020	20/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
184	NCT04023396 (ClinicalTrials.gov)	January 13, 2020	5/7/2019	Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis	A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: ABX464	Abivax S.A.	NULL	Active, not recruiting	18 Years	75 Years	All	217	Phase 2	Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom
185	EUCTR2018-002136-24-IT (EUCTR)	10/01/2020	17/06/2021	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473] Product Name: TD-1473 Product Code: [TD-1473]	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
186	EUCTR2018-003986-33-LT (EUCTR)	31/12/2019	08/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
187	EUCTR2018-003987-29-ES (EUCTR)	20/12/2019	20/12/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	702	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
188	EUCTR2019-003662-40-DE (EUCTR)	18/12/2019	22/10/2019	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis)	Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED	MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen INN or Proposed INN: ADALIMUMAB	Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	82	Phase 4	Germany
189	EUCTR2018-005086-39-HR (EUCTR)	16/12/2019	17/01/2020	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
190	EUCTR2018-003278-28-NL (EUCTR)	13/12/2019	22/07/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of
191	EUCTR2019-000733-39-ES (EUCTR)	11/12/2019	11/11/2019	Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients	A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany
192	EUCTR2018-003558-26-FR (EUCTR)	10/12/2019	08/02/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	232	Phase 2	Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands
193	JPRN-jRCTs031190156	09/12/2019	09/12/2019	IN for practical use	Study on efficacy and safety of indigo naturalis in patients with intractable ulcerative colitis.	ulcertive colitis	administration of one indigo naturalis FC enteric-coated tablet (including 0.5g indigo naturalis per tablet)twice a day for 4 weeks	Kanai Takanori	NULL	Recruiting	>= 16age old	Not applicable	Both	100	Phase 3	Japan
194	NCT04133194 (ClinicalTrials.gov)	November 28, 2019	10/10/2019	Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis	Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)	Ulcerative Colitis	Drug: Mesalazine	Flemming Bendtsen	NULL	Recruiting	18 Years	60 Years	All	200	Phase 4	Denmark
195	EUCTR2018-000334-35-NO (EUCTR)	27/11/2019	12/06/2019	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Norway KS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Canada;Austria;Netherlands;Belgium;Norway;Korea, Republic of;Poland;Italy;Germany
196	ChiCTR2000029648	2019-11-26	2020-02-09	The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study	The dynamic alteration of gut microenvironment of moderate to severe UC patient under glucocorticoid induction of remission: an observational study	Ulcerative Colitis	GC treatment:1mg/kg prednison or other GC with same dose;Health Control:NO intervention;	Peking Union Medical College Hospital	NULL	Recruiting	18	65	Both	GC treatment:120;Health Control:30;	N/A	China
197	EUCTR2017-003703-22-HR (EUCTR)	20/11/2019	13/01/2020	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: Vidofludimus calcium	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;Portugal;United States;Belarus;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Poland;Belgium;Croatia;Romania;Bulgaria;Georgia;Netherlands;Germany;Bosnia and Herzegovina
198	EUCTR2019-003068-39-NL (EUCTR)	20/11/2019	04/11/2019	In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.	Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study	Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Infliximab Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	UMC Utrecht	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 4	Netherlands
199	EUCTR2018-003986-33-HR (EUCTR)	08/11/2019	17/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
200	EUCTR2018-003986-33-HU (EUCTR)	07/11/2019	08/11/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
201	NCT05225545 (ClinicalTrials.gov)	November 4, 2019	9/10/2020	Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis	Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis	Anemia, Iron Deficiency;Ulcerative Colitis	Drug: Sucrosomial Iron;Drug: Oral Iron	American University of Beirut Medical Center	Pharma M	Recruiting	18 Years	N/A	All	30	Phase 3	Lebanon
202	EUCTR2016-000642-62-DE (EUCTR)	04/11/2019	18/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Belarus;Serbia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
203	EUCTR2018-000334-35-HU (EUCTR)	31/10/2019	06/09/2019	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH&Co. KG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of
204	EUCTR2018-003349-41-DE (EUCTR)	30/10/2019	19/12/2018	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany;Belarus;Serbia;United States;Ukraine
205	EUCTR2018-002135-19-BG (EUCTR)	30/10/2019	11/07/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
206	EUCTR2018-003558-26-DE (EUCTR)	30/10/2019	15/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	232	Phase 2	Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands
207	EUCTR2018-005086-39-HU (EUCTR)	28/10/2019	08/04/2019	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested	Landos Biopharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
208	EUCTR2018-003278-28-HU (EUCTR)	24/10/2019	25/03/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
209	EUCTR2018-004002-25-FR (EUCTR)	15/10/2019	14/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkum	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
210	EUCTR2018-003985-15-PT (EUCTR)	14/10/2019	10/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Belarus;Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
211	EUCTR2018-003986-33-BE (EUCTR)	14/10/2019	15/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany
212	NCT04131322 (ClinicalTrials.gov)	October 10, 2019	10/10/2019	Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.	Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study	Crohn Disease;Ulcerative Colitis	Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	NULL	Terminated	18 Years	N/A	All	24	Phase 4	Spain
213	EUCTR2018-001605-93-RO (EUCTR)	10/10/2019	15/03/2022	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
214	EUCTR2018-001605-93-BG (EUCTR)	09/10/2019	20/09/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
215	EUCTR2018-005086-39-PL (EUCTR)	07/10/2019	06/05/2019	A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	Russian Federation;Hungary;United States;Moldova, Republic of;Ukraine;Poland;Georgia;Belarus;Serbia;Bulgaria;Bosnia and Herzegovina;Croatia
216	EUCTR2017-004230-28-CZ (EUCTR)	04/10/2019	11/07/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
217	EUCTR2018-003986-33-NL (EUCTR)	03/10/2019	22/08/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
218	EUCTR2018-003985-15-RO (EUCTR)	03/10/2019	30/03/2022	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	372	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
219	EUCTR2018-004002-25-HU (EUCTR)	01/10/2019	13/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
220	NCT04006977 (ClinicalTrials.gov)	October 2019	1/7/2019	Multistrain Probiotics Reduces UC Depression and Anxiety Scores	Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis	Ulcerative Colitis	Dietary Supplement: a multistrain probiotic product (DSF);Dietary Supplement: Placebo	Xijing Hospital of Digestive Diseases	MENDES SA	Not yet recruiting	18 Years	65 Years	All	60	N/A	China
221	EUCTR2018-003490-10-FR (EUCTR)	30/09/2019	26/09/2019	An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial	An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial - CONTROL	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: HUMIRA INN or Proposed INN: ADALIMUMAB	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	238	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France
222	EUCTR2018-003985-15-DK (EUCTR)	27/09/2019	24/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
223	EUCTR2018-003985-15-BG (EUCTR)	27/09/2019	12/08/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Portugal;Serbia;Belarus;Taiwan;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
224	NCT04033445 (ClinicalTrials.gov)	September 26, 2019	24/7/2019	A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Placebo;Drug: Guselkumab	Janssen Research & Development, LLC	NULL	Active, not recruiting	18 Years	N/A	All	1064	Phase 2/Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Romania
225	EUCTR2018-003985-15-CZ (EUCTR)	26/09/2019	31/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
226	EUCTR2018-003278-28-CZ (EUCTR)	25/09/2019	15/04/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	Serbia;United States;Czechia;Estonia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
227	EUCTR2018-004694-27-DE (EUCTR)	24/09/2019	24/05/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Czechia;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
228	EUCTR2018-001605-93-BE (EUCTR)	23/09/2019	07/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2b Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
229	EUCTR2018-003985-15-NL (EUCTR)	18/09/2019	09/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
230	EUCTR2018-002135-19-GR (EUCTR)	13/09/2019	04/06/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
231	EUCTR2018-001605-93-FR (EUCTR)	13/09/2019	25/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
232	EUCTR2018-002136-24-FR (EUCTR)	10/09/2019	19/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
233	EUCTR2017-004230-28-HU (EUCTR)	06/09/2019	08/07/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece
234	NCT03937609 (ClinicalTrials.gov)	September 4, 2019	30/4/2019	TITRATE (inducTIon for acuTe ulceRATivE Colitis)	Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients With Acute Severe Ulcerative Colitis	Colitis, Ulcerative	Drug: Infliximab	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Pfizer	Recruiting	18 Years	N/A	All	120	Phase 4	Ireland;Netherlands;Norway
235	EUCTR2016-000642-62-HR (EUCTR)	30/08/2019	20/01/2020	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
236	EUCTR2018-003558-26-BE (EUCTR)	29/08/2019	27/05/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	244	Phase 2	United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
237	EUCTR2018-003985-15-LT (EUCTR)	27/08/2019	10/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
238	EUCTR2018-003985-15-EE (EUCTR)	26/08/2019	15/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
239	EUCTR2018-002135-19-DE (EUCTR)	26/08/2019	25/02/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
240	EUCTR2018-004491-35-PL (EUCTR)	19/08/2019	03/07/2019	A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis	A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Itacitinib Product Code: INCB039110 INN or Proposed INN: ITACITINIB ADIPATE Other descriptive name: ITACITINIB ADIPATE	Incyte Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	206	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Czech Republic;Poland;Romania;Germany
241	EUCTR2017-004092-31-HR (EUCTR)	19/08/2019	20/01/2020	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
242	EUCTR2018-004694-27-CZ (EUCTR)	13/08/2019	19/07/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
243	EUCTR2018-003278-28-PL (EUCTR)	03/08/2019	11/06/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of
244	NCT04029649 (ClinicalTrials.gov)	August 2019	17/7/2019	Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis	The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial	Ulcerative Colitis	Drug: Beta-1,3/1,6-D-Glucan;Drug: Placebo	Fakultas Kedokteran Universitas Indonesia	NULL	Not yet recruiting	18 Years	N/A	All	204	Phase 2/Phase 3	Indonesia
245	NCT03948919 (ClinicalTrials.gov)	July 31, 2019	10/5/2019	Low Sulfur Fecal Transplant for Ulcerative Colitis	Low Sulfur Fecal Transplant for Ulcerative Colitis	Ulcerative Colitis	Drug: Fecal microbiota;Other: Placebo	University of Minnesota	NULL	Active, not recruiting	18 Years	89 Years	All	20	Phase 1	United States
246	EUCTR2016-000642-62-PT (EUCTR)	29/07/2019	16/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Belarus;Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
247	EUCTR2018-003985-15-HU (EUCTR)	29/07/2019	16/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
248	EUCTR2016-000642-62-GB (EUCTR)	26/07/2019	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
249	EUCTR2018-004694-27-GB (EUCTR)	23/07/2019	30/04/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
250	EUCTR2019-001032-54-FR (EUCTR)	23/07/2019	19/06/2019	Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy	Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy - CYTOVEDO	Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058881;Term: Cytomegalovirus viremia;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: valganciclovir Product Name: valganciclovir Trade Name: vedolizumab Product Name: vedolizumab	CHU de Saint Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France
251	EUCTR2018-003349-41-IT (EUCTR)	16/07/2019	17/06/2021	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis - CYC-202	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: [FP-CYA-050] INN or Proposed INN: CICLOSPORIN Product Name: ST-0529 Product Code: [FP-CYA-053] INN or Proposed INN: CICLOSPORIN	Sublimity Therapeutics HoldCo Limited	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
252	NCT04018599 (ClinicalTrials.gov)	July 15, 2019	11/7/2019	Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS	A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects	Rheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious Uveitis	Drug: 40 mg MSB11022	Fresenius Kabi SwissBioSim GmbH	PRA Health Sciences	Completed	18 Years	55 Years	All	216	Phase 1	United States
253	EUCTR2018-003349-41-FR (EUCTR)	11/07/2019	27/05/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Belarus;Serbia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
254	EUCTR2018-003985-15-LV (EUCTR)	05/07/2019	02/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
255	EUCTR2018-003986-33-SK (EUCTR)	01/07/2019	02/05/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
256	NCT03914261 (ClinicalTrials.gov)	July 1, 2019	11/4/2019	Expanded Access to Risankizumab	Expanded Access to Risankizumab	Crohn's Disease;Ulcerative Colitis (UC)	Drug: Risankizumab	AbbVie	NULL	No longer available	18 Years	N/A	All			Belgium;Israel;Spain;Switzerland;United States
257	NCT03934216 (ClinicalTrials.gov)	July 1, 2019	30/4/2019	Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: BMS-986165;Other: Placebo	Bristol-Myers Squibb	NULL	Active, not recruiting	18 Years	80 Years	All	131	Phase 2	United States;Australia;Belgium;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Poland;Russian Federation;United Kingdom;Canada
258	EUCTR2017-004230-28-GR (EUCTR)	01/07/2019	03/05/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	Argentina;Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Greece;Canada;Austria;Czech Republic;Netherlands;Belgium;Norway;China;Taiwan;Denmark;Korea, Republic of;Poland;Italy;Mexico;Israel;Australia;Germany
259	EUCTR2018-003349-41-RO (EUCTR)	01/07/2019	09/05/2022	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Belarus;Serbia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
260	EUCTR2018-004694-27-PL (EUCTR)	30/06/2019	15/05/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
261	EUCTR2017-003229-14-RO (EUCTR)	28/06/2019	20/05/2022	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Germany;Japan
262	EUCTR2019-000717-37-ES (EUCTR)	27/06/2019	28/06/2019	Loss of response of the Adalimumba biosimilar compared with the original drug	LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.ADA-SWITCH Study - ADA-SWITCH Study	Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: AMGEVITA® Product Name: AMGEVITA (Adalimumab biosimilar ) Trade Name: HUMIRA ® Product Name: Humira (adalimumab original)	Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 4	Spain
263	NCT03656627 (ClinicalTrials.gov)	June 27, 2019	31/8/2018	Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease	Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease	Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis	Drug: Nivolumab	Alliance Foundation Trials, LLC.	Bristol-Myers Squibb	Terminated	18 Years	N/A	All	7	Phase 1	United States
264	EUCTR2017-004997-32-DE (EUCTR)	25/06/2019	14/12/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany
265	EUCTR2018-002136-24-DE (EUCTR)	25/06/2019	27/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
266	EUCTR2018-003985-15-SK (EUCTR)	21/06/2019	16/04/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
267	EUCTR2016-000642-62-GR (EUCTR)	21/06/2019	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
268	EUCTR2018-002135-19-PL (EUCTR)	19/06/2019	05/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
269	EUCTR2016-000642-62-IE (EUCTR)	18/06/2019	26/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
270	EUCTR2017-004230-28-DK (EUCTR)	14/06/2019	24/03/2019	BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Denmark A/S	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
271	EUCTR2016-000642-62-NL (EUCTR)	13/06/2019	11/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
272	EUCTR2018-002136-24-BG (EUCTR)	12/06/2019	18/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
273	EUCTR2018-003558-26-SI (EUCTR)	12/06/2019	07/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	244	Phase 2	United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
274	EUCTR2018-003558-26-IT (EUCTR)	11/06/2019	22/01/2021	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - ABX464-103	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABX464 Product Code: [ABX464] Product Name: ABX464 Product Code: [ABX464]	Abivax	NULL	Not Recruiting			Female: yes Male: yes	232	Phase 2	Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands
275	EUCTR2018-002135-19-ES (EUCTR)	10/06/2019	12/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
276	EUCTR2018-002135-19-PT (EUCTR)	05/06/2019	15/03/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;Japan
277	EUCTR2013-004279-11-FR (EUCTR)	03/06/2019	09/04/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
278	NCT03915769 (ClinicalTrials.gov)	June 3, 2019	12/4/2019	To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis	A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Ozanimod;Other: Placebo	Celgene	NULL	Active, not recruiting	18 Years	75 Years	All	195	Phase 3	Japan
279	NCT03941418 (ClinicalTrials.gov)	June 1, 2019	5/5/2019	Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease	Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease	Ulcerative Colitis;Crohn Disease	Dietary Supplement: Boulardii;Dietary Supplement: Placebo	University Clinic Dr Dragisa Misovic-Dedinje	University Clinic Zvezdara	Not yet recruiting	18 Years	80 Years	All	150	N/A	NULL
280	EUCTR2018-003349-41-BG (EUCTR)	29/05/2019	27/02/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Spain;Belarus;Serbia;United States;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
281	EUCTR2018-002135-19-SK (EUCTR)	28/05/2019	15/03/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
282	EUCTR2018-000930-37-ES (EUCTR)	27/05/2019	22/01/2019	A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABBV-323 INN or Proposed INN: RAVAGALIMAB Other descriptive name: ABBV-323	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
283	EUCTR2018-002136-24-ES (EUCTR)	23/05/2019	11/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
284	EUCTR2018-003558-26-SK (EUCTR)	23/05/2019	20/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	244	Phase 2	Belarus;Serbia;United States;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany
285	EUCTR2018-003558-26-CZ (EUCTR)	22/05/2019	14/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	232	Phase 2	Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;France;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy
286	EUCTR2018-003558-26-HU (EUCTR)	21/05/2019	25/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	232	Phase 2	United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany
287	EUCTR2017-004092-31-FR (EUCTR)	21/05/2019	18/04/2019	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
288	EUCTR2018-003558-26-PL (EUCTR)	20/05/2019	12/04/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	244	Phase 2	Belarus;Serbia;United States;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Germany
289	EUCTR2017-004576-57-PL (EUCTR)	18/05/2019	01/08/2019	Novel budesonide capsules vs. budesonide tabltes in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
290	EUCTR2013-001682-16-DK (EUCTR)	09/05/2019	13/05/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	840	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan
291	EUCTR2018-000930-37-FR (EUCTR)	07/05/2019	07/12/2018	A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABBV-323 Other descriptive name: ABBV-323	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
292	EUCTR2018-003278-28-FR (EUCTR)	07/05/2019	09/05/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
293	EUCTR2018-001510-15-DE (EUCTR)	02/05/2019	19/11/2018	A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany
294	EUCTR2018-003594-95-NL (EUCTR)	30/04/2019	30/04/2019	Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy	Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response	Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: methotrexate injection INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Amsterdam UMC location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
295	EUCTR2018-003278-28-GB (EUCTR)	29/04/2019	14/12/2018	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
296	EUCTR2017-004576-57-DE (EUCTR)	26/04/2019	08/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
297	EUCTR2017-003703-22-PL (EUCTR)	25/04/2019	26/04/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: Vidofludimus calcium	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;United States;Belarus;Portugal;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Netherlands;Germany;Bosnia and Herzegovina
298	EUCTR2018-003524-36-NL (EUCTR)	25/04/2019	19/11/2018	Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.	Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade Trade Name: Metoject Trade Name: Puri-Nethol	UMC Amsterdam location AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
299	EUCTR2018-000930-37-DE (EUCTR)	24/04/2019	18/10/2018	A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Ravagalimab Product Code: ABBV-323 Other descriptive name: ABBV-323	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;United States;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
300	EUCTR2018-004587-61-NL (EUCTR)	23/04/2019	13/05/2019	Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximab	Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: TOFACITINIB Trade Name: Inflectra Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	Erasmus Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
301	EUCTR2018-000930-37-IT (EUCTR)	19/04/2019	14/06/2021	A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy - NA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Ravagalimab Product Code: [ABBV-323]	ABBVIE DEUTSCHLAND GMBH & CO. KG	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;United States;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
302	EUCTR2017-004576-57-LV (EUCTR)	15/04/2019	14/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia
303	EUCTR2013-004277-27-HU (EUCTR)	11/04/2019	25/02/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
304	EUCTR2018-002135-19-HU (EUCTR)	11/04/2019	19/02/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)	A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study	Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
305	EUCTR2018-002136-24-PL (EUCTR)	04/04/2019	18/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
306	EUCTR2018-002136-24-GR (EUCTR)	03/04/2019	18/02/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
307	EUCTR2017-004576-57-CZ (EUCTR)	27/03/2019	15/03/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Serbia;Czechia;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Turkey;Russian Federation;Latvia;Germany
308	EUCTR2018-000334-35-NL (EUCTR)	21/03/2019	29/08/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim bv Netherlands	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;Korea, Republic of
309	EUCTR2016-000642-62-LT (EUCTR)	19/03/2019	15/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
310	EUCTR2018-002136-24-PT (EUCTR)	18/03/2019	02/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
311	EUCTR2013-004277-27-CZ (EUCTR)	18/03/2019	29/03/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;New Zealand
312	EUCTR2018-003364-31-PL (EUCTR)	15/03/2019	23/01/2019	A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.	A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Ulcerative Colitis.	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHR0302 INN or Proposed INN: Pending	Reistone Biopharma Company Limited	NULL	Not Recruiting			Female: yes Male: yes	152	Phase 2	United States;Poland;Ukraine;China
313	EUCTR2017-004576-57-LT (EUCTR)	15/03/2019	29/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
314	EUCTR2016-000642-62-PL (EUCTR)	14/03/2019	12/06/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Croatia;Germany;Norway;Japan;Sweden;Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey
315	EUCTR2017-004576-57-SK (EUCTR)	12/03/2019	18/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	777	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
316	EUCTR2017-004576-57-HU (EUCTR)	11/03/2019	16/01/2019	Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine	Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2	Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	777	Phase 3	Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
317	EUCTR2016-000642-62-IT (EUCTR)	05/03/2019	11/03/2021	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis - NA	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib	ABBVIE DEUTSCHLAND GMBH & CO. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
318	EUCTR2018-001510-15-PL (EUCTR)	01/03/2019	04/02/2019	A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany
319	JPRN-JapicCTI-184217	27/2/2019	22/11/2018	I6T-MC-AMBG	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 2)	Ulcerative Colitis	Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection, Subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : -	Eli Lilly Japan K.K.	NULL	complete	18	80	BOTH	1044	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania
320	EUCTR2018-003349-41-PL (EUCTR)	27/02/2019	15/01/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
321	EUCTR2017-000574-11-GR (EUCTR)	26/02/2019	27/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA	Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
322	EUCTR2018-000334-35-PL (EUCTR)	21/02/2019	07/12/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH&Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Denmark;Australia;Norway;Netherlands;Germany;Japan;Korea, Republic of
323	EUCTR2018-003349-41-HU (EUCTR)	19/02/2019	08/01/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Belarus;Serbia;United States;Spain;Ukraine;Ireland;Turkey;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany
324	EUCTR2018-002136-24-SK (EUCTR)	19/02/2019	28/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
325	EUCTR2018-002136-24-HU (EUCTR)	18/02/2019	29/03/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
326	EUCTR2017-003229-14-HR (EUCTR)	08/02/2019	16/05/2019	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
327	EUCTR2017-003238-96-HR (EUCTR)	08/02/2019	17/05/2019	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan
328	EUCTR2017-004997-32-HU (EUCTR)	04/02/2019	04/04/2019	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
329	EUCTR2016-004677-40-HR (EUCTR)	31/01/2019	16/05/2019	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
330	EUCTR2017-004997-32-NL (EUCTR)	30/01/2019	06/12/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
331	EUCTR2016-000642-62-SK (EUCTR)	28/01/2019	28/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
332	EUCTR2017-004092-31-HU (EUCTR)	23/01/2019	15/06/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
333	EUCTR2016-000642-62-ES (EUCTR)	17/01/2019	24/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
334	EUCTR2016-000642-62-CZ (EUCTR)	14/01/2019	14/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
335	EUCTR2016-000642-62-AT (EUCTR)	02/01/2019	30/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
336	EUCTR2018-002925-47-ES (EUCTR)	28/12/2018	16/11/2018	prediction of response to therapy in inflammatory bowel disease	Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches	Inflammatory bowel disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Vedolizumab INN or Proposed INN: VEDOLIZUMAB Other descriptive name: VEDOLIZUMAB	Fundación de Investigación Biomédica del Hospital Universitario de La Princesa	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Spain
337	EUCTR2018-000930-37-NL (EUCTR)	21/12/2018	11/10/2018	A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Ravagalimab Product Code: ABBV-323 INN or Proposed INN: Not assigned Other descriptive name: ABBV-323	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;United States;Hungary;Canada;Spain;Germany;Netherlands;United Kingdom;Italy;Korea, Republic of
338	NCT03765450 (ClinicalTrials.gov)	December 21, 2018	4/12/2018	Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis	Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis	Ulcerative Colitis	Drug: Infliximab	Alimentiv Inc.	NULL	Active, not recruiting	18 Years	N/A	All	18		United States;Canada
339	EUCTR2016-000642-62-HU (EUCTR)	19/12/2018	08/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
340	JPRN-JapicCTI-184131	18/12/2018	28/09/2018	A Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis [M14-675]	Ulcerative Colitis	Intervention name : ABT-494 INN of the intervention : upadacitinib Dosage And administration of the intervention : Will be orally administered Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Will be orally administered	AbbVie GK	NULL	complete	16	75	BOTH	45	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa, -
341	EUCTR2017-004496-31-FR (EUCTR)	17/12/2018	14/09/2018	A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	Janssen Biologics BV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of
342	EUCTR2016-000642-62-LV (EUCTR)	13/12/2018	15/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
343	EUCTR2018-000334-35-DE (EUCTR)	12/12/2018	20/08/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Czechia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Korea, Republic of
344	EUCTR2017-004997-32-ES (EUCTR)	10/12/2018	17/09/2018	A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease	A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE	Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc	Roche Farma, S.A por delegación de Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
345	JPRN-UMIN000034016	2018/12/01	03/09/2018	The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study	The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY study	ulcerative colitis	Additional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema The continuation of concomitant treatment at the remission induction by budesonide form enema (control group)	Hyogo College of Medicine	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	84	Not selected	Japan
346	EUCTR2016-000642-62-NO (EUCTR)	28/11/2018	15/10/2020	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Singapore;Croatia;Germany;Norway;Japan;Sweden;Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil
347	NCT03729674 (ClinicalTrials.gov)	November 26, 2018	11/10/2018	Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs	Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs	Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease	Drug: Biosimilar;Drug: Originator (legacy) drug	McGill University Health Centre/Research Institute of the McGill University Health Centre	Université de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research Group	Recruiting	18 Years	N/A	All	800		Canada
348	EUCTR2017-003238-96-DK (EUCTR)	20/11/2018	09/10/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly Cork Limited	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
349	EUCTR2017-003229-14-DK (EUCTR)	20/11/2018	11/10/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly Cork Limited	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
350	NCT03662542 (ClinicalTrials.gov)	November 20, 2018	6/9/2018	A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo	Janssen Research & Development, LLC	NULL	Completed	18 Years	65 Years	All	214	Phase 2	United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine
351	EUCTR2016-004676-22-DK (EUCTR)	15/11/2018	02/05/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
352	EUCTR2016-000642-62-FI (EUCTR)	13/11/2018	16/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
353	NCT03653026 (ClinicalTrials.gov)	November 12, 2018	28/8/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: Upadacitinib (ABT-494);Drug: Placebo	AbbVie	NULL	Completed	16 Years	75 Years	All	522	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Egypt;Ireland;Romania;Sweden
354	EUCTR2017-004092-31-LV (EUCTR)	02/11/2018	27/08/2018	A study of the efficacy and safety of Mirikizumab in Ulcerative Colitis	I6T-MC-AMAP A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long- Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 3) - LUCENT 3	moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: mirikizumab Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	840	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Germany;Japan
355	EUCTR2018-000334-35-IT (EUCTR)	30/10/2018	17/06/2021	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130(SPESOLIMAB) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials - -	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Trade Name: - Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: - Product Code: [BI 655130] INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: - Product Code: [BI 655130] INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	BOEHRINGER-INGELHEIM ITALIA S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Australia;Norway;Germany
356	NCT03596645 (ClinicalTrials.gov)	October 29, 2018	13/7/2018	A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab;Drug: Infliximab	Janssen Research & Development, LLC	NULL	Active, not recruiting	2 Years	17 Years	All	84	Phase 3	United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan
357	NCT03648541 (ClinicalTrials.gov)	October 29, 2018	24/8/2018	BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis	An Open Label, Long Term Safety Trial of BI 655130 (SPESOLIMAB) Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials	Colitis, Ulcerative	Drug: Spesolimab IV infusion;Drug: Spesolimab SC solution for injection	Boehringer Ingelheim	NULL	Active, not recruiting	18 Years	N/A	All	79	Phase 2	United States;Austria;Belgium;Canada;Germany;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom
358	EUCTR2016-004677-40-GR (EUCTR)	26/10/2018	04/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
359	EUCTR2017-003238-96-AT (EUCTR)	24/10/2018	22/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
360	EUCTR2017-003229-14-AT (EUCTR)	24/10/2018	22/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
361	EUCTR2017-003229-14-GB (EUCTR)	24/10/2018	04/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
362	JPRN-JapicCTI-184216	22/10/2018	22/11/2018	I6T-MC-AMAN	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1)	Ulcerative Colitis	Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : intravenous injection	Eli Lilly Japan K.K.	NULL	complete	18	80	BOTH	1160	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania
363	EUCTR2018-000334-35-BE (EUCTR)	22/10/2018	06/07/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	SCS Boehringer Ingelheim Comm. V	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Netherlands;Japan;Korea, Republic of;United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Belgium;Poland;Norway;Germany
364	EUCTR2017-003238-96-GB (EUCTR)	22/10/2018	04/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
365	EUCTR2018-000334-35-GB (EUCTR)	22/10/2018	25/07/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim LImited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Hungary;Canada;Belgium;Poland;Norway;Germany;Netherlands;Japan;Korea, Republic of
366	NCT03524092 (ClinicalTrials.gov)	October 19, 2018	10/5/2018	A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)	Ulcerative Colitis	Drug: Mirikizumab;Drug: Placebo	Eli Lilly and Company	NULL	Active, not recruiting	18 Years	80 Years	All	1177	Phase 3	United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil;Croatia;Saudi Arabia
367	EUCTR2017-000402-38-SE (EUCTR)	19/10/2018	25/05/2018	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis	To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	United States;Portugal;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;United Kingdom;Italy;India;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
368	EUCTR2017-003238-96-DE (EUCTR)	15/10/2018	03/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	Denmark;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
369	EUCTR2017-003229-14-DE (EUCTR)	15/10/2018	30/04/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
370	EUCTR2017-002350-36-GR (EUCTR)	03/10/2018	10/09/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
371	EUCTR2017-002350-36-DE (EUCTR)	27/09/2018	13/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
372	EUCTR2017-003238-96-HU (EUCTR)	27/09/2018	13/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
373	EUCTR2017-003229-14-HU (EUCTR)	27/09/2018	15/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly Cork Limited	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan
374	EUCTR2018-002794-21-GB (EUCTR)	11/09/2018	04/09/2018	Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis	Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitis - FAVOUR	Ulcerative colitis (UC) MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Vedolizumab Product Name: Vedolizumab	Guy's & St Thomas NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
375	EUCTR2017-003229-14-SK (EUCTR)	06/09/2018	06/07/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany;Japan
376	EUCTR2017-003238-96-SK (EUCTR)	04/09/2018	20/07/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany;Japan
377	EUCTR2017-003238-96-LV (EUCTR)	30/08/2018	21/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	Poland;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium
378	EUCTR2017-004230-28-NL (EUCTR)	30/08/2018	15/03/2018	BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim bv	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of
379	NCT03398135 (ClinicalTrials.gov)	August 28, 2018	8/1/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: risankizumab;Drug: placebo for risankizumab	AbbVie	NULL	Active, not recruiting	16 Years	80 Years	All	1242	Phase 3	Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;United States;American Samoa;Australia;Hungary;Malaysia;Argentina;Austria
380	EUCTR2017-002350-36-NL (EUCTR)	28/08/2018	24/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
381	EUCTR2017-002350-36-IE (EUCTR)	28/08/2018	16/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
382	JPRN-JapicCTI-184008	28/8/2018	21/06/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066]	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066]	Ulcerative Colitis (UC)	Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	AbbVie GK	NULL	recruiting	16	80	BOTH	70	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
383	EUCTR2017-000573-37-EE (EUCTR)	27/08/2018	11/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United States;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
384	EUCTR2017-003238-96-IT (EUCTR)	22/08/2018	01/10/2021	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: N/A Product Name: mirikizumab Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: N/A Product Name: mirikizumab Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	ELI LILLY & COMPANY, LILLY CORPORATE CENTER	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
385	EUCTR2017-002350-36-BG (EUCTR)	22/08/2018	28/05/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
386	EUCTR2018-000334-35-AT (EUCTR)	20/08/2018	09/07/2018	BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis	An open label, long term safety trial of BI 655130 (Spesolimab) treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH&Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Spain;Austria;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Norway;Netherlands;Germany;Japan;Korea, Republic of
387	EUCTR2017-003238-96-CZ (EUCTR)	16/08/2018	30/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
388	EUCTR2017-003229-14-CZ (EUCTR)	16/08/2018	30/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
389	NCT03546868 (ClinicalTrials.gov)	August 14, 2018	10/5/2018	Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease	Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Subjects With Inflammatory Bowel Disease.	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease	Drug: [18F]FSPG	Asan Foundation	NULL	Completed	19 Years	79 Years	All	20	Phase 2	Korea, Republic of
390	EUCTR2017-003229-14-LV (EUCTR)	03/08/2018	21/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan
391	JPRN-JapicCTI-184062	02/8/2018	10/08/2018	I6T-MC-AMAP	A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)	Ulcerative Colitis	Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Mirikizumab administered subcutaneously (SC) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Eli Lilly Japan K.K.	NULL	complete	18	80	BOTH	142	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania, Middle East
392	EUCTR2017-003238-96-ES (EUCTR)	01/08/2018	04/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
393	NCT03196427 (ClinicalTrials.gov)	July 30, 2018	20/6/2017	Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab	Takeda	Takeda Development Center Americas, Inc.	Active, not recruiting	2 Years	17 Years	All	59	Phase 2	United States;Belgium;France;Hungary;Israel;Poland;Ukraine;United Kingdom;Canada;Netherlands
394	EUCTR2017-003229-14-BE (EUCTR)	27/07/2018	08/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
395	EUCTR2017-003238-96-BE (EUCTR)	27/07/2018	07/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland
396	EUCTR2017-000402-38-RO (EUCTR)	26/07/2018	23/05/2022	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis	To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	Portugal;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;United Kingdom;Italy;India;Hungary;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
397	EUCTR2017-000402-38-BE (EUCTR)	25/07/2018	30/05/2018	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Poland;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden
398	EUCTR2017-002108-28-DE (EUCTR)	25/07/2018	27/03/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 2	United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
399	EUCTR2015-001600-64-AT (EUCTR)	25/07/2018	17/04/2018	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
400	EUCTR2017-003703-22-NL (EUCTR)	24/07/2018	05/03/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: Vidofludimus calcium	Immunic AG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Belarus;Serbia;United States;Portugal;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
401	EUCTR2015-000319-41-GR (EUCTR)	23/07/2018	18/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
402	EUCTR2017-000402-38-ES (EUCTR)	13/07/2018	25/07/2018	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis	To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Sweden
403	EUCTR2015-001600-64-ES (EUCTR)	12/07/2018	21/05/2018	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
404	EUCTR2015-000319-41-ES (EUCTR)	12/07/2018	21/05/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
405	EUCTR2018-001546-33-GB (EUCTR)	11/07/2018	14/05/2018	The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease	IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0	Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab	University Southampton Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United Kingdom
406	EUCTR2017-003229-14-LT (EUCTR)	05/07/2018	31/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
407	EUCTR2017-003238-96-LT (EUCTR)	05/07/2018	31/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
408	EUCTR2016-002765-58-IT (EUCTR)	28/06/2018	17/06/2021	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis - NA	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib	GILEAD SCIENCES INCORPORATED	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden
409	EUCTR2017-002274-39-NL (EUCTR)	27/06/2018	19/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3;Phase 4	Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
410	EUCTR2015-000319-41-LV (EUCTR)	22/06/2018	13/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
411	EUCTR2015-001600-64-LV (EUCTR)	22/06/2018	13/04/2018	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
412	EUCTR2017-002350-36-HU (EUCTR)	14/06/2018	19/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
413	EUCTR2017-000572-28-BE (EUCTR)	08/06/2018	14/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
414	NCT03531892 (ClinicalTrials.gov)	June 6, 2018	9/5/2018	A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis	Phase III Study of AJM300 in Patients With Active Ulcerative Colitis	Colitis, Ulcerative	Drug: AJM300;Drug: Placebo	EA Pharma Co., Ltd.	Kissei Pharmaceutical Co., Ltd.	Active, not recruiting	16 Years	74 Years	All	198	Phase 3	Japan
415	EUCTR2017-004230-28-DE (EUCTR)	04/06/2018	31/01/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
416	JPRN-JapicCTI-183997	29/5/2018	12/06/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067]	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067]	Ulcerative Colitis (UC)	Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	AbbVie GK	NULL	recruiting	16	80	BOTH	65	Phase 2-3	Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
417	EUCTR2015-000319-41-AT (EUCTR)	25/05/2018	17/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
418	EUCTR2017-000402-38-NL (EUCTR)	24/05/2018	13/11/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;New Zealand;Sweden
419	EUCTR2017-004230-28-IT (EUCTR)	22/05/2018	05/11/2020	BI 655130 induction treatment in patients with moderate-tosevereulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy - -	Moderate-to-severely active ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: - Product Code: [BI 655130] Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	BOEHRINGER-INGELHEIM ITALIA S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	Japan;Korea, Republic of;United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands
420	EUCTR2017-002108-28-IT (EUCTR)	15/05/2018	22/01/2021	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: [PF-06687234] INN or Proposed INN: PF-06687234	PFIZER INC	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;Serbia;Saudi Arabia;Spain;Belgium;Korea, Democratic People's Republic of;Australia;Israel;Germany;Italy
421	EUCTR2017-002231-41-NL (EUCTR)	14/05/2018	26/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary
422	EUCTR2017-003649-10-DE (EUCTR)	30/04/2018	07/02/2018	A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease	A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE	Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 1	United States;Poland;Belgium;Spain;Germany;United Kingdom
423	EUCTR2017-003703-22-ES (EUCTR)	29/04/2018	20/02/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom
424	EUCTR2017-000573-37-HR (EUCTR)	23/04/2018	07/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;United States;Serbia;Portugal;Estonia;Slovakia;Greece
425	EUCTR2017-000599-27-HR (EUCTR)	20/04/2018	07/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Czechia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
426	EUCTR2016-003708-29-BG (EUCTR)	20/04/2018	17/01/2018	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 2	Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
427	EUCTR2017-000599-27-IT (EUCTR)	19/04/2018	22/01/2021	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis,compared with placebo (dummy treatment) ¿ using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects withModerate to Severe Ulcerative Colitis (FIGARO UC 301) - FIGARO UC 301	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: - Product Code: [SHP647] INN or Proposed INN: ontamalimab Product Name: - Product Code: [SHP647] INN or Proposed INN: ontamalimab	SHIRE HUMAN GENETIC THERAPIES, INC	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	Serbia;United States;Czechia;Slovenia;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand
428	EUCTR2017-000573-37-IT (EUCTR)	19/04/2018	22/01/2021	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis,compared with placebo (dummy treatment) ¿ using a randomised andblinded study design (investigator and patients are not aware whetherthey receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel groupEfficacy and Safety Study of SHP647 as Maintenance Therapy in SubjectsWith Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: [SHP647] INN or Proposed INN: ontamalimab Product Code: [SHP647] INN or Proposed INN: ontamalimab	SHIRE HUMAN GENETIC THERAPIES, INC	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
429	EUCTR2017-004230-28-GB (EUCTR)	13/04/2018	01/02/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
430	EUCTR2017-002274-39-GB (EUCTR)	12/04/2018	20/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	130	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
431	EUCTR2017-002108-28-ES (EUCTR)	12/04/2018	20/04/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: Dekavil Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of
432	EUCTR2017-000574-11-DE (EUCTR)	10/04/2018	25/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA	Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2453	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
433	EUCTR2017-000599-27-DE (EUCTR)	10/04/2018	24/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
434	EUCTR2017-000573-37-DE (EUCTR)	10/04/2018	24/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
435	EUCTR2017-004230-28-ES (EUCTR)	09/04/2018	08/02/2018	BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of
436	EUCTR2017-003284-35-PL (EUCTR)	06/04/2018	05/03/2018	A follow-up study in patients with moderate to severe active ulcerative colitis.	A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Belgium;Hungary;Poland;Spain
437	JPRN-jRCTs041190010	06/04/2018	10/04/2019	The usefulness of kestose for ulcerative colitis	The usefulness of kestose for ulcerative colitis	Ulcerative colitis	arm A Kestose(10g) every day 8 weeksar arm B Maltose(5g) every day 8 weeks	Honda Takashi	NULL	Not Recruiting	>= 20age old	<= 80age old	Both	40	N/A	Japan
438	EUCTR2016-004112-35-SE (EUCTR)	04/04/2018	21/06/2017	A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel disease	Low-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study	Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Imurel Product Name: Azathioprine Product Code: NA Trade Name: Allopurinol Product Name: Allopurinol Product Code: NA	SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	Sweden
439	EUCTR2017-002108-28-BE (EUCTR)	30/03/2018	22/03/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 2	United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
440	EUCTR2016-000641-31-BE (EUCTR)	29/03/2018	31/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel
441	NCT03482635 (ClinicalTrials.gov)	March 27, 2018	15/3/2018	BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy	Colitis, Ulcerative	Drug: Spesolimab;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	18 Years	75 Years	All	98	Phase 2/Phase 3	United States;Austria;Belgium;Canada;Germany;Greece;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Australia;Czechia;Denmark;Hungary;Norway
442	NCT03478956 (ClinicalTrials.gov)	March 27, 2018	26/3/2018	A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease	A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease	Ulcerative Colitis;Crohn's Disease	Drug: Etrolizumab	Hoffmann-La Roche	NULL	Active, not recruiting	4 Years	17 Years	All	24	Phase 1	Belgium;Poland;Spain;United Kingdom;Germany;United States
443	EUCTR2017-002182-21-NL (EUCTR)	20/03/2018	28/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom
444	NCT03482648 (ClinicalTrials.gov)	March 20, 2018	17/3/2018	First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers	A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects	Ulcerative Colitis	Drug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: Placebo	Bridge Biotherapeutics, Inc.	KCRN Research, LLC	Completed	19 Years	55 Years	All	80	Phase 1	United States
445	EUCTR2017-000573-37-NL (EUCTR)	15/03/2018	02/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
446	EUCTR2017-000599-27-NL (EUCTR)	15/03/2018	02/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	Serbia;United States;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand
447	NCT03341962 (ClinicalTrials.gov)	March 15, 2018	8/11/2017	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative Colitis	Ulcerative Colitis	Drug: IMU-838;Drug: Placebo	Immunic AG	NULL	Active, not recruiting	18 Years	80 Years	All	263	Phase 2	United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Netherlands;North Macedonia;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom
448	EUCTR2017-000572-28-PT (EUCTR)	13/03/2018	22/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
449	EUCTR2017-000573-37-IE (EUCTR)	13/03/2018	04/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
450	EUCTR2017-000573-37-PT (EUCTR)	13/03/2018	21/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Russian Federation;United States;Portugal;Greece;Austria;Netherlands;Ireland;Brazil;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Lithuania;Serbia;Bosnia and Herzegovina;Croatia;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Switzerland;Spain;New Zealand;Canada;Czech Republic;Belgium;Italy;Mexico;South Africa;Israel;Australia;Germany;Estonia
451	EUCTR2017-004230-28-BE (EUCTR)	09/03/2018	22/01/2018	BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	SCS Boehringer Ingelheim Comm. V	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	Argentina;Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Greece;Canada;Austria;Czech Republic;Netherlands;Belgium;China;Taiwan;Denmark;Korea, Republic of;Poland;Italy;Mexico;Israel;Australia;Germany
452	NCT03398148 (ClinicalTrials.gov)	March 7, 2018	8/1/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: risankizumab IV;Drug: placebo for risankizumab;Drug: risankizumab SC	AbbVie	NULL	Active, not recruiting	16 Years	80 Years	All	1554	Phase 2/Phase 3	United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Hungary
453	EUCTR2017-000599-27-GB (EUCTR)	07/03/2018	05/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
454	EUCTR2017-000573-37-GB (EUCTR)	07/03/2018	25/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
455	NCT03283085 (ClinicalTrials.gov)	February 27, 2018	12/9/2017	A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)	A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)	Crohn's Disease;Ulcerative Colitis	Drug: 25 mg Ontamalimab;Drug: 75 mg Ontamalimab	Shire	NULL	Active, not recruiting	16 Years	80 Years	All	557	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom
456	EUCTR2017-000573-37-CZ (EUCTR)	27/02/2018	01/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
457	EUCTR2017-004230-28-AT (EUCTR)	27/02/2018	18/01/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
458	EUCTR2017-000599-27-CZ (EUCTR)	26/02/2018	01/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
459	EUCTR2017-000937-30-AT (EUCTR)	22/02/2018	03/01/2018	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Poland;Belgium;Austria;Germany
460	EUCTR2017-002274-39-BE (EUCTR)	22/02/2018	18/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3;Phase 4	United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
461	EUCTR2016-004217-26-IT (EUCTR)	22/02/2018	22/02/2018	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT	Moderate to Severe left-sided Active Ulcerative Colitis MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: DIMs0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	INDEX PHARMACEUTICALS AB	NULL	Not Recruiting			Female: yes Male: yes	215	Phase 2	Serbia;Spain;Ukraine;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Germany;Sweden
462	EUCTR2017-002274-39-IT (EUCTR)	20/02/2018	12/02/2021	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLELGROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION - NA	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib	PFIZER INC	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3;Phase 4	Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
463	EUCTR2017-000572-28-FR (EUCTR)	16/02/2018	16/02/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
464	EUCTR2017-000572-28-ES (EUCTR)	16/02/2018	19/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) - FIGARO UC 302	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
465	EUCTR2017-000573-37-ES (EUCTR)	16/02/2018	19/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
466	JPRN-UMIN000030000	2018/02/07	01/12/2017	The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.	The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. - The efficacy and safety of topical budezonide for pouchitis.	ulcerative colitispouchitis	Topical budesonido 2weeks of 2mg daily Topical prednisolone 2weeks 20mg daily Topical aminosalicylate 2weeks 1g daily	Department of Inflammatory Bowel DiseaseHyogo College of Medicine	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	30	Phase 1	Japan
467	EUCTR2017-004772-65-DK (EUCTR)	05/02/2018	04/12/2017	Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO)	Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) - PROCTO	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TSO INN or Proposed INN: TSO Other descriptive name: SUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML	ParaTech A/S	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Denmark
468	JPRN-JapicCTI-183858	01/2/2018	08/02/2018	Prospective, Post Marketing Surveillance of RECTABUL2mg rectal form	Prospective, Post Marketing Surveillance of RECTABUL2mg rectal form	Ulcerative colitis (except for severe disease)	Intervention name : RECTABUL2mg rectal form INN of the intervention : Budesonide Dosage And administration of the intervention : Usually, this drug is administered 2 times (1time 2mg) daily through rectal. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : no	EA Pharma Co.,Ltd.	KISSEI Pharmaceutical Co., Ltd.	complete			BOTH	600	NA	Japan
469	JPRN-UMIN000030988	2018/02/01	01/02/2018	Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy	Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy - Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study)	Ulcerative Colitis	Induce azathioprine and continue maintenance therapy by azathioprine Induce adalimumab and continue maintenance therapy by adalimumab	Sakura Medical Center, Toho university	NULL	Pending	15years-old	Not applicable	Male and Female	53	Not applicable	Japan
470	EUCTR2017-000599-27-LT (EUCTR)	30/01/2018	31/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	Serbia;United States;Czechia;Slovakia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand
471	EUCTR2017-000573-37-LT (EUCTR)	30/01/2018	31/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
472	EUCTR2017-000402-38-PT (EUCTR)	29/01/2018	13/11/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Galapagos NV	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	Portugal;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Netherlands;Germany;New Zealand;Sweden
473	EUCTR2017-000573-37-BG (EUCTR)	24/01/2018	22/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
474	EUCTR2013-001744-65-BE (EUCTR)	23/01/2018	27/02/2017	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
475	EUCTR2017-000402-38-DE (EUCTR)	23/01/2018	27/10/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	United States;Portugal;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
476	EUCTR2017-000573-37-HU (EUCTR)	22/01/2018	23/01/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
477	EUCTR2017-000572-28-HU (EUCTR)	22/01/2018	27/10/2017	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
478	NCT03368118 (ClinicalTrials.gov)	January 20, 2018	13/11/2017	Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis	A Follow-up Phase IIa Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 50 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis.	Ulcerative Colitis	Drug: ABX464	Abivax S.A.	Orion Corporation, Orion Pharma	Active, not recruiting	18 Years	70 Years	All	22	Phase 2	Belgium
479	EUCTR2017-000402-38-AT (EUCTR)	19/01/2018	30/10/2017	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	United States;Portugal;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
480	EUCTR2017-000402-38-GB (EUCTR)	19/01/2018	23/10/2017	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	United States;Portugal;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
481	EUCTR2017-000572-28-BG (EUCTR)	19/01/2018	24/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
482	EUCTR2017-002231-41-PL (EUCTR)	17/01/2018	13/10/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
483	EUCTR2017-002274-39-CZ (EUCTR)	16/01/2018	14/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3;Phase 4	Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
484	EUCTR2017-002231-41-BE (EUCTR)	10/01/2018	14/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
485	EUCTR2013-001744-65-DE (EUCTR)	10/01/2018	20/02/2017	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
486	EUCTR2017-002274-39-AT (EUCTR)	04/01/2018	20/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3	Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
487	JPRN-UMIN000029633	2017/12/27	20/10/2017	The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis.	The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis. - The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis.	ulcerative colitis	administration of the suppository ,which contains 0.05g indigo naturalis, for 4 weeks	Keio University School of Medicine	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	10	Not selected	Japan
488	EUCTR2017-000573-37-AT (EUCTR)	22/12/2017	30/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
489	EUCTR2017-000599-27-AT (EUCTR)	22/12/2017	30/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
490	EUCTR2017-002274-39-ES (EUCTR)	21/12/2017	22/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3	United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
491	EUCTR2017-002274-39-HU (EUCTR)	21/12/2017	19/12/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3;Phase 4	United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
492	NCT03269695 (ClinicalTrials.gov)	December 20, 2017	30/8/2017	Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)	Ulcerative Colitis	Drug: PF-06687234;Drug: Placebo	Pfizer	NULL	Terminated	18 Years	75 Years	All	20	Phase 2	United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Turkey;Spain
493	EUCTR2017-002182-21-FR (EUCTR)	18/12/2017	15/12/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
494	EUCTR2017-002231-41-DE (EUCTR)	18/12/2017	14/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
495	JPRN-UMIN000032250	2017/12/15	14/04/2018	Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia	Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia - Dual center study of pCLE for UCAN	suspected ulcerative colitis-associated neoplasia	pCLE after intravenous administration of fluorescein	Fujita Health University School of Medicine, Department of Gastroenterology	Center for Diagnostic and Therapeutic Endoscopy, School of Medicine KeioUniversity	Recruiting	20years-old	85years-old	Male and Female	40	Not applicable	Japan
496	EUCTR2017-000572-28-SK (EUCTR)	13/12/2017	21/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
497	EUCTR2017-000937-30-PL (EUCTR)	13/12/2017	25/09/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Belgium;Poland;Austria;Germany
498	EUCTR2017-000572-28-GR (EUCTR)	11/12/2017	28/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
499	EUCTR2017-000573-37-GR (EUCTR)	11/12/2017	01/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
500	EUCTR2017-002274-39-SK (EUCTR)	08/12/2017	27/10/2017	A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 3;Phase 4	United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
501	EUCTR2017-000573-37-SK (EUCTR)	08/12/2017	21/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
502	NCT02559713 (ClinicalTrials.gov)	November 29, 2017	23/9/2015	Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease	An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically	Colitis, Ulcerative;Crohn's Disease	Drug: Vedolizumab	Takeda	NULL	Completed	18 Years	N/A	Female	11	Phase 4	United States
503	EUCTR2017-000937-30-ES (EUCTR)	27/11/2017	10/10/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Hungary;Poland;Belgium;Spain;Austria;Germany
504	NCT03182166 (ClinicalTrials.gov)	November 21, 2017	29/5/2017	Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization	Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization	Ulcerative Colitis	Drug: Golimumab (Optimization);Diagnostic Test: Rectosigmoidoscopy;Biological: Blood samples	Centre Hospitalier Universitaire de Saint Etienne	Merck Sharp & Dohme Corp.	Completed	18 Years	N/A	All	51	Phase 2	France
505	NCT03408847 (ClinicalTrials.gov)	November 20, 2017	24/11/2017	Monocultivar Coratina Extra Virgin Olive Oil in UC Patients	Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis	Ulcerative Colitis Chronic Mild	Combination Product: Beclomethasone dipropionate in addition to MC-EVOO;Combination Product: Beclomethasone dipropionate in addition to refined oil	Casa Sollievo della Sofferenza IRCCS	Fondazione Schena	Unknown status	18 Years	70 Years	All	30	N/A	Italy
506	EUCTR2016-000420-26-BG (EUCTR)	17/11/2017	19/04/2017	A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.	A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940	UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Czech Republic;Spain;Poland;Romania;South Africa;Georgia;Bulgaria;United Kingdom;Moldova, Republic of;Italy
507	NCT03281304 (ClinicalTrials.gov)	November 16, 2017	11/9/2017	A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission	A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION	Ulcerative Colitis	Drug: CP-690,500 5 mg;Drug: CP-690,550 10 mg	Pfizer	NULL	Active, not recruiting	18 Years	N/A	All	141	Phase 4	United States;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom
508	EUCTR2017-002231-41-GB (EUCTR)	15/11/2017	11/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
509	NCT03266484 (ClinicalTrials.gov)	November 13, 2017	25/8/2017	Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease	Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial	Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis	Dietary Supplement: Probiotic Mixture;Dietary Supplement: Placebo	Massachusetts General Hospital	Winclove Bio Industries BV	Active, not recruiting	18 Years	75 Years	All	100	N/A	United States
510	EUCTR2016-003708-29-NL (EUCTR)	09/11/2017	19/07/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Serbia;Slovakia;Spain;Ukraine;Ireland;Turkey;Lithuania;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of;United States
511	NCT03138655 (ClinicalTrials.gov)	November 8, 2017	19/4/2017	Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab	Takeda	Takeda Development Center Americas, Inc.;Takeda Development Centre Europe Ltd.	Completed	2 Years	17 Years	All	90	Phase 2	United States;Belgium;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom
512	EUCTR2017-000937-30-FR (EUCTR)	07/11/2017	19/09/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Poland;Belgium;Austria;Germany
513	EUCTR2016-001392-78-NL (EUCTR)	06/11/2017	16/08/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
514	EUCTR2016-002765-58-NL (EUCTR)	06/11/2017	16/08/2017	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
515	EUCTR2017-002231-41-HU (EUCTR)	25/10/2017	19/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
516	EUCTR2016-002691-27-NL (EUCTR)	19/10/2017	01/06/2017	An open label study to study changes in the structure of the mucosa of the bowel in subjects during treatment with tofacitinib for moderate to severe ulcerative colitis	An open label exploratory analysis of the histological, immunological and microbiome changes of the colonic mucosa during treatment with tofacitinib for moderate-severe ulcerative colitis - TOFA-histo	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Xeljanz 5 mg film-coated tablets	Academic Medical Center	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Netherlands
517	EUCTR2017-000937-30-DE (EUCTR)	10/10/2017	25/09/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Hungary;Spain;Poland;Belgium;Austria;Germany
518	EUCTR2017-000937-30-BE (EUCTR)	29/09/2017	03/08/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Poland;Belgium;Austria;Germany
519	EUCTR2017-001389-10-GB (EUCTR)	28/09/2017	17/08/2017	Randomised Double Blind Clinical Trial in Acute Severe Colitis: The IASO trial	A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis - IASO	Acute Severe Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Anakinra Product Name: Anakinra Product Code: N/A INN or Proposed INN: Anakinra	Cambridge University Hospitals NHS Foundation Trust & University of Cambridge	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	214	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
520	EUCTR2016-004217-26-SE (EUCTR)	20/09/2017	03/03/2017	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT	Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	215	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
521	EUCTR2016-003708-29-IT (EUCTR)	01/09/2017	22/01/2021	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06651600 10 mg Product Code: [PF-06651600 10 mg] INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06651600 50 mg Product Code: [PF-06651600 50 mg] INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg Product Code: [PF-06700841 5 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg Product Code: [PF-06700841 25 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	PFIZER INC	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
522	EUCTR2016-000674-38-HR (EUCTR)	21/08/2017	06/11/2017	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Portugal;Serbia;Belarus;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
523	EUCTR2016-000641-31-HR (EUCTR)	21/08/2017	06/11/2017	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
524	JPRN-jRCTs071180073	08/08/2017	22/03/2019	Further maintenance of remission for a year after Qing-Dai withdrawal in ulcerative colitis treatment:randomized controlled trial	Further maintenance of remission for a year after Qing-Dai withdrawal in ulcerative colitis treatment:randomized controlled trial - None	Ulcerative colitis Ulcerative colitis	arm A :stop oral administration of indigo naturalis arm B :continue oral administration of indigo naturalis	Kitazono Takanari	NULL	Complete	>= 16age old	Not applicable	Both	40	Phase 2	Japan
525	EUCTR2016-003708-29-DE (EUCTR)	07/08/2017	24/04/2017	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 2	Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
526	EUCTR2016-003708-29-AT (EUCTR)	07/08/2017	24/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of
527	EUCTR2016-004572-21-DE (EUCTR)	26/07/2017	24/03/2017	A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.	Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy	Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Spain;Denmark;Netherlands;Norway;Germany;United Kingdom
528	EUCTR2017-001374-42-GB (EUCTR)	21/07/2017	19/07/2017	Measuring levels of golimumab to improve the understanding of differences in its effectiveness amongst patients with ulcerative colitis	Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels - GO-LEVEL	Ulcerative Colitis (UC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Simponi Product Name: Golimumab	Guy's and St Thomas' NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	112	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
529	EUCTR2017-000100-20-GB (EUCTR)	17/07/2017	14/03/2017	This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.	Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	10	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Belgium;Germany;United Kingdom
530	EUCTR2016-003708-29-HU (EUCTR)	30/06/2017	11/05/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
531	EUCTR2016-003708-29-DK (EUCTR)	27/06/2017	21/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 2	Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
532	EUCTR2016-002765-58-HR (EUCTR)	26/06/2017	12/09/2017	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
533	EUCTR2016-001392-78-HR (EUCTR)	26/06/2017	12/09/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Georgia;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia
534	EUCTR2016-003452-75-NL (EUCTR)	23/06/2017	04/01/2017	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina
535	JPRN-UMIN000026175	2017/06/23	01/03/2017	Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis	Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis	Ulcerative colitis	Time dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa . PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .	Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University	NULL	Complete: follow-up complete	20years-old	99years-old	Male and Female	60	Not applicable	Japan
536	EUCTR2016-004217-26-FR (EUCTR)	22/06/2017	31/08/2017	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT	Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	215	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
537	NCT03178669 (ClinicalTrials.gov)	June 21, 2017	5/6/2017	The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	Ulcerative Colitis	Drug: cobitolimod;Drug: Placebo	InDex Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	213	Phase 2	Czechia;France;Germany;Hungary;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine
538	EUCTR2016-004572-21-NL (EUCTR)	21/06/2017	28/03/2017	A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.	Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy	Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim BV Netherlands	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Spain;Denmark;Germany;Norway;Netherlands;United Kingdom
539	EUCTR2016-000674-38-IE (EUCTR)	19/06/2017	04/10/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
540	EUCTR2016-004217-26-CZ (EUCTR)	09/06/2017	31/03/2017	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT	Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	215	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
541	EUCTR2016-004572-21-GB (EUCTR)	09/06/2017	26/04/2017	A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.	Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy	Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Spain;Denmark;Netherlands;Germany;Norway;United Kingdom
542	EUCTR2016-004217-26-ES (EUCTR)	08/06/2017	10/03/2017	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT	Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	215	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
543	EUCTR2016-004572-21-DK (EUCTR)	07/06/2017	09/03/2017	A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.	Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy	Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Spain;Denmark;Netherlands;Germany;Norway;United Kingdom
544	EUCTR2016-003708-29-PL (EUCTR)	07/06/2017	26/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 2	Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
545	NCT03123120 (ClinicalTrials.gov)	June 7, 2017	13/4/2017	A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy	Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy	Colitis, Ulcerative	Drug: Spesolimab;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	18 Years	75 Years	All	22	Phase 2	Denmark;Germany;Netherlands;Norway;Spain;United Kingdom;Ireland
546	EUCTR2016-003708-29-LT (EUCTR)	06/06/2017	18/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
547	EUCTR2017-000100-20-DE (EUCTR)	06/06/2017	09/03/2017	This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.	Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 2	Belgium;Germany;United Kingdom
548	NCT03299413 (ClinicalTrials.gov)	June 5, 2017	27/9/2017	Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease	Ulcerative Colitis Stem Cell Therapy	Inflammatory Bowel Diseases	Biological: Wharton Jelly Mesenchymal stem cells	Hanan Jafar	Scientific Research Support fund	Active, not recruiting	18 Years	75 Years	All	20	Phase 1/Phase 2	Jordan
549	EUCTR2016-001392-78-NO (EUCTR)	31/05/2017	13/05/2019	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	Italy;United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Iceland;New Zealand;Japan;Sweden
550	JPRN-UMIN000027465	2017/05/29	24/05/2017	Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis	Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients	ulcerative colitis	Infliximab (5mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)	University of Toyama	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Not selected	Japan
551	EUCTR2016-004572-21-NO (EUCTR)	24/05/2017	14/03/2017	A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.	Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy	Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Norway KS	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Spain;Denmark;Netherlands;Germany;Norway;United Kingdom
552	EUCTR2016-001392-78-SE (EUCTR)	24/05/2017	12/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
553	EUCTR2016-002765-58-SE (EUCTR)	24/05/2017	12/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Portugal;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
554	EUCTR2016-003708-29-ES (EUCTR)	22/05/2017	31/05/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Serbia;Philippines;Slovakia;Spain;Ukraine;Turkey;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Norway;Netherlands;Germany;Korea, Republic of
555	EUCTR2016-000641-31-FR (EUCTR)	22/05/2017	02/06/2017	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
556	EUCTR2016-001158-16-NL (EUCTR)	17/05/2017	01/06/2017	Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis	A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: PF-06480605	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;France;Poland;Belgium;Netherlands;Italy;Korea, Republic of
557	EUCTR2015-001942-28-FR (EUCTR)	16/05/2017	02/12/2015	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand
558	EUCTR2016-003452-75-HR (EUCTR)	11/05/2017	07/06/2017	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina
559	EUCTR2016-004572-21-ES (EUCTR)	11/05/2017	31/03/2017	A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.	Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy	Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Spain;Denmark;Netherlands;Germany;Norway;United Kingdom
560	EUCTR2017-000100-20-BE (EUCTR)	08/05/2017	17/03/2017	This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.	Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC)	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	SCS Boehringer Ingelheim Comm. V	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 2	Belgium;Germany;United Kingdom
561	EUCTR2016-002765-58-GR (EUCTR)	05/05/2017	14/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
562	EUCTR2016-001392-78-IS (EUCTR)	24/04/2017	21/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	Czech Republic;Hungary;Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden
563	EUCTR2016-002765-58-IS (EUCTR)	24/04/2017	21/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
564	EUCTR2016-001833-29-NL (EUCTR)	24/04/2017	23/01/2017	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis	A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.	Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	Poland;Germany;Netherlands;United Kingdom;Sweden
565	EUCTR2016-004217-26-DE (EUCTR)	21/04/2017	16/02/2017	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT	Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	215	Phase 2	Serbia;France;Hungary;Czech Republic;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
566	EUCTR2016-004217-26-HU (EUCTR)	20/04/2017	23/02/2017	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT	Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150 Product Name: Cobitolimod Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	215	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;France;Czech Republic;Hungary;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
567	EUCTR2016-001684-36-ES (EUCTR)	19/04/2017	10/03/2017	EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS	A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO	PPM SERVICES SA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 2	France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy
568	EUCTR2016-003708-29-SK (EUCTR)	18/04/2017	24/02/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ritlecitinib 10 mg Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Russian Federation;Italy;Hungary;Canada;Poland;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Korea, Republic of
569	EUCTR2016-000674-38-CZ (EUCTR)	06/04/2017	22/09/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
570	EUCTR2016-002765-58-BG (EUCTR)	04/04/2017	31/03/2017	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden
571	EUCTR2016-001392-78-BG (EUCTR)	04/04/2017	07/02/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
572	EUCTR2016-003452-75-CZ (EUCTR)	03/04/2017	19/12/2016	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina
573	EUCTR2016-001392-78-GR (EUCTR)	31/03/2017	14/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
574	EUCTR2016-000674-38-LT (EUCTR)	31/03/2017	25/10/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
575	EUCTR2016-001392-78-BE (EUCTR)	31/03/2017	09/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
576	EUCTR2016-002765-58-BE (EUCTR)	31/03/2017	09/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Hungary;Mexico;Canada;Argentina;Belgium;Serbia;Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic
577	EUCTR2016-000641-31-LT (EUCTR)	31/03/2017	11/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Croatia;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil
578	NCT03029143 (ClinicalTrials.gov)	March 29, 2017	20/1/2017	Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis	A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET)	Colitis, Ulcerative	Drug: Vedolizumab IV	Takeda	NULL	Completed	18 Years	85 Years	All	278	Phase 4	United States;Canada
579	EUCTR2015-001942-28-DE (EUCTR)	27/03/2017	13/10/2015	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
580	EUCTR2016-001392-78-DE (EUCTR)	27/03/2017	05/04/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
581	EUCTR2016-002765-58-DE (EUCTR)	27/03/2017	05/04/2017	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Israel;Sri Lanka;Italy;Serbia;Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation
582	EUCTR2016-003633-26-PL (EUCTR)	23/03/2017	27/12/2016	A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937	Lycera Corp.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
583	EUCTR2015-002558-11-BG (EUCTR)	14/03/2017	06/01/2017	A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
584	EUCTR2015-002557-35-BG (EUCTR)	14/03/2017	06/01/2017	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
585	EUCTR2016-001392-78-PT (EUCTR)	13/03/2017	13/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
586	EUCTR2016-002765-58-PT (EUCTR)	13/03/2017	13/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Japan;Sweden;United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand
587	EUCTR2016-003633-26-CZ (EUCTR)	10/03/2017	12/12/2016	A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937	Lycera Corp.	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
588	EUCTR2016-000641-31-CZ (EUCTR)	02/03/2017	29/09/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway
589	EUCTR2016-003797-40-BE (EUCTR)	23/02/2017	28/10/2016	A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions	A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations	Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	United States;Belgium;Germany
590	EUCTR2016-000674-38-DE (EUCTR)	23/02/2017	28/09/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib - Direct compression-yellow Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib -Direct compression-yellow Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib -Direct compression-yellow Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;European Union;Mexico;Canada;Brazil;Romania;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Germany;Norway;New Zealand;Japan
591	NCT02914535 (ClinicalTrials.gov)	February 23, 2017	22/9/2016	Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis	Ulcerative Colitis	Drug: Filgotinib;Drug: Placebo	Galapagos NV	Gilead Sciences	Active, not recruiting	18 Years	N/A	All	1173	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic;Iceland
592	EUCTR2016-003797-40-DE (EUCTR)	21/02/2017	09/11/2016	A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions	A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations	Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	United States;Belgium;Germany
593	EUCTR2016-000674-38-FI (EUCTR)	21/02/2017	26/09/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Romania;Croatia;Germany;Norway;Japan;Sweden;Portugal;Belarus;Serbia;United States;Estonia
594	EUCTR2016-001684-36-LV (EUCTR)	20/02/2017	22/12/2016	EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS	A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO	PPM SERVICES SA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 2	France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy
595	EUCTR2016-003452-75-LV (EUCTR)	20/02/2017	23/11/2016	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Latvia;Germany;Netherlands;Bosnia and Herzegovina
596	EUCTR2016-001392-78-SK (EUCTR)	16/02/2017	14/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
597	EUCTR2016-002765-58-SK (EUCTR)	16/02/2017	14/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
598	EUCTR2016-003452-75-HU (EUCTR)	13/02/2017	01/12/2016	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina
599	EUCTR2016-003452-75-BE (EUCTR)	13/02/2017	07/12/2016	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina
600	EUCTR2016-003452-75-PL (EUCTR)	09/02/2017	04/01/2017	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina
601	EUCTR2016-002765-58-CZ (EUCTR)	09/02/2017	12/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Sweden;Iceland;New Zealand;Japan;Serbia;Portugal;Belarus;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Norway;Germany
602	EUCTR2016-000641-31-FI (EUCTR)	07/02/2017	26/09/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
603	ChiCTR-IPR-17010306	2017-02-01	2017-01-01	Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis	Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis	Ulcerative colitis	Group A:Mesalazine combined with placebo; Group B:Methalazine combined with probiotics;Group C:Probiotics combined with placebo;Normal control group:Blank control;	Affiliated Hospital of Inner Mongolia Medical University	NULL	Pending	18		Both	Group A:30; Group B:30;Group C:30;Normal control group:30;		China
604	JPRN-UMIN000025846	2017/02/01	01/02/2017	A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease	A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease - A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease	ulcerative colitis, Crohn's disease	Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks	Juntendo university school of medicineDepartment of gastroenterology	NULL	Recruiting	16years-old	Not applicable	Male and Female	60	Not selected	Japan
605	JPRN-jRCTs031180415	01/02/2017	22/03/2019	A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease	Single center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease	Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)	AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults). FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. A-FMT arm : Patient undergoes FMT two days after AFM therapy.	Ishikawa Dai	NULL	Recruiting	>= 6age old	Not applicable	Both	120	N/A	Japan
606	EUCTR2016-002765-58-ES (EUCTR)	31/01/2017	01/02/2017	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
607	EUCTR2016-001392-78-ES (EUCTR)	31/01/2017	01/02/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1300	Phase 2;Phase 3	Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
608	NCT03006068 (ClinicalTrials.gov)	January 31, 2017	20/12/2016	A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: Upadacitinib (ABT-494);Drug: Placebo	AbbVie	NULL	Active, not recruiting	16 Years	75 Years	All	950	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Egypt;Romania
609	EUCTR2016-000420-26-PL (EUCTR)	31/01/2017	01/02/2017	A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.	A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940	UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	France;Czech Republic;Spain;Poland;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom
610	EUCTR2016-002765-58-AT (EUCTR)	31/01/2017	13/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Serbia;Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
611	EUCTR2016-001392-78-AT (EUCTR)	31/01/2017	13/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
612	EUCTR2016-000641-31-SE (EUCTR)	30/01/2017	29/09/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
613	EUCTR2016-000674-38-SE (EUCTR)	30/01/2017	28/09/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	950	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
614	EUCTR2016-001392-78-HU (EUCTR)	30/01/2017	01/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
615	EUCTR2016-002765-58-HU (EUCTR)	30/01/2017	01/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden
616	EUCTR2016-002765-58-FR (EUCTR)	25/01/2017	19/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden;Argentina;Poland;Belgium;Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada
617	EUCTR2015-000319-41-HR (EUCTR)	17/01/2017	05/06/2017	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
618	EUCTR2016-003633-26-NL (EUCTR)	17/01/2017	24/10/2016	A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937	Lycera Corp.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
619	EUCTR2016-000641-31-PT (EUCTR)	09/01/2017	06/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;European Union;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
620	EUCTR2016-001833-29-PL (EUCTR)	09/01/2017	26/10/2016	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.	Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Poland;Netherlands;Germany;United Kingdom;Sweden
621	EUCTR2016-000674-38-PT (EUCTR)	09/01/2017	11/10/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;European Union;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;Japan;New Zealand
622	EUCTR2016-000674-38-BE (EUCTR)	06/01/2017	31/10/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Germany;Norway;Japan;New Zealand;Sweden
623	EUCTR2016-000678-40-BG (EUCTR)	05/01/2017	01/11/2016	Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe Limited	NULL	Not Recruiting			Female: yes Male: yes	385	Phase 4	Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Serbia;Taiwan;Estonia;Slovakia;Ukraine;Romania;Australia;Bulgaria;South Africa;Latvia;New Zealand;Korea, Republic of
624	EUCTR2016-003633-26-HU (EUCTR)	23/12/2016	08/11/2016	A STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937	Lycera Corp.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands
625	EUCTR2016-000641-31-IE (EUCTR)	22/12/2016	04/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
626	EUCTR2016-000674-38-GR (EUCTR)	21/12/2016	03/10/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
627	EUCTR2016-000641-31-GR (EUCTR)	19/12/2016	12/10/2016	Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABT-494 INN or Proposed INN: - Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: - Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: - Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
628	EUCTR2016-000674-38-ES (EUCTR)	16/12/2016	14/12/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand
629	EUCTR2016-000641-31-ES (EUCTR)	16/12/2016	14/12/2016	Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
630	JPRN-UMIN000024520	2016/12/15	22/10/2016	Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis	Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis - Antibiotic combination therapy(amoxicillin,tetracycline,metronidazole) for refractory UC	ulcerative colitis	placebo metronidazole metronidazole,amoxicillin metronidazole,amoxicillin,tetracycline	Hokkaido University Hospital	NULL	Complete: follow-up complete	16years-old	80years-old	Male and Female	212	Not selected	Japan
631	EUCTR2016-001684-36-SK (EUCTR)	12/12/2016	26/07/2016	EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS	A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO	PPM SERVICES SA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 2	France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom
632	EUCTR2016-001392-78-GB (EUCTR)	08/12/2016	06/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
633	EUCTR2016-002765-58-GB (EUCTR)	08/12/2016	06/12/2016	A Long Term Study to Follow the Safety of a New Treatment in Patients with Ulcerative Colitis	A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden
634	EUCTR2016-000641-31-EE (EUCTR)	08/12/2016	03/11/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
635	EUCTR2016-000674-38-EE (EUCTR)	08/12/2016	04/10/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Portugal;Serbia;Belarus;United States;Saudi Arabia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden
636	EUCTR2016-000641-31-GB (EUCTR)	07/12/2016	11/01/2017	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
637	EUCTR2016-001409-18-NO (EUCTR)	06/12/2016	09/05/2016	A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence	A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: 1.Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Helse More og Romsdal Hospital Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Norway
638	EUCTR2016-001158-16-BE (EUCTR)	05/12/2016	15/09/2016	Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis	A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: PF-06480605	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;United States;Poland;Belgium;Netherlands;Italy;Korea, Republic of
639	EUCTR2016-001158-16-IT (EUCTR)	01/12/2016	07/01/2021	Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis	A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-06480605	PFIZER INC	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;United States;Poland;Belgium;Netherlands;Italy;Korea, Republic of
640	NCT02425865 (ClinicalTrials.gov)	December 2016	21/4/2015	Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET	Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET	ULCERATIVE COLITIS	Drug: GOLIMUMAB	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	NULL	Active, not recruiting	18 Years	75 Years	All	202	Phase 4	Belgium;France
641	JPRN-UMIN000024936	2016/11/30	22/11/2016	Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis	Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis - Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis	Ulcerative colitis	patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml.	Keio University Gastroenterology and Hepatology	NULL	Recruiting	16years-old	150years-old	Male and Female	30	Not selected	Japan
642	EUCTR2016-000641-31-HU (EUCTR)	29/11/2016	28/09/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
643	NCT02808390 (ClinicalTrials.gov)	November 28, 2016	14/6/2016	Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC	A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis	Ulcerative Colitis	Drug: GED-0507-34-Levo 80 mg;Drug: GED-0507-34-Levo 160 mg;Drug: Placebo	PPM Services S.A.	NULL	Terminated	18 Years	N/A	All	19	Phase 2	United States;Bulgaria;Canada;France;Hungary;Italy;Latvia;Poland;Slovakia;Ukraine
644	NCT03018054 (ClinicalTrials.gov)	November 28, 2016	10/1/2017	Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis	A Phase 2, Double-Blind, Parallel-Group, Placebo-Controlled Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis	Moderate Active Ulcerative Colitis	Drug: E6007;Drug: Placebo	EA Pharma Co., Ltd.	NULL	Completed	20 Years	74 Years	All	147	Phase 2	Japan
645	EUCTR2016-000674-38-GB (EUCTR)	25/11/2016	28/09/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
646	EUCTR2016-000674-38-HU (EUCTR)	24/11/2016	10/10/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 19.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand
647	EUCTR2016-000674-38-AT (EUCTR)	23/11/2016	23/09/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Czech Republic;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;European Union;Mexico;Canada;Brazil;Romania;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
648	EUCTR2016-000641-31-NL (EUCTR)	23/11/2016	08/08/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Norway;Germany;New Zealand;Japan;Kazakhstan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore
649	EUCTR2016-000674-38-NL (EUCTR)	23/11/2016	22/08/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden;South Africa;Latvia;Netherlands;Portugal;Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia
650	EUCTR2016-000674-38-LV (EUCTR)	22/11/2016	29/09/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand
651	EUCTR2016-000641-31-LV (EUCTR)	22/11/2016	10/10/2016	Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
652	EUCTR2016-001684-36-BG (EUCTR)	17/11/2016	18/10/2016	EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS	A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 100000016704 MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 MedDRA version: 20.0;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO	PPM SERVICES SA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 2	France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom
653	NCT02903966 (ClinicalTrials.gov)	November 15, 2016	13/9/2016	GSK2982772 Study in Subjects With Ulcerative Colitis	A Multicentre, Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled Study With Open Label Extension to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Active Ulcerative Colitis	Colitis, Ulcerative	Drug: GSK2982772;Drug: Placebo	GlaxoSmithKline	NULL	Completed	18 Years	75 Years	All	36	Phase 2	United States;Germany;Netherlands;Poland;Russian Federation;Sweden;United Kingdom
654	NCT02914522 (ClinicalTrials.gov)	November 14, 2016	22/9/2016	Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Filgotinib;Drug: Placebo to match filgotinib	Gilead Sciences	Galapagos NV	Completed	18 Years	75 Years	All	1351	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Iceland
655	EUCTR2016-000674-38-IT (EUCTR)	08/11/2016	17/06/2021	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) - N.A.	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	ABBVIE DEUTSCHLAND GMBH & CO. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Mexico;Canada;Brazil;Croatia;Sweden;Serbia;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic
656	EUCTR2016-000518-31-CZ (EUCTR)	07/11/2016	30/08/2016	A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937	Lycera Corp.	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
657	NCT02764229 (ClinicalTrials.gov)	November 1, 2016	4/5/2016	Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis	A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis	Colitis, Ulcerative	Drug: LYC-30937-EC	Lycera Corp.	NULL	Terminated	18 Years	75 Years	All	112	Phase 2	United States;Czechia;Hungary;Netherlands;Poland;Serbia
658	NCT02760615 (ClinicalTrials.gov)	November 1, 2016	2/5/2016	Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study	An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease	Colitis, Ulcerative;Crohn Disease	Drug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: Vedolizumab	Takeda	NULL	Withdrawn	18 Years	55 Years	All	0	Phase 4	United States
659	NCT02291523 (ClinicalTrials.gov)	November 2016	11/11/2014	The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis	The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis	Ulcerative Colitis	Biological: Fecal Microbial Transplant	Children's Hospital Los Angeles	NULL	Active, not recruiting	7 Years	21 Years	All	101	Phase 1	United States
660	NCT02910245 (ClinicalTrials.gov)	November 2016	9/9/2016	Mercaptopurine Therapy in Ulcerative Colitis	Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)	Colitis, Ulcerative	Drug: Mercaptopurine (Purinethol);Drug: Placebo;Drug: Mesalamine;Drug: Prednisone	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	ZonMw: The Netherlands Organisation for Health Research and Development	Recruiting	18 Years	80 Years	All	136	Phase 3	Netherlands
661	NCT02962245 (ClinicalTrials.gov)	November 2016	14/10/2016	Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis	Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial	Ulcerative Colitis	Drug: berberine;Drug: regular treatment	Xijing Hospital of Digestive Diseases	NULL	Withdrawn	18 Years	70 Years	All	0	Phase 4	NULL
662	EUCTR2016-000509-35-BG (EUCTR)	27/10/2016	03/08/2016	Drug OPRX-106 in Patients with Ulcerative Colitis	An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients with Active Mild to Moderate Ulcerative Colitis	Active mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 8mg Product Code: OPRX-106 Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 2mg Product Code: OPRX-106	Protalix Biotherapeutics Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Serbia;Israel;Bulgaria
663	EUCTR2016-000641-31-PL (EUCTR)	25/10/2016	30/09/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Malaysia;Kazakhstan;Portugal;Greece;Latvia;Austria;Brazil;Korea, Republic of;Chile;Colombia;Argentina;Hungary;Japan;Ukraine;Belarus;New Zealand;Canada;Belgium;Taiwan;Finland;South Africa;Germany;Puerto Rico;Russian Federation;Singapore;United States;Egypt;Saudi Arabia;Netherlands;Sweden;China;Ireland;Poland;Slovakia;Serbia;Lithuania;France;Bosnia and Herzegovina;Croatia;Romania;United Kingdom;Switzerland;Spain;Czech Republic;European Union;Norway;Mexico;Israel;Australia;Estonia
664	EUCTR2016-000674-38-PL (EUCTR)	25/10/2016	27/09/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Portugal;Serbia;United States;Belarus;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Romania;Croatia;Germany;Norway;Japan;Sweden
665	EUCTR2016-000518-31-PL (EUCTR)	21/10/2016	19/08/2016	A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937	Lycera Corp.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
666	EUCTR2013-004280-31-SK (EUCTR)	21/10/2016	26/07/2016	A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany
667	EUCTR2016-001684-36-HU (EUCTR)	19/10/2016	10/08/2016	EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS	A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO	PPM SERVICES SA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 2	United States;Slovakia;Spain;Ukraine;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Bulgaria;Latvia
668	EUCTR2016-000641-31-AT (EUCTR)	17/10/2016	11/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Czech Republic;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Mexico;European Union;Canada;Brazil;Belarus
669	EUCTR2016-002061-54-IT (EUCTR)	13/10/2016	15/11/2018	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)	Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Italy
670	EUCTR2016-000420-26-CZ (EUCTR)	06/10/2016	27/07/2016	A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.	A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940	UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	France;Czech Republic;Poland;Spain;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom
671	EUCTR2016-000420-26-ES (EUCTR)	05/10/2016	05/08/2016	A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.	A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 19.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940	UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Poland;Spain;Romania;France;Czech Republic;Bulgaria;South Africa;Georgia;United Kingdom;Moldova, Republic of;Italy
672	EUCTR2016-000518-31-HU (EUCTR)	05/10/2016	27/07/2016	A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937	Lycera Corp.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands
673	EUCTR2013-004280-31-PL (EUCTR)	29/09/2016	12/09/2016	A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	350	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany
674	JPRN-JapicCTI-163356	29/9/2016	23/08/2016	I6T-MC-AMAC	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Induction:High, Mid or Low dose LY3074828. Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:LY3074828 dose schedule1 or 2. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction:Placebo Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:Placebo	Eli Lilly Japan K.K.	NULL	complete	18	75	BOTH	30	Phase 2	Japan, North America, Europe, Oceania
675	EUCTR2016-003073-18-GB (EUCTR)	29/09/2016	16/09/2016	A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body	A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)	The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride	Celgene International II Sàrl	NULL	Not Recruiting			Female: no Male: yes	6	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
676	NCT02819635 (ClinicalTrials.gov)	September 26, 2016	28/6/2016	A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: Placebo;Drug: Updacitinib (ABT-494)	AbbVie	NULL	Active, not recruiting	16 Years	75 Years	All	844	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Egypt;Romania
677	EUCTR2016-001158-16-PL (EUCTR)	23/09/2016	21/09/2016	Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis	A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: PF-06480605	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	France;United States;Belgium;Poland;Netherlands;Italy;Korea, Republic of
678	EUCTR2014-004904-31-BE (EUCTR)	21/09/2016	29/07/2016	A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.	Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remsima (infliximab)	Mundipharma Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 4	Belgium;Netherlands
679	EUCTR2016-000641-31-SK (EUCTR)	20/09/2016	26/07/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
680	EUCTR2016-000674-38-SK (EUCTR)	20/09/2016	26/07/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 3	Colombia;Italy;Switzerland;Puerto Rico;Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
681	EUCTR2016-001833-29-GB (EUCTR)	16/09/2016	08/08/2016	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.	Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Poland;Netherlands;Germany;United Kingdom;Sweden
682	EUCTR2015-002109-12-LT (EUCTR)	09/09/2016	21/03/2016	A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
683	EUCTR2016-001833-29-SE (EUCTR)	07/09/2016	19/07/2016	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis	A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.	Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	United States;Poland;Russian Federation;Netherlands;Germany;United Kingdom;Sweden
684	EUCTR2015-002557-35-LV (EUCTR)	01/09/2016	01/07/2016	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia
685	JPRN-UMIN000022588	2016/09/01	01/07/2016	Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.	Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection. - Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.	Ulcerative colitis	Additional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks) Additional immunosuppressive therapies without administration of ganciclovir	Department of Gastroenterology and Hepatology, Kyoto University Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	120	Not applicable	Japan
686	EUCTR2015-002558-11-LV (EUCTR)	01/09/2016	01/07/2016	A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia
687	EUCTR2016-000390-20-BG (EUCTR)	29/08/2016	18/07/2016	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution	TOPIVERT Pharma Limited	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
688	EUCTR2015-002109-12-AT (EUCTR)	26/08/2016	22/06/2016	A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia
689	EUCTR2015-003123-57-PL (EUCTR)	26/08/2016	16/05/2016	An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan
690	EUCTR2015-001942-28-AT (EUCTR)	26/08/2016	28/06/2016	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Latvia
691	EUCTR2016-002433-30-DK (EUCTR)	25/08/2016	21/06/2016	Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitis	Low-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUC	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Imurel INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Allopurinol INN or Proposed INN: ALLOPURINOL	Hvidovre Hospital	NULL	Not Recruiting			Female: yes Male: yes	84	Phase 3	Denmark
692	EUCTR2015-001346-29-BE (EUCTR)	22/08/2016	22/09/2015	A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	93	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Japan;New Zealand;Sweden
693	EUCTR2016-000678-40-LV (EUCTR)	19/08/2016	10/05/2016	Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe Limited	NULL	Not Recruiting			Female: yes Male: yes	385	Phase 4	Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
694	EUCTR2016-000518-31-NL (EUCTR)	16/08/2016	27/06/2016	A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LYC-30937-EC INN or Proposed INN: LYC-30937 Other descriptive name: LYC-30937	Lycera Corp.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands
695	JPRN-UMIN000026485	2016/08/01	10/03/2017	Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis.	Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis. - Research on the Efficacy of FMT to the Children with UC	ulcerative colitis	Fecal Microbiota Transplantation(on Day1, 2 and 3, week 2, 3 and 5) after antibiotic pretreatment using amoxicillin 40mg/kg/day, fosfomycin 100mg/kg/day and metronidazole 16mg/kg/day.	National Center for Child Health and Development	10Probiotics Research Laboratory, Juntendo University Graduate School of Medicine, Tokyo, Japan. Yakult Central Institute, Tokyo, Japan	Recruiting	2years-old	18years-old	Male and Female	12	Not selected	Japan
696	EUCTR2015-002109-12-BG (EUCTR)	27/07/2016	27/04/2016	A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	156	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
697	EUCTR2016-000390-20-CZ (EUCTR)	18/07/2016	18/07/2016	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	Symptomatic Ulcerative Colitis Patients with Moderate to Severe DiseaseActivity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution	TOPIVERT Pharma Limited	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
698	EUCTR2016-000390-20-LT (EUCTR)	15/07/2016	05/07/2016	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution	TOPIVERT Pharma Limited	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
699	EUCTR2016-000390-20-HU (EUCTR)	05/07/2016	14/06/2016	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution	TOPIVERT Pharma Limited	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
700	JPRN-UMIN000019958	2016/07/02	27/11/2015	Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments	Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments	Crohn's disease, ulcerative colitis	Patients with Crohn's disease or ulcerative colitis Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens.	Iwate Medical UniversityKochi Medical School HospitalKeio University School of Medicine	NULL	Complete: follow-up complete	15years-old	Not applicable	Male and Female	100	Not applicable	Japan
701	EUCTR2015-000480-14-BE (EUCTR)	30/06/2016	14/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
702	EUCTR2014-005217-24-ES (EUCTR)	29/06/2016	10/11/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis - NA	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
703	EUCTR2016-000390-20-PL (EUCTR)	28/06/2016	16/06/2016	English A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution	TOPIVERT Pharma Limited	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
704	EUCTR2016-000678-40-CZ (EUCTR)	27/06/2016	18/05/2016	Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: vedolizumab IV Product Code: MLN002 INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	385	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
705	EUCTR2015-002109-12-BE (EUCTR)	20/06/2016	14/04/2016	A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia
706	EUCTR2016-000390-20-LV (EUCTR)	17/06/2016	14/06/2016	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution	TOPIVERT Pharma Limited	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
707	NCT02365480 (ClinicalTrials.gov)	June 16, 2016	17/2/2015	Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission	Phase I Trial of Berberine in Subjects With Ulcerative Colitis	Ulcerative Colitis	Drug: Berberine Chloride;Other: Laboratory Biomarker Analysis;Other: Placebo Administration	National Cancer Institute (NCI)	NULL	Active, not recruiting	18 Years	70 Years	All	18	Phase 1	United States;China
708	EUCTR2015-000480-14-DE (EUCTR)	14/06/2016	09/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
709	EUCTR2015-000480-14-HR (EUCTR)	10/06/2016	06/07/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
710	EUCTR2016-000390-20-GB (EUCTR)	10/06/2016	06/06/2016	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution	TOPIVERT Pharma Limited	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
711	EUCTR2016-001278-13-FI (EUCTR)	08/06/2016	15/04/2016	Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis	Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD	Ulcerative colitis and Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB	Taina Sipponen	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Finland
712	EUCTR2015-003123-57-DK (EUCTR)	03/06/2016	22/03/2016	An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;Georgia;Netherlands;Moldova, Republic of;Japan
713	EUCTR2015-003123-57-NL (EUCTR)	02/06/2016	12/11/2015	An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC	Ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Denmark;Georgia;Netherlands;Japan;Moldova, Republic of
714	EUCTR2015-000480-14-DK (EUCTR)	31/05/2016	17/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
715	EUCTR2015-000480-14-ES (EUCTR)	29/05/2016	18/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
716	EUCTR2015-000482-31-ES (EUCTR)	29/05/2016	18/03/2016	Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease	A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn?s Disease - Vedolizumab SC Long-Term Open-Label Extension Study	Ulcerative ColitisCrohn?s Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	692	Phase 3	United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
717	EUCTR2015-000482-31-NL (EUCTR)	25/05/2016	27/01/2016	Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease	A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study	Ulcerative Colitis Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: - Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	692	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
718	EUCTR2014-005217-24-DE (EUCTR)	24/05/2016	23/10/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
719	EUCTR2014-005217-24-IS (EUCTR)	10/05/2016	28/04/2016	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Germany;Iceland;New Zealand;Sweden
720	EUCTR2015-002109-12-CZ (EUCTR)	09/05/2016	22/02/2016	A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
721	EUCTR2015-000480-14-HU (EUCTR)	09/05/2016	22/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
722	EUCTR2015-000480-14-RO (EUCTR)	05/05/2016	22/06/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
723	EUCTR2015-000480-14-LT (EUCTR)	04/05/2016	18/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
724	EUCTR2015-001942-28-BE (EUCTR)	03/05/2016	17/03/2016	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia
725	EUCTR2015-001942-28-PL (EUCTR)	29/04/2016	19/01/2016	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
726	EUCTR2015-001555-69-PL (EUCTR)	28/04/2016	22/12/2015	A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis	Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation
727	EUCTR2015-000480-14-IT (EUCTR)	18/04/2016	08/06/2021	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis.	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy. - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ENTYVIO - 300 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	TAKEDA DEVELOPMENT CENTRE EUROPE LTD	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
728	JPRN-JapicCTI-163220	15/4/2016	08/04/2016	A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease	A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease	Ulcerative colitis or Crohn's disease	Intervention name : Vedolizumab SC 108 mg INN of the intervention : Vedolizumab Dosage And administration of the intervention : Group A: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who completed the Maintenance Period (Week 52), or were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6 will receive vedolizumab SC 108 mg Q2W; Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure, or Participants from current study who experience treatment failure while on study will receive vedolizumab SC 108 mg QW. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Takeda Pharmaceutical Company Limited	NULL	complete	18	80	BOTH	746	Phase 3	Japan, Refer to Othersection
729	NCT02620046 (ClinicalTrials.gov)	April 15, 2016	19/11/2015	A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease	A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease	Colitis, Ulcerative;Crohn's Disease	Drug: Vedolizumab SC	Takeda	NULL	Active, not recruiting	18 Years	80 Years	All	746	Phase 3	Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;United States;Colombia;Czech Republic
730	EUCTR2015-000480-14-CZ (EUCTR)	13/04/2016	21/01/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
731	EUCTR2015-000482-31-SE (EUCTR)	05/04/2016	16/03/2016	Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease	A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study	Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	692	Phase 3	United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
732	EUCTR2015-000480-14-SE (EUCTR)	04/04/2016	16/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
733	JPRN-UMIN000020029	2016/04/01	01/12/2015	The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection	The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation	Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies.	Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more.	Saitama Medical University	NULL	Recruiting	16years-old	Not applicable	Male and Female	300	Not selected	Japan
734	EUCTR2015-001346-29-ES (EUCTR)	31/03/2016	30/10/2015	A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	93	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Japan;New Zealand;Sweden
735	EUCTR2014-005217-24-HR (EUCTR)	29/03/2016	28/04/2016	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
736	EUCTR2015-003123-57-GB (EUCTR)	29/03/2016	04/11/2015	An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan
737	EUCTR2015-000482-31-BG (EUCTR)	23/03/2016	16/02/2016	Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease	A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study	Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	692	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
738	EUCTR2015-000480-14-NL (EUCTR)	21/03/2016	29/12/2015	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
739	EUCTR2015-000480-14-BG (EUCTR)	17/03/2016	16/02/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
740	EUCTR2015-000480-14-GB (EUCTR)	14/03/2016	07/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
741	EUCTR2015-002109-12-GB (EUCTR)	14/03/2016	29/12/2015	A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand
742	EUCTR2013-001205-84-BE (EUCTR)	11/03/2016	17/02/2015	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC	Maintenance of remission in ulcerative colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
743	EUCTR2015-001555-69-CZ (EUCTR)	07/03/2016	14/12/2015	A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis	Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation
744	EUCTR2013-001205-84-HU (EUCTR)	07/03/2016	04/01/2016	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC	Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
745	EUCTR2014-005217-24-SE (EUCTR)	02/03/2016	03/11/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
746	EUCTR2015-002109-12-ES (EUCTR)	25/02/2016	10/12/2015	A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
747	EUCTR2015-000939-33-HR (EUCTR)	16/02/2016	28/04/2016	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
748	EUCTR2015-003364-36-HU (EUCTR)	09/02/2016	02/12/2015	A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis.	A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis.	Ulcerative Colitis. MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Hungary;Slovakia;Canada;Poland;Bulgaria
749	EUCTR2015-003364-36-BG (EUCTR)	09/02/2016	28/01/2016	A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis.	A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis.	Ulcerative Colitis. MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Hungary;Slovakia;Canada;Poland;Bulgaria
750	EUCTR2015-002558-11-HU (EUCTR)	09/02/2016	16/11/2015	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	United States;Serbia;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
751	EUCTR2015-003123-57-BE (EUCTR)	09/02/2016	01/10/2015	An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan
752	EUCTR2015-002557-35-HU (EUCTR)	09/02/2016	16/11/2015	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
753	EUCTR2015-001346-29-GB (EUCTR)	08/02/2016	28/09/2015	A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	93	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden
754	EUCTR2014-005606-38-PL (EUCTR)	05/02/2016	17/11/2015	A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
755	JPRN-UMIN000020840	2016/02/02	02/02/2016	A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients	A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients - ROSE Study	ulcerative colitis	discontinuation of adalimumab therapy	Fukuyama Medical Center	NULL	Recruiting	15years-old	Not applicable	Male and Female	50	Not selected	Japan
756	EUCTR2015-000319-41-NL (EUCTR)	26/01/2016	01/07/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	1050	Phase 3	Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
757	EUCTR2015-000480-14-SK (EUCTR)	22/01/2016	05/01/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
758	EUCTR2015-003364-36-SK (EUCTR)	22/01/2016	07/12/2015	A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis.	A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis.	Ulcerative Colitis. MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen Other descriptive name: GED-0301	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Hungary;Slovakia;Canada;Poland;Bulgaria
759	EUCTR2015-000939-33-NL (EUCTR)	21/01/2016	30/09/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	658	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
760	EUCTR2014-002981-64-BG (EUCTR)	20/01/2016	25/09/2015	Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin	A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Subjects with active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
761	EUCTR2015-002109-12-HU (EUCTR)	18/01/2016	21/01/2016	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand
762	EUCTR2015-001555-69-HU (EUCTR)	15/01/2016	17/11/2015	A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis	Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation
763	JPRN-UMIN000022954	2016/01/15	05/07/2016	A study related to usability of Mesalazine Controlled-Release Tablets and Granules.	A study related to usability of Mesalazine Controlled-Release Tablets and Granules. - A study related to usability of Mesalazine Controlled-Release Tablets and Granules.	ulcerative colitis	Patients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 weeks	Kitasato University Kitasato Institute Hospital	NULL	Complete: follow-up complete	Not applicable	100years-old	Male and Female	60	Not applicable	Japan
764	EUCTR2015-003123-57-CZ (EUCTR)	14/01/2016	05/11/2015	An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan
765	EUCTR2014-005217-24-BE (EUCTR)	14/01/2016	26/10/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
766	EUCTR2015-001942-28-GB (EUCTR)	12/01/2016	21/09/2015	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
767	EUCTR2015-000939-33-PT (EUCTR)	08/01/2016	25/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	658	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
768	EUCTR2015-002109-12-LV (EUCTR)	08/01/2016	20/11/2015	A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
769	EUCTR2015-000939-33-PL (EUCTR)	08/01/2016	24/11/2015	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Phase 3	United States;Serbia;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Denmark;Australia;Latvia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
770	EUCTR2015-003123-57-HU (EUCTR)	05/01/2016	06/11/2015	An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan
771	EUCTR2015-000939-33-ES (EUCTR)	05/01/2016	05/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	658	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
772	EUCTR2015-000939-33-HU (EUCTR)	05/01/2016	03/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
773	EUCTR2014-005217-24-BG (EUCTR)	05/01/2016	19/10/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
774	EUCTR2015-001942-28-LT (EUCTR)	31/12/2015	20/11/2015	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Canada;Poland;Belgium;Romania;United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Australia;Bulgaria;Latvia;Germany;New Zealand;Korea, Republic of
775	EUCTR2015-003123-57-LT (EUCTR)	31/12/2015	17/11/2015	An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mirikizumab Product Code: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan
776	EUCTR2014-005217-24-CZ (EUCTR)	22/12/2015	06/10/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
777	EUCTR2014-005217-24-NL (EUCTR)	17/12/2015	26/10/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
778	EUCTR2015-000939-33-SK (EUCTR)	11/12/2015	27/08/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
779	EUCTR2015-001942-28-CZ (EUCTR)	10/12/2015	15/09/2015	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
780	EUCTR2015-000939-33-LT (EUCTR)	08/12/2015	12/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
781	EUCTR2015-002558-11-BE (EUCTR)	07/12/2015	04/11/2015	A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of
782	EUCTR2015-002557-35-BE (EUCTR)	07/12/2015	04/11/2015	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia
783	EUCTR2015-000939-33-BE (EUCTR)	07/12/2015	04/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
784	EUCTR2015-001942-28-ES (EUCTR)	04/12/2015	05/10/2015	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
785	EUCTR2015-000939-33-DK (EUCTR)	04/12/2015	25/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
786	NCT02531126 (ClinicalTrials.gov)	December 2, 2015	20/8/2015	An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: RPC1063	Celgene	NULL	Active, not recruiting	18 Years	75 Years	All	878	Phase 3	United States;Belgium;Greece;Slovakia;Argentina;Australia;Austria;Belarus;Bulgaria;Canada;Croatia;Czech Republic;Czechia;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom
787	EUCTR2015-001022-42-IT (EUCTR)	01/12/2015	29/03/2019	A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis	A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis	Active, Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: IBD98-M Delayed-release Capsules Product Code: IBD98-M INN or Proposed INN: SODIUM HYALURONATE Other descriptive name: SODIUM HYALURONATE INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-ASA	Holy Stone Healthcare Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	51	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Italy
788	NCT02636517 (ClinicalTrials.gov)	December 2015	16/12/2015	Fecal Microbiome Transplant	Fecal Microbiome Transplant in Pediatric C. Difficile	Clostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis	Biological: Fecal Microbiota Transplant	Children's Hospital of Philadelphia	NULL	Active, not recruiting	3 Years	21 Years	All	250	N/A	United States
789	EUCTR2014-005217-24-GB (EUCTR)	27/11/2015	22/10/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	United States;Belarus;Philippines;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Croatia;Romania;Bulgaria;Iceland;Germany;New Zealand;Sweden
790	EUCTR2015-000939-33-LV (EUCTR)	27/11/2015	05/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
791	EUCTR2015-000939-33-BG (EUCTR)	26/11/2015	05/10/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
792	NCT02632175 (ClinicalTrials.gov)	November 26, 2015	14/12/2015	Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis	A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290	Ulcerative Colitis	Biological: Adalimumab	AbbVie	NULL	Active, not recruiting	4 Years	17 Years	All	101	Phase 3	United States;Japan;Poland;Slovakia;Spain;United Kingdom
793	EUCTR2015-000939-33-IT (EUCTR)	24/11/2015	08/06/2021	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitiscompared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 1 SIRINGA PRERIEMPITA 0.8 ML + 1 TAMPONE IMBEVUTO DI ALCOL IN UN BLISTER	TAKEDA DEVELOPMENT CENTRE EUROPE LTD	NULL	Not Recruiting			Female: yes Male: yes	658	Phase 3	Portugal;Serbia;United States;Taiwan;Hong Kong;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
794	EUCTR2015-000319-41-IT (EUCTR)	19/11/2015	29/01/2021	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis. - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: NA Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	CELGENE INTERNATIONAL II SàRL	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
795	EUCTR2014-005217-24-HU (EUCTR)	19/11/2015	22/09/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
796	EUCTR2015-000939-33-EE (EUCTR)	16/11/2015	10/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
797	EUCTR2014-005217-24-SK (EUCTR)	12/11/2015	07/10/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
798	EUCTR2014-005217-24-IE (EUCTR)	12/11/2015	11/12/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
799	EUCTR2015-000939-33-CZ (EUCTR)	11/11/2015	18/08/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
800	EUCTR2015-000939-33-DE (EUCTR)	10/11/2015	30/10/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
801	EUCTR2015-000939-33-GB (EUCTR)	06/11/2015	29/10/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Phase 3	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
802	EUCTR2014-005217-24-AT (EUCTR)	06/11/2015	22/10/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden;Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain
803	EUCTR2014-005217-24-LV (EUCTR)	06/11/2015	03/11/2015	An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis	A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	1600	Phase 2;Phase 3	Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden
804	EUCTR2013-003032-77-PL (EUCTR)	05/11/2015	28/08/2014	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	Abbvie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	93	Phase 3	United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;New Zealand
805	EUCTR2014-005606-38-DK (EUCTR)	02/11/2015	30/06/2015	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
806	JPRN-UMIN000019310	2015/11/01	01/11/2015	Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis	Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis - Randomized controlled study for concomitant use of 5-ASA suppository with increased dose of oral 5-ASA for moderate to severe patients with ulcerative colitis	ulcerative colitis	Arm A: Increase of oral 5-ASA (oral administration of 5-ASA in a maximum dose for 8 weeks) Arm B: Increase of oral 5-ASA and addition of 5-ASA suppository (oral administration of 5-ASA in a maximum dose for 8 weeks and topical administration of 1 g of 5-ASA suppository for 4 weeks)	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	90	Not selected	Japan
807	NCT02330653 (ClinicalTrials.gov)	November 2015	29/12/2014	Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis	A Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative Colitis and Pediatric Active Crohn's Colitis	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease	Biological: Fecal Microbiota Transplant (FMT);Biological: Placebo	Stacy A. Kahn	NULL	Completed	5 Years	30 Years	All	15	Phase 1/Phase 2	United States
808	NCT02487238 (ClinicalTrials.gov)	November 2015	25/6/2015	Pediatric FEcal Microbiota Transplant for Ulcerative Colitis	A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified	Inflammatory Bowel Disease;Ulcerative Colitis	Biological: Fecal Microbiota Enema;Biological: Normal Saline Enema	McMaster Children's Hospital	London Health Sciences Centre;St. Justine's Hospital	Completed	3 Years	17 Years	All	35	Phase 1	Canada
809	EUCTR2015-000319-41-SK (EUCTR)	22/10/2015	04/06/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	1050	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
810	EUCTR2014-005606-38-SK (EUCTR)	22/10/2015	07/07/2015	A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
811	EUCTR2014-005606-38-BG (EUCTR)	21/10/2015	03/09/2015	A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Bulgaria;South Africa;Netherlands;Germany;New Zealand;Korea, Republic of
812	EUCTR2014-005635-14-LT (EUCTR)	21/10/2015	03/07/2015	Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis	Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC	Patients with active ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg capsules, hard (BUX-PV) INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Lithuania;Latvia
813	JPRN-UMIN000021460	2015/10/20	13/03/2016	Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer.	Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer. - Chromoendoscopy of colitic cancer using an acetic acid indigocarmine mixture	patients with ulcerative colitis had high risk of colitic cancer.A:patients suspected dysplasia(low/high grade) or cancer.B:patients had plan of treatment of the dysplasia or cancer.	40mL AIM solution (0.6% acetic acid with 0.4% IC) was sprinkled onto the lesions and images were recorded.	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	30	Not selected	Japan
814	EUCTR2013-001205-84-AT (EUCTR)	13/10/2015	02/09/2015	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC	Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
815	EUCTR2015-001600-64-HU (EUCTR)	12/10/2015	01/09/2015	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sárl (CIS II)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1350	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
816	EUCTR2014-005606-38-DE (EUCTR)	07/10/2015	04/05/2015	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
817	EUCTR2015-000319-41-BE (EUCTR)	06/10/2015	24/07/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
818	EUCTR2015-001600-64-GB (EUCTR)	28/09/2015	06/08/2015	The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (Clinical Study”) - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben	Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
819	JPRN-UMIN000019066	2015/09/25	18/09/2015	An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis	An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis - An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis	Ulcerative colitis	Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks. In addition to Adalimumab Therapy, co-treatment of GMA 3times a week up to 2 weeks	Sakura Medical Center,Toho university	NULL	Pending	20years-old	Not applicable	Male and Female	58	Not applicable	Japan
820	EUCTR2014-005606-38-BE (EUCTR)	24/09/2015	08/07/2015	A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
821	JPRN-JapicCTI-163122	24/9/2015	06/01/2016	A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative, Inflammatory Bowel Diseases	Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : week 0: Participants will be randomized to receive single dose of placebo, Ustekinumab 130mg or Ustekinumab 6 mg/kg as Intravenous (IV: into the vein) infusion at Week 0. At week 8: Participants without clinical response to placebo will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo. Participants without clinical response to ustekinumab (130 mg or 6 mg/kg [IV]) will receive a single dose of ustekinumab 90 mg SC along with matching placebo IV. Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized. Participants in clinical response will be randomized to receive placebo SC, ustekinumab 90 mg SC every 12 weeks or 90 mg subcutaneously every 8 weeks beginning Week 0 of Maintenance study through Week 44. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Janssen Pharmaceutical K.K.	NULL	complete	18		BOTH	92	Phase 3	Japan, Asia except Japan, North America, Europe, Oceania
822	EUCTR2015-000319-41-DE (EUCTR)	18/09/2015	02/06/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	1050	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
823	EUCTR2014-005606-38-NL (EUCTR)	16/09/2015	03/07/2015	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	Serbia;United States;Czechia;Slovakia;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Germany;Netherlands;New Zealand;Korea, Republic of
824	EUCTR2015-000319-41-CZ (EUCTR)	14/09/2015	16/06/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
825	EUCTR2015-001954-14-NL (EUCTR)	14/09/2015	25/08/2015	Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial”	SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research	ulcerative colitis and Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion Product Name: Inflectra 100 mg powder for concentrate for solution for infusion Trade Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Code: EMEA/H/C/000240	Santeon	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
826	JPRN-UMIN000018745	2015/09/01	01/09/2015	The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy	The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy - The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy	ulcerative colitis	Administration of Infliximab and enteral nutrition Administration of Infliximab	Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatology	NULL	Pending	15years-old	75years-old	Male and Female	40	Not selected	Japan
827	NCT02345733 (ClinicalTrials.gov)	September 1, 2015	19/1/2015	Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis	Use of a Novel Diet (UC DIET) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study	Ulcerative Colitis (UC)	Other: Ulcerative Colitis Diet;Drug: Antibiotic cocktail	Prof. Arie Levine	NULL	Completed	8 Years	19 Years	All	20	Phase 4	United States;Canada;Israel
828	NCT02084550 (ClinicalTrials.gov)	September 2015	5/3/2014	Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis	Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial	Ulcerative Colitis	Dietary Supplement: Vaminolac;Other: Saline	Aarhus University Hospital	NULL	Active, not recruiting	18 Years	50 Years	All	8	N/A	Denmark
829	EUCTR2014-005606-38-CZ (EUCTR)	27/08/2015	26/06/2015	A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	Russian Federation;Romania;Hungary;United States;United Kingdom;New Zealand;Canada;Czech Republic;Austria;Netherlands;Belgium;Denmark;Korea, Republic of;Poland;Italy;South Africa;Israel;Slovakia;Australia;Bulgaria;France;Serbia;Germany
830	JPRN-UMIN000018801	2015/08/27	27/08/2015	Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis	Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis - Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis	ulcerative colitis	Colonosocopy using carbon dioxide insufflation Colonosocopy using air insufflation	Osaka University, Graduate School of Medicine,Department of Gastroenterology and Hepatology	NULL	Recruiting	16years-old	Not applicable	Male and Female	250	Not selected	Japan
831	EUCTR2014-002981-64-IT (EUCTR)	20/08/2015	05/11/2020	Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin	A Phase 2, randomized, placebo-controlled, multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for treatment of subjects with active ulcerative colitis - na	Subjects with active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: [CC-10004] INN or Proposed INN: Apremilast Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST	CELGENE CORPORATION	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	United States;Czechia;Slovakia;Spain;Ukraine;Turkey;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
832	EUCTR2014-002981-64-CZ (EUCTR)	13/08/2015	05/05/2015	Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin	A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Subjects with active ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST Product Name: Apremilast Product Code: CC-10004 INN or Proposed INN: APREMILAST Other descriptive name: APREMILAST	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	165	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
833	JPRN-UMIN000018642	2015/08/12	11/08/2015	A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis	A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis - A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis	ulcerative colitis	Antibiotics therapy:Taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks. FMT:Administration of the fecal material from healthy donors to patients.	Juntendo university school of medicine Department of gastroenterology	NULL	Complete: follow-up complete	6years-old	Not applicable	Male and Female	50	Not selected	Japan
834	EUCTR2014-005606-38-HU (EUCTR)	12/08/2015	16/06/2015	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
835	EUCTR2015-000319-41-GB (EUCTR)	10/08/2015	13/07/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
836	EUCTR2015-000319-41-HU (EUCTR)	10/08/2015	05/06/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sárl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
837	EUCTR2014-004887-39-PL (EUCTR)	08/08/2015	07/07/2015	A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis	An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis	Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd	NULL	Not Recruiting			Female: yes Male: yes			Poland
838	EUCTR2014-005635-14-HU (EUCTR)	29/07/2015	03/06/2015	Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis	Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC	Patients with active ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg capsules, hard (BUX-PV) INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Lithuania;Latvia
839	EUCTR2014-005606-38-AT (EUCTR)	20/07/2015	16/06/2015	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	951	Phase 3	United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
840	EUCTR2014-005443-40-NL (EUCTR)	15/07/2015	08/01/2015	An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC	An open label observational phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio	Academic Medical Center/ Gastroenterology	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	Hungary;Belgium;Netherlands
841	EUCTR2014-005635-14-LV (EUCTR)	10/07/2015	23/02/2015	Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis	Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC	Patients with active ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg capsules, hard (BUX-PV) INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Lithuania;Latvia
842	NCT02497469 (ClinicalTrials.gov)	June 29, 2015	10/7/2015	An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Colitis, Ulcerative	Drug: Vedolizumab;Drug: Adalimumab placebo;Drug: Adalimumab;Drug: Vedolizumab placebo	Takeda	NULL	Completed	18 Years	85 Years	All	771	Phase 3	United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Chile;Czech Republic;Finland;Norway;South Africa;Sweden
843	JPRN-UMIN000018075	2015/06/26	25/06/2015	Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions	Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions - Clinical trial for UC-AC	Ulcerative colitis	normal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA no optimized therapy	Center for Diagnostic and Therapeutic Endoscopy,Keio University	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not selected	Japan
844	JPRN-UMIN000017844	2015/06/22	22/06/2015	Antibiotic combination therapy for ulcerative colitis	Antibiotic combination therapy for ulcerative colitis - Antibiotic combination therapy for ulcerative colitis	ulcerative colitis	amoxicillin, tetracycline, and metronidazole	Shiga University of Medical Science	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	20	Not selected	Japan
845	EUCTR2014-005635-14-DE (EUCTR)	08/06/2015	18/02/2015	Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis	Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC	Patients with active ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide 9 mg capsules, hard (BUX-PV) INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Lithuania;Latvia;Germany
846	EUCTR2014-005443-40-BE (EUCTR)	02/06/2015	03/02/2015	An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC	An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab	Academic Medical Center/ Gastroenterology	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	Hungary;Belgium;Netherlands
847	JPRN-UMIN000017359	2015/05/07	01/05/2015	Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis	Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis - Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis	ulcerative colitis	Oral administration of Indigo naturalis 2g/day, 4 weeks	Osaka University, Graduate School of Medicine, Department of Gastroenterology and Hepatology	NULL	Recruiting	20years-old	95years-old	Male and Female	20	Not selected	Japan
848	NCT02435160 (ClinicalTrials.gov)	May 2015	23/4/2015	The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis		Ulcerative Colitis;Fecal Microbiota Transplantation	Biological: Fecal Microbiota Transplantation	Jun Liu	NULL	Not yet recruiting	25 Years	60 Years	Male	20	Phase 2/Phase 3	NULL
849	NCT02442037 (ClinicalTrials.gov)	May 2015	6/5/2015	Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis	Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.	Ulcerative Colitis	Biological: UCMSC group;Other: Control group(Normal saline)	Affiliated Hospital to Academy of Military Medical Sciences	Ivy Institute of Stem Cells Co. Ltd	Recruiting	18 Years	65 Years	Both	30	Phase 1/Phase 2	China
850	NCT02539368 (ClinicalTrials.gov)	April 22, 2015	22/7/2015	Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease	POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's Disease	Drug: CT-P13;Drug: Remicade	Pfizer	Hospira, now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	All	2565		Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland
851	EUCTR2014-000784-41-DK (EUCTR)	15/04/2015	28/01/2015	Amino acids in j-pouch surgery for ulcerative colitis	Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial - Amino acids in ileal pouch-anal anastomosis	Ileal pouch-anal anastomosis for ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Vaminolac, komb. Product Name: Vaminolac, komb. INN or Proposed INN: Vaminolac, komb. Other descriptive name: Vaminolac, komb.	Department of Medicine and Endocrinology	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 3	Denmark
852	EUCTR2013-000366-11-RO (EUCTR)	25/03/2015	11/03/2015	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
853	NCT02674308 (ClinicalTrials.gov)	March 24, 2015	29/1/2016	Entyvio (Vedolizumab) Long Term Safety Study	Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease	Ulcerative Colitis and Crohn's Disease	Drug: Vedolizumab;Other: Other Biologic Agents	Takeda	NULL	Completed	18 Years	N/A	All	5302		United States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom
854	EUCTR2013-001205-84-SK (EUCTR)	23/03/2015	05/02/2015	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC	Maintenance of remission in ulcerative colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
855	EUCTR2013-004435-72-BG (EUCTR)	16/03/2015	06/11/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMab Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
856	EUCTR2014-002579-27-IT (EUCTR)	03/03/2015	19/01/2015	Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone	Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL	active steroid-dependent ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: SIMPONI Product Name: SIMPONI Product Code: NA INN or Proposed INN: GOLIMUMAB	Istituto Clinico Humanitas	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Italy
857	EUCTR2013-001744-65-NL (EUCTR)	02/03/2015	07/08/2014	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Devlopment LLC	NULL	Not Recruiting			Female: yes Male: yes	128	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Germany;Netherlands;United Kingdom
858	EUCTR2013-004435-72-IT (EUCTR)	27/02/2015	29/09/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ND Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2568	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
859	EUCTR2013-001205-84-LV (EUCTR)	26/02/2015	23/12/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC	Maintenance of remission in ulcerative colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands
860	EUCTR2013-004435-72-DE (EUCTR)	06/02/2015	18/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Malaysia;Viet Nam;Denmark;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
861	EUCTR2013-002042-36-FR (EUCTR)	04/02/2015	22/06/2015	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;United States
862	EUCTR2013-004435-72-NL (EUCTR)	28/01/2015	04/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: unknown Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
863	EUCTR2014-001893-32-PL (EUCTR)	20/01/2015	22/10/2014	Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis	Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Czech Republic;Belgium;Poland;Russian Federation;Germany
864	EUCTR2013-001205-84-PL (EUCTR)	20/01/2015	22/09/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC	Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands
865	EUCTR2014-001893-32-CZ (EUCTR)	19/01/2015	18/09/2014	Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis	Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany
866	EUCTR2013-001682-16-BE (EUCTR)	15/01/2015	22/04/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	840	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Canada;Poland;Spain;Belgium;Israel;Netherlands;Germany;Italy;Japan;Switzerland
867	EUCTR2013-004282-14-NL (EUCTR)	13/01/2015	04/08/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Netherlands;Germany;Norway;Sweden;Korea, Republic of
868	EUCTR2013-001205-84-DE (EUCTR)	13/01/2015	08/08/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC	Maintenance of remission in ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
869	EUCTR2013-004279-11-BG (EUCTR)	12/01/2015	06/10/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
870	EUCTR2013-004277-27-BG (EUCTR)	12/01/2015	06/10/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
871	EUCTR2013-004435-72-PT (EUCTR)	09/01/2015	23/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Portugal;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
872	EUCTR2013-004282-14-PT (EUCTR)	09/01/2015	23/07/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
873	NCT03441893 (ClinicalTrials.gov)	January 1, 2015	8/2/2018	Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis	Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis	Ulcerative Colitis;Ulcerative Colitis Exacerbation;Protozoan Infections;Helminth Infection	Diagnostic Test: parasitological diagnostics (coproscopy);Drug: Nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250Mg;Drug: Placebo tabletes	Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan	NULL	Active, not recruiting	18 Years	90 Years	All	300	Phase 1/Phase 2	NULL
874	NCT02136069 (ClinicalTrials.gov)	December 24, 2014	15/4/2014	A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors	Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors	Ulcerative Colitis	Drug: Etrolizumab;Drug: Infliximab;Other: Placebo (IV);Other: Placebo (Injection)	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	397	Phase 3	Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Portugal;Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Philippines;Vietnam
875	EUCTR2013-004435-72-ES (EUCTR)	22/12/2014	11/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: - Other descriptive name: ETROLIZUMAB	Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2568	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
876	JPRN-JapicCTI-142649	22/12/2014	03/09/2014	Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [M11-290]	Ulcerateive Colotis	Intervention name : abalimumab INN of the intervention : Adalimumab Dosage And administration of the intervention : subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : subcutaneous injection	AbbVie GK	NULL	complete	4	17	BOTH	9	Phase 3	Japan, North America, Europe
877	EUCTR2013-004435-72-BE (EUCTR)	22/12/2014	27/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
878	EUCTR2014-004740-35-DK (EUCTR)	19/12/2014	25/11/2014	Loperamide vs. Placebo's effect on Ileostomy output	Loperamide vs. Placebo's effect on ileostomy output: A clincal randomized patientblinded crossover study	Patients with ileostomy because of ulcerative colitis, rectal cancer or short bowel syndrom MedDRA version: 17.1;Level: LLT;Classification code 10012727;Term: Diarrhea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Imolope Product Name: Imolope Product Code: A07DA03 INN or Proposed INN: LOPERAMIDE	Department of surgery, Odense University Hospital	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Denmark
879	EUCTR2013-004280-31-DK (EUCTR)	17/12/2014	29/07/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMABCOMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - Laurel	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Denmark;South Africa;Israel;Germany
880	JPRN-UMIN000015912	2014/12/15	15/12/2014	Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus	Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus - Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus	ulcerative colitis	Tacrolimus will be decreased gradually three months after it was administered. Adalimumab will be administrated three months after tacrolimus was administered, and tacrolimus will be decreased gradually.	Osaka Medical College	NULL	Recruiting	16years-old	70years-old	Male and Female	50	Not applicable	Japan
881	EUCTR2014-001893-32-DE (EUCTR)	15/12/2014	24/09/2014	Placebo-controlled study to assess efficacy, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis	Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany
882	EUCTR2014-003262-25-PT (EUCTR)	12/12/2014	20/11/2014	Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab	An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	37	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal
883	EUCTR2013-004282-14-BE (EUCTR)	11/12/2014	27/08/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
884	EUCTR2013-004277-27-GR (EUCTR)	08/12/2014	08/12/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Brazil;Malaysia;Poland;Croatia;Australia;Bulgaria;Latvia;New Zealand
885	EUCTR2013-001682-16-PL (EUCTR)	08/12/2014	22/09/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
886	EUCTR2014-001893-32-HU (EUCTR)	08/12/2014	18/09/2014	Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis	Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Czech Republic;Hungary;Poland;Belgium;Russian Federation;Germany
887	EUCTR2013-003032-77-HU (EUCTR)	04/12/2014	30/12/2013	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 3	Hungary;United States;United Kingdom;Spain;New Zealand;Canada;Austria;Czech Republic;Belgium;Poland;Italy;Israel;Slovakia;Australia;France
888	EUCTR2013-004435-72-FR (EUCTR)	02/12/2014	22/06/2015	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2568	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
889	EUCTR2013-004282-14-ES (EUCTR)	25/11/2014	06/08/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
890	EUCTR2014-001893-32-BE (EUCTR)	24/11/2014	18/09/2014	Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis	Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany
891	EUCTR2013-004280-31-DE (EUCTR)	24/11/2014	30/07/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMABCOMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany
892	EUCTR2013-004278-88-BE (EUCTR)	21/11/2014	10/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.	PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	Denmark;Netherlands;Germany;Korea, Republic of;United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia
893	EUCTR2013-004278-88-NL (EUCTR)	19/11/2014	23/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta 7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
894	NCT02171429 (ClinicalTrials.gov)	November 14, 2014	20/6/2014	A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors	Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors	Ulcerative Colitis	Drug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab Placebo	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	358	Phase 3	United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;Czechia;France;Greece;Hungary;Latvia;Lithuania;Malaysia;New Zealand;Poland;Russian Federation;Turkey;Ukraine
895	EUCTR2013-004435-72-SK (EUCTR)	13/11/2014	20/10/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	United States;Serbia;Portugal;Philippines;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
896	EUCTR2013-004279-11-SK (EUCTR)	13/11/2014	08/10/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	Serbia;United States;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
897	EUCTR2013-004282-14-IT (EUCTR)	10/11/2014	16/09/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
898	EUCTR2013-004282-14-DE (EUCTR)	10/11/2014	18/07/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
899	EUCTR2013-004435-72-DK (EUCTR)	07/11/2014	21/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
900	EUCTR2013-003032-77-CZ (EUCTR)	06/11/2014	31/07/2014	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	Abbvie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	93	Phase 3	United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;New Zealand
901	EUCTR2013-004435-72-SE (EUCTR)	05/11/2014	16/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Phase 3	Bulgaria;Norway;Germany;New Zealand;Sweden;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico
902	NCT02163759 (ClinicalTrials.gov)	November 4, 2014	12/6/2014	A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors	Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors	Ulcerative Colitis	Drug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab Placebo	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	358	Phase 3	United States;Argentina;Australia;Brazil;Bulgaria;Estonia;France;Hong Kong;Mexico;Poland;Russian Federation;Serbia;Slovakia;Ukraine
903	NCT02246686 (ClinicalTrials.gov)	November 2014	19/9/2014	Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients	A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis	Colitis, Ulcerative	Drug: STW5-II (Iberogast N, BAY98-7410);Drug: Placebo	Bayer	NULL	Terminated	18 Years	80 Years	Both	3	Phase 2	Germany
904	NCT02361957 (ClinicalTrials.gov)	November 2014	15/1/2015	The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients	The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients	Ulcerative Colitis	Dietary Supplement: Ecologic 825;Dietary Supplement: Placebo	Wageningen University	NULL	Suspended	18 Years	65 Years	Both	40	N/A	Netherlands
905	EUCTR2013-003032-77-GB (EUCTR)	30/10/2014	19/12/2013	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	85	Phase 3	United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand
906	EUCTR2013-004435-72-HU (EUCTR)	29/10/2014	30/10/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
907	EUCTR2013-004282-14-HU (EUCTR)	29/10/2014	30/10/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
908	EUCTR2013-004435-72-GB (EUCTR)	24/10/2014	15/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
909	EUCTR2013-001744-65-GB (EUCTR)	22/10/2014	31/03/2014	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	132	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
910	EUCTR2012-003702-27-BE (EUCTR)	21/10/2014	04/02/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia
911	EUCTR2013-001744-65-PL (EUCTR)	20/10/2014	19/08/2014	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Devlopment LLC	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Netherlands;Germany;United Kingdom;Sweden
912	EUCTR2013-004278-88-DE (EUCTR)	20/10/2014	06/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
913	EUCTR2013-004435-72-NO (EUCTR)	17/10/2014	06/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
914	EUCTR2013-004282-14-NO (EUCTR)	17/10/2014	04/08/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	Singapore;Romania;South Africa;Norway;Germany;Netherlands;Sweden;Korea, Republic of;Canada;Belgium;Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary
915	EUCTR2013-004280-31-CZ (EUCTR)	07/10/2014	21/07/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany
916	EUCTR2013-004279-11-EE (EUCTR)	03/10/2014	09/09/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
917	EUCTR2013-004435-72-CZ (EUCTR)	02/10/2014	21/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
918	NCT02148640 (ClinicalTrials.gov)	October 2014	23/5/2014	The NOR-SWITCH Study	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY	Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic	Drug: Innovator infliximab;Drug: Biosimilar infliximab	Diakonhjemmet Hospital	South-Eastern Norway Regional Health Authority	Completed	18 Years	N/A	All	482	Phase 4	Norway
919	NCT02217722 (ClinicalTrials.gov)	October 2014	20/7/2014	Use of the Ulcerative Colitis Diet for Induction of Remission	An Open Label Non Randomized Pilot Study: Use of the Ulcerative Colitis Diet for Induction of Remission.	Ulcerative Colitis (UC)	Other: Ulcerative Colitis Diet;Drug: Antibiotic cocktail	Prof. Arie Levine	NULL	Terminated	5 Years	18 Years	Both	9	N/A	Israel
920	EUCTR2013-004435-72-LT (EUCTR)	30/09/2014	22/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
921	EUCTR2013-004435-72-GR (EUCTR)	30/09/2014	20/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2568	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
922	EUCTR2013-004277-27-LT (EUCTR)	30/09/2014	22/07/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
923	EUCTR2012-003702-27-NL (EUCTR)	30/09/2014	14/04/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia
924	EUCTR2013-004282-14-GB (EUCTR)	29/09/2014	15/07/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
925	EUCTR2013-002042-36-NL (EUCTR)	24/09/2014	13/06/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany
926	EUCTR2013-001744-65-HU (EUCTR)	24/09/2014	15/07/2014	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Devlopment LLC	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 3	United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom
927	EUCTR2013-004278-88-GR (EUCTR)	22/09/2014	03/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
928	EUCTR2013-004280-31-HU (EUCTR)	19/09/2014	31/07/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Slovakia;Ukraine;Israel;Italy;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Denmark;South Africa;Germany
929	EUCTR2013-004435-72-EE (EUCTR)	19/09/2014	29/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
930	EUCTR2013-004282-14-CZ (EUCTR)	16/09/2014	18/07/2014	A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania
931	NCT02118584 (ClinicalTrials.gov)	September 15, 2014	16/4/2014	Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies	An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies	Ulcerative Colitis	Drug: Etrolizumab	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	N/A	All	1822	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic;Philippines;Sweden;Vietnam
932	EUCTR2013-002042-36-BG (EUCTR)	11/09/2014	30/04/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
933	EUCTR2013-001744-65-SK (EUCTR)	11/09/2014	17/07/2014	A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases	Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine	Shire Devlopment LLC	NULL	Not Recruiting			Female: yes Male: yes	132	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
934	EUCTR2013-003032-77-IT (EUCTR)	10/09/2014	19/12/2013	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 3	United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand
935	JPRN-UMIN000015068	2014/09/05	05/09/2014	An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis		Ulcerative colitis	Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks GMA will be administrated 10 times	Hiroshima University Hospital, Department of Endoscopy	NULL	Enrolling by invitation	20years-old	Not applicable	Male and Female	150	Not applicable	Japan
936	EUCTR2013-004435-72-LV (EUCTR)	05/09/2014	22/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
937	EUCTR2013-004278-88-FR (EUCTR)	04/09/2014	22/06/2015	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
938	EUCTR2013-000263-88-RO (EUCTR)	03/09/2014	30/05/2014	A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not available Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not available Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not available Other descriptive name: ASP015K	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany
939	EUCTR2013-004435-72-AT (EUCTR)	03/09/2014	22/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	2100	Phase 3	United States;Serbia;Portugal;Philippines;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
940	EUCTR2013-004282-14-AT (EUCTR)	03/09/2014	22/07/2014	A study to evaluate the effectiveness (efficacy) and safety of Etrolizumabcompared with Infliximab in patients with moderate to severe ulcerativecolitis who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
941	EUCTR2013-001682-16-IT (EUCTR)	02/09/2014	23/04/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
942	EUCTR2013-004278-88-IT (EUCTR)	01/09/2014	01/07/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
943	EUCTR2013-003032-77-BE (EUCTR)	25/08/2014	02/01/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	Abbvie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 3	Hungary;United States;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Czech Republic;Belgium;Poland;Italy;Israel;Slovakia;Australia;France
944	EUCTR2013-004278-88-DK (EUCTR)	21/08/2014	10/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Hungary;United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Korea, Republic of
945	EUCTR2013-001682-16-CZ (EUCTR)	21/08/2014	18/06/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
946	EUCTR2013-004277-27-HR (EUCTR)	12/08/2014	05/09/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
947	EUCTR2013-004435-72-HR (EUCTR)	12/08/2014	05/09/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
948	EUCTR2014-002056-40-NO (EUCTR)	12/08/2014	13/06/2014	A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis	A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH	Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning	Diakonhjemmet Hospital AS	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 4	Norway
949	EUCTR2013-002042-36-DE (EUCTR)	31/07/2014	27/05/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
950	EUCTR2012-003702-27-PL (EUCTR)	29/07/2014	20/05/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands
951	EUCTR2013-004282-14-FR (EUCTR)	28/07/2014	22/06/2015	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden
952	EUCTR2013-004277-27-LV (EUCTR)	28/07/2014	21/07/2014	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
953	EUCTR2013-001682-16-ES (EUCTR)	25/07/2014	08/05/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	525	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan
954	EUCTR2013-004278-88-ES (EUCTR)	25/07/2014	13/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: - Other descriptive name: ETROLIZUMAB	Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
955	JPRN-JapicCTI-142648	22/7/2014	03/09/2014	Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis [M14-033]	Ulcerative Colitis	Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : subcutaneous injection	AbbVie GK	NULL	complete	18	75	BOTH	100	Phase 3	Japan, North America, Europe
956	EUCTR2013-000891-13-DE (EUCTR)	21/07/2014	24/06/2014	Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease)	A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitits	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Iberogast N Product Name: Iberogast N Product Code: STW5-II INN or Proposed INN: Bitterschleifenblume-ganzpflanze 1,5ml/10ml Other descriptive name: BITTER CANDYTUFT FRESH PLANT EXTRACT INN or Proposed INN: Kümmel 2ml/10ml Other descriptive name: CARVI EXTRACTUM FLUIDUM INN or Proposed INN: Pfefferminzblätter 1ml/10ml Other descriptive name: MENTHA × PIPERITA L. FOLIUM INN or Proposed INN: Süßholzwurzel 1ml/10ml Other descriptive name: GLYCYRRHIZA GLABRA ROOT INN or Proposed INN: Kamillenblüten 3ml/10ml Other descriptive name: MATRICARIA RECUTITA L. FLOS INN or Proposed INN: Melissenblätter 15ml/10ml Other descriptive name: MELISSAE FOLII DRY AQUEOUS EXTRACT	Steigerwald Arzneimittelwerk GmbH	NULL	Not Recruiting			Female: yes Male: yes			Germany
957	EUCTR2013-002042-36-BE (EUCTR)	10/07/2014	20/02/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
958	EUCTR2013-004278-88-CZ (EUCTR)	09/07/2014	09/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.	PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	605	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
959	EUCTR2013-004278-88-AT (EUCTR)	02/07/2014	11/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	Spain;United States;Greece;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
960	EUCTR2013-005013-13-PL (EUCTR)	25/06/2014	31/03/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
961	JPRN-UMIN000014275	2014/06/24	24/06/2014	Efficacy of infliximab for refractory pouchitis with complexed anal fistula	Efficacy of infliximab for refractory pouchitis with complexed anal fistula - Efficacy of infliximab for pouchitis with anal fistula	ulcerative colitis	infliximab	Hyogo College of Medicine	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	10	Phase 1	Japan
962	EUCTR2013-004278-88-LT (EUCTR)	19/06/2014	24/04/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
963	EUCTR2013-000366-11-SK (EUCTR)	19/06/2014	21/05/2014	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden
964	EUCTR2013-003060-31-BG (EUCTR)	18/06/2014	10/04/2014	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4)	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia
965	EUCTR2013-001682-16-HU (EUCTR)	18/06/2014	22/04/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan
966	EUCTR2014-000656-29-BE (EUCTR)	13/06/2014	05/03/2014	Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device	Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART	Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi	MSD Belgium BVBA/SPRL	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 4	Belgium
967	EUCTR2013-003060-31-PL (EUCTR)	11/06/2014	19/03/2014	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4)	Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia
968	EUCTR2012-003702-27-SK (EUCTR)	10/06/2014	06/03/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
969	EUCTR2013-001682-16-SK (EUCTR)	10/06/2014	29/04/2014	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 3	United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan
970	EUCTR2013-002042-36-PL (EUCTR)	09/06/2014	06/05/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Germany;Netherlands
971	JPRN-UMIN000014152	2014/06/04	04/06/2014	A trial of a combination therapy of fecal microbiota transplantation and antibiotics or simple fecal microbiota therapy for ulcerative colitis	A trial of a combination therapy of fecal microbiota transplantation and antibiotics or simple fecal microbiota therapy for ulcerative colitis - A trial of a combination therapy of FMT and antibiotics or FMT for ulcerative colitis	ulcerative colitis	Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks	Juntendo university school of medicine Department of gastroenterology	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	30	Not selected	Japan
972	EUCTR2013-002042-36-CZ (EUCTR)	04/06/2014	21/03/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
973	JPRN-UMIN000013546	2014/06/01	31/03/2014	The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus	The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus	rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis	take a glass of grapefruit juice every day do not take grapefruit juice	Department of Rheumatology and Clinical Immunology, Kyoto University Hospital	NULL	Pending	16years-old	80years-old	Male and Female	20	Not applicable	Japan
974	NCT02186886 (ClinicalTrials.gov)	June 2014	1/7/2014	Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab	Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi)	Ulcerative Colitis	Drug: Golimumab	Kliniken im Naturpark Altmuehltal	NULL	Recruiting	18 Years	N/A	Both	50	Phase 4	Germany
975	EUCTR2012-003702-27-LV (EUCTR)	20/05/2014	25/03/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Netherlands;Germany
976	EUCTR2012-003702-27-HU (EUCTR)	19/05/2014	07/03/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Hungary;Czech Republic;Belgium;Poland;Germany;Latvia;Netherlands
977	EUCTR2012-003702-27-CZ (EUCTR)	15/05/2014	24/02/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
978	JPRN-UMIN000013694	2014/05/13	11/04/2014	Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs	Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs - Tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs	ulcerative colitis	determine CYP3A5 SNP status increase the initial dosage of tacrolimus	Kitasato University Kitasato Institute Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	30	Not selected	Japan
979	EUCTR2012-003702-27-LT (EUCTR)	12/05/2014	19/03/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia
980	EUCTR2013-002042-36-HU (EUCTR)	12/05/2014	21/02/2014	A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Ukraine;Israel;Russian Federation;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany
981	EUCTR2012-003702-27-DE (EUCTR)	08/05/2014	30/12/2013	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands
982	EUCTR2013-005013-13-BG (EUCTR)	28/04/2014	23/04/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
983	EUCTR2013-004599-36-DE (EUCTR)	23/04/2014	03/02/2014	SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily	SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE	Active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: SB012 INN or Proposed INN: hgd40	sterna biologicals GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 2	Germany
984	EUCTR2013-000366-11-BG (EUCTR)	23/04/2014	06/03/2014	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
985	JPRN-UMIN000013716	2014/04/15	15/04/2014	A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis	A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis - A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis	ulcerative colitis	After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg. Infliximab monotherapy	Yokohama City University Medical Center	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	40	Phase 2	Japan
986	EUCTR2013-000263-88-BG (EUCTR)	14/04/2014	17/02/2014	A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany
987	EUCTR2013-003060-31-CZ (EUCTR)	10/04/2014	04/02/2014	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy.(NATRUL-4)	Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia
988	EUCTR2012-002030-37-HR (EUCTR)	09/04/2014	14/10/2014	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
989	EUCTR2013-005013-13-LT (EUCTR)	08/04/2014	13/02/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
990	EUCTR2013-005013-13-CZ (EUCTR)	03/04/2014	13/02/2014	A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	490		Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
991	EUCTR2013-003060-31-HU (EUCTR)	02/04/2014	31/01/2014	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4)	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia
992	EUCTR2012-003702-27-AT (EUCTR)	02/04/2014	10/02/2014	LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis	Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC	Acute Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	762	Phase 3	Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia
993	EUCTR2011-005251-13-EE (EUCTR)	31/03/2014	15/01/2014	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Latvia;Germany;Netherlands;Norway;New Zealand
994	EUCTR2013-003032-77-ES (EUCTR)	25/03/2014	27/02/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	Abbvie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand
995	EUCTR2013-000366-11-LV (EUCTR)	14/03/2014	07/02/2014	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
996	EUCTR2013-003032-77-SK (EUCTR)	13/03/2014	23/01/2014	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	Abbvie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	93	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand
997	EUCTR2013-000366-11-LT (EUCTR)	10/03/2014	22/01/2014	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
998	EUCTR2011-005251-13-LV (EUCTR)	03/03/2014	16/01/2014	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Latvia;Netherlands;Norway;Germany;New Zealand
999	EUCTR2013-000366-11-HU (EUCTR)	24/02/2014	28/11/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
1000	EUCTR2013-003060-31-LV (EUCTR)	17/02/2014	16/12/2013	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4)	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1001	EUCTR2013-003060-31-LT (EUCTR)	11/02/2014	30/12/2013	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4)	Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1002	JPRN-UMIN000013033	2014/02/01	01/02/2014	Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis.	Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. - Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis	Ulcerative colitis	Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks)	Department of Internal Medicine,Juntendo University	NULL	Pending	20years-old	Not applicable	Male and Female	30	Not selected	Japan
1003	EUCTR2013-003032-77-AT (EUCTR)	29/01/2014	08/01/2014	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	Abbvie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	93	Phase 3	Hungary;United States;United Kingdom;Spain;New Zealand;Canada;Austria;Czech Republic;Belgium;Poland;Italy;Israel;Slovakia;France
1004	EUCTR2013-000263-88-PL (EUCTR)	29/01/2014	26/11/2013	A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands
1005	EUCTR2013-004583-56-GB (EUCTR)	28/01/2014	23/12/2013	Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis	Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi Product Name: Simponi INN or Proposed INN: golimumab	MSD	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United Kingdom
1006	EUCTR2013-000263-88-NL (EUCTR)	23/01/2014	21/11/2013	A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands
1007	EUCTR2013-001012-30-DE (EUCTR)	20/01/2014	07/10/2013	Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658	Sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	80		United States;Canada;Poland;Belgium;Austria;Germany;Italy
1008	EUCTR2013-000263-88-HU (EUCTR)	16/01/2014	21/11/2013	A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: JNJ-54781532-AAD-5 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg Other descriptive name: ASP015K	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany
1009	EUCTR2013-000263-88-BE (EUCTR)	08/01/2014	29/10/2013	A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	United States;Ukraine;Russian Federation;Israel;France;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands
1010	EUCTR2013-000263-88-DE (EUCTR)	07/01/2014	14/10/2013	A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: JNJ-54781532-AAD-5 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-10 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K Product Name: JNJ-54781532-AAD-30 mg INN or Proposed INN: Not Assigned Other descriptive name: ASP015K	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany
1011	EUCTR2013-002116-27-BG (EUCTR)	19/12/2013	16/10/2013	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1012	EUCTR2011-002411-29-PL (EUCTR)	19/12/2013	17/10/2013	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 17.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
1013	EUCTR2012-004366-18-DE (EUCTR)	17/12/2013	29/07/2013	A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK	Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany
1014	EUCTR2013-000366-11-PL (EUCTR)	12/12/2013	05/09/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden
1015	EUCTR2012-004366-18-DK (EUCTR)	11/12/2013	03/12/2013	A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK	Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 1	United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands
1016	JPRN-UMIN000004201	2013/12/02	14/09/2010	The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis	The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis - Hyogo College of Medicine, Osaka Medical College, Osaka City University Project 1, Tacrolimus-Ulcerative Colitis, 3 [Mucosal Healing for Prognosis]: HOOP1 (TCL-UC)-3 [MHP]	The patients with moderate to severe active refractory ulcerative colitis	Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus, Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus,	Osaka City University, Graduate School of Medicine,Department of Gastroenterology	NULL	Complete: follow-up complete	16years-old	65years-old	Male and Female	50	Not selected	Japan
1017	NCT01959165 (ClinicalTrials.gov)	November 21, 2013	8/10/2013	MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients		Ulcerative Colitis	Drug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching Placebo	AstraZeneca	NULL	Completed	18 Years	65 Years	All	44	Phase 2	Japan
1018	EUCTR2011-002411-29-CZ (EUCTR)	15/11/2013	16/09/2013	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
1019	NCT01959282 (ClinicalTrials.gov)	November 15, 2013	7/10/2013	A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Placebo;Drug: JNJ-54781532 25 mg once daily;Drug: JNJ-54781532 75 mg once daily;Drug: JNJ-54781532 150 mg once daily;Drug: JNJ-54781532 75 mg twice daily	Janssen Research & Development, LLC	NULL	Completed	18 Years	N/A	All	219	Phase 2	United States;Australia;Belgium;Bulgaria;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Ukraine
1020	EUCTR2013-002116-27-LT (EUCTR)	14/11/2013	06/08/2013	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of
1021	EUCTR2011-002411-29-SK (EUCTR)	11/11/2013	14/10/2013	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
1022	EUCTR2012-002031-28-DE (EUCTR)	05/11/2013	22/05/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	331	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1023	NCT03268213 (ClinicalTrials.gov)	November 2013	22/3/2016	Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis	Fecal Microbial Transplantation in Patients With Medication Refractory Clostridium Difficile and/or Ulcerative Colitis or Indeterminate Colitis	Clostridium Difficile Infection;Ulcerative Colitis;Indeterminate Colitis	Biological: Fecal Microbial Transplantation	Stony Brook University	NULL	Completed	7 Years	N/A	All	12	Early Phase 1	United States
1024	NCT01971814 (ClinicalTrials.gov)	November 2013	17/10/2013	Early Serum Infliximab Levels in Severe Ulcerative Colitis.	Early Serum Infliximab Levels in Severe Ulcerative Colitis	Ulcerative Colitis (UC);Inflammatory Bowel Disease	Drug: Infliximab	University of California, San Francisco	NULL	Completed	18 Years	N/A	Both	11	Phase 1	United States
1025	NCT01896635 (ClinicalTrials.gov)	November 2013	6/7/2013	Faecal Microbiota Transplantation in Ulcerative Colitis	Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety	Ulcerative Colitis;Inflammatory Bowel Disease	Biological: FMT infusions;Other: Placebo infusion	The University of New South Wales	NULL	Completed	18 Years	75 Years	Both	81	Phase 2	Australia
1026	NCT01953354 (ClinicalTrials.gov)	November 2013	24/9/2013	Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis	A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and Microbiota	Colitis, Ulcerative	Biological: Trichuris suis ova (TSO);Biological: Placebo	National Institute of Allergy and Infectious Diseases (NIAID)	Coronado Biosciences, Inc.;Autoimmunity Centers of Excellence	Terminated	18 Years	70 Years	All	16	Phase 2	United States
1027	EUCTR2012-003123-38-NL (EUCTR)	29/10/2013	27/05/2013	A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063	Celgene International II Sàrl (CIS II).	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 2	United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of
1028	EUCTR2013-002116-27-LV (EUCTR)	28/10/2013	26/06/2013	A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis	A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of
1029	EUCTR2013-002116-27-HU (EUCTR)	24/10/2013	24/07/2013	A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis	A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of
1030	EUCTR2013-001012-30-PL (EUCTR)	17/10/2013	05/09/2013	Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658	Sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	80		United States;Canada;Poland;Austria;Germany;Italy
1031	EUCTR2012-002031-28-SE (EUCTR)	09/10/2013	27/05/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Slovakia;Spain;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1032	EUCTR2013-002116-27-CZ (EUCTR)	09/10/2013	08/08/2013	A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis	A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)	Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide)	Nutrition Science Partners Limited	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of
1033	EUCTR2013-001012-30-BE (EUCTR)	09/10/2013	12/08/2013	Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658	Sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;Canada;Poland;Belgium;Austria;Germany;Italy
1034	EUCTR2013-000366-11-ES (EUCTR)	07/10/2013	12/07/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800		Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden
1035	EUCTR2012-002031-28-BG (EUCTR)	03/10/2013	13/08/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody	Shire Human Genetic Therapie, Inc.	NULL	Not Recruiting			Female: yes Male: yes	331	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1036	EUCTR2012-002030-37-BG (EUCTR)	03/10/2013	24/09/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1037	EUCTR2013-001012-30-IT (EUCTR)	30/09/2013	02/07/2013	Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658	Sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	80		United States;Canada;Poland;Austria;Germany;Italy
1038	EUCTR2012-002030-37-DE (EUCTR)	27/09/2013	22/05/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: not available Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1039	EUCTR2012-002013-19-DE (EUCTR)	25/09/2013	17/05/2013	Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis	A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab	Sanofi aventis Recherche&Développement	NULL	Not Recruiting			Female: yes Male: yes	93		France;United States;Canada;Belgium;Poland;Austria;Germany;Italy
1040	JPRN-UMIN000010127	2013/09/24	01/04/2013	Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis	Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis - Mucosal concentration of 5-ASA by once-daily vs conventional dosing	ulcerative colitis	Eligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks	Department of Gastroenterology and Hepatology, Kyoto University Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not applicable	Japan
1041	EUCTR2013-000366-11-CZ (EUCTR)	12/09/2013	05/06/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
1042	EUCTR2012-002013-19-PL (EUCTR)	12/09/2013	14/06/2013	Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis	A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA	Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab	Sanofi aventis Recherche&Développement	NULL	Not Recruiting			Female: yes Male: yes	93		France;United States;Canada;Belgium;Poland;Austria;Germany;Italy
1043	EUCTR2011-003208-19-CZ (EUCTR)	05/09/2013	03/04/2013	GWP42003 symptomatic treatment of ulcerative colitis.	A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.	Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GWP42003 INN or Proposed INN: Not Applicable Other descriptive name: CANNABIDIOL	GW Pharma Ltd.	NULL	Not Recruiting			Female: yes Male: yes	62	Phase 2	Czech Republic;United Kingdom
1044	EUCTR2013-001012-30-AT (EUCTR)	04/09/2013	12/07/2013	Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab Other descriptive name: SAR339658	Sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	80		United States;Canada;Poland;Austria;Germany;Italy
1045	EUCTR2013-000366-11-BE (EUCTR)	02/09/2013	11/07/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
1046	EUCTR2013-000366-11-GB (EUCTR)	30/08/2013	09/07/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
1047	EUCTR2011-004579-35-HR (EUCTR)	27/08/2013	28/08/2014	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1048	EUCTR2011-004581-14-HR (EUCTR)	26/08/2013	28/08/2014	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	725	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
1049	EUCTR2011-004578-27-HR (EUCTR)	26/08/2013	28/08/2014	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1050	EUCTR2011-004580-79-HR (EUCTR)	26/08/2013	28/08/2014	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1051	EUCTR2013-000366-11-FI (EUCTR)	20/08/2013	05/07/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
1052	EUCTR2012-002013-19-BE (EUCTR)	19/07/2013	19/02/2013	Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis	A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab	Sanofi aventis Recherche&Développement	NULL	Not Recruiting			Female: yes Male: yes	93	Phase 2	France;United States;Canada;Poland;Belgium;Austria;Germany;Italy
1053	EUCTR2013-000366-11-IE (EUCTR)	17/07/2013	16/05/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
1054	EUCTR2012-002031-28-HU (EUCTR)	11/07/2013	15/05/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	331	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1055	EUCTR2013-000366-11-DK (EUCTR)	10/07/2013	10/07/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
1056	EUCTR2012-002030-37-ES (EUCTR)	04/07/2013	10/06/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: . Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1057	EUCTR2012-002031-28-ES (EUCTR)	04/07/2013	10/06/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: . Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1058	JPRN-UMIN000013892	2013/07/01	06/05/2014	A prospective randomized controlled trial of AJG522 versus standard PEG plus E as bowel preparation for colonoscopy	A prospective randomized controlled trial of AJG522 versus standard PEG plus E as bowel preparation for colonoscopy - AJG522 versus PEG plus E for colonoscopy	Ulcerative colitis and so on	AJG522 PEG plus E (Niflec&#174;)	Gunma University Graduate School of Medicine	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	80	Phase 4	Japan
1059	EUCTR2013-000366-11-SE (EUCTR)	28/06/2013	13/05/2013	Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.	A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE	Tillotts Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden
1060	EUCTR2012-002030-37-HU (EUCTR)	27/06/2013	15/05/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1061	EUCTR2012-003123-38-GR (EUCTR)	25/06/2013	10/05/2013	A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Moderately to severely active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063	Receptos, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Slovakia;Greece;Russian Federation;Israel;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of
1062	EUCTR2012-002031-28-PL (EUCTR)	18/06/2013	10/05/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1063	EUCTR2012-004768-23-DE (EUCTR)	12/06/2013	06/02/2013	A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis	A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis	Ulcerative Colitis with active endoscopic lesion(s), ranging in severity from moderate to severe in endoscopic score not responding sufficiently to conventional treatment MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: STNM01 1.84 mg Product Code: STNM01 INN or Proposed INN: STNM01	STELIC INSTITUTE & CO.	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Germany
1064	EUCTR2012-002031-28-AT (EUCTR)	11/06/2013	29/05/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	331	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1065	EUCTR2012-002030-37-AT (EUCTR)	11/06/2013	29/05/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: not available Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1066	JPRN-UMIN000013371	2013/06/05	07/03/2014	Efficacy of infliximab therapy for arthritis after restorative proctocolectomy in patients with ulcerative colitis	Efficacy of infliximab therapy for arthritis after restorative proctocolectomy in patients with ulcerative colitis - Efficacy of infliximab for arthritis after colectomy in ulcerative colitis	ulcerative colitis	infliximab	Hyogo college of medicine	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	10	Not selected	Japan
1067	EUCTR2012-002013-19-IT (EUCTR)	02/06/2013	08/04/2013	Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis	A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab	Sanofi aventis Recherche&Développement	NULL	Not Recruiting			Female: yes Male: yes	93		United States;France;Canada;Poland;Belgium;Austria;Germany;Italy
1068	JPRN-UMIN000010776	2013/06/01	01/06/2013	An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis	An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis - Tacrolimus versus cyclosporine treatment for severe UC	Ulcerative colitis	tacrolimus (Prograf) cyclosporine (Sandimmune)	Chiba University Hospital	NULL	Recruiting	16years-old	65years-old	Male and Female	40	Not selected	Japan
1069	EUCTR2012-002030-37-SE (EUCTR)	31/05/2013	27/05/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1070	EUCTR2012-002031-28-CZ (EUCTR)	30/05/2013	16/05/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Slovakia;Spain;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1071	EUCTR2012-002030-37-CZ (EUCTR)	30/05/2013	16/05/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1072	EUCTR2012-005521-73-CZ (EUCTR)	16/05/2013	01/03/2013	Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis	Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study	Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG0974 INN or Proposed INN: GLPG0974	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	Czech Republic;Belgium;Latvia
1073	EUCTR2012-002030-37-NL (EUCTR)	15/05/2013	12/02/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1074	EUCTR2012-002031-28-NL (EUCTR)	15/05/2013	22/02/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1075	EUCTR2012-002031-28-IT (EUCTR)	08/05/2013	01/07/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1076	EUCTR2012-002030-37-PL (EUCTR)	07/05/2013	12/04/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1077	EUCTR2012-002030-37-SK (EUCTR)	02/05/2013	09/05/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1078	EUCTR2012-002031-28-SK (EUCTR)	02/05/2013	05/02/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: Anti-MAdCAM antibody Other descriptive name: PF-00547659	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	331	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1079	JPRN-UMIN000010340	2013/05/01	01/04/2013	Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study)	Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study) - CORRECT Study	Ulcerative colitis	Randomized treatment with mesalazine suppository or oral mesalazine for 2 weeks Switch from oral mesalazine to mesalazine suppository for 2 weeks	Saitama Medical Center, Saitama Medical University	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	60	Not selected	Japan
1080	JPRN-UMIN000010612	2013/05/01	01/05/2013	A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis	A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis - A comparison of the efficacy of tacrolimus with infliximab in ulcerative colitis	Ulcerative colitis	Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period. Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks.	Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	130	Phase 4	Japan
1081	JPRN-UMIN000013266	2013/05/01	25/02/2014	Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy	Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy - Controlled study of Dermacrin A for patients with perianal delmatitis after total colectomy	ulcerative colitis, familial adenomatous polyposis	1% of Dermacrin A ointment 0.033% of Guaiazulene ointment	Mie University Graduate School of Medicine, Gastrointestinal and Pediatric Surgery	NULL	Pending	20years-old	Not applicable	Male and Female	30	Not applicable	Japan
1082	NCT02073526 (ClinicalTrials.gov)	May 2013	9/1/2014	Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease	Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease	Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis	Drug: Infliximab, adalimumab, certolizumab pegol	Oslo University Hospital	NULL	Completed	18 Years	N/A	Both	1230	N/A	Norway
1083	EUCTR2012-005521-73-LV (EUCTR)	29/04/2013	13/03/2013	Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis	Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study	Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG0974 INN or Proposed INN: GLPG0974	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	Czech Republic;Latvia
1084	EUCTR2012-003123-38-BG (EUCTR)	24/04/2013	05/03/2013	A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063	Celgene International II Sàrl (CIS II).	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 2	United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of
1085	EUCTR2011-005251-13-PL (EUCTR)	23/04/2013	10/01/2013	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany
1086	EUCTR2012-002030-37-IT (EUCTR)	20/04/2013	02/04/2013	Study to test whether PF-00547659 is safe and improves symptoms in patients with UC	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: NA Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
1087	EUCTR2012-002013-19-AT (EUCTR)	16/04/2013	21/03/2013	Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis	A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA	Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SAR339658 INN or Proposed INN: Vatelizumab	Sanofi aventis Recherche&Développement	NULL	Not Recruiting			Female: yes Male: yes	93		France;United States;Canada;Belgium;Poland;Austria;Germany;Italy
1088	EUCTR2012-002031-28-BE (EUCTR)	02/04/2013	01/02/2013	Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis	A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH ULCERATIVE COLITIS (TURANDOT II) - TURANDOT II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	331	Phase 2	Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden
1089	NCT01846026 (ClinicalTrials.gov)	April 2013	30/4/2013	Ulcerative Colitis and Vitamin D Supplementation	Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.	Ulcerative Colitis	Drug: Vitamin D;Drug: placebo	University Hospital of North Norway	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 1/Phase 2	Norway
1090	EUCTR2012-005521-73-BE (EUCTR)	20/03/2013	08/02/2013	Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis	Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study	Mild to moderate Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GLPG0974 INN or Proposed INN: GLPG0974	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	Czech Republic;Belgium;Latvia
1091	EUCTR2011-004578-27-NL (EUCTR)	04/03/2013	12/03/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada
1092	EUCTR2012-003123-38-HU (EUCTR)	12/02/2013	04/12/2012	A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Moderately to severely active Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063	Celgene International II Sàrl (CIS II).	NULL	Not Recruiting			Female: yes Male: yes	113	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of
1093	EUCTR2012-003123-38-PL (EUCTR)	10/02/2013	15/01/2013	A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 2	United States;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Korea, Republic of
1094	EUCTR2012-001830-32-LT (EUCTR)	04/02/2013	04/10/2012	A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC	Active ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia
1095	EUCTR2012-001830-32-PL (EUCTR)	01/02/2013	18/10/2012	A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC	Active ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia
1096	EUCTR2012-003123-38-SK (EUCTR)	28/01/2013	04/03/2013	A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063	Celgene International II Sàrl (CIS II).	NULL	Not Recruiting			Female: yes Male: yes	86	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of
1097	EUCTR2011-004578-27-IT (EUCTR)	18/01/2013	07/08/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulverative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib	PFIZER INC.	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;Japan
1098	EUCTR2012-003974-18-BG (EUCTR)	18/01/2013	07/11/2012	A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis	A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: VB-201 INN or Proposed INN: Not applicable	Vascular Biogenics Ltd.	NULL	Not Recruiting			Female: yes Male: yes	110		Hungary;Bulgaria
1099	EUCTR2011-004580-79-IT (EUCTR)	18/01/2013	07/08/2012	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	ulcerative colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: NA Product Code: CP-690,550-10 Other descriptive name: tofacitinib	PFIZER LIMITED	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;Australia;Denmark;South Africa;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;New Zealand;Japan
1100	EUCTR2012-001830-32-DE (EUCTR)	15/01/2013	14/08/2012	A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC	Active ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
1101	EUCTR2011-001568-22-HU (EUCTR)	15/01/2013	18/07/2012	A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis	A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis	Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	90		Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation
1102	EUCTR2011-005251-13-NL (EUCTR)	08/01/2013	23/07/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 2	United States;Estonia;Greece;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany
1103	EUCTR2012-002030-37-BE (EUCTR)	08/01/2013	05/09/2012	A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT	Crohn’s Disease (CD) and Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;Slovakia;Spain;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Australia;Denmark;South Africa;Bulgaria;Norway;Germany;Netherlands;Sweden
1104	EUCTR2011-000164-10-GB (EUCTR)	04/01/2013	19/09/2012	Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis	A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SPD476 INN or Proposed INN: mesalazine Product Code: SPD476 INN or Proposed INN: mesalazine Trade Name: Mezavant XL 1200mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 1	United States;Slovakia;Poland;Australia;United Kingdom
1105	NCT02922374 (ClinicalTrials.gov)	January 2013	28/9/2016	Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis	Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study	Acute Severe Colitis (ASC)	Drug: corticosteroids	Jinling Hospital, China	NULL	Active, not recruiting	18 Years	N/A	Both	117	Phase 1/Phase 2	China
1106	EUCTR2011-005251-13-DE (EUCTR)	21/12/2012	09/07/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Latvia;Germany
1107	EUCTR2012-004851-35-FI (EUCTR)	19/12/2012	07/12/2012	Mesalalazine in pediatric ulcerative colitis	Once versus twice daily mesalazine to introduce remission in pediatric ulcerative colitis: a randomized controlled trial	Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Product Name: Pentasa INN or Proposed INN: MESALAZINE Trade Name: Pentasa Product Name: Pentasa INN or Proposed INN: MESALAZINE	Children´s Hospital, University of Helsinki	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Finland;Israel
1108	EUCTR2012-003123-38-BE (EUCTR)	11/12/2012	10/10/2012	A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS	Moderately to severely active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 0.5 mg RPC1063 INN or Proposed INN: RPC1063 Product Name: 1 mg RPC1063 INN or Proposed INN: RPC1063	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	86	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of
1109	EUCTR2012-003974-18-HU (EUCTR)	10/12/2012	28/09/2012	Study to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis	A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: VB-201 INN or Proposed INN: Not applicable	Vascular Biogenics Ltd.	NULL	Not Recruiting			Female: yes Male: yes	110		Hungary;Bulgaria
1110	NCT04032652 (ClinicalTrials.gov)	December 2012	4/12/2012	Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol	Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol	Ulcerative Colitis	Procedure: Rectal dialysis;Drug: Rectal dialysis	NorthShore University HealthSystem	NULL	Terminated	18 Years	45 Years	All	2	Phase 2	NULL
1111	NCT01078935 (ClinicalTrials.gov)	December 2012	1/3/2010	The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation	The Effect of Probiotics on Bowel Disease	Crohn's Disease;Ulcerative Colitis	Dietary Supplement: probiotics;Dietary Supplement: placebo	The Baruch Padeh Medical Center, Poriya	Ministry of Health, Israel	Not yet recruiting	18 Years	80 Years	Both	100	Phase 4	NULL
1112	JPRN-UMIN000009364	2012/11/24	24/11/2012	Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis	Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis - long-term administration of FBRA in patients with UC	ulcerative colitis	Patients receive 6 sachets (21 g) of FBRA, brown rice fermented by Aspergillus oryzae, daily (after every meal, 3 times daily) for 2 years.	Graduate School of Medical Science, KyotoPrefectural University of Medicine	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Phase 2	Japan
1113	EUCTR2011-002462-20-SK (EUCTR)	19/11/2012	27/09/2011	Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis	Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study	Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate	Dr August Wolff GmbH & Co KG Arzneimittel	NULL	Not Recruiting			Female: yes Male: yes			Hungary;Czech Republic;Slovakia;Poland;Germany;Italy
1114	NCT01694485 (ClinicalTrials.gov)	November 16, 2012	24/9/2012	Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis	A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Biological: Abrilumab;Drug: Placebo	Amgen	NULL	Completed	18 Years	65 Years	All	359	Phase 2	United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Switzerland;United Kingdom;Czech Republic
1115	NCT01620255 (ClinicalTrials.gov)	November 2, 2012	13/6/2012	A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis	A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)	Ulcerative Colitis	Drug: Placebo;Drug: PF-00547659 SC Injection	Shire	NULL	Completed	18 Years	65 Years	All	357	Phase 2	United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Croatia;Czech Republic;Norway;Sweden;United Kingdom
1116	NCT01790061 (ClinicalTrials.gov)	November 2012	9/2/2013	Standardized Fecal Microbiota Transplantation for Ulcerative Colitis	Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis	Bacteria;Microbiota;Fecal Microbiota Transplantation;Inflammatory Bowel Disease;Ulcerative Colitis	Procedure: Standardized FMT;Drug: Traditional treatments	The Second Hospital of Nanjing Medical University	Air Force Military Medical University, China	Recruiting	6 Years	80 Years	All	500	Phase 2/Phase 3	China
1117	EUCTR2011-004581-14-NL (EUCTR)	10/10/2012	12/03/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
1118	EUCTR2011-004579-35-NL (EUCTR)	10/10/2012	12/03/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
1119	EUCTR2011-001568-22-BG (EUCTR)	05/10/2012	16/08/2012	A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis	A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis	Mild to moderate Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	90		Hungary;European Union;Ukraine;Croatia;Denmark;Russian Federation;Bulgaria
1120	EUCTR2012-001830-32-HU (EUCTR)	04/10/2012	16/08/2012	A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC	Active ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Salofalk® 500 mg tablets INN or Proposed INN: Mesalazine	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia
1121	EUCTR2012-001830-32-LV (EUCTR)	02/10/2012	05/09/2012	A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC	Active ulcerative colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia
1122	NCT01706159 (ClinicalTrials.gov)	October 2012	9/10/2012	A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis	A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis	Inflammation;Ulcerative Colitis	Drug: catridecacog;Drug: placebo	Novo Nordisk A/S	NULL	Terminated	18 Years	64 Years	All	20	Phase 2	Bulgaria;Croatia;Denmark;Hungary;Poland;Russian Federation;Ukraine
1123	EUCTR2012-002023-15-AT (EUCTR)	21/09/2012	04/09/2012	Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis	Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis - Mesacol	Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant 1200 mg magensaftresistente Retardtabletten INN or Proposed INN: MESALAZINE Other descriptive name: 5-aminosalicylic acid	Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	Austria
1124	EUCTR2011-004578-27-PL (EUCTR)	18/09/2012	20/06/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan
1125	EUCTR2011-004579-35-PL (EUCTR)	17/09/2012	28/06/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand
1126	EUCTR2011-004581-14-PL (EUCTR)	17/09/2012	22/06/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc., 235 East 42nd Street, New York, New York 10017, United States	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
1127	EUCTR2011-005251-13-IT (EUCTR)	16/09/2012	27/08/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG181 Product Code: AMG181	AMGEN INC.	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 2	United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Poland;Belgium;Australia
1128	EUCTR2011-005251-13-BE (EUCTR)	14/09/2012	18/07/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Latvia;Germany;Netherlands;Norway
1129	EUCTR2011-005115-82-LT (EUCTR)	12/09/2012	24/05/2012	An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen	Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE	Santarus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500		United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1130	EUCTR2011-005251-13-HU (EUCTR)	11/09/2012	18/07/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Germany;Norway
1131	EUCTR2011-005251-13-AT (EUCTR)	10/09/2012	23/07/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany
1132	EUCTR2011-005251-13-GB (EUCTR)	06/09/2012	13/07/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Estonia;Greece;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany
1133	EUCTR2011-004765-32-NL (EUCTR)	27/08/2012	25/04/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE HYDROCHLORIDE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	Czech Republic;Slovakia;Belgium;Russian Federation;Israel;Netherlands;Italy
1134	EUCTR2011-001568-22-DK (EUCTR)	23/08/2012	02/08/2012	A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis	A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis	Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	90		Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation
1135	EUCTR2011-005251-13-DK (EUCTR)	16/08/2012	11/07/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Latvia;Norway;Netherlands;Germany
1136	EUCTR2011-002411-29-ES (EUCTR)	10/08/2012	18/10/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
1137	EUCTR2011-004580-79-PL (EUCTR)	05/08/2012	12/06/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan
1138	JPRN-UMIN000008352	2012/08/01	01/08/2012	Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis	Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis - Once Daily Oral Mesalazine Swich Trial in UC-Patients	Ulcerative Colitis	Switch from several times to once daily oral mesalazine administration	Saitama Medical Center, Saitama Medical University	NULL	Complete: follow-up complete	15years-old	70years-old	Male and Female	50	Not selected	Japan
1139	EUCTR2011-005251-13-CZ (EUCTR)	26/07/2012	17/07/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	United States;Estonia;Greece;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Norway;Germany
1140	EUCTR2011-004578-27-ES (EUCTR)	11/07/2012	09/03/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
1141	EUCTR2011-004579-35-ES (EUCTR)	11/07/2012	09/03/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
1142	NCT01640496 (ClinicalTrials.gov)	July 2012	11/7/2012	Vitamin D Treatment in Ulcerative Colitis	Vitamin D Treatment in Ulcerative Colitis	Ulcerative Colitis;Inflammatory Bowel Disease	Drug: Vitamin D3;Other: Placebo	University of Chicago	North Shore University Hospital	Withdrawn	18 Years	N/A	Both	0	N/A	United States
1143	EUCTR2011-002411-29-FI (EUCTR)	29/06/2012	11/06/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 15.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
1144	EUCTR2011-004579-35-CZ (EUCTR)	29/06/2012	08/02/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc	,NULL	Not Recruiting			Female: yes Male: yes	545	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
1145	EUCTR2011-004578-27-CZ (EUCTR)	29/06/2012	08/02/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc	,NULL	Not Recruiting			Female: yes Male: yes	545	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1146	EUCTR2011-004581-14-CZ (EUCTR)	29/06/2012	08/02/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed) Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;New Zealand
1147	EUCTR2011-004580-79-CZ (EUCTR)	26/06/2012	08/02/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy
1148	EUCTR2011-004770-28-AT (EUCTR)	26/06/2012	15/02/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia
1149	EUCTR2011-002411-29-AT (EUCTR)	26/06/2012	01/02/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
1150	EUCTR2011-000164-10-SK (EUCTR)	21/06/2012	13/04/2016	Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis	A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine	Shire Development Inc	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 1	United States;Slovakia;United Kingdom
1151	EUCTR2011-005115-82-LV (EUCTR)	15/06/2012	21/05/2012	An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE	Santarus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500		United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1152	EUCTR2010-022766-27-SK (EUCTR)	11/06/2012	27/01/2012	Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis	A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION	Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	128	Phase 2	United States;Hungary;Slovakia;Canada;Belgium;Poland;Italy;Sweden
1153	EUCTR2011-004580-79-BE (EUCTR)	08/06/2012	07/03/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1154	EUCTR2011-004579-35-BE (EUCTR)	08/06/2012	08/03/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
1155	EUCTR2011-004581-14-BE (EUCTR)	07/06/2012	07/03/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
1156	EUCTR2011-004578-27-BE (EUCTR)	06/06/2012	07/03/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1157	EUCTR2011-004580-79-DE (EUCTR)	06/06/2012	28/03/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia
1158	EUCTR2011-004581-14-DE (EUCTR)	05/06/2012	29/03/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (Phase III Formulation) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercialFormulation - debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
1159	EUCTR2011-005251-13-GR (EUCTR)	05/06/2012	14/05/2012	A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis	A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis	Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	315	Phase 2	United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Latvia;Germany;Norway
1160	EUCTR2011-005115-82-EE (EUCTR)	05/06/2012	09/05/2012	An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE	Santarus, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500		United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1161	JPRN-UMIN000007806	2012/06/01	01/05/2012	The feasibility study of accelated infliximab infusion during maintenance phase	The feasibility study of accelated infliximab infusion during maintenance phase - The feasibility study of accelated infliximab infusion during maintenance phase	patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)	Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.	Chiba University Hospital	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	54	Phase 2	Japan
1162	EUCTR2011-002411-29-PT (EUCTR)	01/06/2012	03/01/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
1163	NCT01586533 (ClinicalTrials.gov)	June 2012	25/4/2012	Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis	A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis	Ulcerative Colitis;Left-sided Ulcerative Colitis;Distal Ulcerative Colitis	Drug: Zoenasa-1:4;Drug: Mesalamine Enema	Altheus Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	64 Years	Both	120	Phase 2	United States
1164	EUCTR2011-004578-27-HU (EUCTR)	30/05/2012	10/02/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1165	EUCTR2011-004579-35-DE (EUCTR)	29/05/2012	21/03/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	545	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1166	EUCTR2011-004580-79-LV (EUCTR)	23/05/2012	01/03/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1167	EUCTR2011-004578-27-DE (EUCTR)	23/05/2012	05/03/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not availble Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	545	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1168	EUCTR2011-004579-35-LV (EUCTR)	23/05/2012	01/03/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1169	EUCTR2011-004578-27-LV (EUCTR)	23/05/2012	01/03/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1170	EUCTR2011-004581-14-LV (EUCTR)	23/05/2012	01/03/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	725	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
1171	EUCTR2011-004579-35-AT (EUCTR)	18/05/2012	21/03/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1172	EUCTR2011-004581-14-ES (EUCTR)	18/05/2012	14/03/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	725	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
1173	EUCTR2011-004580-79-AT (EUCTR)	18/05/2012	27/03/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1174	EUCTR2011-004581-14-AT (EUCTR)	18/05/2012	27/03/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand
1175	EUCTR2011-004580-79-ES (EUCTR)	18/05/2012	09/03/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;New Zealand;United States
1176	EUCTR2011-004578-27-AT (EUCTR)	18/05/2012	27/03/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 INN or Proposed INN: not available Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1177	EUCTR2011-005115-82-BG (EUCTR)	11/05/2012	11/04/2012	An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE	Santarus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500		United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1178	EUCTR2011-002411-29-DE (EUCTR)	11/05/2012	11/11/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 16.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
1179	EUCTR2011-004579-35-HU (EUCTR)	10/05/2012	10/02/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1180	EUCTR2011-004580-79-HU (EUCTR)	10/05/2012	10/02/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1181	EUCTR2011-004581-14-HU (EUCTR)	10/05/2012	10/02/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
1182	EUCTR2011-002411-29-GB (EUCTR)	03/05/2012	07/11/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	Abbvie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
1183	EUCTR2011-004580-79-SK (EUCTR)	03/05/2012	10/04/2013	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1184	EUCTR2011-004770-28-DE (EUCTR)	03/05/2012	09/02/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Propionylcarnitinhydrochlorid Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany
1185	EUCTR2011-004578-27-SK (EUCTR)	02/05/2012	12/04/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1186	EUCTR2011-004581-14-SK (EUCTR)	02/05/2012	13/04/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand
1187	EUCTR2011-004579-35-SK (EUCTR)	02/05/2012	13/04/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1188	JPRN-UMIN000007593	2012/05/01	02/04/2012	Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial	Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial - B-FLORA	ulcerative colitis	Bifidobacterium breve fermented milk placebo	Public Health Research foundation	NULL	Complete: follow-up complete	20years-old	70years-old	Male and Female	600	Not applicable	Japan
1189	EUCTR2011-004581-14-GB (EUCTR)	01/05/2012	01/03/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
1190	EUCTR2011-004579-35-GB (EUCTR)	01/05/2012	12/01/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1191	NCT01387594 (ClinicalTrials.gov)	May 2012	30/6/2011	Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs	A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)	Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative Colitis	Procedure: lumbar puncture;Drug: lumbar puncture	Shire	NULL	Completed	18 Years	75 Years	All	49	Phase 1	Austria;Belgium;France;Germany;Netherlands
1192	NCT01550965 (ClinicalTrials.gov)	May 2012	8/3/2012	A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting	Ulcerative Colitis	Biological: Adalimumab	AbbVie (prior sponsor, Abbott)	NULL	Completed	18 Years	75 Years	All	463	Phase 3	Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom
1193	EUCTR2011-004580-79-GB (EUCTR)	30/04/2012	14/02/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1194	EUCTR2011-004578-27-EE (EUCTR)	26/04/2012	14/02/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1195	EUCTR2011-004578-27-GB (EUCTR)	26/04/2012	12/01/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1196	EUCTR2011-004581-14-EE (EUCTR)	26/04/2012	13/02/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
1197	EUCTR2011-004765-32-IT (EUCTR)	26/04/2012	23/07/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	SIGMA-TAU	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Czech Republic;Belgium;Netherlands;Italy
1198	EUCTR2011-002411-29-SE (EUCTR)	26/04/2012	13/10/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
1199	EUCTR2011-004579-35-EE (EUCTR)	26/04/2012	14/02/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545		Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1200	EUCTR2011-004580-79-EE (EUCTR)	26/04/2012	13/02/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1201	EUCTR2010-023762-49-BE (EUCTR)	23/04/2012	21/11/2011	A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study	Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Spain;Poland;Belgium;Romania;Austria;Bulgaria;Germany;Netherlands
1202	EUCTR2011-005115-82-CZ (EUCTR)	18/04/2012	08/02/2012	An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen	Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE	Santarus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500		United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1203	EUCTR2011-004770-28-LT (EUCTR)	12/04/2012	15/02/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 16.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany
1204	EUCTR2011-004812-40-GB (EUCTR)	12/04/2012	21/03/2012	Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.	A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 2	Czech Republic;Netherlands;Germany;Italy;United Kingdom
1205	EUCTR2010-023588-16-DE (EUCTR)	10/04/2012	05/05/2011	A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1)	A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC	Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)	Iron Therapeutics (Switzerland) AG	NULL	Not Recruiting			Female: yes Male: yes	60		Hungary;Austria;Germany;United Kingdom
1206	EUCTR2011-005115-82-PL (EUCTR)	10/04/2012	16/03/2012	An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen	Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE	Santarus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500		United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1207	EUCTR2011-002411-29-IE (EUCTR)	30/03/2012	09/02/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
1208	EUCTR2011-002411-29-DK (EUCTR)	30/03/2012	28/11/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
1209	EUCTR2010-022766-27-IT (EUCTR)	28/03/2012	27/04/2012	Study of safety and effectiveness of human-derived stem cells (multistem, also know as PF-05285401) in the treatment of ulcerative colitis.	A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Multistem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: Multistem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten INN or Proposed INN: DEXTRAN 1 FOR INJECTION	PFIZER LIMITED	NULL	Not Recruiting			Female: yes Male: yes	128	Phase 2	United States;Hungary;Canada;Belgium;Italy;Sweden
1210	EUCTR2011-005115-82-HU (EUCTR)	26/03/2012	07/02/2012	An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE	Santarus, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500		United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
1211	EUCTR2011-004770-28-HU (EUCTR)	21/03/2012	23/01/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia
1212	EUCTR2011-004581-14-DK (EUCTR)	20/03/2012	09/02/2012	A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis	A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
1213	EUCTR2011-004770-28-PL (EUCTR)	17/03/2012	16/02/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 15.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany
1214	EUCTR2011-003130-14-IT (EUCTR)	12/03/2012	05/03/2012	Clinical Trial to assess the efficacy and safety of Kappaproct	A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients” - CSUC-01/10	Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Kappaproct Product Code: DIMS0150 INN or Proposed INN: NA Other descriptive name: NA	INDEX PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes	132		Czech Republic;Hungary;Poland;Germany;United Kingdom;Italy
1215	EUCTR2011-002411-29-BE (EUCTR)	07/03/2012	23/11/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	455		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden
1216	EUCTR2011-004770-28-LV (EUCTR)	29/02/2012	24/01/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	France;Hungary;Spain;Poland;Lithuania;Austria;Germany;Latvia
1217	EUCTR2011-004770-28-ES (EUCTR)	28/02/2012	11/01/2012	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	France;Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany
1218	EUCTR2011-004579-35-DK (EUCTR)	24/02/2012	24/02/2012	A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to severe active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
1219	EUCTR2011-004580-79-DK (EUCTR)	24/02/2012	23/01/2012	A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	654	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
1220	EUCTR2011-004578-27-DK (EUCTR)	24/02/2012	09/02/2012	A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.	A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: CP-690,550-10 Product Code: CP-690,550-10 Other descriptive name: tofacitinib	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	545	Phase 3	Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
1221	EUCTR2011-004765-32-CZ (EUCTR)	21/02/2012	15/12/2011	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	Czech Republic;Belgium;Netherlands;Italy
1222	EUCTR2011-002411-29-IT (EUCTR)	20/02/2012	07/03/2012	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting.	Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB	ABBOTT GMBH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden
1223	EUCTR2011-002818-37-BE (EUCTR)	15/02/2012	03/10/2011	A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.	A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis.	Subjects with Active Ulcerative Colitis. MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GSK1605786A Product Code: GSK1605786A	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	Belgium;Netherlands;United Kingdom
1224	EUCTR2011-003532-32-LT (EUCTR)	14/02/2012	28/11/2011	A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis	Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis	Acute mild to moderate ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LX1606 Product Code: LX1606 INN or Proposed INN: Telotristat etiprate Other descriptive name: telotristat etiprate	Lexicon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Slovakia;Poland;Belgium;Lithuania
1225	EUCTR2011-003409-36-DE (EUCTR)	09/02/2012	17/11/2011	A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)	A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand
1226	EUCTR2010-022766-27-BE (EUCTR)	09/02/2012	08/11/2011	Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis	A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MultiStem Product Code: PF-05285401 INN or Proposed INN: N/A Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 INN or Proposed INN: N/A Other descriptive name: Multistem Trade Name: Promiten INN or Proposed INN: Dextran Other descriptive name: DEXTRAN 1 FOR INJECTION	Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	128	Phase 2	United States;Hungary;Slovakia;Canada;Poland;Belgium;Germany;Italy;Sweden
1227	EUCTR2011-002818-37-GB (EUCTR)	08/02/2012	07/11/2011	A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.	A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis.	Subjects with Active Ulcerative Colitis. MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GSK1605786A Product Code: GSK1605786A	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	Netherlands;United Kingdom
1228	EUCTR2010-022766-27-HU (EUCTR)	07/02/2012	05/12/2011	Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis	A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION	Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	128	Phase 2	United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden
1229	JPRN-UMIN000007341	2012/02/01	21/02/2012	The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab	The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab - The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab	ulcerative colitis	Patients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54). Patients in discontinuation group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54).	Tohoku University Graduate School of Medicine (Tohoku University Hospital)	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	90	Not applicable	Japan
1230	NCT01393405 (ClinicalTrials.gov)	February 2012	11/7/2011	Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis	Randomized, Double Blind, Prospective Trial Investigating the Efficacy of Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis (MEthotrexate Response In Treatment of UC - MERIT-UC)	Ulcerative Colitis	Drug: Methotrexate	University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	18 Years	70 Years	All	179	Phase 2	United States
1231	NCT01532648 (ClinicalTrials.gov)	January 27, 2012	13/12/2011	Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen	Ulcerative Colitis	Drug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASA	Bausch Health Americas, Inc.	NULL	Completed	18 Years	75 Years	All	510	Phase 3	United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic
1232	EUCTR2011-004812-40-DE (EUCTR)	26/01/2012	25/11/2011	Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.	A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 2	Czech Republic;Netherlands;Germany;United Kingdom;Italy
1233	EUCTR2011-004812-40-NL (EUCTR)	25/01/2012	22/12/2011	Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.	A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis	Ulcerative Colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 2	Czech Republic;Netherlands;United Kingdom;Italy
1234	EUCTR2011-004812-40-CZ (EUCTR)	24/01/2012	29/12/2011	Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.	A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 2	Czech Republic;Netherlands;United Kingdom;Italy
1235	EUCTR2011-004765-32-SK (EUCTR)	19/01/2012	09/12/2011	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	Czech Republic;Slovakia;Belgium;Netherlands;Italy
1236	EUCTR2010-022766-27-SE (EUCTR)	19/01/2012	03/11/2011	Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis	A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Product Name: MultiStem Product Code: PF-05285401 Other descriptive name: Multistem Trade Name: Promiten Other descriptive name: DEXTRAN 1 FOR INJECTION	Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	128	Phase 2	United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden
1237	EUCTR2011-003130-14-CZ (EUCTR)	13/01/2012	14/10/2011	A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment	A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients	Chronic active treatment refractory ulcerative colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Kappaproct INN or Proposed INN: DIMS0150 Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	120		Hungary;Czech Republic;Poland;Germany;Italy;United Kingdom
1238	EUCTR2011-003409-36-CZ (EUCTR)	11/01/2012	18/11/2011	A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)	A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: RO5490261/F02 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;New Zealand;United Kingdom
1239	EUCTR2011-004765-32-BE (EUCTR)	10/01/2012	06/12/2011	Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates	Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis	Mild ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 INN or Proposed INN: Levocarnitine propyl hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	444	Phase 3	Czech Republic;Slovakia;Belgium;Netherlands;Italy
1240	EUCTR2011-005693-36-IT (EUCTR)	09/01/2012	02/03/2012	Evaluation of the number of colon intraephitelial tumours in patients with ulcerative colitis after oral administration of the vital dye methylene blue	Intraepithelial neoplasia detection rate after single oral dose of methylene blue MMX modified release tablets administered to patients with long standing ulcerative colitis undergoing colonoscopy - NA	Patients affecetd by Long standing ulcerative colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Methylene blue 25mg tablets Product Code: NA INN or Proposed INN: METHYLENE BLUE Other descriptive name: NA	COSMO TECHNOLOGIES LTD	NULL	Not Recruiting			Female: yes Male: yes			Italy
1241	EUCTR2011-002411-29-GR (EUCTR)	09/01/2012	07/12/2011	A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.	An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A	Ulcerative Colitis MedDRA version: 14.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	680		Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
1242	EUCTR2011-003283-78-IT (EUCTR)	09/01/2012	01/03/2012	A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS	A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS	Active Ulcerative Colitis Patients MedDRA version: 14.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: NA Product Code: GED-0507-34-Levo INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid Other descriptive name: NA	GIULIANI	NULL	Not Recruiting			Female: yes Male: yes			Italy
1243	EUCTR2010-023762-49-PL (EUCTR)	06/01/2012	05/07/2011	A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Spain;Belgium;Poland;Romania;Austria;Bulgaria;Germany;Netherlands
1244	EUCTR2011-002818-37-NL (EUCTR)	03/01/2012	16/02/2012	A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.	A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis.	Subjects with Active Ulcerative Colitis. MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GSK1605786A Product Code: GSK1605786A	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	Netherlands;United Kingdom
1245	EUCTR2011-002462-20-IT (EUCTR)	02/01/2012	08/03/2012	Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis.	Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis:PoC study	mild to moderate ulcerative colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Lysine-D-proline-threonine Product Code: K(D)PT INN or Proposed INN: NA Other descriptive name: L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate	DR. AUGUST WOLFF GMBH & CO. KG	NULL	Not Recruiting			Female: yes Male: yes	160		Hungary;Czech Republic;Slovakia;Poland;Germany;Italy
1246	NCT01494857 (ClinicalTrials.gov)	January 2012	15/12/2011	Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis	Open-Label, Non-Randomized, Single Patient Group, Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Adalimumab	Clalit Health Services	NULL	Recruiting	18 Years	N/A	Both	200	Phase 3	Israel
1247	EUCTR2011-003130-14-DE (EUCTR)	30/12/2011	19/09/2011	A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment	A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients	Chronic active treatment refractory ulcerative colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Kappaproct INN or Proposed INN: DIMS0150 Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	120		Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom
1248	EUCTR2011-002462-20-PL (EUCTR)	27/12/2011	20/10/2011	Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis	Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study	Acute mild to moderate ulcerative colitis. MedDRA version: 15.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate	Dr August Wolff GmbH & Co KG Arzneimittel	NULL	Not Recruiting			Female: yes Male: yes	160		Hungary;Czech Republic;Poland;Germany;Italy
1249	EUCTR2011-003409-36-ES (EUCTR)	23/12/2011	18/11/2011	A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)	A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Belgium;Spain;Australia;Israel;Germany;United Kingdom;New Zealand
1250	EUCTR2011-003130-14-PL (EUCTR)	22/12/2011	10/10/2011	A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment	A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients	Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Kappaproct Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	120		Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom
1251	EUCTR2010-020448-37-NL (EUCTR)	21/12/2011	16/09/2010	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE	Enceladus Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Belgium;Netherlands
1252	EUCTR2011-003532-32-SK (EUCTR)	19/12/2011	10/11/2011	A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis	Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis	Acute mild to moderate ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LX1606 Product Code: LX1606 INN or Proposed INN: Non as of yet Other descriptive name: telotristat etiprate	Lexicon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Slovakia;Belgium;Poland;Lithuania
1253	EUCTR2011-004268-31-DK (EUCTR)	13/12/2011	21/11/2011	Adalimumab (Humira) in the treatment of chronic pouchitis	Adalimumab (Humira) in the treatment of chronic pouchitis	Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis MedDRA version: 14.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringes Product Name: Humira Product Code: EMEA/H/C/000481	Odense University Hospital	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 3	Denmark
1254	EUCTR2011-004812-40-IT (EUCTR)	12/12/2011	02/03/2012	A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis	A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab Other descriptive name: NA	ASTRAZENECA	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 2	Czech Republic;Netherlands;Germany;United Kingdom;Italy
1255	EUCTR2011-002462-20-HU (EUCTR)	07/12/2011	22/09/2011	Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis	Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study	Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate	Dr August Wolff GmbH & Co KG Arzneimittel	NULL	Not Recruiting			Female: yes Male: yes			Czech Republic;Hungary;Poland;Germany;Italy
1256	EUCTR2011-003409-36-GB (EUCTR)	02/12/2011	06/12/2011	A study to evaluate the long term safety of etrolizumab in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)	A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: RO5490261 / F02 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7; Anti Beta7; PRO145223	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;New Zealand;United Kingdom
1257	NCT01496053 (ClinicalTrials.gov)	December 2011	15/12/2011	Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)	Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study	Ulcerative Colitis;Crohn's Disease;Inflammatory Bowel Disease	Dietary Supplement: AndoSan;Dietary Supplement: Sugar Extract	Oslo University Hospital	ImmunoPharma AS	Completed	18 Years	60 Years	All	100	Phase 2/Phase 3	Norway
1258	EUCTR2010-023762-49-DE (EUCTR)	29/11/2011	17/08/2011	A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Spain;Romania;Austria;Bulgaria;Netherlands;Germany
1259	NCT01461317 (ClinicalTrials.gov)	November 29, 2011	12/10/2011	Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis	A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: Etrolizumab	Genentech, Inc.	NULL	Completed	18 Years	75 Years	All	121	Phase 2	United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom;Czech Republic
1260	EUCTR2011-002462-20-CZ (EUCTR)	24/11/2011	20/09/2011	Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis	Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study	Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate	Dr August Wolff GmbH & Co KG Arzneimittel	NULL	Not Recruiting			Female: yes Male: yes			Hungary;Czech Republic;Poland;Germany;Italy
1261	EUCTR2011-003208-19-GB (EUCTR)	16/11/2011	28/09/2011	GWP42003 symptomatic treatment of ulcerative colitis.	A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.	Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GWP42003 INN or Proposed INN: Not applicable Other descriptive name: CANNABIDIOL	GW Pharma Ltd.	NULL	Not Recruiting			Female: yes Male: yes	62	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;United Kingdom
1262	EUCTR2011-003409-36-BE (EUCTR)	14/11/2011	14/11/2011	A study to evaluate the long term safety of rhuMab Beta7 in patients with moderate to severe ulcerative colitis (a form of inflammatory bowel disease)	A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb Beta7 in Patients with Moderate to Severe Ulcerative Colitis	Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand
1263	EUCTR2010-023762-49-HU (EUCTR)	09/11/2011	13/05/2011	A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study	Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	Hungary;Germany;Canada;Netherlands;Belgium;Romania;France;Bulgaria;Spain;United States;Poland;Austria
1264	EUCTR2011-002462-20-DE (EUCTR)	25/10/2011	13/09/2011	Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis	Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study	Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate	Dr August Wolff GmbH & Co KG Arzneimittel	NULL	Not Recruiting			Female: yes Male: yes	160		Hungary;Czech Republic;Poland;Germany;Italy
1265	EUCTR2010-022506-41-PL (EUCTR)	24/10/2011	05/09/2011	Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis	A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06	Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	386	Phase 2	United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany
1266	EUCTR2011-000897-80-DE (EUCTR)	19/10/2011	15/07/2011	A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease	PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Israel;Germany;United States;Hungary;Czech Republic;Canada;Spain;Australia;United Kingdom;New Zealand
1267	EUCTR2011-003130-14-GB (EUCTR)	06/10/2011	11/08/2011	A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment	A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients	Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Kappaproct Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom
1268	JPRN-UMIN000006141	2011/10/01	12/08/2011	Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis	Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis - Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis	ulcerative colitis	Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54). Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54).	Department of Gastroenterology and Hepatology, Kyoto University Hospital	NULL	Complete: follow-up complete	16years-old	75years-old	Male and Female	50	Not applicable	Japan
1269	EUCTR2011-000897-80-ES (EUCTR)	23/09/2011	04/07/2011	A clinical study to investigate the safety and efficacy of the productrhuMAb BETA7 in treating patients with ulcerative colitis, a form ofinflammatory bowel disease	PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDYTO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 INPATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand
1270	EUCTR2011-000897-80-CZ (EUCTR)	14/09/2011	29/06/2011	A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease	PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand
1271	EUCTR2011-000897-80-GB (EUCTR)	06/09/2011	29/06/2011	A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease	PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;New Zealand;United Kingdom
1272	EUCTR2011-000897-80-HU (EUCTR)	05/09/2011	07/09/2011	A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease	PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Czech Republic;Hungary;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand
1273	EUCTR2010-022506-41-BE (EUCTR)	23/08/2011	17/06/2011	Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis	A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05	Colitis, Ulcerative MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	386	Phase 2	United States;Austria;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Australia;South Africa;Netherlands;Germany
1274	EUCTR2011-000897-80-BE (EUCTR)	16/08/2011	27/06/2011	A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease	PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) INN or Proposed INN: n.a. Other descriptive name: rhuMAb Beta7	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand
1275	EUCTR2010-023797-39-GB (EUCTR)	12/08/2011	16/07/2011	TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE	TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD.	Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders	Trade Name: Iron sulphate 200mg coated tablets Product Name: Ferrous sulphate Product Code: Ferrous sulphate INN or Proposed INN: Iron sulphate Trade Name: CosmoFer Product Name: CosmoFer 50mg/ml solution for infusion or injection INN or Proposed INN: iron(III)- hydroxide dextran complex	Barts Health NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	90	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1276	EUCTR2010-023588-16-HU (EUCTR)	11/08/2011	27/05/2011	A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1)	A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC	Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)	Iron Therapeutics (Switzerland) AG	NULL	Not Recruiting			Female: yes Male: yes	60		Hungary;Austria;Germany;United Kingdom
1277	EUCTR2010-023588-16-GB (EUCTR)	02/08/2011	11/05/2011	A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1)	A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC	Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 16.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)	Iron Therapeutics (Switzerland) AG	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Austria;Germany;United Kingdom
1278	EUCTR2010-023762-49-AT (EUCTR)	22/07/2011	26/04/2011	A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Belgium;Spain;Poland;Romania;Austria;Bulgaria;Germany;Netherlands
1279	EUCTR2010-022506-41-DE (EUCTR)	18/07/2011	28/02/2011	Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis	A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis	Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	386	Phase 2	United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Germany;Netherlands
1280	JPRN-UMIN000005824	2011/07/01	21/06/2011	Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis	Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis - Examination of efficacy and safety of tacrolimus for an outpatient with ulcerative colitis	ulcerative colitis	Tacrolimus (12weeks)	Juntendo University	NULL	Recruiting	16years-old	65years-old	Male and Female	20	Not applicable	Japan
1281	EUCTR2011-002061-38-BE (EUCTR)	29/06/2011	08/06/2011	Treating patients with infliximab based on their trough levels	A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT	2) Crohn's disease and ulcerative colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade Product Code: Remicade INN or Proposed INN: INFLIXIMAB	Katholieke Universiteit Leuven	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Belgium
1282	EUCTR2010-023588-16-AT (EUCTR)	22/06/2011	16/05/2011	A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1)	A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC	Iron deficiency anaemia in quiescent ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)	Iron Therapeutics (Switzerland) AG	NULL	Not Recruiting			Female: yes Male: yes	60		Hungary;Austria;Germany;United Kingdom
1283	EUCTR2010-023762-49-BG (EUCTR)	06/06/2011	31/05/2011	A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study	Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Belgium;Spain;Poland;Romania;Austria;Bulgaria;Germany;Netherlands
1284	EUCTR2010-022506-41-HU (EUCTR)	31/05/2011	13/04/2011	Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis	A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 03 incorporating Protocol amendment 05	Colitis, Ulcerative MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	386	Phase 2	United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany
1285	EUCTR2010-023762-49-ES (EUCTR)	16/05/2011	11/02/2011	ESTUDIO EN FASE 2A, ALEATORIZADO, DOBLE CIEGO, SIN ENMASCARAMIENTO PARA EL PROMOTOR, CONTROLADO CON PLACEBO, DE DOSIS MÚLTIPLES PARA EVALUAR LA FARMACODINÁMICA, LA FARMACOCINÉTICA Y LA SEGURIDAD DE ANRUKINZUMAB EN PACIENTES CON COLITIS ULCEROSA ACTIVAA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS	ESTUDIO EN FASE 2A, ALEATORIZADO, DOBLE CIEGO, SIN ENMASCARAMIENTO PARA EL PROMOTOR, CONTROLADO CON PLACEBO, DE DOSIS MÚLTIPLES PARA EVALUAR LA FARMACODINÁMICA, LA FARMACOCINÉTICA Y LA SEGURIDAD DE ANRUKINZUMAB EN PACIENTES CON COLITIS ULCEROSA ACTIVAA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS	Colitis ulcerosa MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer, S.L.U.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Belgium;Poland;Spain;Bulgaria;Germany
1286	EUCTR2010-022506-41-IT (EUCTR)	16/05/2011	28/12/2011	A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)	A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC) - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis	Colitis, Ulcerative MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	386	Phase 2	United States;Hungary;Mexico;Canada;Poland;Brazil;Austria;Australia;South Africa;Germany;Italy
1287	EUCTR2010-022506-41-AT (EUCTR)	05/05/2011	01/03/2011	Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis	A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06 - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis	Colitis, Ulcerative MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	386	Phase 2	United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Netherlands;Germany
1288	JPRN-UMIN000011236	2011/05/02	20/07/2013	Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -	Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission - - Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation	Ulcerative colitis	Upon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding.	Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine	NULL	Complete: follow-up complete	15years-old	65years-old	Male and Female	200	Not selected	Japan
1289	JPRN-UMIN000005358	2011/04/01	01/04/2011	Rapid LeukocyAPheresis InDuction for Ulcerative Colitis	Rapid LeukocyAPheresis InDuction for Ulcerative Colitis - RAPID-UC	ulcerative colitis	LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days. LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days.	Lower Gastroenterology, Hyogo College of Medicine	Department of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical College	Complete: follow-up complete	12years-old	81years-old	Male and Female	40	Phase 2,3	Japan
1290	JPRN-UMIN000005033	2011/03/01	01/03/2011	Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis	Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis - Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis	ulcerative colitis	Patients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks)) Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week.	Saitama Medical Center, Saitama Medical University	NULL	Complete: follow-up complete	12years-old	75years-old	Male and Female	50	Not applicable	Japan
1291	EUCTR2010-019558-42-SK (EUCTR)	23/02/2011	27/10/2010	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept	Biogen Idec Ltd.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Hungary;Czech Republic;Slovakia;Belgium
1292	EUCTR2010-023494-19-SE (EUCTR)	10/02/2011	27/12/2010	A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis	A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis	Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Lysine-D-Proline-Threonine Product Code: K(D)PT	Dr. August Wolff GmbH & Co. KG Arzneimittel	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	Sweden
1293	EUCTR2010-019970-33-GB (EUCTR)	01/02/2011	13/10/2010		A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis -	Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: KRP203A Product Code: KRP203A Product Code: KRP203A	Novartis Services AG	NULL	Not Recruiting			Female: yes Male: yes	80		Hungary;Germany;United Kingdom;Belgium;Sweden
1294	EUCTR2010-019558-42-HU (EUCTR)	20/01/2011	10/11/2010	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept	Biogen Idec Ltd.	NULL	Not Recruiting			Female: yes Male: yes	100		Hungary;Czech Republic;Belgium
1295	EUCTR2010-019558-42-CZ (EUCTR)	10/01/2011	25/10/2010	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept	Biogen Idec Ltd.	NULL	Not Recruiting			Female: yes Male: yes	100		Hungary;Czech Republic;Belgium
1296	EUCTR2010-019558-42-BE (EUCTR)	23/12/2010	13/10/2010	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Baminercept Product Code: BG9924 INN or Proposed INN: N/A Other descriptive name: Baminercept	Biogen Idec Ltd.	NULL	Not Recruiting			Female: yes Male: yes	100		Hungary;Czech Republic;Belgium
1297	EUCTR2010-019970-33-DE (EUCTR)	22/12/2010	15/10/2010		A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis -	Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: KRP203 Product Code: KRP203 Product Name: KRP203 Product Code: KRP203 Product Name: KRP203 Product Code: KRP203	Novartis Services AG	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;United Kingdom;Germany;Belgium;Sweden
1298	EUCTR2010-020448-37-BE (EUCTR)	10/12/2010	22/12/2010	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE	Enceladus Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Belgium;Netherlands
1299	EUCTR2010-019970-33-BE (EUCTR)	07/12/2010	20/09/2010	A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis	A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Product Code: KRP203A Product Code: KRP203A Product Code: KRP203A	Novartis Services AG	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 2	Hungary;Belgium;Germany;United Kingdom;Sweden
1300	NCT01375179 (ClinicalTrials.gov)	December 2010	12/5/2011	Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients	A Multi-centre, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of KRP203 in Subjects With Moderately Active Refractory Ulcerative Colitis	Ulcerative Colitis	Drug: KRP203;Drug: Placebo matching KRP203	Novartis Pharmaceuticals	NULL	Terminated	18 Years	65 Years	All	27	Phase 2	Belgium;Germany;Hungary;Sweden;Switzerland;United Kingdom
1301	EUCTR2010-019970-33-HU (EUCTR)	11/11/2010	07/09/2010		A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis -	Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: n.a. Product Code: KRP203A Product Name: n.a Product Code: KRP203A Product Name: n.a Product Code: KRP203A	Novartis Services AG	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Germany;United Kingdom;Belgium;Sweden
1302	EUCTR2009-017044-13-DE (EUCTR)	03/11/2010	16/06/2010	A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development Inc	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
1303	NCT01257399 (ClinicalTrials.gov)	November 2010	8/12/2010	Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase	Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase	Ulcerative Colitis in Remission	Drug: Asacol®;Drug: Mesalazine	Tillotts Pharma AG	Zeria Pharmaceutical	Completed	18 Years	64 Years	Both	251	Phase 3	China
1304	NCT01257386 (ClinicalTrials.gov)	November 2010	8/12/2010	Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis	Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis	Active Ulcerative Colitis	Drug: Asacol®;Drug: Mesalazine	Tillotts Pharma AG	Zeria Pharmaceutical	Completed	18 Years	64 Years	Both	251	Phase 3	China
1305	EUCTR2010-019970-33-SE (EUCTR)	29/10/2010	10/09/2010	A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis	A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis	Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: KRP203 Product Code: KRP203A Product Name: KRP203 Product Code: KRP203A Product Name: KRP203 Product Code: KRP203A	Novartis Services AG	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Belgium;Germany;United Kingdom;Sweden
1306	EUCTR2009-017044-13-BE (EUCTR)	14/09/2010	06/05/2010	A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany
1307	NCT01221428 (ClinicalTrials.gov)	September 2010	14/10/2010	Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis	Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis	Ulcerative Colitis;Mesenchymal Stem Cells;Umbilical Cord	Biological: Umbilical Cord Mesenchymal Stem Cells	Qingdao University	NULL	Active, not recruiting	18 Years	70 Years	Both	50	Phase 1/Phase 2	China
1308	EUCTR2009-017044-13-IE (EUCTR)	10/08/2010	20/04/2010	A study to Evaluate the Ability to Maintain Clinical andEndoscopic Remission During a 12-Month period with 2.4g/day of druggiven once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
1309	EUCTR2009-017044-13-CZ (EUCTR)	05/08/2010	28/05/2010	A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic
1310	EUCTR2009-017044-13-FR (EUCTR)	27/07/2010	22/06/2010	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development Inc	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom
1311	EUCTR2009-017044-13-HU (EUCTR)	21/07/2010	26/04/2010	A Study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
1312	JPRN-UMIN000003952	2010/07/01	26/07/2010	A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis	A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis - Oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis	ulcerative colitis	Fasting condition group: Tacrolimus ingestion 1 hour before meal Fed condition group: Tacrolimus ingestion immediately following consumption of meal	Department of lower gastroenterology, Hyogo College of Medicine	Osaka Medical CollegeOsaka City University	Complete: follow-up complete	16years-old	Not applicable	Male and Female	40	Phase 4	Japan
1313	NCT01216280 (ClinicalTrials.gov)	July 2010	2/9/2010	Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis	Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis	Ulcerative Colitis	Drug: placebo capsule;Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule;Drug: 2 x 10 mg Natura-alpha capsules	Natrogen Therapeutics International, Inc	NULL	Active, not recruiting	18 Years	70 Years	Both	75	Phase 2	United States
1314	EUCTR2009-017044-13-GB (EUCTR)	30/06/2010	17/03/2010	A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany
1315	EUCTR2009-017044-13-ES (EUCTR)	25/06/2010	19/04/2010	Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis	Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis	Colitis UlcerosaUlcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development Inc.	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom
1316	EUCTR2009-013890-16-PT (EUCTR)	28/05/2010	21/12/2009	Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica	Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica	This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy.Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients. MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856	Trade Name: Remicade Product Name: Remicade	GEDII - Grupo de Estudo da Doença inflamatória Intestinal	NULL	Not Recruiting			Female: yes Male: yes	20		Portugal
1317	EUCTR2006-003398-28-CZ (EUCTR)	24/05/2010	10/02/2010	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2/3	France;Hungary;Czech Republic;Belgium;Lithuania;Denmark;Austria;Bulgaria;Netherlands;Latvia;Germany;Sweden
1318	EUCTR2006-003399-37-CZ (EUCTR)	24/05/2010	10/02/2010	A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1228	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden
1319	EUCTR2009-017839-18-DE (EUCTR)	14/05/2010	16/02/2010	A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS	A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS	Active mild-to-moderate distal ulcerative colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex)	PurGenesis Techonologies Inc.	NULL	Not Recruiting			Female: yes Male: yes	56		Germany
1320	EUCTR2008-005903-25-BG (EUCTR)	23/04/2010	14/04/2010	Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)	Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)	inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS	Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon	4SC AG	NULL	Not Recruiting			Female: yes Male: yes	24		Germany;Bulgaria
1321	NCT00572585 (ClinicalTrials.gov)	April 2010	12/12/2007	Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis	A Randomized, Double Blind, Placebo Controlled, Parallel Group Design Study to Explore the Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: AEB071;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	60	Phase 2	United States;Denmark;Germany;Poland
1322	EUCTR2008-002784-14-GB (EUCTR)	26/03/2010	28/06/2010	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Serbia;Estonia;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1323	EUCTR2008-003169-19-GB (EUCTR)	04/03/2010	17/09/2009	A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: CyCol Product Code: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN)	Sigmoid Pharma Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Ireland;United Kingdom
1324	EUCTR2008-002784-14-SE (EUCTR)	12/02/2010	23/01/2009	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1325	NCT01065571 (ClinicalTrials.gov)	January 2010	4/2/2010	Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity	Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity	Ulcerative Colitis	Dietary Supplement: carrageenan;Other: dietary intervention with no-carrageenan diet	University of Illinois at Chicago	The Broad Foundation;University of Chicago	Completed	18 Years	N/A	All	15	N/A	United States
1326	EUCTR2008-002782-32-DK (EUCTR)	18/12/2009	06/11/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1327	NCT01011322 (ClinicalTrials.gov)	December 2009	10/11/2009	A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis		Ulcerative Colitis;Large Intestine;Diarrhea;Abdominal Pain	Drug: LT-02;Drug: placebo	Lipid Therapeutics GmbH	NULL	Active, not recruiting	18 Years	N/A	Both	156	Phase 2	Germany;Lithuania;Romania
1328	EUCTR2008-007952-90-LT (EUCTR)	23/11/2009	15/09/2009	A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis.	A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis.	Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit. MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine	Lipid Therapeutics GmbH	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 2	Germany;Lithuania
1329	EUCTR2009-015077-12-GB (EUCTR)	23/11/2009	17/09/2009	The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia	The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia	chronic ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Budenofalk 2mg rectal foam Product Name: Budenofalk rectal foam	University Hospital Birmingham NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	50	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1330	EUCTR2009-015136-14-BE (EUCTR)	20/11/2009	12/10/2009	Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study	Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study	Pouchitis MedDRA version: 12.0;Level: LLT;Classification code 10036463;Term: Pouchitis	Product Name: Metronidazole capsule 50 mg Product Code: FP-110 INN or Proposed INN: Metronidazole Trade Name: Flagyl INN or Proposed INN: Metronidazole	FORMAC Pharmaceuticals NV	NULL	Not Recruiting			Female: yes Male: yes			Belgium
1331	EUCTR2008-007952-90-DE (EUCTR)	17/11/2009	04/08/2009	A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010	A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010	Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit. MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine	Lipid Therapeutics GmbH	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Germany;Lithuania
1332	EUCTR2008-003169-19-IE (EUCTR)	09/11/2009	05/06/2008	A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN) Product Name: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN)	Sigmoid Pharma Ltd	NULL	Not Recruiting			Female: yes Male: yes	0		United Kingdom;Ireland
1333	NCT01020708 (ClinicalTrials.gov)	November 2009	20/11/2009	Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis	A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis	Ulcerative Colitis	Drug: mesalamine;Drug: ALTH12-1:4;Drug: ALTH12-2:4	Altheus Therapeutics, Inc.	NULL	Completed	18 Years	64 Years	Both	9	Phase 1	United States
1334	NCT01059344 (ClinicalTrials.gov)	November 2009	28/1/2010	Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis	A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis	Ulcerative Colitis	Drug: Mesalamin	Tillotts Pharma AG	NULL	Completed	18 Years	N/A	All	281	Phase 3	Belarus;India;Turkey;Ukraine
1335	NCT00984568 (ClinicalTrials.gov)	November 2009	24/9/2009	Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)	Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study	Colitis, Ulcerative	Biological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: Azathioprine	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	N/A	All	28	Phase 3	Germany
1336	EUCTR2007-004157-28-SE (EUCTR)	22/10/2009	06/05/2009	Long-term open-label safety and efficacy study of Adalimumab in subjectswith Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden
1337	EUCTR2009-015649-21-NO (EUCTR)	21/10/2009	16/09/2009	Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.	Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab.	Ulcerative colitis	Trade Name: Dekristol Product Name: cholecalciferol Product Code: na	Medical clinic, University Hospital of North Norway	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200		Norway
1338	NCT03747068 (ClinicalTrials.gov)	October 9, 2009	12/11/2018	The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.	Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis	Ulcerative Colitis;Anti TNF Therapy;Ileal Pouch Anal Anastomosis (IPAA)	Drug: Anti-TNF Drug	HaEmek Medical Center, Israel	Mount Sinai Hospital, Canada;University of Toronto	Completed	N/A	N/A	All	130		NULL
1339	EUCTR2009-011608-51-DE (EUCTR)	09/10/2009	21/07/2009	A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis	A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686	GlaxoSmithKline Research and Development Ltd.	NULL	Not Recruiting			Female: yes Male: yes	60		Germany;Sweden
1340	EUCTR2004-004184-29-DK (EUCTR)	10/09/2009	10/10/2007	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	830	Phase 3	Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
1341	EUCTR2008-002784-14-DE (EUCTR)	02/09/2009	02/06/2009	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 17.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden;Greece;Spain;Ukraine;Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia
1342	NCT01036022 (ClinicalTrials.gov)	September 1, 2009	17/12/2009	Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis	A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis	Colitis, Ulcerative	Drug: GSK1399686	GlaxoSmithKline	NULL	Completed	18 Years	65 Years	All	120	Phase 2	Belgium;Canada;Germany;Norway;Sweden
1343	EUCTR2008-002782-32-DE (EUCTR)	24/08/2009	23/04/2009	Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	995	Phase 3	Portugal;Serbia;Taiwan;Estonia;Hong Kong;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand
1344	EUCTR2009-010065-23-DE (EUCTR)	17/08/2009	14/04/2009	Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX	Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX	Active Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: 100 Trade Name: Pentasa 500 mg Retardtabletten Product Name: 5-Aminosalicylic acid (5-ASA) INN or Proposed INN: 5-Aminosalicylic acid Trade Name: Imurek 25mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Imurek 50mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Decortin H 1 mg INN or Proposed INN: prednisolone Trade Name: Decortin H 5mg INN or Proposed INN: prednisolone Trade Name: Decortin H 10mg INN or Proposed INN: prednisolone Trade Name: Decortin H 20mg INN or Proposed INN: prednisolone Trade Name: Decortin H 50 mg INN or Proposed INN: prednisolone	Essex Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Germany
1345	EUCTR2009-011608-51-SE (EUCTR)	17/08/2009	22/06/2009	A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis	A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686	GlaxoSmithKline Research and Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	60		Germany;Sweden
1346	EUCTR2008-002782-32-AT (EUCTR)	13/08/2009	28/10/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB Other descriptive name: LDP-02	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1347	EUCTR2008-002784-14-AT (EUCTR)	13/08/2009	28/10/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1348	EUCTR2009-011608-51-BE (EUCTR)	03/08/2009	23/06/2009	A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis	A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686	GlaxoSmithKline Research and Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Belgium;Germany;Sweden
1349	EUCTR2007-003815-30-PT (EUCTR)	31/07/2009	05/03/2009	An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis	An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis	Mild or Moderately Active Steroid Dependent Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Trade Name: Dacortin Product Name: prednisone INN or Proposed INN: Prednisone INN or Proposed INN: Prednisone Trade Name: Dacortin Product Name: prednisone Product Code: H02AB INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE	GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)	NULL	Not Recruiting			Female: yes Male: yes			Portugal;Spain
1350	EUCTR2008-002784-14-IT (EUCTR)	22/07/2009	17/03/2009	A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND	A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND	Patients with Ulcerative Colitis (UC) and Crohn?s Disease (CD) MedDRA version: 9.1;Level: LLT;Classification code 10045282 MedDRA version: 9.1;Level: PT;Classification code 10011401	Product Name: Vedolizumab Product Code: MLN0002	MILLENNIUM PHARMACEUTICALS, INC.	NULL	Not Recruiting			Female: yes Male: yes	1508	Phase 3	Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1351	EUCTR2008-002782-32-IT (EUCTR)	22/07/2009	22/01/2009	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis - ND	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis - ND	Patients with Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab	MILLENNIUM PHARMACEUTICALS, INC.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1352	EUCTR2008-002782-32-GB (EUCTR)	20/07/2009	27/11/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1353	EUCTR2008-002782-32-CZ (EUCTR)	13/07/2009	31/10/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1354	NCT01149694 (ClinicalTrials.gov)	June 2009	22/6/2010	A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers	A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers	Ulcerative Colitis	Drug: PUR 0110 Rectal Enema or Placebo Enema	PurGenesis Technologies Inc.	NULL	Completed	18 Years	55 Years	Male	24	Phase 1	Germany
1355	EUCTR2007-004867-22-SK (EUCTR)	25/05/2009	28/05/2009	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Avonex Product Name: Avonex	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Czech Republic;Hungary;Slovakia
1356	EUCTR2008-003913-28-IT (EUCTR)	25/05/2009	16/04/2009	Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND	Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND	Mild to moderate ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide	COSMO TECHNOLOGIES LTD	NULL	Not Recruiting			Female: yes Male: yes	150		Italy
1357	EUCTR2008-004564-40-GB (EUCTR)	20/05/2009	14/10/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
1358	EUCTR2008-002784-14-EE (EUCTR)	28/04/2009	27/10/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia
1359	EUCTR2006-003607-40-FI (EUCTR)	23/04/2009	26/02/2009	METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEBO IN THE REMISSION OF STEROID-DEPENDENT ULCERATIVE COLITIS - METEOR	METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEBO IN THE REMISSION OF STEROID-DEPENDENT ULCERATIVE COLITIS - METEOR	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Trexan inj 25 mg/ml INN or Proposed INN: Methotrexate	GETAID, Jean Minjoz Hospital	NULL	Not Recruiting			Female: yes Male: yes	110		Finland;Belgium;Austria;Netherlands
1360	EUCTR2008-002784-14-BE (EUCTR)	21/04/2009	14/11/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1361	EUCTR2008-002784-14-HU (EUCTR)	20/04/2009	27/10/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1362	EUCTR2008-007519-34-SE (EUCTR)	17/04/2009	02/03/2009	Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION	Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION	This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with	Trade Name: Remicade	University of Leuven Hospitals, Division of Gastroenterology	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 4	Sweden
1363	EUCTR2008-002782-32-HU (EUCTR)	14/04/2009	27/10/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1364	EUCTR2008-002784-14-GR (EUCTR)	07/04/2009	05/11/2009	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1508	Phase 3	Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1365	EUCTR2008-002782-32-GR (EUCTR)	07/04/2009	05/11/2009	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1366	EUCTR2008-004610-27-SK (EUCTR)	06/04/2009	09/02/2009	A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine	Palau Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Slovakia;Spain;Belgium
1367	EUCTR2008-002784-14-ES (EUCTR)	02/04/2009	18/11/2008	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC)	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC)	Ulcerative Colitis and Crohn?s DiseaseColitis ulcerosa (CU) y enfermedad de Crohn (EC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1508	Phase 3	Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1368	EUCTR2008-007292-25-IT (EUCTR)	24/03/2009	16/03/2009	AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08	AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08	Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure) MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis	Trade Name: MEZAVANT INN or Proposed INN: Mesalazine Trade Name: ASACOL INN or Proposed INN: Mesalazine	GIULIANI	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Italy
1369	EUCTR2008-004564-40-NL (EUCTR)	24/03/2009	11/11/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden
1370	EUCTR2008-002784-14-FR (EUCTR)	23/03/2009	14/11/2008	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1508	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1371	EUCTR2008-000045-59-GB (EUCTR)	17/03/2009	15/07/2008	Multicentre, controlled, randomized, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis. - MOTUS	Multicentre, controlled, randomized, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis. - MOTUS	Patients with mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode	Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE	Ferring Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	398		United Kingdom;Netherlands;Belgium;France
1372	EUCTR2007-004157-28-PT (EUCTR)	17/03/2009	12/12/2008	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
1373	EUCTR2008-002782-32-FR (EUCTR)	13/03/2009	14/11/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1374	EUCTR2008-002782-32-PT (EUCTR)	09/03/2009	06/11/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1375	EUCTR2008-002784-14-PT (EUCTR)	06/03/2009	06/11/2008	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1508	Phase 3	Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
1376	EUCTR2008-002782-32-ES (EUCTR)	02/03/2009	23/10/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave	Moderate to Severe Ulcerative ColitisColitis ulcerosa moderada o grave MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1377	EUCTR2008-004610-27-HU (EUCTR)	26/02/2009	15/12/2008	A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine	Palau Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Belgium;Spain
1378	EUCTR2008-002784-14-CZ (EUCTR)	20/02/2009	31/10/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1379	EUCTR2008-002784-14-NL (EUCTR)	18/02/2009	05/11/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1380	EUCTR2008-002782-32-NL (EUCTR)	18/02/2009	05/11/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Netherlands;Latvia;Iceland
1381	EUCTR2008-002782-32-BE (EUCTR)	08/02/2009	14/11/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1382	EUCTR2008-004564-40-CZ (EUCTR)	05/02/2009	23/01/2009	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Slovakia;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Sweden
1383	EUCTR2008-002783-33-AT (EUCTR)	29/01/2009	28/10/2008	Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Crohn's Disease MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1060	Phase 3	Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden
1384	EUCTR2008-002782-32-MT (EUCTR)	28/01/2009	02/02/2009	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Iceland;Malta;Denmark;Belgium;Estonia;Spain;Greece
1385	EUCTR2008-002783-33-MT (EUCTR)	28/01/2009	25/11/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1060	Phase 3	Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Belgium;Malta;Denmark;Estonia;Spain;Greece
1386	EUCTR2008-002784-14-MT (EUCTR)	28/01/2009	25/11/2008	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1508	Phase 3	Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Malta;Belgium;Estonia;Spain;Greece
1387	EUCTR2008-002784-14-IS (EUCTR)	27/01/2009	06/11/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients WithUlcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd	NULL	Not Recruiting			Female: yes Male: yes	1508	Phase 3	Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden
1388	EUCTR2008-004564-40-FR (EUCTR)	26/01/2009	16/03/2009	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden
1389	EUCTR2008-004564-40-IT (EUCTR)	23/01/2009	29/09/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC	Product Name: CP-690,550 Product Name: CP-690,550 Product Name: CP-690,550	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
1390	EUCTR2008-002784-14-BG (EUCTR)	16/01/2009	12/01/2009	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1391	EUCTR2008-004564-40-SE (EUCTR)	16/01/2009	01/10/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
1392	EUCTR2008-002784-14-SK (EUCTR)	15/01/2009	28/10/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1393	EUCTR2008-004564-40-BE (EUCTR)	13/01/2009	14/11/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
1394	EUCTR2008-002784-14-IE (EUCTR)	09/01/2009	28/10/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden
1395	EUCTR2008-002782-32-IE (EUCTR)	09/01/2009	28/10/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1396	EUCTR2008-002782-32-EE (EUCTR)	09/01/2009	24/10/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1397	EUCTR2008-002782-32-IS (EUCTR)	09/01/2009	06/11/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Iceland;Latvia;Netherlands
1398	EUCTR2008-002782-32-BG (EUCTR)	08/01/2009	12/01/2009	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1399	EUCTR2008-005903-25-DE (EUCTR)	08/01/2009	03/11/2008	Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)	Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis)	inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS	Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon	4SC AG	NULL	Not Recruiting			Female: yes Male: yes	35		Bulgaria;Germany
1400	JPRN-UMIN000008967	2009/01/01	24/09/2012	Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis	Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis - Efficacy of Polaprezinc enema in UC	Ulcerative Colitis	Polaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week Placebo group: 100 mL tap water enema daily for one week	The Jikei University School of MedicineDivision of Gastroenterology and Hepatology	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	30	Not applicable	Japan
1401	EUCTR2008-000045-59-BE (EUCTR)	23/12/2008	22/09/2008	Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS	Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS	Patients with mild to moderate ulcerative colitis	Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE	Ferring SAS	NULL	Not Recruiting			Female: yes Male: yes	398	Phase 3	France;Belgium;Netherlands;United Kingdom
1402	EUCTR2008-002782-32-LV (EUCTR)	19/12/2008	31/10/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
1403	EUCTR2008-002784-14-LV (EUCTR)	19/12/2008	31/10/2008	An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Takeda Development Centre Europe Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2200	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden
1404	EUCTR2008-004564-40-ES (EUCTR)	15/12/2008	17/10/2008	ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP 690,550 EN SUJETOS CON COLITIS ULCEROSA DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP 690,550 EN SUJETOS CON COLITIS ULCEROSA DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP 690,550 es un fármaco en desarrollo para el tratamiento de los pacientes con colitis ulcerosa de moderada a grave.CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer S.A	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden
1405	EUCTR2007-004157-28-NL (EUCTR)	09/12/2008	10/12/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
1406	EUCTR2008-004610-27-BE (EUCTR)	02/12/2008	24/07/2008	A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine	Palau Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Belgium;Spain
1407	EUCTR2008-004610-27-ES (EUCTR)	25/11/2008	26/09/2008	Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Dersalazina sodica INN or Proposed INN: dersalazine sodium Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE	Palau Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Slovakia;Belgium;Spain
1408	EUCTR2008-004564-40-HU (EUCTR)	20/11/2008	17/10/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	200		Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
1409	EUCTR2006-003607-40-NL (EUCTR)	13/11/2008	13/08/2008	A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR	A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR	Steroid-dependent ulcerative colitis	Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml	Besancon University Hospital	NULL	Not Recruiting			Female: yes Male: yes	110		Finland;Netherlands;Austria
1410	EUCTR2008-004564-40-SK (EUCTR)	11/11/2008	24/10/2008	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden
1411	NCT00793130 (ClinicalTrials.gov)	November 2008	16/11/2008	The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label	The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label	Ulcerative Colitis	Dietary Supplement: Coltect	Tel-Aviv Sourasky Medical Center	NULL	Recruiting	18 Years	75 Years	Both	30	N/A	Israel
1412	NCT00737789 (ClinicalTrials.gov)	November 2008	19/8/2008	Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.	Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.	Ulcerative Colitis	Drug: Mesalazine slow-release granules;Drug: Mesalazine liquid enema	Ferring Pharmaceuticals	NULL	Completed	18 Years	N/A	Both	206	Phase 3	Belgium;France;Netherlands;United Kingdom
1413	EUCTR2006-003397-94-SE (EUCTR)	23/10/2008	21/12/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden
1414	EUCTR2007-002544-25-CZ (EUCTR)	21/10/2008	07/01/2008	A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis	A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis	Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: MDX-1100 Product Code: MDX-1100	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	106	Phase 2	Hungary;Czech Republic;Latvia
1415	EUCTR2006-004776-12-IT (EUCTR)	15/10/2008	20/03/2009	Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02	Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02	Patients with mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide Trade Name: ENTOCORT CR INN or Proposed INN: Budesonide Product Name: Budesonide MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide	COSMO TECHNOLOGIES LTD	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
1416	EUCTR2007-004867-22-CZ (EUCTR)	07/10/2008	26/02/2008	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Avonex Product Name: Avonex	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	120		Hungary;Czech Republic
1417	EUCTR2008-000045-59-NL (EUCTR)	06/10/2008	13/08/2008	Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS	Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS	Patients with mild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode	Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE	Ferring SAS	NULL	Not Recruiting			Female: yes Male: yes	398		United Kingdom;Netherlands;Belgium;France
1418	EUCTR2007-005520-32-NL (EUCTR)	01/10/2008	05/08/2008	An open label, 7-day repeat dose study to evaluate the pharmacodynamics of SB-656933-AAA in patients with Ulcerative Colitis.	An open label, 7-day repeat dose study to evaluate the pharmacodynamics of SB-656933-AAA in patients with Ulcerative Colitis.	ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: SB-656933 Tablets Product Code: SB-656933	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes			Netherlands
1419	JPRN-UMIN000048515	2008/10/01	31/07/2022	A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients	A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients - A comparative trial between antibiotic combination therapy and steroid therapy for ulcerative colitis patients	Ulcerative colitis	14 days oral intake of amoxicillin 1500 mg/day, tetracycline 1500 mg/day and metronidazole 750 mg/day	Juntendo University	NULL	Complete: follow-up continuing	18years-old	Not applicable	Male and Female	350	Not selected	Japan
1420	NCT00751933 (ClinicalTrials.gov)	October 2008	11/9/2008	Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis	A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis.	Ulcerative Colitis	Biological: Vaccine Vivotif + Vaccine Dukoral + oats;Biological: Vaccine Vivotif + Vaccine Dukoral;Dietary Supplement: Oats;Other: Placebo	Haukeland University Hospital	Helse Vest	Terminated	18 Years	80 Years	All	3	Phase 2	Norway
1421	EUCTR2006-003398-28-DK (EUCTR)	25/09/2008	04/12/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Belgium;Denmark;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1422	EUCTR2006-003399-37-DK (EUCTR)	25/09/2008	10/12/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
1423	EUCTR2006-004776-12-SK (EUCTR)	18/09/2008	16/07/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden
1424	EUCTR2008-000967-40-SE (EUCTR)	29/08/2008	04/06/2008	A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis	A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis	Moderately Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011	ActoGeniX NV.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Netherlands;Belgium;Sweden
1425	EUCTR2008-001968-36-GB (EUCTR)	27/08/2008	15/07/2008	Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT	Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT	Acute severe steroid resistant ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders	Trade Name: Remicade Trade Name: Sandimmun Trade Name: Neoral Soft Gelatin Capsules	Swansea University	NULL	Not Recruiting			Female: yes Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Kingdom
1426	EUCTR2006-003398-28-SE (EUCTR)	26/08/2008	21/12/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden
1427	EUCTR2006-003399-37-SE (EUCTR)	26/08/2008	21/12/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
1428	EUCTR2007-004157-28-DE (EUCTR)	07/08/2008	25/03/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden
1429	EUCTR2007-004157-28-SK (EUCTR)	04/08/2008	09/04/2008	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
1430	EUCTR2006-004776-12-EE (EUCTR)	04/08/2008	11/06/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;France;Estonia;Italy;Latvia;Lithuania;Sweden
1431	EUCTR2007-005166-12-DE (EUCTR)	29/07/2008	15/01/2008	A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine	A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine	active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract)	Hutchison MediPharma Enterprises Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Germany
1432	EUCTR2006-004776-12-GB (EUCTR)	23/07/2008	25/04/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden
1433	EUCTR2007-004157-28-FR (EUCTR)	10/07/2008	14/04/2008	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	800	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
1434	EUCTR2007-004157-28-HU (EUCTR)	09/07/2008	28/03/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden;Portugal;Slovakia
1435	EUCTR2006-004776-12-BE (EUCTR)	01/07/2008	18/06/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
1436	EUCTR2005-003471-20-LT (EUCTR)	26/06/2008	12/02/2008	Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment	Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment	Ulcerative Colitis MedDRA version: 9.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Propionyl-L-carnitine Product Code: ST261 INN or Proposed INN: Propionyl-L-Carnitine	SIGMA-TAU	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Italy;Lithuania
1437	EUCTR2007-004157-28-BE (EUCTR)	23/06/2008	13/12/2007	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Germany;Norway;New Zealand;Sweden;Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands
1438	EUCTR2007-004867-22-HU (EUCTR)	18/06/2008	21/02/2008	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.	Moderate to Severe Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Avonex Product Name: Avonex	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	120		Hungary;Czech Republic
1439	EUCTR2007-004157-28-IT (EUCTR)	17/06/2008	01/10/2008	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Ulcerative Colitis - ND	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Ulcerative Colitis - ND	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	800	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden
1440	EUCTR2006-004776-12-LT (EUCTR)	17/06/2008	22/04/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Sweden;Lithuania
1441	EUCTR2008-000967-40-BE (EUCTR)	13/06/2008	05/08/2008	A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis	A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis	Moderately Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011	ActoGeniX N.V	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Netherlands;Belgium;Sweden
1442	EUCTR2006-002670-22-GB (EUCTR)	11/06/2008	01/08/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
1443	EUCTR2006-003398-28-BG (EUCTR)	10/06/2008	30/04/2008	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania
1444	EUCTR2007-004157-28-CZ (EUCTR)	09/06/2008	10/04/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 17.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
1445	EUCTR2008-000045-59-FR (EUCTR)	04/06/2008	22/04/2008	Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS	Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS	Patients with mild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode	Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE	Ferring SAS	NULL	Not Recruiting			Female: yes Male: yes	398	Phase 3	France;Belgium;Netherlands;United Kingdom
1446	EUCTR2007-007928-18-DE (EUCTR)	04/06/2008	12/11/2008	Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU	Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU	ulcerative colitis patients in clinical remission MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Myrrhinil-Intest® INN or Proposed INN: MATRICARIA FLOWER Other descriptive name: MATRICARIA FLOWER INN or Proposed INN: MYRRH Other descriptive name: MYRRH INN or Proposed INN: COFFEE COAL Other descriptive name: COFFEE COAL Trade Name: Salofalk® 500mg INN or Proposed INN: MESALAZINE	REPHA GmbH	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Germany
1447	EUCTR2006-004776-12-SE (EUCTR)	02/06/2008	10/04/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
1448	EUCTR2006-003397-94-BG (EUCTR)	30/05/2008	30/04/2008	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Germany;Netherlands;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania
1449	EUCTR2006-003399-37-BG (EUCTR)	30/05/2008	30/04/2008	A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1228	Phase 3	United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden
1450	EUCTR2006-004776-12-LV (EUCTR)	29/05/2008	29/04/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
1451	EUCTR2007-002544-25-LV (EUCTR)	29/05/2008	18/02/2008	A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis	A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis	Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: MDX-1100 Product Code: MDX-1100	Bristol-Myers Squibb Company	NULL	Not Recruiting			Female: yes Male: yes	106	Phase 2	Hungary;Czech Republic;Latvia
1452	EUCTR2007-002544-25-HU (EUCTR)	23/05/2008	07/01/2008	A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis	A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis	Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: MDX-1100 Product Code: MDX-1100	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	106	Phase 2	Hungary;Czech Republic;Latvia
1453	EUCTR2006-002781-20-SE (EUCTR)	23/05/2008	04/03/2008	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	575		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
1454	EUCTR2007-004732-23-PL (EUCTR)	05/05/2008	12/05/2008	A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)	A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)	Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative	Product Name: Mesalamine INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE	EMET Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	435		Estonia;Latvia;Poland
1455	EUCTR2007-004157-28-AT (EUCTR)	30/04/2008	08/04/2008	Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis.	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	592	Phase 3	Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden
1456	EUCTR2008-001467-10-GB (EUCTR)	30/04/2008	28/03/2008		Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3	Ulcerative colitis - in remissionCrohn's Disease - in remission MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease	Trade Name: Vigantol Oel Product Name: Vigantol Oel TM	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom
1457	EUCTR2007-006692-37-GB (EUCTR)	10/04/2008	25/01/2008	The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit	The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit	IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Vigantol Oel Product Name: Vigantol Oel TM	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1458	EUCTR2007-007702-30-IT (EUCTR)	03/04/2008	08/07/2008	Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND	Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND	Ulcerative colitis MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	COSMO TECHNOLOGIES LTD	NULL	Not Recruiting			Female: no Male: yes			Italy
1459	EUCTR2006-002782-40-AT (EUCTR)	16/03/2008	20/03/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria
1460	EUCTR2006-003604-19-PL (EUCTR)	27/02/2008	07/11/2007	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date 06-Dec-2006), 03 (Version 1.0, Date 05-Mar-2007) and Administrative Letter 01.	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date 06-Dec-2006), 03 (Version 1.0, Date 05-Mar-2007) and Administrative Letter 01.	ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	978	Phase 3	Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland
1461	EUCTR2007-004732-23-LV (EUCTR)	27/02/2008	28/02/2008	A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis	A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis	Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE	EMET Pharmaceuticals LLC	NULL	Not Recruiting			Female: yes Male: yes	435		Estonia;Latvia;Poland
1462	EUCTR2006-002781-20-AT (EUCTR)	27/02/2008	23/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	475		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
1463	EUCTR2006-005299-42-FI (EUCTR)	25/02/2008	27/12/2007	A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY	A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY	Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Neoral INN or Proposed INN: CICLOSPORIN Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten INN or Proposed INN: INFLIXIMAB	Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)	NULL	Not Recruiting			Female: yes Male: yes	100		France;Finland;Belgium;Spain
1464	EUCTR2006-002782-40-DE (EUCTR)	20/02/2008	18/04/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;Hungary;Czech Republic;Germany;Denmark;France;Austria
1465	EUCTR2006-002670-22-SK (EUCTR)	08/02/2008	15/04/2008	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
1466	EUCTR2006-003399-37-LT (EUCTR)	29/01/2008	30/08/2007	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1467	EUCTR2006-003397-94-LT (EUCTR)	29/01/2008	30/08/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1468	EUCTR2006-003398-28-LT (EUCTR)	29/01/2008	30/08/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1469	EUCTR2006-003398-28-NL (EUCTR)	17/01/2008	08/10/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1470	EUCTR2006-003397-94-NL (EUCTR)	17/01/2008	07/08/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1471	EUCTR2006-003399-37-NL (EUCTR)	17/01/2008	08/10/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics BV	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
1472	EUCTR2004-004184-29-NL (EUCTR)	15/01/2008	17/10/2007	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Czech Republic;Hungary;Spain;Denmark;Germany;Netherlands;United Kingdom;Sweden
1473	EUCTR2006-004230-32-BE (EUCTR)	21/12/2007	04/12/2007	Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study	Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study	Ulcerative colitis extending proximally beyond the rectum. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Clipper 30 cpr 5mg R.M. INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene 20 cpr 5mg INN or Proposed INN: PREDNISONE Trade Name: Deltacortene 10 cpr 25mg INN or Proposed INN: PREDNISONE	CHIESI Farmaceutici S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	300		Belgium;Spain;Italy;Poland
1474	EUCTR2004-004184-29-PT (EUCTR)	14/12/2007	11/10/2007	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
1475	EUCTR2006-005377-22-ES (EUCTR)	12/12/2007	29/10/2007	Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa	Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa	Tratamiento de colitis ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany
1476	EUCTR2006-003398-28-BE (EUCTR)	10/12/2007	18/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1477	EUCTR2006-004230-32-PL (EUCTR)	07/12/2007	05/09/2007	EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study	EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study	Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Clipper INN or Proposed INN: Beclomethasone diproprionate Trade Name: Deltacortene INN or Proposed INN: Prednisone Trade Name: Deltacortene INN or Proposed INN: Prednisone	Chiesi Farmaceutici SpA	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Belgium;Spain;Poland;Italy
1478	EUCTR2007-002542-38-DK (EUCTR)	28/11/2007	08/11/2007	A clinical study to explore the safe and effective use of the drug sotrastaurin in patients with ulcerative colitis	A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. - A2210	Ulcerative colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Sotrastaurin Product Code: AEB071 INN or Proposed INN: Sotrastaurin (INN) acetate Product Name: Vitamin B2 INN or Proposed INN: Riboflavin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Denmark;Germany
1479	NCT00573794 (ClinicalTrials.gov)	November 28, 2007	12/12/2007	Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis	A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis	Ulcerative Colitis	Biological: adalimumab	AbbVie (prior sponsor, Abbott)	NULL	Completed	18 Years	N/A	All	592	Phase 3	Australia;Austria;Belgium;Canada;Czech Republic;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Poland;Puerto Rico;Slovakia;Spain;Sweden;Switzerland;United States
1480	EUCTR2006-002670-22-IT (EUCTR)	27/11/2007	04/10/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)	moderately to severely active Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remicade INN or Proposed INN: Infliximab Trade Name: imuran INN or Proposed INN: azathioprine	SCHERING-PLOUGH	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy
1481	EUCTR2006-003399-37-DE (EUCTR)	27/11/2007	03/07/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
1482	EUCTR2007-003815-30-ES (EUCTR)	27/11/2007	24/10/2007	Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada.	Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada.	Colitis ulcerosa corticodependiente leve o moderada MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: DACORTIN Product Name: PREDNISONE INN or Proposed INN: PREDNISONE Other descriptive name: N/A	GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)	NULL	Not Recruiting			Female: yes Male: yes			Portugal;Spain
1483	EUCTR2004-004184-29-SE (EUCTR)	22/11/2007	27/09/2007	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	830	Phase 3	Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
1484	EUCTR2006-003398-28-DE (EUCTR)	15/11/2007	03/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1485	EUCTR2006-003397-94-AT (EUCTR)	15/11/2007	16/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1486	EUCTR2006-003399-37-BE (EUCTR)	15/11/2007	18/07/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden
1487	EUCTR2006-003397-94-BE (EUCTR)	15/11/2007	18/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1488	EUCTR2006-000410-20-NL (EUCTR)	13/11/2007	09/08/2007	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Netherlands;Belgium;Denmark;Italy
1489	EUCTR2006-005377-22-LT (EUCTR)	13/11/2007	14/08/2007	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Czech Republic;Germany;Spain;Latvia;Poland;Lithuania
1490	EUCTR2006-002670-22-DE (EUCTR)	31/10/2007	12/06/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
1491	EUCTR2006-003397-94-HU (EUCTR)	30/10/2007	10/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 2;Phase 3	Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden;France;Hungary;Slovakia;Belgium
1492	EUCTR2006-003399-37-HU (EUCTR)	30/10/2007	10/07/2007	A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1228	Phase 3	Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden
1493	EUCTR2006-003398-28-HU (EUCTR)	29/10/2007	10/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1494	EUCTR2007-002542-38-DE (EUCTR)	29/10/2007	22/02/2008	A clinical study to explore the safe and effective use of the drugsotrastaurin in patients with ulcerative colitis	A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis.	Ulcerative colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: AEB071A Trade Name: B2-ASmedic Product Name: B2-ASmedic INN or Proposed INN: RIBOFLAVIN	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60		Denmark;Germany
1495	EUCTR2006-005377-22-DE (EUCTR)	23/10/2007	16/07/2007	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Czech Republic;Poland;Spain;Lithuania;Latvia;Germany
1496	EUCTR2007-004732-23-EE (EUCTR)	22/10/2007	23/10/2007	A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis	A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis	Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE	EMET Pharmaceuticals LLC	NULL	Not Recruiting			Female: yes Male: yes	435		Estonia;Latvia;Poland
1497	EUCTR2006-002670-22-PT (EUCTR)	12/10/2007	20/07/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
1498	EUCTR2006-003397-94-SK (EUCTR)	04/10/2007	16/04/2008	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden
1499	EUCTR2006-003398-28-SK (EUCTR)	04/10/2007	23/12/2009	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2;Phase 3	Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden
1500	EUCTR2006-003399-37-SK (EUCTR)	04/10/2007	23/12/2009	A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics BV	NULL	Not Recruiting			Female: yes Male: yes	1228	Phase 3	Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden
1501	NCT00603733 (ClinicalTrials.gov)	October 2007	16/1/2008	Canadian Active & Maintenance Modified Pentasa Study	A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks	Active Ulcerative Colitis;Remission of Ulcerative Colitis	Drug: 5-ASA (5-Aminosalicylate)	Ferring Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	288	Phase 3	Canada
1502	EUCTR2006-005377-22-LV (EUCTR)	27/09/2007	12/09/2007	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Czech Republic;Germany;Spain;Latvia;Poland;Lithuania
1503	EUCTR2006-003399-37-AT (EUCTR)	27/09/2007	17/07/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
1504	EUCTR2006-003398-28-FR (EUCTR)	21/09/2007	23/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden
1505	EUCTR2006-003397-94-FR (EUCTR)	21/09/2007	23/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2;Phase 3	France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden
1506	EUCTR2006-003399-37-FR (EUCTR)	21/09/2007	23/07/2007	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden
1507	EUCTR2006-002670-22-ES (EUCTR)	20/09/2007	26/07/2007	Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte).	Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte).	Colitis Ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom
1508	EUCTR2006-005377-22-CZ (EUCTR)	17/09/2007	14/09/2007	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-stix® INN or Proposed INN: MESALAZINE Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Germany;Czech Republic;Spain;Latvia;Poland;Lithuania
1509	EUCTR2006-005377-22-SK (EUCTR)	14/09/2007	16/04/2008	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix® INN or Proposed INN: MESALAZINE Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany
1510	EUCTR2006-002670-22-FR (EUCTR)	07/09/2007	14/06/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2)	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Azathioprine (Imuran) 50 mg Overencapsulated Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
1511	EUCTR2006-002782-40-PT (EUCTR)	07/09/2007	18/06/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Hungary;Portugal;Germany;Czech Republic;Denmark;France;Austria
1512	EUCTR2006-003398-28-AT (EUCTR)	06/09/2007	17/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1513	EUCTR2006-003397-94-DE (EUCTR)	05/09/2007	03/07/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1514	EUCTR2006-003399-37-LV (EUCTR)	03/09/2007	04/09/2007	The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis	A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance	Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	1350	Phase 3	Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan
1515	EUCTR2006-003398-28-LV (EUCTR)	03/09/2007	04/09/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1516	EUCTR2006-003397-94-LV (EUCTR)	03/09/2007	04/09/2007	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	676	Phase 2/3	Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania
1517	EUCTR2006-002670-22-CZ (EUCTR)	29/08/2007	20/07/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;Hungary;United Kingdom;Germany;Czech Republic;Belgium;France;Spain;Italy
1518	EUCTR2006-004230-32-ES (EUCTR)	22/08/2007	26/09/2007	EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA	EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA	Colitis ulcerosa activa, extendiéndose en sentido proximal más allá del recto. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Clipper INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE	Chiesi Farmaceutici SpA	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Belgium;Poland;Spain;Italy
1519	EUCTR2006-003604-19-GB (EUCTR)	16/08/2007	09/03/2007	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. + Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Protocol amendment 04 - Biopsy substudy - Site specific+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-2006).	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. + Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Protocol amendment 04 - Biopsy substudy - Site specific+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-2006).	ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	978	Phase 3	Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Ireland;Germany
1520	EUCTR2006-003604-19-CZ (EUCTR)	15/08/2007	11/05/2007	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03.	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03.	ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	978	Phase 3	United Kingdom;Germany;Czech Republic;Belgium;France;Ireland;Italy;Poland
1521	EUCTR2006-000410-20-DK (EUCTR)	13/08/2007	09/01/2007	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade INN or Proposed INN: infliximab	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	Netherlands;Belgium;Denmark;Italy
1522	EUCTR2006-002670-22-HU (EUCTR)	09/08/2007	04/07/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy
1523	EUCTR2006-006052-35-IT (EUCTR)	08/08/2007	15/05/2007	An open label study to determine the safety and tolerability oftwo dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitismaintained by steroid therapy. - ND	An open label study to determine the safety and tolerability oftwo dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitismaintained by steroid therapy. - ND	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Nicolon	S.L.A. PHARMA (UK) LTD	NULL	Not Recruiting			Female: yes Male: yes			Italy
1524	EUCTR2006-003604-19-DE (EUCTR)	06/08/2007	15/12/2006	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific	ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	978	Phase 3	Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland
1525	EUCTR2006-000410-20-IT (EUCTR)	02/08/2007	08/08/2007	A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72	A Phase 3, Randomized, Open-label, Parallel-group, MulticenterTrial to Evaluate the Safety and Efficacy of Infliximab(REMICADE) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis - Protocol C0168T72	Moderately to severely active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: REMICADE INN or Proposed INN: Infliximab	CENTOCOR	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Netherlands;Belgium;Denmark;Italy
1526	EUCTR2006-002670-22-BE (EUCTR)	25/07/2007	15/06/2007	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Germany;Italy;United Kingdom
1527	EUCTR2006-002781-20-BE (EUCTR)	16/07/2007	10/01/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	475		Hungary;Czech Republic;Belgium;Austria;Germany;Italy;Sweden
1528	EUCTR2006-002782-40-DK (EUCTR)	09/07/2007	07/03/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria
1529	NCT00505778 (ClinicalTrials.gov)	July 2007	20/7/2007	A Comparison of Once a Day Dose Compared to 2 Doses/Day	A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis	Ulcerative Colitis	Drug: Mesalamine Once-Daily;Drug: Mesalamine Twice-Daily	Warner Chilcott	NULL	Completed	18 Years	N/A	All	1027	Phase 3	United States;Canada;Puerto Rico
1530	EUCTR2006-002781-20-DE (EUCTR)	27/06/2007	04/04/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	575		Hungary;Czech Republic;Germany;Italy;Austria;Sweden
1531	EUCTR2006-003604-19-IE (EUCTR)	26/06/2007	13/02/2007	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01.	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01.	ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	978	Phase 3	Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland
1532	EUCTR2006-002782-40-FR (EUCTR)	19/06/2007	06/03/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany
1533	EUCTR2006-002782-40-BE (EUCTR)	19/06/2007	05/01/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany
1534	EUCTR2006-002782-40-CZ (EUCTR)	18/06/2007	10/04/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria
1535	EUCTR2006-004303-19-BE (EUCTR)	08/06/2007	07/02/2007	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001	Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab	Cerimon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	135		Czech Republic;United Kingdom;Belgium
1536	EUCTR2006-004230-32-IT (EUCTR)	06/06/2007	12/11/2007	Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA	Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA	Mild moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: CLIPPER*30CPR 5MG R.M. INN or Proposed INN: Beclometasone Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: Prednisone Trade Name: DELTACORTENE FORTE*10CPR 25MG INN or Proposed INN: Prednisone	CHIESI	NULL	Not Recruiting			Female: yes Male: yes	300		Belgium;Spain;Italy;Poland
1537	NCT00705484 (ClinicalTrials.gov)	June 1, 2007	23/6/2008	European Safety Registry in Ulcerative Colitis (P04808)	Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program	Ulcerative Colitis	Biological: infliximab;Drug: Standard Therapy	Merck Sharp & Dohme Corp.	Centocor, Inc.	Completed	18 Years	N/A	All	2239		Austria;Belgium;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom;United States
1538	NCT00606346 (ClinicalTrials.gov)	May 31, 2007	21/1/2008	A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease	A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease	Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases	Biological: Anti TNF therapy including infliximab;Drug: No Biologics	Janssen Biotech, Inc.	NULL	Active, not recruiting	1 Month	17 Years	All	4970		United States;Canada
1539	EUCTR2005-003707-37-BE (EUCTR)	25/05/2007	18/12/2006	A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Belgium;Austria
1540	EUCTR2006-006319-54-BE (EUCTR)	24/05/2007	08/02/2007	An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002	An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002	Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab	Cerimon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	135		United Kingdom;Belgium
1541	EUCTR2006-006319-54-CZ (EUCTR)	14/05/2007	20/02/2007	An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002	An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002	Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab	Cerimon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2	Czech Republic;Belgium;United Kingdom
1542	EUCTR2006-003604-19-BE (EUCTR)	10/05/2007	20/02/2007	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific	ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	978	Phase 3	Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland
1543	EUCTR2005-003707-37-AT (EUCTR)	09/05/2007	03/01/2007	A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Belgium;Austria
1544	EUCTR2006-004303-19-CZ (EUCTR)	09/05/2007	20/02/2007	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001	Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab	Cerimon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	181		United Kingdom;Czech Republic;Belgium
1545	EUCTR2006-006319-54-SK (EUCTR)	07/05/2007	08/03/2007	An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002	An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002	Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab	Cerimon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2	Czech Republic;Slovakia;Belgium;United Kingdom
1546	EUCTR2006-004303-19-SK (EUCTR)	04/05/2007	08/03/2007	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001	Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab	Cerimon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	181	Phase 2	Czech Republic;Slovakia;Belgium;United Kingdom
1547	EUCTR2006-002781-20-CZ (EUCTR)	04/05/2007	16/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
1548	EUCTR2006-004303-19-GB (EUCTR)	25/04/2007	06/12/2006	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001	Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab	Cerimon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2	Czech Republic;Slovakia;Belgium;United Kingdom
1549	EUCTR2006-006319-54-GB (EUCTR)	25/04/2007	07/12/2006	An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002	An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002	Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab	Cerimon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	135	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Slovakia;Belgium;United Kingdom
1550	EUCTR2006-000410-20-BE (EUCTR)	18/04/2007	11/01/2007	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade INN or Proposed INN: infliximab	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Netherlands;Denmark;Belgium;Italy
1551	EUCTR2006-002782-40-HU (EUCTR)	18/04/2007	20/03/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany
1552	EUCTR2006-002781-20-IT (EUCTR)	17/04/2007	07/03/2007	A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND	A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND	Moderately to severely active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Trade Name: HUMIRA	Abbott GmbH Co. KG	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
1553	EUCTR2006-002781-20-HU (EUCTR)	26/03/2007	28/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	575		Hungary;Germany;Czech Republic;Italy;Austria;Sweden
1554	EUCTR2006-002782-40-ES (EUCTR)	23/03/2007	05/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.	Moderately to severely active ulcerative colitis.Colitis Ulcerosa Activa de Intensidad Moderada a Severa MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;France;Czech Republic;Hungary;Belgium;Spain;Austria;Denmark;Germany
1555	EUCTR2006-002781-20-SK (EUCTR)	19/03/2007	01/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.	Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	575	Phase 3	Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Italy;Sweden
1556	EUCTR2005-004105-28-GR (EUCTR)	15/03/2007	15/02/2007	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S	Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece
1557	EUCTR2006-003604-19-IT (EUCTR)	09/03/2007	14/07/2008	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03.	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03.	ulcerative colitis, NOS MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Orencia INN or Proposed INN: abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	978	Phase 3	France;Czech Republic;Poland;Belgium;Ireland;Germany;United Kingdom;Italy
1558	EUCTR2004-005032-35-BE (EUCTR)	06/03/2007	23/11/2006	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Italy;Sweden
1559	JPRN-UMIN000013925	2007/03/01	31/05/2014	The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection	The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection - KIBDG-Protocol 1	Ulcerative colitis	A Group: Ganciclovir monotherapy B Group: Ganciclovir and GMAA combination therapy C Group: GMAA monotherapy	Graduate School of Medicine, Kyoto University, Gastroenterology and Hepatology	NULL	Recruiting	15years-old	80years-old	Male and Female	90	Not applicable	Japan
1560	EUCTR2006-004162-13-DE (EUCTR)	27/02/2007	06/10/2006	Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients	Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients	Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano. MedDRA version: 8.1;Level: LLT;Classification code 10021972;Term: Inflammatory bowel disease	Trade Name: Salofalk 4g/60ml Klysma INN or Proposed INN: MESALAZINE	Charité Universitätsmedizin, Campus Charité Mitte	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Germany
1561	EUCTR2005-003482-17-GB (EUCTR)	26/02/2007	01/02/2006	A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	United Kingdom;Spain;Ireland;Italy;Greece
1562	EUCTR2006-003604-19-FR (EUCTR)	14/02/2007	29/12/2006	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01.	A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01.	ULCERATIVE COLITIS,NOS MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	978	Phase 3	France;Czech Republic;Poland;Belgium;Ireland;Germany;Italy;United Kingdom
1563	EUCTR2005-003481-42-GR (EUCTR)	30/01/2007	24/11/2006	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R	Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80		Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece
1564	EUCTR2005-005363-28-HU (EUCTR)	25/01/2007	25/09/2006	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.	Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon	Ocera Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria
1565	EUCTR2005-005363-28-AT (EUCTR)	08/01/2007	10/01/2007	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.	Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon	Ocera Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria
1566	EUCTR2006-001782-42-HU (EUCTR)	20/12/2006	16/08/2006	Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.	Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.	Active left-sided, mild to moderate ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: CB-01-05-MMX Product Code: CB-01-05-MMX Other descriptive name: PARNAPARIN SODIUM	Cosmo Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	120		Hungary;United Kingdom;Italy
1567	EUCTR2006-001846-15-SE (EUCTR)	06/12/2006	20/10/2006	A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree	A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree	Active ulcerative colitis in steroid refractory or steroid dependent patients	Product Name: Kappaproct Product Code: DIMS0150	InDex Pharmaceuticals AB	NULL	Not Recruiting			Female: yes Male: yes	48		Sweden
1568	EUCTR2006-002036-25-GB (EUCTR)	09/11/2006	15/02/2012	Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC	Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC	Ulcerative Colitis	Product Name: Epidermal growth factor enema Product Code: EGF enema INN or Proposed INN: Epidermal growth factor Trade Name: Pentasa enema Product Name: Pentasa INN or Proposed INN: mesalazine enema	University Hospitals of Leicester NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	United Kingdom
1569	EUCTR2006-001782-42-IT (EUCTR)	03/11/2006	20/12/2006	Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND	Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND	Patients with mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: CB-01-05-MMX	COSMO TECHNOLOGIES LTD	NULL	Not Recruiting			Female: yes Male: yes	120		Hungary;United Kingdom;Italy
1570	NCT00408629 (ClinicalTrials.gov)	November 2006	5/12/2006	Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Biological: adalimumab;Biological: placebo	Abbott	NULL	Completed	18 Years	N/A	All	518	Phase 3	United States;Argentina;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;New Zealand;Norway;Poland;Portugal;Spain;Switzerland;Sweden
1571	NCT00385736 (ClinicalTrials.gov)	November 2006	9/10/2006	Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis	A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Biological: adalimumab;Biological: placebo	Abbott	NULL	Completed	18 Years	N/A	All	576	Phase 3	United States;Austria;Belgium;Canada;Czech Republic;Germany;Hungary;Italy;Netherlands;Poland;Puerto Rico;Slovakia;Sweden
1572	EUCTR2006-001782-42-GB (EUCTR)	17/10/2006	29/09/2006	Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.	Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.	Active left-sided, mild to moderate ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: CB-01-05-MMX Product Code: CB-01-05-MMX Other descriptive name: PARNAPARIN SODIUM	Cosmo Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Italy;United Kingdom
1573	EUCTR2005-004105-28-DE (EUCTR)	11/10/2006	10/04/2006	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S	Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;United Kingdom;Germany;Netherlands;France;Ireland;Greece
1574	NCT00355901 (ClinicalTrials.gov)	September 2006	21/7/2006	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis	Ulcerative Colitis	Drug: Visilizumab (Nuvion®; HuM291)	PDL BioPharma, Inc.	NULL	Terminated	18 Years	N/A	Both	300		United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Ireland;Italy;Netherlands;Norway;Ukraine
1575	EUCTR2005-005363-28-BE (EUCTR)	22/08/2006	27/04/2006	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.	Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon	Ocera Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria
1576	NCT00279435 (ClinicalTrials.gov)	August 2006	17/1/2006	Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study	A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study	Ulcerative Colitis	Drug: visilizumab	Facet Biotech	PDL BioPharma, Inc.	Terminated	18 Years	N/A	Both	25	Phase 2/Phase 3	United States;Australia;Austria;Belgium;Canada;Croatia;Czech Republic;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Ukraine
1577	EUCTR2006-001310-32-LT (EUCTR)	17/07/2006	15/05/2006	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III	Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA)	Procter & Gamble Technical Centres Limited	NULL	Not Recruiting			Female: yes Male: yes	770		Hungary;Czech Republic;Estonia;Latvia;Lithuania
1578	EUCTR2005-005363-28-GB (EUCTR)	11/07/2006	17/01/2006	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.	Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon	Ocera Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Czech Republic;Belgium;Austria;Germany;United Kingdom
1579	EUCTR2006-001310-32-HU (EUCTR)	29/06/2006	23/05/2006	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III	Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900	Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA)	Procter & Gamble Technical Centres Limited	NULL	Not Recruiting			Female: yes Male: yes	770		Hungary;Czech Republic;Estonia;Latvia;Lithuania
1580	EUCTR2006-001310-32-CZ (EUCTR)	26/06/2006	17/05/2006	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III	Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900	Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA)	Procter & Gamble Technical Centres Limited	NULL	Not Recruiting			Female: yes Male: yes	770		Hungary;Czech Republic;Estonia;Latvia;Lithuania
1581	EUCTR2005-004105-28-IE (EUCTR)	20/06/2006	10/02/2006	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.	Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0;Level: LLT;Classification code 10045265	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	France;Hungary;Greece;Ireland;Netherlands;Germany;United Kingdom
1582	EUCTR2005-004105-28-GB (EUCTR)	20/06/2006	07/03/2006	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.	An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis.	Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0;Level: LLT;Classification code 10045265	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece
1583	EUCTR2006-001310-32-EE (EUCTR)	16/06/2006	27/04/2006	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III	Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900	Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA)	Procter & Gamble Technical Centres Limited	NULL	Not Recruiting			Female: yes Male: yes	770		Hungary;Czech Republic;Estonia;Latvia;Lithuania
1584	EUCTR2005-003482-17-IT (EUCTR)	08/06/2006	04/12/2006	A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis.	A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis.	Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis MedDRA version: 6.1;Level: PT;Classification code 10009900	Product Name: visilizumab Product Code: HuM291 Product Name: visilizumab Product Code: HuM291 Product Name: visilizumab Product Code: HuM291	PDL BioPharma , Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United Kingdom;Spain;Ireland;Italy;Greece
1585	EUCTR2005-003481-42-IT (EUCTR)	08/06/2006	11/07/2007	A Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - ND	A Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - ND	subjects with IVSR-UC MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: visilizumab INN or Proposed INN: visilizumab	PDL BioPharma, Inc;	NULL	Not Recruiting			Female: yes Male: yes	80		Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece
1586	EUCTR2005-005363-28-CZ (EUCTR)	15/05/2006	18/04/2006	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.	Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon	Ocera Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;Germany;United Kingdom;Czech Republic;Belgium;Austria
1587	EUCTR2004-005032-35-IT (EUCTR)	10/05/2006	19/01/2007	A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis	A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Trade Name: PREDNISOLONE INN or Proposed INN: Prednisolone	ALIZYME	NULL	Not Recruiting			Female: yes Male: yes	890	Phase 3	Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
1588	EUCTR2005-005363-28-DE (EUCTR)	02/05/2006	02/06/2006	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS	The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.	Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 INN or Proposed INN: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon	Ocera Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240		Hungary;Czech Republic;United Kingdom;Germany;Belgium;Austria
1589	EUCTR2006-001310-32-LV (EUCTR)	28/04/2006	22/08/2006	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III	A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III	Ulcerative Colitis	Product Name: Asacol 800mg tablet INN or Proposed INN: mesalazine Product Name: Asacol 400mg tablet INN or Proposed INN: mesalazine	Procter & Gamble Technical Centres Limited	NULL	Not Recruiting			Female: yes Male: yes	470		Hungary;Czech Republic;Estonia;Latvia;Lithuania
1590	EUCTR2005-003481-42-HU (EUCTR)	04/04/2006	28/11/2005	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R	Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80		Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece
1591	EUCTR2005-002063-87-HU (EUCTR)	04/04/2006	02/05/2007	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous steroid-refractory ulcerative colitis (IVSR-UC)	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody	Protein Design Labs, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2/3	Hungary;Germany;Czech Republic;Belgium
1592	EUCTR2005-003481-42-IE (EUCTR)	04/04/2006	10/01/2006	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study	Intravenous steroid-refractory ulcerative colitis (IVSR-UC)	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany
1593	EUCTR2005-003481-42-DE (EUCTR)	22/03/2006	29/11/2005	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R	Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80		Hungary;Czech Republic;Slovakia;Germany;Spain;Ireland;Italy;Greece
1594	EUCTR2005-002063-87-DE (EUCTR)	22/03/2006	29/11/2005	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2/3	Hungary;Czech Republic;Germany;Belgium
1595	EUCTR2006-000197-69-IT (EUCTR)	16/03/2006	05/06/2006	A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02	A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02	Inflammatory Blowel Disease MedDRA version: 6.1;Level: PT;Classification code 10009900	Product Name: Bovine-Calf Alkaline Phosphatase BIAP Product Code: BIAP	AM PHARMA B.V.	NULL	Not Recruiting			Female: yes Male: yes	24		Italy
1596	EUCTR2005-002063-87-SK (EUCTR)	16/03/2006	23/11/2005	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2;Phase 3	Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany
1597	EUCTR2005-003482-17-IE (EUCTR)	03/03/2006	10/01/2006	A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0;Level: LLT;Classification code 10045265	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Greece;Spain;Ireland;Italy;United Kingdom
1598	EUCTR2005-002063-87-BE (EUCTR)	09/02/2006	24/11/2005	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous steroid-refractory ulcerative colitis (IVSR-UC)	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody	Protein Design Labs, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2/3	Hungary;Germany;Czech Republic;Belgium
1599	EUCTR2005-002784-91-GB (EUCTR)	06/02/2006	24/11/2005	A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol)	A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol)	Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.	Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid	Cardiff and Vale NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	630	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Kingdom
1600	NCT00279422 (ClinicalTrials.gov)	February 2006	17/1/2006	A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis	Ulcerative Colitis	Drug: visilizumab	Facet Biotech	PDL BioPharma, Inc.	Terminated	18 Years	N/A	Both	127	Phase 2/Phase 3	United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;Norway;Slovakia;Ukraine
1601	EUCTR2005-003481-42-AT (EUCTR)	04/01/2006	30/11/2005	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study	Intravenous steroid-refractory ulcerative colitis (IVSR-UC)	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	Protein Design Labs, Inc	NULL	Not Recruiting			Female: yes Male: yes	80		Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany
1602	EUCTR2005-002063-87-AT (EUCTR)	28/12/2005	23/11/2005	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis	Intravenous steroid-refractory ulcerative colitis (IVSR-UC)	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody	Protein Design Labs, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2/3	Hungary;Czech Republic;Belgium;Austria;Germany
1603	EUCTR2004-001218-15-SI (EUCTR)	22/12/2005	26/10/2005	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Maintenance therapy of ulcerative colitis	Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	510		Estonia;Hungary;Slovenia;Lithuania;Latvia;Germany
1604	EUCTR2004-001216-31-SI (EUCTR)	22/12/2005	26/10/2005	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816	Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	320		Estonia;Czech Republic;Hungary;Slovenia;Lithuania;Latvia;Germany
1605	EUCTR2005-003471-20-IT (EUCTR)	07/12/2005	17/01/2007	Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment	Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment	ULCERATIVE COLITIS MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Propionyl-L-carnitine Product Code: ST261 INN or Proposed INN: Levocarnitine	SIGMA-TAU	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Lithuania;Italy
1606	EUCTR2005-003724-19-CZ (EUCTR)	21/11/2005	05/10/2005	A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol	A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol	Active Ulcerative Colitis MedDRA version: 8.0;Level: LLT;Classification code 10058816	Product Name: OPC-6535 Product Code: OPC-6535 INN or Proposed INN: Not applicable Other descriptive name: OPC-6535	Otsuka Maryland Research Institute, Inc.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 3	Hungary;Czech Republic
1607	EUCTR2004-005032-35-SE (EUCTR)	17/11/2005	14/09/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
1608	EUCTR2004-005032-35-CZ (EUCTR)	04/11/2005	16/09/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Italy;Sweden
1609	NCT00309660 (ClinicalTrials.gov)	November 2005	30/3/2006	Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis		Ulcerative Colitis	Drug: Rosiglitazone	Herlev Hospital	NULL	Recruiting	18 Years	80 Years	Both	20	Phase 1/Phase 2	Denmark
1610	EUCTR2005-003724-19-HU (EUCTR)	24/10/2005	07/09/2005	A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol	A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol	Active Ulcerative Colitis MedDRA version: 8.0;Level: LLT;Classification code 10058816	Product Name: OPC-6535 Product Code: OPC-6535 INN or Proposed INN: Not applicable Other descriptive name: OPC-6535	Otsuka Maryland Research Institute, Inc.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 3	Czech Republic;Hungary
1611	EUCTR2004-005032-35-DK (EUCTR)	24/10/2005	04/10/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
1612	EUCTR2004-005032-35-HU (EUCTR)	24/10/2005	22/09/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890		Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
1613	EUCTR2004-005032-35-GB (EUCTR)	11/10/2005	24/02/2005	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.	Moderate acute ulcerative colitis.	Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Trade Name: Prednisolone Tablets B.P. 5mg Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate	Alizyme Therapeutics Limited	NULL	Not Recruiting			Female: yes Male: yes	890	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Czech Republic;Belgium;Spain;Denmark;Italy;United Kingdom;Sweden
1614	EUCTR2005-000695-40-GB (EUCTR)	27/09/2005	17/08/2005	A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial	A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial	The medical condition is Ulcerative Colitis.	Product Name: products containing azathioprine or 6-mercaptopurine INN or Proposed INN: azathioprine INN or Proposed INN: azathioprine INN or Proposed INN: 6-mercaptopurine Product Name: Products containing aminosalicylate INN or Proposed INN: Sulphsalazine, Pentasa, Asacol, Colazide, Depentum	University of Nottingham	NULL	Not Recruiting			Female: yes Male: yes	420	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1615	NCT00928681 (ClinicalTrials.gov)	September 2005	22/6/2009	A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis	A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis.	Colitis, Ulcerative	Biological: Single dose-group A;Biological: Multiple dose- Group B;Biological: Multiple dose-Group B	Pfizer	NULL	Completed	18 Years	70 Years	Both	80	Phase 1	Belgium;Czech Republic;Denmark;Germany;Norway;Slovakia;Spain
1616	EUCTR2004-004565-15-FI (EUCTR)	26/08/2005	28/04/2005	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900	Trade Name: Pentasa Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Trade Name: NA Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine	Ferring BV	NULL	Not Recruiting			Female: yes Male: yes	360		Finland;Germany;Czech Republic;Denmark;Norway;Sweden
1617	EUCTR2004-001216-31-CZ (EUCTR)	17/08/2005	17/08/2005	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816	Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	320		Hungary;Germany;Czech Republic;Estonia;Latvia;Lithuania
1618	EUCTR2004-001216-31-HU (EUCTR)	28/07/2005	20/06/2005	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816	Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	320		Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
1619	EUCTR2004-001216-31-SK (EUCTR)	28/07/2005	23/05/2005	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816	Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 3	Estonia;Czech Republic;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany
1620	EUCTR2004-001216-31-LV (EUCTR)	25/07/2005	25/07/2005	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816	Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	320		Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
1621	EUCTR2004-000734-36-CZ (EUCTR)	13/07/2005	08/10/2004	A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.	A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.	Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study	Product Name: Mesalazine Product Code: SPD476 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA)	Shire Pharmaceutical Development Inc.	NULL	Not Recruiting			Female: yes Male: yes	125	Phase 3	Czech Republic
1622	EUCTR2004-001218-15-EE (EUCTR)	07/06/2005	27/04/2005	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Maintenance therapy of ulcerative colitis	Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;Germany;Estonia;Latvia;Lithuania
1623	EUCTR2004-004184-29-DE (EUCTR)	06/06/2005	01/03/2005	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	Ulcerative colitis	Product Name: None given Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	410	Phase 3	Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden
1624	EUCTR2004-001677-26-IT (EUCTR)	06/06/2005	15/02/2006	Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study	Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study	Patients with 5-aminosalicylic 5-ASA or sulphasalazine resistant ulcerative colitis MedDRA version: 6.1;Level: PT;Classification code 10009900	Product Name: Nolpitantium Besylate Product Code: SR140333B	SANOFI-SYNTHELABO	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
1625	EUCTR2004-001216-31-LT (EUCTR)	06/06/2005	28/04/2005	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816	Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	320		Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
1626	EUCTR2004-004565-15-CZ (EUCTR)	03/06/2005	13/04/2005	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900	Trade Name: Pentasa sachet 1g Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine	Ferring BV	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Czech Republic;Finland;Denmark;Germany;Norway;Sweden
1627	EUCTR2004-004184-29-GB (EUCTR)	31/05/2005	23/02/2005	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	826	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
1628	EUCTR2004-001216-31-DE (EUCTR)	30/05/2005	04/04/2005	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816	Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	320		Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
1629	EUCTR2004-001218-15-LV (EUCTR)	30/05/2005	30/05/2005	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Maintenance therapy of ulcerative colitis	Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	510		Hungary;Germany;Estonia;Latvia;Lithuania
1630	EUCTR2004-004565-15-SE (EUCTR)	24/05/2005	09/03/2005	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900	Trade Name: Pentasa Sachet 1g Product Name: Pentasa Sachet 1 g INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa Sachet 2 g INN or Proposed INN: mesalazine	Ferring BV	NULL	Not Recruiting			Female: yes Male: yes	360		Finland;Germany;Czech Republic;Denmark;Norway;Sweden
1631	EUCTR2004-004184-29-ES (EUCTR)	05/05/2005	03/04/2006	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis.	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis.	Ulcerative colitis MedDRA version: 3.2;Level: LLT;Classification code 10045365	Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	410	Phase 3	Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
1632	NCT00209300 (ClinicalTrials.gov)	May 2005	13/9/2005	Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission	Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily	Ulcerative Colitis	Drug: Pentasa	Ferring Pharmaceuticals	NULL	Completed	18 Years	N/A	Both	362	Phase 3	Belgium;Czech Republic;Denmark;Finland;Germany;Netherlands;Norway;Sweden
1633	EUCTR2004-004077-29-SK (EUCTR)	25/04/2005	01/02/2005	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis	Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.	Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 2	Czech Republic;Slovakia;Lithuania;Germany;United Kingdom
1634	EUCTR2004-004184-29-CZ (EUCTR)	13/04/2005	11/04/2005	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets. Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden
1635	EUCTR2004-004565-15-NO (EUCTR)	06/04/2005	14/02/2005	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900	Trade Name: Pentasa sachet 1g Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Trade Name: NA Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine	Ferring BV	NULL	Not Recruiting			Female: yes Male: yes	360		Finland;Germany;Czech Republic;Denmark;Norway;Sweden
1636	EUCTR2004-001218-15-DE (EUCTR)	04/04/2005	10/12/2004	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Maintenance therapy of ulcerative colitis	INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	510		Hungary;Germany;Estonia;Latvia;Lithuania
1637	NCT00232258 (ClinicalTrials.gov)	April 2005	3/10/2005	Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study	Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study	Ulcerative Colitis;Inflammatory Bowel Disease	Drug: Nolpitantium besylate	Sanofi	NULL	Completed	18 Years	N/A	Both	307	Phase 2	Argentina;Belgium;Brazil;Canada;Chile;Czech Republic;Estonia;Hungary;Italy;Russian Federation;Singapore;South Africa;Spain;Sweden;France;United States
1638	EUCTR2004-004565-15-DK (EUCTR)	31/03/2005	24/02/2005	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900	Product Name: Pentasa Sachet INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa Sachet INN or Proposed INN: mesalazine	Ferring BV	NULL	Not Recruiting			Female: yes Male: yes	360		Finland;Germany;Czech Republic;Denmark;Norway;Sweden
1639	EUCTR2004-004184-29-HU (EUCTR)	30/03/2005	10/02/2005	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA	Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets. Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid	Shire Pharmaceutical Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
1640	EUCTR2004-001218-15-SK (EUCTR)	24/03/2005	02/02/2005	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Maintenance therapy of ulcerative colitis	Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Estonia;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany
1641	EUCTR2004-001677-26-EE (EUCTR)	23/03/2005	23/03/2005	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE	Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365	Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate	Sanofi-Synthelabo Recherche	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
1642	EUCTR2004-001218-15-HU (EUCTR)	17/03/2005	04/02/2005	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Maintenance therapy of ulcerative colitis	Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	510		Hungary;Germany;Estonia;Latvia;Lithuania
1643	EUCTR2004-004077-29-GB (EUCTR)	18/02/2005	23/02/2005	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis	Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.	Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid	Procter & Gamble Technical Centres Ltd	NULL	Not Recruiting			Female: yes Male: yes	250		Czech Republic;Lithuania;Germany;United Kingdom
1644	EUCTR2004-004077-29-LT (EUCTR)	09/02/2005	22/12/2004	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis	Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.	Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	250		United Kingdom;Czech Republic;Germany;Lithuania
1645	EUCTR2004-001218-15-LT (EUCTR)	09/02/2005	27/12/2004	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC	Maintenance therapy of ulcerative colitis	Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;Germany;Estonia;Latvia;Lithuania
1646	EUCTR2004-001677-26-SE (EUCTR)	07/02/2005	23/12/2004	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE	Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365	Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate	Sanofi-Synthelabo Recherche	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
1647	EUCTR2004-004077-29-DE (EUCTR)	04/02/2005	22/12/2004	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis	Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.	Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	250		United Kingdom;Czech Republic;Germany;Lithuania
1648	EUCTR2004-004077-29-CZ (EUCTR)	03/02/2005	03/02/2005	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis	A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis	Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.	Product Name: RDP58 Product Code: RDP58 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	250		United Kingdom;Germany;Czech Republic;Lithuania
1649	EUCTR2004-001677-26-HU (EUCTR)	25/01/2005	03/11/2004	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE	Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365	Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate	Sanofi-Synthelabo Recherche	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Estonia;Czech Republic;Hungary;Spain;Italy;Sweden
1650	EUCTR2004-001677-26-ES (EUCTR)	14/01/2005	01/06/2005	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE	Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365	Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate	Sanofi-Synthelabo Recherche	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Estonia;Czech Republic;Hungary;Spain;Italy;Sweden
1651	EUCTR2004-001216-31-EE (EUCTR)	11/01/2005	20/09/2005	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC	Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816	Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	320		Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania
1652	EUCTR2004-000611-25-IE (EUCTR)	19/10/2004	16/08/2004	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE	Maintenance of remission of ulcerative colitis	Product Name: OPC-6535 Product Code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid	Otsuka Maryland Research Institute, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1725	Phase 3	Hungary;Ireland
1653	EUCTR2004-000611-25-HU (EUCTR)	15/10/2004	21/07/2004	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE	Maintenance of remission of ulcerative colitis	Product Name: OPC-6535 Product Code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid	Otsuka Maryland Research Institute, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1725	Phase 3	Hungary;Ireland
1654	EUCTR2004-000916-25-IT (EUCTR)	28/09/2004	18/05/2005	A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS	A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS	TREATMENT OF ULCERATIVE COLITIS IN ACTIVE PHASE AND IN THE MAINTENANCE OF CLINICAL REMISSION MedDRA version: 6.1;Level: PT;Classification code 10021972	Product Name: 5-ASA MMx INN or Proposed INN: Mesalazine	GIULIANI	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Italy
1655	EUCTR2004-000733-12-CZ (EUCTR)	14/07/2004	01/07/2004	A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.	A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.	Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.	Product Name: Mesalazine Product Code: SPD476 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA)	Shire Pharmaceutical Development Inc	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	Czech Republic
1656	EUCTR2004-001677-26-CZ (EUCTR)	09/03/2004	10/02/2005	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE	Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365	Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate	sanofi-aventis recherche & developpement	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Czech Republic;Estonia;Spain;Italy;Sweden
1657	NCT00151944 (ClinicalTrials.gov)	November 26, 2003	7/9/2005	Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.	A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.	Colitis, Ulcerative	Drug: SPD476 (mesalazine)	Shire	NULL	Completed	18 Years	N/A	All	400	Phase 3	NULL
1658	NCT00259571 (ClinicalTrials.gov)	April 2003	28/11/2005	Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.	Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte (Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa.	Ulcerative Colitis	Drug: retarded release phosphatidylcholine	Heidelberg University	Dietmar Hopp Stiftung	Withdrawn	15 Years	80 Years	Both	0	Phase 2/Phase 3	Germany
1659	NCT00063414 (ClinicalTrials.gov)	November 20, 2002	25/6/2003	ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis	ISIS 2302-CS22, Phase II, Double-Blinded, Active-Controlled Study of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis (Left-Sided Colitis or Pancolitis With Left Sided Disease Flare)	Ulcerative Colitis	Drug: Alicaforsen	Ionis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All		Phase 2	United States
1660	NCT00510978 (ClinicalTrials.gov)	January 2002	2/8/2007	Probiotics in GastroIntestinal Disorders	One Year, Randomised, Double Blind, Placebo Controlled Trial of Probiotics, Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118, as Food Supplements for Maintenance of Remission in Crohn's Disease and Ulcerative Colitis	Ulcerative Colitis;Crohn's Disease	Biological: Bifidobacterium infantis 35624;Biological: Lactobacillus salivarius UCC118;Biological: Placebo	University College Cork	European Commission	Active, not recruiting	N/A	75 Years	Both	360	Phase 2/Phase 3	Ireland
1661	NCT00038922 (ClinicalTrials.gov)	September 1994	5/6/2002	Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis	Ulcerative Colitis;Inflammatory Bowel Disease	Drug: rhIL-11	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Terminated	18 Years	N/A	Both		Phase 1	United States
1662	EUCTR2018-003986-33-EE (EUCTR)		19/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
1663	EUCTR2018-003986-33-DE (EUCTR)		19/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
1664	EUCTR2018-003987-29-EE (EUCTR)		12/09/2019	An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	NA			Female: yes Male: yes	702	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
1665	EUCTR2017-002231-41-FR (EUCTR)		15/12/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
1666	EUCTR2017-000573-37-BE (EUCTR)		14/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Baxalta Innovations GmbH	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
1667	EUCTR2017-000572-28-IE (EUCTR)		04/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
1668	EUCTR2017-000573-37-PL (EUCTR)		01/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;United States
1669	EUCTR2006-005377-22-PL (EUCTR)		14/02/2008	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC	Treatment of ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Slovakia;Spain;Poland;Lithuania;Latvia;Germany
1670	EUCTR2017-000599-27-PL (EUCTR)		04/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;New Zealand;Japan
1671	EUCTR2018-003985-15-DE (EUCTR)		01/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Portugal;Serbia;Belarus;Taiwan;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
1672	EUCTR2017-003649-10-PL (EUCTR)		11/12/2017	A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease	A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE	Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	NA			Female: yes Male: yes	60	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Belgium;Spain;Poland;Germany;United Kingdom
1673	EUCTR2016-001392-78-IT (EUCTR)		12/02/2021	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis - NA	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib	GILEAD SCIENCES INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden
1674	EUCTR2007-005702-49-PL (EUCTR)		17/06/2009	A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II	A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II	Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents MedDRA version: 11.0;Level: LLT;Classification code 10045365;Term:	Trade Name: Asacol Product Name: Asacol Product Code: NA INN or Proposed INN: MESALAZINE	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Poland
1675	EUCTR2018-003986-33-CZ (EUCTR)		20/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Portugal;Belarus;Serbia;United States;Estonia;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
1676	EUCTR2018-003986-33-PL (EUCTR)		15/11/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany
1677	EUCTR2016-000641-31-DE (EUCTR)		06/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
1678	EUCTR2018-003985-15-BE (EUCTR)		08/05/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
1679	EUCTR2016-000674-38-NO (EUCTR)		01/11/2016	Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.	A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	NA			Female: yes Male: yes	950	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
1680	EUCTR2016-000641-31-NO (EUCTR)		07/11/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Romania;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
1681	EUCTR2015-000319-41-PL (EUCTR)		16/09/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
1682	EUCTR2018-003985-15-PL (EUCTR)		02/08/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
1683	EUCTR2013-003032-77-FR (EUCTR)		19/06/2015	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB	Abbvie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	225	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand
1684	EUCTR2015-000319-41-BG (EUCTR)		12/08/2015	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	1050	Phase 3	Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
1685	EUCTR2004-004565-15-DE (EUCTR)		15/09/2005	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM	Ulcerative collitis (UC) MedDRA version: 4.1;Level: PT;Classification code 10009900	Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine	Ferring BV	NULL	Not Recruiting			Female: yes Male: yes	360		Finland;Czech Republic;Germany;Denmark;Norway;Sweden

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臨床試験数 : 310 /  薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05667909 (ClinicalTrials.gov)	June 2023	7/12/2022	Prognostic Model of Rituximab in the Treatment of MN	Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Rituximab	Idiopathic Membranous Nephropathy	Drug: Rituximab	Qianfoshan Hospital	NULL	Not yet recruiting	18 Years	75 Years	All	50		NULL
2	NCT05667896 (ClinicalTrials.gov)	June 2023	7/12/2022	Prognostic Model of GC/TAC in the Treatment of MN	Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Glucocorticoids Plus Tacrolimus	Idiopathic Membranous Nephropathy	Drug: glucocorticoid + tacrolimus	Qianfoshan Hospital	NULL	Not yet recruiting	18 Years	75 Years	All	50		NULL
3	NCT05667922 (ClinicalTrials.gov)	June 2023	7/12/2022	Prognostic Model of TAC in the Treatment of MN	Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Tacrolimus	Idiopathic Membranous Nephropathy	Drug: Tacrolimus	Qianfoshan Hospital	NULL	Not yet recruiting	18 Years	75 Years	All	50		NULL
4	NCT05667883 (ClinicalTrials.gov)	June 2023	7/12/2022	Prognostic Model of GC/CTX in the Treatment of MN	Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Glucocorticoids Plus Cytoxan	Idiopathic Membranous Nephropathy	Drug: glucocorticoid + cytoxan	Qianfoshan Hospital	NULL	Not yet recruiting	18 Years	75 Years	All	50		NULL
5	NCT05707377 (ClinicalTrials.gov)	April 2023	23/1/2023	A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy	A Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous Nephropathy	Primary Membranous Nephropathy	Drug: Zanubrutinib;Drug: Tacrolimus	BeiGene	NULL	Not yet recruiting	18 Years	75 Years	All	282	Phase 2/Phase 3	NULL
6	NCT05772871 (ClinicalTrials.gov)	March 30, 2023	24/2/2023	The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children	Compare the Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule Versus Combined With Levamisole for Primary Nephrotic Syndrome in Children: A Prospective, Multi-center, Randomized, Double-blind, Non-inferiority Study	Nephrotic Syndrome in Children	Drug: Huaiqihuang granule;Drug: Prednisone;Drug: Levamisole placebo;Drug: Levamisole;Drug: Huaiqihuang Granule placebo	Jianhua Zhou	LinkDoc Technology (Beijing) Co. Ltd.	Not yet recruiting	18 Months	18 Years	All	402	Phase 4	NULL
7	NCT05732402 (ClinicalTrials.gov)	March 2023	8/2/2023	An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases	An Open-Label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects With Autoantibody-Associated Glomerular Diseases (RUBY-3)	Lupus Nephritis;Immunoglobulin A Nephropathy;Membranous Nephropathy	Drug: povetacicept	Alpine Immune Sciences, Inc.	NULL	Not yet recruiting	18 Years	N/A	All	42	Phase 1	NULL
8	NCT05668403 (ClinicalTrials.gov)	February 28, 2023	12/12/2022	A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy	A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy	Primary Membranous Nephropathy	Drug: B007	Shanghai Jiaolian Drug Research and Development Co., Ltd	Shanghai Pharmaceuticals Holding Co., Ltd	Not yet recruiting	18 Years	75 Years	All	52	Phase 1	China
9	EUCTR2020-000384-23-DE (EUCTR)	19/12/2022	17/05/2022	A study to test BI 764198 in people with a type of kidney disease calledfocal segmental glomerulosclerosis.	A multicenter, randomized, double-blind, parallel group, placebo controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics profile of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis - PoCP study in FSGS	Focal segmental glomerulosclerosis MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]	Product Code: BI 764198 INN or Proposed INN: None yet Other descriptive name: BI 764198 Product Code: BI 764198 INN or Proposed INN: None yet Other descriptive name: BI 764198 Product Code: BI 764198 INN or Proposed INN: None yet Other descriptive name: BI 764198	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	France;United States;Hungary;Belgium;Spain;Ireland;Australia;Germany;United Kingdom;Italy;China
10	EUCTR2020-005855-19-HU (EUCTR)	03/11/2022	08/04/2022	Evaluating oral BCX9930 in renal diseases	An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW	complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride Product Name: BCX9930 Product Code: BCX9930 INN or Proposed INN: BCX9930 Other descriptive name: BCX9930 hydrochloride	BioCryst Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	France;Hungary;Spain;Romania;Germany;United Kingdom;Italy
11	NCT05532111 (ClinicalTrials.gov)	September 1, 2022	1/9/2022	Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical Trial	Efficacy and Safety of Rituximab Combined With Tacrolimus in the Treatment of Intermediate-to-high Risk Primary Membranous Nephropathy: A Randomized Clinical Trial	Efficacy and Safety	Drug: Rituximab combined with tacrolimus induction + rituximab maintenance;Drug: Rituximab combined with tacrolimus induction + tacrolimus maintenance;Drug: Glucocorticoid combined with cyclophosphamide induction + maintenance	RenJi Hospital	NULL	Not yet recruiting	18 Years	75 Years	All	60	N/A	NULL
12	EUCTR2020-000384-23-ES (EUCTR)	17/05/2022	28/03/2022	A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis (FSGS).	A multicenter, randomized, double-blind, parallel group, placebo controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis - PoCP study in FSGS	Glomerulosclerosis MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]	Product Code: BI 764198 INN or Proposed INN: None yet Other descriptive name: BI 764198 Product Code: BI 764198 INN or Proposed INN: None yet Other descriptive name: BI 764198 Product Code: BI 764198 INN or Proposed INN: None yet Other descriptive name: BI 764198	Boehringer Ingelheim España S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	United States;Hungary;Belgium;France;Spain;Ireland;Australia;Germany;United Kingdom;Italy
13	NCT05441826 (ClinicalTrials.gov)	May 3, 2022	7/6/2022	Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)	A Phase 2 Study of VB119 in Adult Subjects With Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)	Minimal Change Disease;Focal Segmental Glomerulosclerosis	Drug: VB119	ValenzaBio, Inc.	NULL	Active, not recruiting	18 Years	N/A	All	20	Phase 2	United States
14	NCT05067127 (ClinicalTrials.gov)	November 12, 2021	23/9/2021	Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis	A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis	C3G;IC-MPGN;C3 Glomerulopathy;C3 Glomerulonephritis;Complement 3 Glomerulopathy;Complement 3 Glomerulopathy (C3G);Complement 3 Glomerulonephritis;Dense Deposit Disease;DDD;Membranoproliferative Glomerulonephritis;Membranoproliferative Glomerulonephritis (MPGN);Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)	Drug: Pegcetacoplan;Other: Placebo	Apellis Pharmaceuticals, Inc.	NULL	Recruiting	12 Years	N/A	All	90	Phase 3	Spain;Switzerland;United States;Australia;Belgium;France;Italy;Netherlands;Poland
15	ChiCTR2100048518	2021-10-31	2021-07-09	A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy	A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy	idiopathic membranous nephropathy	low-dose multi-target group:No;tacrolimus combined with belimumab sequential group:No;intravenous cyclophosphamide pulse group:No;	The Second Affiliated Hospital of Xi'an Jiaotong University	NULL	Pending	18	70	Both	low-dose multi-target group:100;tacrolimus combined with belimumab sequential group:100;intravenous cyclophosphamide pulse group:100;		China
16	NCT04893096 (ClinicalTrials.gov)	October 22, 2021	11/5/2021	Rescue Therapy With the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients With Membranous Nephropathy Who Failed Anti-CD20 Target Therapy	Rescue Therapy With the Human Anti-CD38 Antibody MOR202 (Felzartamab) in Patients With Membranous Nephropathy Who Failed Anti-CD20 Target Therapy	Membranous Nephropathy	Drug: MOR202	Mario Negri Institute for Pharmacological Research	MorphoSys AG	Active, not recruiting	18 Years	N/A	All	10	Phase 2	Italy
17	EUCTR2020-000971-18-NO (EUCTR)	28/06/2021	23/02/2021	A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effect	An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003	Idiopathic membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	18	Phase 2	Denmark;Norway
18	EUCTR2020-002637-15-FR (EUCTR)	09/06/2021	02/02/2021	Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN	AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE	complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy
19	EUCTR2020-002637-15-IT (EUCTR)	09/04/2021	04/06/2021	Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN	An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE	complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Pegcetacoplan Product Code: [APL-2] INN or Proposed INN: Pegcetacoplan Trade Name: Prevenar 13 suspension for injection Product Name: Prevenar 13 suspension for injection Product Code: [na] INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg Trade Name: Pneumococcal polysaccharide vaccine Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial Product Code: [na] INN or Proposed INN: Pneumococcal Polysaccharide Vaccine Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide	APELLIS PHARMACEUTCIALS, INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States
20	EUCTR2020-002637-15-AT (EUCTR)	01/04/2021	23/12/2020	Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN	AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE	complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	France;United States;Argentina;Spain;Brazil;Australia;Austria;Netherlands;United Kingdom;Italy;Switzerland
21	EUCTR2020-002637-15-NL (EUCTR)	29/03/2021	04/01/2021	Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN	An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN - NOBLE	complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	France;United States;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Italy;Switzerland;United Kingdom
22	NCT02399462 (ClinicalTrials.gov)	March 2021	8/1/2015	Acthar for Treatment of Post-transplant FSGS	Acthar for Treatment of Post-transplant FSGS	FSGS;Renal Transplantation;Kidney Transplantation	Drug: Acthar	University of North Carolina, Chapel Hill	Mallinckrodt	Withdrawn	18 Years	N/A	All	0	Phase 4	United States
23	ChiCTR2000037508	2021-01-01	2020-08-28	To build a precise diagnosis and treatment system for membranous nephropathy based on the correlation between intestinal microecology and TCM tongue diagnosis	To build a precise diagnosis and treatment system for membranous nephropathy based on the correlation between intestinal microecology and TCM tongue diagnosis	CKD MN	Healthy Volunteer Group:NO;MN group:Yiqi Huoxue Huashi Recipe;	Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	NULL	Pending	18	75	Both	Healthy Volunteer Group:50;MN group:100;		China
24	ITMCTR2000004026	2021-01-01	2020-08-28	To build a precise diagnosis and treatment system for membranous nephropathy based on the correlation between intestinal microecology and TCM tongue diagnosis	To build a precise diagnosis and treatment system for membranous nephropathy based on the correlation between intestinal microecology and TCM tongue diagnosis	CKD MN	MN group:Yiqi Huoxue Huashi Recipe;Healthy Volunteer Group:NO;	Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	NULL	Pending	18	75	Both	MN group:100;Healthy Volunteer Group:50;		China
25	EUCTR2020-002637-15-GB (EUCTR)	22/12/2020	23/10/2020	Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGN	AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE	complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: Pegcetacoplan	Apellis Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Switzerland;Italy;United Kingdom
26	EUCTR2020-002985-15-DE (EUCTR)	21/12/2020	31/08/2020	Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)	A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE	Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087	MorphoSys AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	22	Phase 2	France;Taiwan;Hong Kong;Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
27	EUCTR2019-003607-35-CZ (EUCTR)	26/11/2020	26/11/2020	A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)	A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)	Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]	Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 2	United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Romania;Germany;Japan
28	EUCTR2019-003607-35-SK (EUCTR)	12/11/2020	09/10/2020	A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)	A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)	Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]	Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 2	United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan
29	EUCTR2019-003607-35-DE (EUCTR)	26/10/2020	02/10/2020	A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)	PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)	Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]	Product Name: PF-06730512 Product Code: PF-06730512 INN or Proposed INN: PF-06730512 Other descriptive name: PF-06730512	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 2	United States;Czechia;Slovakia;Thailand;Spain;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Germany;Japan
30	EUCTR2020-002985-15-GR (EUCTR)	22/10/2020	11/09/2020	Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)	A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE	Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087	Human Immunology Biosciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	22	Phase 2	Greece;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
31	EUCTR2020-002985-15-GB (EUCTR)	12/10/2020	25/08/2020	Open-label, 2-arm, multicenter clinical trial to assess safety, efficacy and PK/PD of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN)	A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE	Anti-PLA2R antibody positive membranous nephropathy (aMN) MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: MOR202 INN or Proposed INN: not yet assigned Other descriptive name: MOR03087	MorphoSys AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	22	Phase 2	Taiwan;Greece;Australia;Russian Federation;Georgia;Germany;United Kingdom;Korea, Republic of
32	EUCTR2019-001212-29-DK (EUCTR)	26/08/2020	09/06/2020	Causes and prevention of thrombosis developed due to the kidney disease nephrotic syndrome	Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome	Nephrotic syndrome is defined as severe proteinuria (> 0.5 g / day), edema and hypoalbuminemia. It is conditioned by a defect in the kidney's glomerular filtration barrier, resulting in the loss of a large number of plasma proteins including coagulation factors and consequently a increased risk of thromboembolic complications. The most frequent cause of nephrotic syndrome is the renal disease membranous nephropathy, which is associated with the greatest risk of thromboembolic complications. MedDRA version: 21.1;Level: LLT;Classification code 10029167;Term: Nephrotic syndrome with lesion of membranous glomerulonephritis;System Organ Class: 100000004857 MedDRA version: 20.0;Classification code 10029165;Term: Nephrotic syndrome in diseases classified elsewhere;System Organ Class: 100000004857;Therapeutic area: Not possible to specify	Trade Name: Fragmin INN or Proposed INN: Dalteparin Other descriptive name: Dalteparin Trade Name: Eliquis INN or Proposed INN: Apixaban Other descriptive name: Apixaban	Aarhus University Hospital, Henrik Birn	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 1;Phase 2	Denmark
33	NCT04498962 (ClinicalTrials.gov)	August 2020	21/7/2020	The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial	The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial	Chronic Stable Angina;Vascular Dementia;Idiopathic Membranous Nephropathy	Drug: Danzhu Fuyuan Granule	Jingqing Hu	NULL	Not yet recruiting	18 Years	70 Years	All	240	N/A	China
34	ChiCTR2000033540	2020-06-01	2020-06-04	Prospective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous Nephropathy	Prospective Randomized Trial on Efficacy of Rituximab Combined Therapy and Supportive Therapy on Early-Stage Non-Nephrotic Primary Membranous Nephropathy	Membranous Nephropathy	experimental group:Rituximab 600mg iv, and supportive treatment;control group:Supportive treatment according to KDIGO guideline;	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	NULL	Recruiting	18	70	Both	experimental group:19;control group:19;	Phase 4	China
35	EUCTR2020-000971-18-DK (EUCTR)	28/05/2020	04/04/2020	A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effect	An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003	Idiopathic membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	18	Phase 2	Denmark
36	EUCTR2019-001734-34-NL (EUCTR)	07/04/2020	22/08/2019	Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.	A randomized, open-label, two-arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy	Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	52	Phase 2	United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Argentina;Singapore;Netherlands;Germany;China
37	NCT04154787 (ClinicalTrials.gov)	November 23, 2019	8/10/2019	Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy	A Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous Nephropathy	Glomerulonephritis, Membranous	Drug: LNP023;Drug: Rituximab	Novartis Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	37	Phase 2	Argentina;China;Czechia;Germany;India;Netherlands;Spain;Taiwan;United Kingdom;France;Singapore;United States
38	EUCTR2019-001734-34-ES (EUCTR)	12/11/2019	04/09/2019	Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.	A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.	Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Rituximab INN or Proposed INN: RITUXIMAB	Novartis Farmacéutica, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
39	EUCTR2019-001734-34-DE (EUCTR)	30/10/2019	12/09/2019	Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.	A randomized, open-label, two arm, parallel group, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.	Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	52	Phase 2	United States;Czechia;Taiwan;Spain;Russian Federation;United Kingdom;India;France;Czech Republic;Argentina;Singapore;Germany;Netherlands;China
40	EUCTR2019-000780-24-ES (EUCTR)	25/10/2019	26/07/2019	Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy	A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE	Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087	MorphoSys AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 1;Phase 2	France;United States;European Union;Spain;Netherlands
41	EUCTR2019-001734-34-FR (EUCTR)	23/10/2019	13/09/2019	Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.	A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.	Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
42	EUCTR2017-003022-32-PL (EUCTR)	12/10/2019	20/08/2019	An open, dose escalation study in patients with Primary Focal Segmental Glomerulosclerosis (FSGS - a type of glomerular disease causes scarring in the kidney) and Nephrotic Syndrom (collection of symptoms due to kidney damage)	An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome	Primary Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CCX140-B INN or Proposed INN: not available yet	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	13	Phase 2	United States;France;Canada;Poland;United Kingdom
43	EUCTR2019-000780-24-IT (EUCTR)	08/10/2019	22/01/2020	Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy	A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE	Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087	MorphoSys AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 1;Phase 2	France;United States;European Union;Spain;Netherlands;Italy
44	JPRN-UMIN000038242	2019/10/01	09/10/2019	The effect of Evolocumab on primary nephrotic syndrome	The effect of Evolocumab on primary nephrotic syndrome - The effect of Evolocumab on primary nephrotic syndrome	Primary nephrotic syndrome	Evolocumab	Department of Nephrology, Nippon Medical School	NULL	Recruiting	16years-old	Not applicable	Male and Female	10	Not selected	Japan
45	EUCTR2019-000780-24-NL (EUCTR)	24/09/2019	03/07/2019	Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy	A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE	Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087	MorphoSys AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 1;Phase 2	France;United States;European Union;Poland;Spain;Australia;Netherlands;Italy;Korea, Republic of
46	EUCTR2019-001734-34-GB (EUCTR)	23/09/2019	07/08/2019	Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.	A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.	Idiopathic Membranous nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: MabThera 500 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB Trade Name: MabThera 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72	Phase 2	United States;France;Czech Republic;Argentina;Spain;Singapore;Russian Federation;Netherlands;Germany;United Kingdom;India
47	EUCTR2019-000780-24-FR (EUCTR)	23/09/2019	15/10/2019	Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous Nephropathy	A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE	Primary (anti-PLA2R antibody positive) Membranous Nephropathy MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: MOR202 Product Code: MOR202 INN or Proposed INN: No INN assigned yet Other descriptive name: MOR03087	MorphoSys AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;France;European Union;Spain;Netherlands
48	EUCTR2018-004611-50-GB (EUCTR)	14/06/2019	11/04/2019	The Use of Rituximab IN treatment of immune-mediated Glomerulonephritis (TURING)	A randomised, two-arm (1:1 ratio), double blind, placebo controlled phase III trial to assess the efficacy, safety, cost and cost-effectiveness of rituximab in treating de novo or relapsing NS in patients with MCD/FSGS (TURING) - TURING	Minimal Change Disease (MCD) and Focal segmental glomerulosclerosis (FSGS)	Product Name: Rituximab INN or Proposed INN: Rituximab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	112	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Kingdom
49	EUCTR2018-002476-40-FR (EUCTR)	07/05/2019	14/08/2018	Personalized Medicine for Membranous Nephropathy PMMN	Personalized Medicine for Membranous Nephropathy PMMN - PMMN	Idiopathic Membranous Nephropathy MedDRA version: 20.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Trade Name: TRUXIMA Product Name: TRUXIMAB	CHU de Nice	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	64	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France
50	EUCTR2018-003437-15-FR (EUCTR)	03/04/2019	27/02/2019	Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome	Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome - RIFIREINS	Minimal Change Nephrotic Syndrome (MCNS) MedDRA version: 20.0;Level: LLT;Classification code 10029168;Term: Nephrotic syndrome with lesion of minimal change glomerulonephritis;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	148	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France
51	EUCTR2017-002674-39-NL (EUCTR)	30/01/2019	18/07/2018	A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)	An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471	biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2 MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471	Achillion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	United States;Belgium;Australia;Netherlands;Italy
52	NCT03864250 (ClinicalTrials.gov)	November 26, 2018	4/3/2019	Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy	Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial	Tacrolimus;Idiopathic Membranous Nephropathy;Clinical Trial	Drug: Tacrolimus;Drug: Prednisone	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	NULL	Recruiting	18 Years	80 Years	All	124	N/A	China
53	EUCTR2017-003021-15-GB (EUCTR)	23/10/2018	14/03/2018	A study in which the safety and efficacy of CCX140-B is compared with placebo in patients with Focal Segmental Glomerulosclerosis	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS)	Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CCX140-B	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;United States;Czech Republic;Canada;Poland;Australia;Germany;New Zealand;Italy;United Kingdom
54	NCT03448692 (ClinicalTrials.gov)	October 15, 2018	22/2/2018	A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)	A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)	Focal Segmental Glomerulosclerosis (FSGS)	Drug: PF-06730512	Pfizer	NULL	Active, not recruiting	18 Years	N/A	All	35	Phase 2	United States;Canada;Czechia;France;Germany;Italy;Japan;Mexico;Poland;Slovakia;Spain;United Kingdom
55	EUCTR2016-005141-23-HU (EUCTR)	29/08/2018	26/06/2018	Effectiveness and Safety of Sparsentan as treatment for Primary Focal Segmental Glomerulosclerosis (FSGS)	A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)	Focal segmental glomerulosclerosis (FSGS) MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN Trade Name: Irbesartan tablets (Approved in the USA. Reference listed drug Avapro) NDC # 43547-0374-03 Product Name: over-encapsulated 75 mg Irbesartan Tablets INN or Proposed INN: Irbesartan Other descriptive name: IRBESARTAN	Retrophin, Inc.	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Estonia;Taiwan;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;South Africa;Germany;Sweden;Korea, Republic of
56	EUCTR2017-002674-39-IT (EUCTR)	03/08/2018	08/06/2021	A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (ICMPGN)	An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 - N/A	C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) MedDRA version: 20.1;Level: PT;Classification code 10018364;Term: Glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ACH-0144471 compresse Product Code: ACH-0144471 INN or Proposed INN: ACH-0144471 Product Name: ACH-0144471 compresse Product Code: ACH-0144471 INN or Proposed INN: ACH-0144471 Product Name: ACH0144471 compresse Product Code: ACH0144471 INN or Proposed INN: ACH-0144471 Trade Name: TETRACT-HIB - 1 SIRINGA PRECARICATA 0.5 ML Product Name: ACT-HIB Product Code: [ACT-HIB] Product Name: Bexsero Product Code: [Bexsero] Product Name: Menveo Product Code: [Menveo] Trade Name: PREVENAR 13 - 0.5 ML SOSPENSIONE INIETTABILE - USO INTRAMUSCOLARE - FLACONCINO MONODOSE (0,5 ML VETRO TIPO I) - 1 FLACONCINO MONODOSE Product Name: Prevenar 13 Product Code:	ACHILLION PHARMACEUTICALS, INC.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	United States;Belgium;Australia;Netherlands;Italy
57	EUCTR2017-001821-42-GB (EUCTR)	02/08/2018	12/09/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy	C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN	ChemoCentryx, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	88	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Canada;Belgium;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom
58	EUCTR2017-002674-39-BE (EUCTR)	31/07/2018	16/05/2018	A treatment study of ACH-0144471 in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)	An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471	biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and eGFR >30 mL/min/1.73 m^2 MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471	Achillion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	United States;Belgium;Australia;Netherlands;Italy
59	EUCTR2017-003021-15-IT (EUCTR)	04/07/2018	10/11/2020	A study to evaluate the efficacy og CCX140-B in patients with FSGS	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) - NA	Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: - Product Code: [CCX140-B]	CHEMOCENTRYX, INC.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;France;Czechia;Canada;Poland;Australia;Germany;United Kingdom;New Zealand;Italy
60	EUCTR2016-003525-42-NL (EUCTR)	26/06/2018	09/01/2018	A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)	A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)	biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471	Achillion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	10	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Belgium;Australia;Netherlands
61	EUCTR2017-003021-15-PL (EUCTR)	19/06/2018	18/05/2018	A controlled study to evaluate the safety and efficacy of the study drug, CCX140-B, in subjects with Focal Segmental Glomerulosclerosis (a type of glomerular disease)	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS)	Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CCX140-B INN or Proposed INN: INN not available yet	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;United States;Czech Republic;Canada;Poland;Australia;Germany;New Zealand;Italy;United Kingdom
62	EUCTR2017-003021-15-FR (EUCTR)	18/05/2018	13/03/2018	Study to determine the dose CCX140-B and to evaluate the its safety and efficacy of in Subjects with Focal Segmental Glomerulosclerosis (FSGS)	A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS)	Focal Segmental Glomerulosclerosis (FSGS) MedDRA version: 20.0;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CCX140-B	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;France;Czech Republic;Canada;Poland;Australia;Germany;New Zealand;Italy;United Kingdom
63	NCT03493685 (ClinicalTrials.gov)	April 17, 2018	3/4/2018	Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)	A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS	Focal Segmental Glomerulosclerosis	Drug: sparsentan;Drug: Irbesartan	Travere Therapeutics, Inc.	NULL	Active, not recruiting	8 Years	75 Years	All	371	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Italy;Korea, Republic of;New Zealand;Poland;Portugal;Spain;Sweden;Taiwan;United Kingdom;Hungary
64	EUCTR2017-001821-42-NL (EUCTR)	13/02/2018	16/10/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy	C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	France;United States;Canada;Spain;Belgium;Ireland;Denmark;Germany;Netherlands;United Kingdom;Italy
65	ChiCTR1800014719	2018-02-01	2018-01-31	A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis	A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis	idiopathic focal segmental glomerulosclerosis	tacrolimus group:nothing;prednisone group:nothing;	the First Affiliated Hospital of Third Military Medical University	NULL	Recruiting			Both	tacrolimus group:24;prednisone group:17;		China
66	NCT03453619 (ClinicalTrials.gov)	January 22, 2018	27/2/2018	Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies	A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease)	IgA Nephropathy;Lupus Nephritis;Membranous Nephropathy;C3 Glomerulonephritis;Dense Deposit Disease	Drug: APL-2	Apellis Pharmaceuticals, Inc.	NULL	Active, not recruiting	18 Years	N/A	All	21	Phase 2	United States
67	EUCTR2017-001821-42-BE (EUCTR)	15/01/2018	06/10/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy	C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
68	EUCTR2017-001821-42-DK (EUCTR)	19/12/2017	25/10/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy	C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
69	EUCTR2017-001821-42-IE (EUCTR)	01/12/2017	09/01/2018	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy	C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
70	EUCTR2017-001821-42-DE (EUCTR)	22/11/2017	09/10/2017	A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy	C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
71	EUCTR2017-001821-42-FR (EUCTR)	06/11/2017	09/11/2017	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy	C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN). MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: AVACOPAN	ChemoCentryx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Netherlands;Germany;United Kingdom;Italy
72	NCT03180723 (ClinicalTrials.gov)	July 1, 2017	3/6/2017	Effect of Rituximab in Treatment of Membranoproliferative Glomerulonephritis	Effect of Rituximab in Treatment of Primary Membranoproliferative Glomerulonephritis	Membranoproliferative Glomerulonephritis	Drug: Rituximab;Drug: Cyclosporin	Assiut University	NULL	Not yet recruiting	18 Years	N/A	All	30	Phase 3	NULL
73	NCT02921789 (ClinicalTrials.gov)	May 22, 2017	30/9/2016	Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients	A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients	Kidney Transplantation;Primary Focal Segmental Glomerulosclerosis (FSGS)	Drug: Bleselumab;Drug: Basiliximab;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus Capsules;Drug: Methylprednisone;Drug: Prednisone	Astellas Pharma Global Development, Inc.	Kyowa Kirin Co., Ltd.	Completed	18 Years	N/A	All	67	Phase 2	United States;Canada
74	NCT02966717 (ClinicalTrials.gov)	August 2016	30/10/2016	Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD)	The Clinical Study of Rituximab Combined With Mesenchymal Stem Cells in the Treatment of Primary Nephrotic Syndrome (3-4 Stage of Chronic Kidney Disease)	Renal Insufficiency, Chronic;Nephrotic Syndrome	Drug: Rituximab;Drug: conventional therapy;Drug: Mesenchymal stem cells	Zhujiang Hospital	NULL	Active, not recruiting	18 Years	65 Years	Both	116	Phase 2	China
75	JPRN-UMIN000022150	2016/04/30	01/05/2016	The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome.	The prospective single-center study on the efficacy and safety of rituximab for the treatment of adult and geriatric patients with primary nephrotic syndrome. - The study on efficacy and safety of rituximab for adult and geriatric patients with nephrotic syndrome.	primary nephrotic syndrome	rituximab	Tokyo Metropolitan Geriatric Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	50	Not applicable	Japan
76	NCT02592798 (ClinicalTrials.gov)	March 1, 2016	29/10/2015	Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)	A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change Disease)	Nephrotic Syndrome;Focal Segmental Glomerulosclerosis;Minimal Change Disease	Drug: Abatacept;Other: Normal Saline;Other: D5W	Bristol-Myers Squibb	NULL	Completed	6 Years	N/A	All	36	Phase 2	United States
77	NCT02610595 (ClinicalTrials.gov)	December 2015	18/11/2015	Study on the Therapeutic Effect of TCM Treatment for MDR MN	A Prospective, Multi-center Study of the Chinese Medicine for the Treatment of MDR Membranous Nephropathy in the Traditional Chinese Medicine (a Herbal Formula for Invigorating Spleen and Benefiting qi and Promoting Blood Circulation)	Idiopathic Membranous Nephropathy	Drug: Jianpixiaozhong particles and Wuse Dietotherapy	Shanghai University of Traditional Chinese Medicine	Fudan University;Ruijin Hospital;Shanghai 6th People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Changhai Hospital;Shanghai Putuo District Center Hospital;ShuGuang Hospital;Shanghai Yueyang Integrated Medicine Hospital;Shanghai Changzheng Hospital;Shanghai Minhang Central Hospital;Zhujiang Hospital;Guangxi Traditional Chinese Medical University;Huashan Hospital;The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine;Xinqiao Hospital of Chongqing;Guang'anmen Hospital of China Academy of Chinese Medical Sciences;Nanjing University of Traditional Chinese Medicine;Tongji Hospital;Chinese Academy of Sciences;RenJi Hospital	Not yet recruiting	18 Years	75 Years	Both	220	N/A	China
78	NCT02585804 (ClinicalTrials.gov)	September 2015	22/10/2015	Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects	Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects: The TRANSLATE Study	Focal Segmental Glomerulosclerosis	Drug: Dapagliflozin	University Health Network, Toronto	AstraZeneca;University of Toronto;Toronto General Hospital	Completed	18 Years	N/A	All	10	Phase 4	Canada
79	NCT01613118 (ClinicalTrials.gov)	March 2014	4/6/2012	Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis	Efficacy and Safety of RE-021, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study	Focal Segmental Glomerulosclerosis	Drug: RE-021 (Sparsentan);Drug: Irbesartan	Travere Therapeutics, Inc.	NULL	Active, not recruiting	8 Years	75 Years	All	109	Phase 2	United States;Czechia;Italy;Belgium;Czech Republic
80	EUCTR2013-003826-10-IT (EUCTR)	24/01/2014	28/10/2013	ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS	EVALUATING THE MORPHOFUNCTIONAL EFFECTS OF ECULIZUMAB THERAPY IN PRIMARY MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS: A PILOT, SINGLE ARM STUDY IN TEN PATIENTS WITH PERSISTENT HEAVY PROTEINURIA - Eculizumab in primary MPGN	Membranoproliferative glomerulonephritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB	IRCCS- Mario Negri Institute	NULL	Not Recruiting			Female: yes Male: yes	10	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Italy
81	EUCTR2012-002365-35-DE (EUCTR)	15/07/2013	11/03/2013	A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)	A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis	Focal segmental glomerulosclerosis MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Product Name: Fresolimumab Product Code: GC1008 INN or Proposed INN: Fresolimumab Other descriptive name: GZ402669	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	125	Phase 2	France;United States;Brazil;Spain;Germany;Italy
82	EUCTR2012-002365-35-IT (EUCTR)	22/05/2013	20/03/2013	A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)	A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis	Focal segmental glomerulosclerosis MedDRA version: 15.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Product Name: Fresolimumab Product Code: GC1008 INN or Proposed INN: Fresolimumab Other descriptive name: GZ402669	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	125	Phase 2	France;United States;Brazil;Spain;Germany;Italy
83	EUCTR2012-002365-35-ES (EUCTR)	19/04/2013	09/04/2013	A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)	A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis	Focal segmental glomerulosclerosis MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Product Name: Fresolimumab Product Code: GC1008 INN or Proposed INN: Fresolimumab Other descriptive name: GZ402669	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	125	Phase 2	France;United States;Brazil;Spain;Germany;Italy
84	EUCTR2011-000242-38-CZ (EUCTR)	14/02/2013	13/11/2012	A 2 year study to investigate belimumab in membranous nephropathy	BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy	Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	94		United States;France;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;United Kingdom;Italy
85	EUCTR2011-000242-38-DE (EUCTR)	09/01/2013	25/09/2012	A 2 year study to investigate belimumab in membranous nephropathy	BEL114674: A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy	Idiopathic Membranous Nephropathy (IMN) MedDRA version: 16.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	94		France;United States;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;Italy;United Kingdom
86	EUCTR2011-000242-38-ES (EUCTR)	20/12/2012	22/10/2012	A 2 year study to investigate belimumab in membranous nephropathy	A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy	Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB	GlaxoSmithKline, S.A.	NULL	Not Recruiting			Female: yes Male: yes	94		United States;France;Czech Republic;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
87	EUCTR2011-000242-38-IT (EUCTR)	22/11/2012	11/12/2012	A 2 year study to investigate belimumab in membranous nephropathy	A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy	Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA INN or Proposed INN: BELIMUMAB	GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.	NULL	Not Recruiting			Female: yes Male: yes	94		United States;Czech Republic;Canada;Spain;Germany;United Kingdom;Italy
88	EUCTR2011-000242-38-GB (EUCTR)	01/11/2012	03/10/2012	A 2 year study to investigate belimumab in membranous nephropathy	BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy	Idiopathic Membranous Nephropathy (IMN) MedDRA version: 15.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	94	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Czech Republic;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
89	JPRN-UMIN000008919	2012/09/15	14/09/2012	The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy.	The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy. - The study on efficacy and safety of mizoribine for the aged patients with membranous nephropathy.	The patients with nephrotic syndrome due to primary membranous nephropathy.	Treatment with a combination of mizoribine plus steroid therapy Treatment with steroid monotherapy	The study group of treatment for aged patients with nephrotic syndrome.	NULL	Complete: follow-up complete	65years-old	Not applicable	Male and Female	200	Not applicable	Japan
90	EUCTR2012-000385-38-GB (EUCTR)	18/05/2012	02/04/2012	A study to investigate belimumab in IMGN	BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy	Idiopathic Membranous Glomerulonephropathy (IMGN) MedDRA version: 16.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA® (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: Belimumab	GlaxoSmithKline Research and Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	18	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
91	NCT01508468 (ClinicalTrials.gov)	January 17, 2012	9/12/2011	Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy	Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN)	Idiopathic Membranous Nephropathy	Drug: symptomatic treatment (Converting Enzyme inhibitor, Angiotensin II, Anti-renin, Aldosterone antagonist diuretic, Beta blocker, Calcium inhibitor, statin);Drug: experimental (Non Immunosuppressive Symptomatic Treatment (NIST) and Rituximab)	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	All	80	Phase 3	France
92	NCT03018535 (ClinicalTrials.gov)	January 2012	9/1/2017	Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy	A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy	Glomerulonephritis, Membranous	Drug: Rituximab;Drug: Methylprednisolone;Drug: Cyclophosphamide	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	University of Bari;Azienda Ospedaliera Brotzu;University of Messina;University of Milan;Universita di Verona;University of Chieti;University of Bologna;Azienda Sanitaria Locale Roma E;Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi;Regione Piemonte;University of Modena and Reggio Emilia;University of Pisa;University of Milano Bicocca;Humanitas Hospital, Italy;Azienda Ospedaliera Universitaria Policlinico;Fondazione Salvatore Maugeri;University of Bern;University of Alberta;Istituto Giannina Gaslini	Active, not recruiting	18 Years	N/A	All	76	Phase 3	Italy
93	NCT01180036 (ClinicalTrials.gov)	November 2011	10/8/2010	MEmbranous Nephropathy Trial Of Rituximab	A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)	Idiopathic Membranous Nephropathy	Drug: Rituximab;Drug: Cyclosporine	Mayo Clinic	Columbia University;University of British Columbia;Ohio State University;Stanford University;University of Washington;University of Michigan;University of Alabama at Birmingham;Case Western Reserve University;The Cleveland Clinic;University of Kansas Medical Center;University of Manchester;University Health Network, Toronto;University of Toronto;CHU de Quebec-Universite Laval;Washington University School of Medicine;Florida International University;University of Mississippi Medical Center;NYU Langone Health;Medical College of Wisconsin;University of Arizona;Sunnybrook Health Sciences Centre;Applied Health Research Centre;Fulk Family Foundation	Completed	18 Years	80 Years	All	130	Phase 2/Phase 3	United States;Canada
94	NCT01845688 (ClinicalTrials.gov)	November 2011	29/4/2013	Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy	Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study	Idiopathic Membranous Nephropathy	Drug: Losartan Tablets & QingReMoShen Granule;Drug: Losartan Tablets & Placebo Granule	wanglin	NULL	Active, not recruiting	18 Years	70 Years	Both	72	N/A	China
95	NCT01093781 (ClinicalTrials.gov)	November 2010	24/3/2010	Aliskiren in Patients With Idiopathic Membranous Nephropathy	A Pilot Study to Evaluate the Antiproteinuric Effect of Renin Inhibition With Aliskiren in Patients With Idiopathic Membranous Nephropathy	Idiopathic Membranous Nephropathy	Drug: Aliskiren	Mayo Clinic	NULL	Withdrawn	18 Years	80 Years	Both	0	N/A	United States
96	EUCTR2009-016003-26-GB (EUCTR)	06/05/2010	17/03/2010	RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic	RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic	Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders	Trade Name: Myfortic Product Name: Myfortic 360mg Tablets INN or Proposed INN: mycophenolic acid Other descriptive name: mycophenolate sodium Trade Name: Myfortic Product Name: Myfortic 180mg Tablets INN or Proposed INN: mycophenolic sodium Other descriptive name: mycophenolate sodium Product Name: Prednisolone INN or Proposed INN: prednisolone	UHB NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United Kingdom
97	NCT01197040 (ClinicalTrials.gov)	October 2009	7/9/2010	Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome	Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome	Nephrotic Syndrome	Drug: Prednisone;Drug: acid mycophenolic (Myfortic)	Assistance Publique - Hôpitaux de Paris	Novartis	Completed	18 Years	N/A	All	117	Phase 3	France
98	NCT00956059 (ClinicalTrials.gov)	September 2009	10/8/2009	Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis	Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis	Focal Segmental Glomerulosclerosis	Drug: prednisone, FK506, MMF;Drug: prednisone	Xi’an Jiaotong University College of Medicine	NULL	Not yet recruiting	16 Years	70 Years	Both	40	N/A	China
99	NCT01129557 (ClinicalTrials.gov)	September 2009	21/5/2010	Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease	Aldosterone Breakthrough During Diovan (Valsartan), Tekturna (Aliskiren), and Combination (Valsartan+Aliskiren) Anti-hypertensive Therapy in Patients With Proteinuric Kidney Disease	Proteinuric Kidney Disease;Diabetic Nephropathy;Hypertensive Nephrosclerosis;IgA Nephropathy;Focal Segmental Glomerulosclerosis;Glomerulopathy (Obesity-associated);Glomerulonephritis, Membranous	Drug: Aliskiren;Drug: Valsartan	Columbia University	Novartis Pharmaceuticals	Terminated	18 Years	N/A	All	46	Phase 4	United States
100	EUCTR2008-006750-17-IT (EUCTR)	14/04/2009	27/01/2009	A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO	A prospective, sequential study to assess the efficacy of rituximab therapy in maintaining remission of nephrotic syndrome after steroid and immunosuppressive therapy withdrawal in patients with steroid-dependant or multirelapsing minimal change disease or focal segmental glomerulosclerosis - NEMO	Nephrotic Syndrome secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS. MedDRA version: 9.1;Level: LLT;Classification code 10029171 MedDRA version: 9.1;Classification code 10058326 MedDRA version: 9.1;Classification code 10016832	Trade Name: MABTHERA INN or Proposed INN: Rituximab Trade Name: MABTHERA INN or Proposed INN: Rituximab	IST. DI RICERCHE FARMACOLOG. M. NEGRI	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Italy
101	NCT00816478 (ClinicalTrials.gov)	December 2008	31/12/2008	Effect of Oral Galactose on Focal Segmental Glomerulosclerosis (FSGS) Permeability Factor	Effect of Galactose on Permeability Factor in Patients With Focal Segmental Glomerulosclerosis (FSGS)	Focal Segmental Glomerulosclerosis	Drug: Galactose	North Shore Long Island Jewish Health System	NULL	Terminated	2 Years	60 Years	Both	15	Phase 1	United States
102	NCT00816504 (ClinicalTrials.gov)	December 2008	31/12/2008	Effect of Galactose on Permeblity Factor in Patients With FSGS and CKD Stage 5	Effect of Galactose on Permeability Factor in Patients With Focal Segmental Glomerulosclerosis (FSGS)and Chronic Kidney Disease Stage 5	Focal Segmental Glomerulosclerosis	Drug: Galactose	North Shore Long Island Jewish Health System	Medical College of Wisconsin	Withdrawn	2 Years	60 Years	Both	0	Phase 1	United States
103	NCT00814255 (ClinicalTrials.gov)	December 2008	22/12/2008	Novel Therapies for Resistant FSGS (FONTII): Phase II Clinical Trial	Novel Therapies for Resistant Focal Segmental Glomerulosclerosis	Focal Segmental Glomerulosclerosis	Drug: Adalimumab;Drug: Lisinopril, losartan, and atorvastatin;Drug: galactose	New York University School of Medicine	University of Michigan;The Cleveland Clinic;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	1 Year	65 Years	All	32	Phase 2	United States;Canada
104	JPRN-UMIN000000963	2007/10/01	01/01/2010	Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome	Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome - Cyclosporine for MCNS	Minimal change nephrotic syndrome	administration of cyclosporine	Yoshihiko Saito	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	30	Not applicable	Japan
105	JPRN-UMIN000001099	2007/10/01	31/03/2008	Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome	Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome - Optimal use of ciclosporin in membranous nephropathy (OCIM-NS study)	idiopathic membranous nephropathy associated with nephrotic syndrome	Steroid group: Immunosuppressive therapy is started by predonisolone 0.8mg/kg/day (max 60mg/day). The dose is decreased by 5mg/day in 2 to 4 weeks after remission. The cases who do not reach remission for 4 weeks, predonisolone is decreased to 0.6mg/kg/day, and ciclosporin (2mg/kg/day) is started once a day. Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.) Steroid + ciclosporin group: Immunosupressive therapy is started by predonisolone 0.6mg/kg/day and ciclosporin 2mg/kg/day (once a day). Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.) The dose of predonisolone is decreased by 5mg/day in 2 to 4 weeks after remission. Ciclosporin is continued after remission. (The target C2 is 600-800 ng/mL.) The cases who do not reach remission after 4 weeks, predonisolone is decreased by 5mg/4-8week, and ciclosporin is continued for 6 months. The target C2 is 800-1000ng/mL. At 6 months after, the therapy of non-respnder is not restricted.	Division of Kidney and Dialysis, Department of Internal Medicine,Hyogo College of Medicine	NULL		16years-old	Not applicable	Male and Female	50	Phase 4	Japan
106	NCT00479622 (ClinicalTrials.gov)	August 2007	25/5/2007	Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus	A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: TRU-015	Wyeth is now a wholly owned subsidiary of Pfizer	Emergent Product Development Seattle LLC	Terminated	18 Years	70 Years	Both	20	Phase 1	United States
107	JPRN-UMIN000000621	2007/03/01	28/02/2007	Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission	Okayama nephrotic syndrome treatment group: Study group for short-term combination therapy of angiotensin-2 receptor blocker and cyclosporine for keeping remission - ONTRACK	Minimal change nephrotic syndrome	Prednisolone (+), combination therapy (-) Prednisolone (+), combination therapy (+)	Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	50	Not selected	Japan
108	EUCTR2005-004460-22-BE (EUCTR)	12/05/2006	05/12/2005	Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to corticosteroids with ACE-inhibitors in the treatment of de novo nephrotic syndrome due to focal segmental glomerulosclerosis.	Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to corticosteroids with ACE-inhibitors in the treatment of de novo nephrotic syndrome due to focal segmental glomerulosclerosis.	focal and segmental glomerulosclerosis	Trade Name: Neoral Product Name: Neoral Trade Name: Medrol Product Name: Medrol Trade Name: zestril Product Name: zestril	Hopital Erasme	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		Belgium
109	EUCTR2005-004469-40-BE (EUCTR)	12/05/2006	05/12/2005	Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to ACE-inhibitors alone in the treatment of de novo nephrotic syndrome due to idiopathic membranous glomerulopathy	Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to ACE-inhibitors alone in the treatment of de novo nephrotic syndrome due to idiopathic membranous glomerulopathy	Membranous Nephropathy	Trade Name: Neoral Product Name: Neoral Trade Name: zestril Product Name: zestril	Hopital Erasme	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		Belgium
110	JPRN-C000000158	2006/03/01	01/04/2006	Mizoribin for primary nephrotic syndrome in children(JSRDC09)	Mizoribin for primary nephrotic syndrome in children(JSRDC09) - Mizoribin for primary nephrotic syndrome in children(JSRDC09)	Steroid-sensitive nephrotic syndrome	mizoribine+prednisolone	Japanese Study Group of Renal Disease in Children(JSRDC)	NULL	Complete: follow-up complete	1years-old	10years-old	Male and Female	50	Not selected	Japan
111	NCT00275613 (ClinicalTrials.gov)	November 2005	10/1/2006	Pilot Study of Rituximab for Membranoproliferative Glomerulonephritis	Pilot Study of Rituximab for Membranoproliferative Glomerulonephritis	Glomerulonephritis, Membranoproliferative	Drug: Rituximab	Mayo Clinic	NULL	Completed	18 Years	N/A	Both	10	Phase 1	United States
112	NCT00193648 (ClinicalTrials.gov)	July 2005	10/9/2005	Pilot Studies of Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis (FSGS)	Novel Therapies for Resistant FSGS	Focal Glomerulosclerosis	Drug: Rosiglitazone (Avandia);Drug: Adalimumab (Humira)	North Shore Long Island Jewish Health System	University of North Carolina;The Cleveland Clinic	Completed	2 Years	40 Years	Both	21	Phase 1	United States
113	JPRN-UMIN000004653	2005/01/01	02/12/2010	The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS	The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS - The effects of cyclosporine in onset MCNS	minimal change nephrotic syndrome	cyclosporine A 2-3mg/kg/day	Yokohama city university graduate school of medicine	NULL	Complete: follow-up continuing	16years-old	Not applicable	Male and Female	20	Not applicable	Japan
114	NCT00135811 (ClinicalTrials.gov)	November 2004	24/8/2005	Focal Segmental Glomerulosclerosis Clinical Trial (FSGS-CT)	Focal Segmental Glomerulosclerosis Clinical Trial	Glomerulosclerosis, Focal	Drug: Cyclosporin;Drug: MMF and Dexamethasone	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	The Cleveland Clinic	Completed	2 Years	40 Years	Both	207	Phase 3	United States
115	NCT00362531 (ClinicalTrials.gov)	November 2004	9/8/2006	Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome	Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome	Idiopathic Membranous Nephropathy;Nephrotic Syndrome	Drug: tacrolimus combined with prednisone	Peking University	NULL	Completed	18 Years	70 Years	Both		Phase 2/Phase 3	NULL
116	JPRN-C000000369	2004/04/01	27/03/2006	Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome	Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome - Combine therapy of prednisolone and cyclosporin in refractory nephrotic syndrome	membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome	CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks	Project team for treatment of refractory nephrotic syndrome	The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan	Complete: follow-up complete	16years-old	75years-old	Male and Female	300	Not selected	Japan
117	JPRN-C000000368	2004/04/01	27/03/2006	Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome	Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome - Combined therapy of prednisolone and mizoribine in membranous nephropathy with refractory nephrotic syndrome	membranous nephropathy with primary steroid resistant nephrotic syndrome	mizoribine once a day per os administration (150mg) after breakfast for 2years. mizoribine 3 times a day per os administration (50mg each) after meals for 2years.	Project team for treatment of refractory nephrotic syndrome	The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan	Complete: follow-up complete	16years-old	75years-old	Male and Female	100	Not selected	Japan
118	JPRN-C000000379	2001/04/01	01/04/2006	Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)	Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06) - Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome in children: A randomized controlled trial (JSRDC06)	Steroid-sensitive nephrotic syndrome	prednisolone mizoribine+prednisolone	Japanese Study Group of Renal Disease in Children(JSRDC)	NULL	Complete: follow-up complete	1years-old	10years-old	Male and Female	50	Not selected	Japan
119	EUCTR2021-004192-13-BE (EUCTR)		19/05/2022	R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis	A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis - R3R01 in Alport Syndrome Patients and Primary Steroid-Resistant Focal Segmental Glomerulosclerosis	Alport Syndrome (AS) and Primary Steroid-Resistent FocalSegmental Glomerulosclerosis (FSGS) MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify	Product Name: R3R01 INN or Proposed INN: not available Other descriptive name: R3R01	River 3 Renal, Corporation	NULL	NA			Female: yes Male: yes	50	Phase 2	France;United States;Belgium;Germany;Netherlands;United Kingdom
120	EUCTR2021-000621-27-DE (EUCTR)		08/09/2021	Safety, efficacy and pharmacokinetics of sparsentan in pediatric subjects with selected kidney diseases.	A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK). - EPPIK	Proteinuric glomerular diseases including:•Focal segmental glomerulosclerosis (FSGS) •Minimal change disease (MCD) •Immunoglobulin A nephropathy (IgAN) •Immunoglobulin A vasculitis (IgAV) •Alport syndrome (AS) MedDRA version: 21.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 22.1;Level: LLT;Classification code 10082959;Term: IgA vasculitis;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10058326;Term: Minimal change disease;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Sparsentan Product Code: RE-021 INN or Proposed INN: Sparsentan Other descriptive name: SPARSENTAN	Travere Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	57	Phase 2	France;United States;Spain;Poland;Netherlands;Germany;United Kingdom;Italy;Sweden
121	EUCTR2016-003525-42-BE (EUCTR)		30/10/2017	A treatment study of ACH-0144471 in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)	A Phase 2a Proof-of-Mechanism, Open-Label Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients with Low C3 Levels Due to Either C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)	biopsy-confirmed C3 Glomerulopathy (C3G) or idiopathic Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and a low serum C3 level MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471 Product Code: ACH-0144471 INN or Proposed INN: Not available Other descriptive name: ACH-0144471	Achillion Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	10	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Belgium;Australia;Netherlands

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299. 嚢胞性線維症

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臨床試験数 : 1,695 /  薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05408910 (ClinicalTrials.gov)	July 2023	2/6/2022	Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis	Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis	Cystic Fibrosis;Abdominal Pain;Small Bowel Disease	Drug: Rifaximin 550 MG Oral Tablet [XIFAXAN];Drug: Placebo	Wake Forest University Health Sciences	Emory University;University of Minnesota;University of Texas Southwestern Medical Center	Not yet recruiting	12 Years	N/A	All	100	Phase 2/Phase 3	United States
2	NCT05344508 (ClinicalTrials.gov)	June 30, 2023	6/4/2022	An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis	Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis	Non-Cystic Fibrosis Bronchiectasis	Drug: Brensocatib	Insmed Incorporated	NULL	Available	18 Years	85 Years	All			NULL
3	NCT05740618 (ClinicalTrials.gov)	March 1, 2023	3/2/2023	Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis	Effect of Bronchitol on Mucociliary Clearance in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Modulator Treated Patients With Cystic Fibrosis With Moderate to Severe Lung Disease	Cystic Fibrosis	Drug: Mannitol Inhalant Product	University of North Carolina, Chapel Hill	Chiesi USA, Inc.	Not yet recruiting	18 Years	N/A	All	25	Phase 4	United States
4	NCT05663255 (ClinicalTrials.gov)	March 1, 2023	15/12/2022	Effectiveness of CFTR Modulators According to Co-therapy	Is Effectiveness of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators Impacted by Co-therapy? A Population-based Comparative Effectiveness Study Using Data From French Cystic Fibrosis Registry Linked to French National Healthcare Insurance Database	Cystic Fibrosis	Drug: Discontinuation of respiratory co-therapy (azithromycin, RhDNase, or inhaled antibiotics)	Hospices Civils de Lyon	NULL	Not yet recruiting	6 Years	N/A	All	1990		NULL
5	NCT05668741 (ClinicalTrials.gov)	February 27, 2023	19/12/2022	A Phase 1 Study of VX-522 in Participants With Cystic Fibrosis (CF)	A Phase 1 Single Dose Escalation Study Evaluating the Safety and Tolerability of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy	Cystic Fibrosis	Drug: VX-522 mRNA therapy	Vertex Pharmaceuticals Incorporated	NULL	Recruiting	18 Years	65 Years	All	9	Phase 1	United States
6	NCT05581056 (ClinicalTrials.gov)	February 24, 2023	12/10/2022	Evaluation of the Evolution of Quality of Life in Relation to Naso-sinus Symptomatology Under Treatment With CFTE Modulators in Children Aged 6 to 11 Years With Cystic Fibrosis With Compatible Mutation	Evaluation of the Evolution of Quality of Life in Relation to Naso-sinus Symptomatology Under Treatment With CFTR Modulators in Children Aged 6 to 11 Years With Cystic Fibrosis With Compatible Mutation	Cystic Fibrosis	Drug: CFTR modulators	Hospices Civils de Lyon	NULL	Not yet recruiting	6 Years	11 Years	All	90		France
7	NCT05712538 (ClinicalTrials.gov)	February 15, 2023	26/1/2023	Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects	A Phase 1 Randomized, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Doses of ARCT-032 in Healthy Adult Subjects	Cystic Fibrosis	Drug: ARCT-032;Other: Placebo	Arcturus Therapeutics, Inc.	Novotech CRO	Not yet recruiting	18 Years	65 Years	All	32	Phase 1	New Zealand
8	NCT05548283 (ClinicalTrials.gov)	February 1, 2023	16/9/2022	Standardizing Treatments for Pulmonary Exacerbations - Aminoglycoside Study	Standardizing Treatments for Pulmonary Exacerbations: A Platform for Evaluating Treatment Decisions to Improve Outcomes (STOP360) Aminoglycoside Study (AG Study)	Cystic Fibrosis;Cystic Fibrosis Pulmonary Exacerbation	Drug: Beta-lactam antibiotic;Drug: Aminoglycoside	Chris Goss	University of Washington;Medical University of South Carolina;Cystic Fibrosis Foundation	Not yet recruiting	6 Years	N/A	All	730	Phase 4	NULL
9	NCT05743946 (ClinicalTrials.gov)	February 2023	15/2/2023	Trikafta for Patients With Non-cystic Fibrosis Bronchiectasis	Evaluating Trikafta for the Treatment of Patients With Non-cystic Fibrosis Bronchiectasis (NCFBE)	Non-cystic Fibrosis Bronchiectasis	Drug: Trikafta	Emory University	The Marcus Foundation, Inc.	Recruiting	18 Years	N/A	All	30	Phase 4	United States
10	NCT05696912 (ClinicalTrials.gov)	January 30, 2023	7/12/2022	Functional Tests to Resolve Unsolved Rare Diseases. Rares.	Resolving Unsolved Rare Diseases : Functional Tests and New Diagnosis Strategy to Study Genetic Variants From High-throughput Sequencing (RID)	Intellectual Disability;Rubinstein-Taybi Syndrome;Cystic Fibrosis;Congenital Heart Defect;Periventricular Nodular Heterotopia;Neurodegeneration With Brain Iron Accumulation (NBIA);Albinism	Genetic: Ex-vivo approach concerning 25 patients;Genetic: In-vitro approach concerning 25 patients	University Hospital, Bordeaux	NULL	Recruiting	N/A	N/A	All	50	N/A	France
11	EUCTR2021-000713-17-HU (EUCTR)	24/01/2023	15/11/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	850	Phase 3	Portugal;United States;Czechia;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
12	NCT05616221 (ClinicalTrials.gov)	January 10, 2023	7/11/2022	Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection	A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection	Non-cystic Fibrosis Bronchiectasis;Pseudomonas Aeruginosa;Lung Infection	Biological: AP-PA02;Other: Placebo	Armata Pharmaceuticals, Inc.	NULL	Recruiting	18 Years	N/A	All	60	Phase 2	United States
13	EUCTR2021-000713-17-GR (EUCTR)	04/01/2023	18/10/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	850	Phase 3	Portugal;United States;Czechia;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
14	NCT05601778 (ClinicalTrials.gov)	December 6, 2022	27/10/2022	A Study of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis	Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis	Non-cystic Fibrosis Bronchiectasis (NCFBE)	Drug: HSK31858;Drug: placebo	Haisco Pharmaceutical Group Co., Ltd.	NULL	Recruiting	18 Years	N/A	All	210	Phase 2	China
15	NCT05331183 (ClinicalTrials.gov)	November 23, 2022	8/4/2022	Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del	A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes	Cystic Fibrosis	Drug: ELX/TEZ/IVA;Drug: IVA	Vertex Pharmaceuticals Incorporated	NULL	Enrolling by invitation	6 Years	N/A	All	270	Phase 3	Belgium;France;Germany;Netherlands;Spain;Switzerland
16	NCT05444257 (ClinicalTrials.gov)	November 8, 2022	29/6/2022	A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: VX-121/TEZ/D-IVA	Vertex Pharmaceuticals Incorporated	NULL	Enrolling by invitation	12 Years	N/A	All	850	Phase 3	United States;Australia;Canada;France;Germany
17	NCT05495243 (ClinicalTrials.gov)	October 3, 2022	24/6/2022	Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-CF Bronchiectasis With Excess Mucus and Cough	A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ARINA-1 in Adult Participants With Non-CF Bronchiectasis (NCFBE) With Excess Mucus and Cough	Non-cystic Fibrosis Bronchiectasis	Drug: ARINA-1;Drug: Placebo	Renovion, Inc.	NULL	Recruiting	18 Years	80 Years	All	50	Phase 2	United States
18	NCT05523180 (ClinicalTrials.gov)	September 1, 2022	22/8/2022	A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life	A Prospective, Randomized, Double-blinded, Placebo-controlled Study Evaluating the Safety and Impact of resB® Lung Support on Quality of Life in Adult Volunteers With Chronic Obstructive Pulmonary Disease or Non-cystic Fibrosis Bronchiectasis	Chronic Obstructive Pulmonary Disease;Non-cystic Fibrosis Bronchiectasis	Dietary Supplement: Probiotic;Other: Placebo	ResBiotic Nutrition, Inc.	Nutrasource Pharmaceutical and Nutraceutical Services, Inc.	Recruiting	18 Years	80 Years	All	50	N/A	United States
19	NCT05599230 (ClinicalTrials.gov)	September 1, 2022	21/10/2022	Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.	Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.	Cystic Fibrosis	Drug: Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each evening	CHC Montlegia	NULL	Active, not recruiting	12 Years	N/A	All	20		Belgium
20	EUCTR2021-005914-33-AT (EUCTR)	18/08/2022	15/06/2022	Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor Long-term Safety and Efficacy in Subjects Without F508del	A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes - Study to Evaluate Elx/Tez/Iva Long-term Safety and Efficacy in Subjects Without F508del	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Kaftrio Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: 150mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: 75-mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kaftrio Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 3	Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Norway;Netherlands;Germany;Sweden
21	NCT05274269 (ClinicalTrials.gov)	May 9, 2022	1/3/2022	Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis	Drug: ELX/TEZ/IVA;Drug: IVA;Other: Placebo (matched to ELX/TEZ/IVA);Other: Placebo (matched to IVA)	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	6 Years	N/A	All	307	Phase 3	Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland
22	EUCTR2021-000694-85-HU (EUCTR)	03/05/2022	05/04/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden
23	EUCTR2021-000712-31-HU (EUCTR)	02/05/2022	05/04/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Portugal;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden
24	EUCTR2021-005320-38-SE (EUCTR)	25/04/2022	04/03/2022	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 3	Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Hungary;Belgium;Poland;Germany;Netherlands;Norway;Sweden
25	EUCTR2021-005320-38-NL (EUCTR)	21/04/2022	23/02/2022	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 3	Portugal;France;Spain;Belgium;Austria;Germany;Netherlands;Switzerland;Italy;Sweden
26	NCT05699148 (ClinicalTrials.gov)	April 1, 2022	10/1/2023	Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior	Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior: an Evaluation of Triple Combination Therapy in Children Aged 6 to 11 Years	Cystic Fibrosis	Drug: Elexacaftor / Ivacaftor / Tezacaftor	Nottingham University Hospitals NHS Trust	NULL	Active, not recruiting	6 Years	11 Years	All	17		United Kingdom
27	EUCTR2021-000712-31-ES (EUCTR)	28/03/2022	19/10/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	Portugal;United States;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
28	EUCTR2021-005320-38-PT (EUCTR)	18/03/2022	02/02/2022	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 3	France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
29	EUCTR2021-000694-85-DK (EUCTR)	17/03/2022	27/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden
30	EUCTR2021-005320-38-AT (EUCTR)	15/03/2022	07/01/2022	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 3	France;Portugal;Spain;Belgium;Austria;Norway;Netherlands;Germany;Switzerland;Italy;Sweden
31	NCT05095246 (ClinicalTrials.gov)	March 8, 2022	27/8/2021	A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis	A Phase I Study of Inhaled KB407, a Replication-Incompetent, Non-Integrating Vector Expressing Human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), for the Treatment of Cystic Fibrosis	Cystic Fibrosis	Biological: KB407 (Nebulization)	Krystal Biotech, Inc.	Novotech (Australia) Pty Limited	Recruiting	18 Years	N/A	All	13	Phase 1	Australia
32	EUCTR2021-000694-85-AT (EUCTR)	16/02/2022	27/10/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
33	NCT05239611 (ClinicalTrials.gov)	February 14, 2022	10/1/2022	Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis	Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis to Improve Patient-centered Outcomes, Including a Novel Measure of Ventilation	Cystic Fibrosis	Drug: Exercise	University of Kansas Medical Center	NULL	Recruiting	18 Years	N/A	All	30	Phase 2	United States
34	EUCTR2019-004511-31-ES (EUCTR)	31/01/2022	30/08/2021	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus infection MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil	Bambino Gesù Children´s Hospital	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2;Phase 3	Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
35	EUCTR2021-005320-38-ES (EUCTR)	21/01/2022	01/12/2021	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 3	France;Portugal;Belgium;Spain;Austria;Netherlands;Germany;Switzerland;Italy
36	EUCTR2021-000712-31-SE (EUCTR)	18/01/2022	22/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden
37	EUCTR2021-000712-31-PT (EUCTR)	14/01/2022	16/11/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
38	EUCTR2021-000712-31-DE (EUCTR)	12/01/2022	23/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden
39	EUCTR2019-004511-31-DE (EUCTR)	10/01/2022	30/07/2021	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil INN or Proposed INN: Posaconazole Other descriptive name: Posaconazole Trade Name: Noxafil 100 mg Product Name: Noxafil INN or Proposed INN: Posaconazole Other descriptive name: Posaconazole	Bambino Gesù Children's Hospital	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2;Phase 3	Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
40	EUCTR2019-004511-31-NL (EUCTR)	03/01/2022	29/04/2021	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil	Bambino Gesù Children's Hospital	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2;Phase 3	Portugal;France;Czechia;Greece;Spain;Ireland;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden
41	ChiCTR2100052906	2022-01-01	2021-11-06	A randomized controlled study of comparing the effect of two azithromycin regimens in reducing exacerbation of non-cystic fibrosis	A randomized controlled study of comparing the effect of two azithromycin regimens in reducing exacerbation of non-cystic fibrosis	Bronchiectasis	Daily Azithromycin Group:Azithromycin 250mg QD;Weekly Azithromycin Group:Azithromycin 500mg TIW;Placebo Group:None;	The First People' Hospital of Jiashan	NULL	Recruiting			Both	Daily Azithromycin Group:41;Weekly Azithromycin Group:41;Placebo Group:41;	Phase 4	China
42	EUCTR2021-000694-85-IT (EUCTR)	21/12/2021	15/10/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation - A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Kalydeco Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: ivacaftor Product Name: VX-121/tezacaftor/deutivacaftor Product Code: [VX-121/TEZ/D-IVA] INN or Proposed INN: tezacaftor INN or Proposed INN: deutivacaftor Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: [ELX/TEZ/IVA] INN or Proposed INN: elexacaftor INN or Proposed INN: tezacaftor INN or Proposed INN: ivacaftor	VERTEX PHARMACEUTICALS INCORPORATED	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
43	EUCTR2021-000694-85-DE (EUCTR)	20/12/2021	27/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
44	EUCTR2021-000694-85-NL (EUCTR)	09/12/2021	27/10/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
45	EUCTR2021-000712-31-CZ (EUCTR)	08/12/2021	23/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Portugal;Czechia;Hungary;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
46	EUCTR2021-000694-85-GR (EUCTR)	07/12/2021	19/10/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden
47	EUCTR2021-000694-85-NO (EUCTR)	03/12/2021	20/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden
48	NCT05090904 (ClinicalTrials.gov)	November 30, 2021	14/10/2021	A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis	A Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis	Cystic Fibrosis	Drug: Brensocatib;Drug: Placebo	Insmed Incorporated	NULL	Completed	18 Years	N/A	All	29	Phase 2	United States
49	EUCTR2020-004885-21-ES (EUCTR)	18/11/2021	19/10/2021	A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis	A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	143	Phase 3	Czechia;Czech Republic;Belgium;Spain;Netherlands
50	EUCTR2021-000694-85-SE (EUCTR)	10/11/2021	22/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
51	NCT04938726 (ClinicalTrials.gov)	November 1, 2021	9/6/2021	Ketone Supplementation in Cystic Fibrosis	Ketone Monoester Supplementation in Cystic Fibrosis: A Pilot and Feasibility Study	Cystic Fibrosis	Dietary Supplement: Ketone Monoester	University of Alabama at Birmingham	NULL	Recruiting	18 Years	89 Years	All	25	N/A	United States
52	EUCTR2020-005805-25-NL (EUCTR)	28/10/2021	23/09/2021	A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis.	A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation.	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Galicaftor Product Code: ABBV-2222 INN or Proposed INN: GALICAFTOR Other descriptive name: ABBV-2222 Product Name: Navocaftor Product Code: ABBV-3067 INN or Proposed INN: Navocaftor Product Name: ABBV-119 Product Code: ABBV-119 Other descriptive name: ABBV-119	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Slovakia;Belgium;Australia;Germany;Netherlands;United Kingdom;New Zealand
53	NCT05076149 (ClinicalTrials.gov)	October 27, 2021	29/9/2021	A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis	Drug: VX-121/TEZ/D-IVA;Drug: ELX/TEZ/IVA;Drug: IVA;Drug: Placebo (matched to VX-121/TEZ/D-IVA);Drug: Placebo (matched to ELX/TEZ/IVA);Drug: Placebo (matched to IVA)	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	12 Years	N/A	All	600	Phase 3	United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Sweden;Switzerland;United Kingdom
54	EUCTR2019-004511-31-GR (EUCTR)	16/09/2021	04/03/2021	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil	Bambino Gesù Children's Hospital	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2;Phase 3	Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
55	NCT05033080 (ClinicalTrials.gov)	September 14, 2021	26/8/2021	A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)	Cystic Fibrosis	Drug: VX-121/TEZ/D-IVA;Drug: ELX/TEZ/IVA;Drug: IVA;Drug: Placebo (matched to VX-121/TEZ/D-IVA);Drug: Placebo (matched to ELX/TEZ/IVA);Drug: Placebo (matched to IVA)	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	12 Years	N/A	All	436	Phase 3	United States;Australia;Czechia;Germany;Hungary;Ireland;Israel;New Zealand;Portugal;Spain;Sweden;United Kingdom
56	EUCTR2021-003277-55-AT (EUCTR)	01/09/2021	27/07/2021	COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF	COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF - CAR-CF	COVID-19 vaccine Antibody response from natural infection or after vaccination in patients with Cystic Fibrosis (CF) MedDRA version: 20.0;Level: LLT;Classification code 10021433;Term: Immunization;System Organ Class: 100000004865 MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify	Trade Name: Comirnaty concentrate for dispersion for injection Product Name: Comirnaty INN or Proposed INN: Tozinameran Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Trade Name: Vaxzevria suspension for injection COVID-19 Vaccine (ChAdOx1-S Product Name: Vaxzevria INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19) Trade Name: COVID-19 Vaccine Moderna dispersion for injection Product Name: COVID-19 Vaccine Moderna INN or Proposed INN: Elasomeran Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) Trade Name: COVID-19 Vaccine Janssen suspension for injection Product Name: COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant]) INN or Proposed INN: COVID-19 vaccine (Ad26.COV2-S [recombinant]) Other descriptive name: Ad26.COV2-S.02	Medical University of Innsbruck, University Clinic for Pediatrics III	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	5000	Phase 4	United States;European Union;Canada;Ireland;Austria;United Kingdom
57	NCT05006573 (ClinicalTrials.gov)	July 21, 2021	23/6/2021	Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis	A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE)	Non-cystic Fibrosis Bronchiectasis	Biological: Benralizumab;Biological: Placebo to Benralizumab	AstraZeneca	NULL	Active, not recruiting	18 Years	130 Years	All	100	Phase 3	United States;Argentina;Australia;Canada;China;Denmark;Germany;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Spain;United Kingdom;Vietnam
58	NCT04531410 (ClinicalTrials.gov)	July 1, 2021	18/8/2020	NETwork of Linoleic Acid Supplementation in Cystic Fibrosis	Double-blind Randomized Controlled Study of Linoleic Acid Supplementation for 1 Year in Patients With Cystic Fibrosis - Influence on Clinical Status and Metabolism	Cystic Fibrosis	Dietary Supplement: linoleic acid supplementation;Dietary Supplement: oleic acid supplementation	Karolinska Institutet	European Society of Pediatric Gastroenterology, Hepatology and Nutrition	Enrolling by invitation	5 Years	15 Years	All	90	N/A	Italy;Norway;Poland;Sweden
59	EUCTR2019-004511-31-PT (EUCTR)	18/06/2021	18/01/2021	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil	Bambino Gesù Children's Hospital	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2;Phase 3	France;Portugal;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
60	NCT04294043 (ClinicalTrials.gov)	June 17, 2021	1/3/2020	IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)	A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)	Nontuberculous Mycobacterium Infection	Drug: Gallium nitrate	Chris Goss	Cystic Fibrosis Foundation	Recruiting	18 Years	N/A	All	40	Phase 1	United States
61	EUCTR2020-003688-25-SK (EUCTR)	01/06/2021	10/12/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1660	Phase 3	Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan
62	EUCTR2020-004068-24-IT (EUCTR)	21/05/2021	02/08/2021	Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis	A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE	Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: NA Product Name: benralizumab Product Code: [MEDI-563] INN or Proposed INN: benralizumab Other descriptive name: benralizumab Product Name: Atropina Product Code: [NA] Product Name: Antistaminici H1 - H2 Product Code: [na] Product Name: C01CA04 - Dopamina Product Code: [na] Product Name: Adrenalina Product Code: [NA] Product Name: Salbutamolo Product Code: [NA] Product Name: H02 - Corticosteroidi Sistemici Product Code: [NA]	ASTRAZENECA AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Vietnam;Canada;Argentina;Poland;Australia;Denmark;Germany;China;Korea, Republic of
63	JPRN-jRCT2031210048	30/04/2021	22/04/2021	A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - ASPEN	Non-Cystic Fibrosis Bronchiectasis	- Experimental: Brensocatib 10 mg Participants will receive brensocatib 10 mg once daily, for 52 weeks. - Experimental: Brensocatib 25 mg Participants will receive brensocatib 25 mg once daily, for 52 weeks. - Placebo Comparator: Placebo Participants will receive a brensocatib-matching placebo once daily.	Fernandez C	NULL	Recruiting	>= 18age old	<= 85age old	Both	1620	Phase 3	United States;Canada;Germany;Australia;New Zealand;Taiwan;Japan
64	NCT04884308 (ClinicalTrials.gov)	April 28, 2021	7/5/2021	Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections	Effects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy Volunteers	Cystic Fibrosis;Bronchiectasis Adult;Non-Tuberculous Mycobacteria	Biological: BCG TICE Vaccine	Johns Hopkins University	Cystic Fibrosis Foundation	Recruiting	18 Years	65 Years	All	180	Phase 2	United States
65	NCT04966234 (ClinicalTrials.gov)	April 22, 2021	19/3/2021	A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection	Prospective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus Infection	Cystic Fibrosis;Aspergillosis	Drug: Posaconazole 100 MG [Noxafil];Drug: Posaconazole 40 MG/ML	Bambino Gesù Hospital and Research Institute	University of Exeter;Radboud University;Consorzio per Valutazioni Biologiche e Farmacologiche	Recruiting	8 Years	17 Years	All	135	Phase 2/Phase 3	Czechia;France;Germany;Greece;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom
66	EUCTR2020-003688-25-DE (EUCTR)	08/04/2021	12/10/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1660	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan
67	EUCTR2020-004068-24-DE (EUCTR)	06/04/2021	21/01/2021	Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis	A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE	Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Fasenra Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Canada;Argentina;Poland;Viet Nam;Australia;Denmark;Germany;China;Japan;Korea, Republic of
68	NCT04684641 (ClinicalTrials.gov)	March 29, 2021	18/12/2020	CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)	CYstic Fibrosis bacterioPHage Study at Yale (CYPHY): A Single-site, Randomized, Double-blind, Placebo-controlled Study of Bacteriophage Therapy YPT-01 for Pseudomonas Aeruginosa Infections in Adults With Cystic Fibrosis	Cystic Fibrosis	Drug: Standard Dose YPT-01;Other: Placebo	Yale University	NULL	Active, not recruiting	18 Years	N/A	All	8	Phase 1/Phase 2	United States
69	EUCTR2019-003501-10-NO (EUCTR)	08/03/2021	29/05/2020	Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a phase 4 multicenter randomized controlled study.	Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a phase 4 multicenter randomized controlled study. - MBWtodetectPEXinCF	Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Amoxicillin Product Name: Amoxicillin INN or Proposed INN: AMOXICILLIN Trade Name: Amoxicillin and Clavulanic acid Product Name: Augmentin INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID Trade Name: Heracillin Product Name: Heracillin INN or Proposed INN: FLUCLOXACILLIN Trade Name: Dicloxacillin Product Name: Dicloxacillin INN or Proposed INN: DICLOXACILLIN Trade Name: Trimethoprim and Sulfamethoxazole Product Name: Bactrim INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: SULFAMETHOXAZOLE Trade Name: Clarithromycin Product Name: Klacid INN or Proposed INN: Klacid Other descriptive name: CLARITHROMYCIN Trade Name: Rifampicin Product Name: Rimactan INN or Proposed INN: RIFAMPICIN Trade Name: Doxycycline Product Name: Doxycyclin INN or Proposed INN: DOXYCYCLINE Product Name: Fucidin Tablets INN or Proposed INN: Fusidin Other descriptive name: FUSIDIC ACID Trade Name: Ciprofloxacin Product Name: Ciprofloxacin INN or Proposed INN: Ciproxin Other descriptive name: CIPROFLOXACIN Trade Name: Linez	Vãstre Gõtalandsregionen, Sweden	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	Denmark;Norway;Sweden
70	EUCTR2020-003688-25-LT (EUCTR)	05/03/2021	07/12/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1620	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
71	EUCTR2020-003688-25-EE (EUCTR)	01/03/2021	06/01/2021	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1620	Phase 3	Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
72	EUCTR2020-004068-24-DK (EUCTR)	15/02/2021	22/12/2020	Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis	A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE	Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Fasenra Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Vietnam;Canada;Argentina;Poland;Denmark;Australia;Germany;China;Japan;Korea, Republic of
73	EUCTR2020-003688-25-AT (EUCTR)	11/02/2021	10/12/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1660	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan
74	EUCTR2020-003688-25-BG (EUCTR)	27/01/2021	04/12/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1660	Phase 3	United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Bulgaria;Germany;New Zealand;Japan
75	EUCTR2019-003501-10-DK (EUCTR)	22/01/2021	22/04/2020	Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study.	Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. - MBWtodetectPEXinCF	Cystic fibrosis MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID INN or Proposed INN: AMOXICILLIN INN or Proposed INN: FLUCLOXACILLIN INN or Proposed INN: DICLOXACILLIN INN or Proposed INN: SULFAMETHOXAZOLE INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: RIFAMPICIN INN or Proposed INN: DOXYCYCLINE INN or Proposed INN: Fusidic acid Other descriptive name: FUSIDIC ACID INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN INN or Proposed INN: Linezolid Other descriptive name: LINEZOLID INN or Proposed INN: CLINDAMYCIN Other descriptive name: CLINDAMYCIN INN or Proposed INN: Cefuroxim Other descriptive name: CEFUROXIME INN or Proposed INN: CEFALEXIN	Västra Götalandsregionen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	Denmark;Norway;Sweden
76	EUCTR2020-003688-25-IE (EUCTR)	18/01/2021	30/10/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1660	Phase 3	Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Denmark;Peru;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Bulgaria;Germany;New Zealand;Japan
77	EUCTR2019-002840-26-DE (EUCTR)	15/01/2021	01/10/2020	Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasis	A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis	Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QBW251 INN or Proposed INN: Icenticaftor Other descriptive name: CFTR potentiator	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72	Phase 2	China;United Kingdom;Germany;Spain
78	EUCTR2020-003688-25-IT (EUCTR)	15/01/2021	15/06/2021	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis –The ASPEN Study - ASPEN	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: [INS1007] INN or Proposed INN: Brensocatib Product Name: Brensocatib Product Code: [INS1007] INN or Proposed INN: Brensocatib	INSMED INCORPORATED	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1620	Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Denmark;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
79	EUCTR2020-003688-25-PT (EUCTR)	15/01/2021	16/10/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1620	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
80	EUCTR2020-003688-25-BE (EUCTR)	15/01/2021	15/01/2021	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1620	Phase 3	United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
81	NCT04545515 (ClinicalTrials.gov)	January 11, 2021	3/9/2020	A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF Genotypes	A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic Fibrosis	Drug: ELX/TEZ/IVA;Drug: IVA	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	6 Years	N/A	All	120	Phase 3	Australia;Canada;Denmark;France;Germany;Israel;Netherlands;Spain;Switzerland;United Kingdom
82	EUCTR2020-003688-25-HU (EUCTR)	06/01/2021	16/11/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1620	Phase 3	United States;Serbia;Portugal;Estonia;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan;New Zealand
83	NCT04687319 (ClinicalTrials.gov)	January 2021	7/12/2020	RHEology of the Pulmonary MUcus	Protocol for the Collection of Lung Mucus Samples From Care for a Rheology Research Programme	Bronchial Mucus in COPD and Cystic Fibrosis	Biological: bronchial mucus collection	University Hospital, Grenoble	University Grenoble Alps	Not yet recruiting	18 Years	N/A	All	100		NULL
84	EUCTR2019-002840-26-GB (EUCTR)	22/12/2020	03/09/2020	Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasis	A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis	Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QBW251 INN or Proposed INN: Icenticaftor Other descriptive name: CFTR potentiator	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72	Phase 2	Spain;Germany;China;United Kingdom
85	NCT04596319 (ClinicalTrials.gov)	December 22, 2020	15/10/2020	Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis	A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) Infection	Cystic Fibrosis;Pseudomonas Aeruginosa;Pseudomonas;Lung Infection;Lung Infection Pseudomonal	Biological: AP-PA02;Other: Placebo	Armata Pharmaceuticals, Inc.	Cystic Fibrosis Foundation	Active, not recruiting	18 Years	N/A	All	29	Phase 1/Phase 2	United States
86	EUCTR2020-003688-25-GR (EUCTR)	18/12/2020	23/11/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1660	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
87	EUCTR2020-003688-25-DK (EUCTR)	09/12/2020	22/10/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1660	Phase 3	Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Bulgaria;Germany;New Zealand;Japan
88	NCT04643587 (ClinicalTrials.gov)	December 7, 2020	19/11/2020	Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)	A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Nebulized CSL787 in Healthy Subjects and Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB)	Noncystic Fibrosis Bronchiectasis (NCFB)	Biological: CSL787;Drug: Placebo	CSL Behring	NULL	Recruiting	18 Years	N/A	All	64	Phase 1	Germany;United Kingdom
89	EUCTR2020-003170-44-CZ (EUCTR)	03/12/2020	22/10/2020	A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism	A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
90	NCT04594369 (ClinicalTrials.gov)	December 1, 2020	14/10/2020	A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis	Drug: Brensocatib 10 mg;Drug: Brensocatib 25 mg;Drug: Placebo	Insmed Incorporated	NULL	Recruiting	12 Years	85 Years	All	1620	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Serbia;Slovakia;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Estonia;Lithuania
91	EUCTR2016-004558-13-DE (EUCTR)	01/12/2020	09/04/2020	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;France;United States;Greece;Canada;Argentina;Poland;Germany;Italy
92	NCT04509050 (ClinicalTrials.gov)	November 18, 2020	6/8/2020	Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children	A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN Study)	Cystic Fibrosis	Drug: Ivacaftor or elexacaftor/tezacaftor/ivacaftor	Sonya Heltshe	Cystic Fibrosis Foundation;University of Washington;University of Alabama at Birmingham	Active, not recruiting	N/A	5 Years	All	210		United States
93	NCT04467957 (ClinicalTrials.gov)	November 15, 2020	19/6/2020	Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis	Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis	Cystic Fibrosis	Drug: Initiation of CFTR Modulator;Drug: Hyperpolarized Xenon 129	Children's Hospital Medical Center, Cincinnati	NULL	Active, not recruiting	6 Years	21 Years	All	26	Phase 4	United States
94	NCT04322929 (ClinicalTrials.gov)	November 12, 2020	24/3/2020	Roflumilast in Non-CF Bronchiectasis Study (2019)	Anti-inflammatory Effects of Roflumilast Treatment for 12 Weeks in Stable-state Non-cystic Fibrosis Bronchiectasis	Non-cystic Fibrosis Bronchiectasis	Drug: Roflumilast Oral Tablet	The University of Hong Kong	NULL	Recruiting	18 Years	N/A	All	27	Phase 2	Hong Kong
95	NCT02748798 (ClinicalTrials.gov)	November 10, 2020	19/4/2016	Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders	Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders	Lung Transplant;Lung Resection;Lung Cancer;Asthma;Cystic Fibrosis;Chronic Obstructive Pulmonary Disease;Emphysema;Mesothelioma;Asbestosis;Pulmonary Embolism;Interstitial Lung Disease;Pulmonary Fibrosis;Bronchiectasis;Seasonal Allergies;Cold Virus;Lung Infection;Pulmonary Hypertension;Pulmonary Dysplasia;Obstructive Sleep Apnea	Drug: HP 3He;Drug: HP 129Xe;Drug: PFP;Drug: SF6;Device: 129Xe Small and Large Human Lung Coil;Device: 3He Human Lung Coil;Device: PFP and SF6 Human Lung Coil	Thunder Bay Regional Research Institute	Thunder Bay Regional Health Sciences Centre;St. Joseph's Care Group;Lakehead University	Recruiting	18 Years	N/A	All	160	Early Phase 1	Canada
96	NCT04624490 (ClinicalTrials.gov)	November 2, 2020	31/10/2020	Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease	Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease	Asthma;COPD;Interstitial Lung Disease;Cystic Fibrosis;Pulmonary Hypertension;Pulmonary Infection;Other Lung Disease	Drug: Hyperpolarized Xe129	Mario Castro, MD, MPH	NULL	Recruiting	3 Years	N/A	All	260	Phase 1	United States
97	EUCTR2019-003554-86-FR (EUCTR)	29/10/2020	02/04/2020	A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes	A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 3	France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland
98	EUCTR2019-004511-31-IT (EUCTR)	21/10/2020	07/10/2020	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE Product Name: Noxafil Product Code: [NA] INN or Proposed INN: Posaconazolo Trade Name: Noxafil Product Name: Noxafil Product Code: [NA] INN or Proposed INN: POSACONAZOLO Trade Name: Noxafil Product Name: Noxafil Product Code: [NA] INN or Proposed INN: POSACONAZOLO Product Name: Noxafil Product Code: [na] INN or Proposed INN: POSACONAZOLO Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE Product Name: Noxafil Product Code: [na] INN or Proposed INN: POSACONAZOLO Trade Name: Noxafil Product Name: Noxafil Product Code: [na] INN or Proposed INN: Posaconazolo	IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2;Phase 3	Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
99	EUCTR2016-004558-13-IT (EUCTR)	19/10/2020	21/10/2020	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis II	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin Product Name: Colistimethate sodium Product Code: [NA] Other descriptive name: Colistimethate Sodium Trade Name: Salbutamol-ratiopharm® N metered-dose aerosol inhaler Product Name: Salbutamol-ratiopharm® N metereddose aerosol inhaler Product Code: [Salbutamol] INN or Proposed INN: SALBUTAMOL Other descriptive name: Salbutamol	ZAMBON SPA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	Portugal;United States;France;Greece;Canada;Argentina;Poland;Germany;Italy
100	NCT04658277 (ClinicalTrials.gov)	October 1, 2020	31/8/2020	Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations	Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations	Bronchiectasis Adult	Drug: Clarithromycin;Other: Usual care	Chinese University of Hong Kong	NULL	Recruiting	50 Years	N/A	All	40	N/A	Hong Kong
101	EUCTR2020-001762-11-GB (EUCTR)	17/09/2020	23/07/2020	A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.	An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials	Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2;Phase 3	United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
102	NCT04602468 (ClinicalTrials.gov)	September 3, 2020	20/10/2020	Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)	Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)	Cystic Fibrosis;Cystic Fibrosis Liver Disease;Cystic Fibrosis in Children;Adherence, Medication;Cystic Fibrosis Gastrointestinal Disease	Drug: Kaftrio	Royal College of Surgeons, Ireland	Imperial College London;University College Dublin;University of Limerick;Cystic Fibrosis Registry of Ireland;Erasmus Medical Center;Medizinische Hochschule Brandenburg Theodor Fontane;Queen's University, Belfast;Teagasc;The Hospital for Sick Children;St. James's Hospital, Ireland;Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Recruiting	6 Years	N/A	All	237	Phase 4	Ireland;United Kingdom
103	NCT04509661 (ClinicalTrials.gov)	September 1, 2020	22/4/2020	Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation	Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial	Bronchiectasis Adult	Drug: LABA/LAMA or Placebo inhalation	Shanghai Pulmonary Hospital, Shanghai, China	NULL	Not yet recruiting	18 Years	N/A	All	200	Phase 4	NULL
104	EUCTR2020-001762-11-HU (EUCTR)	26/08/2020	02/07/2020	A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.	An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials	Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2;Phase 3	United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
105	EUCTR2019-003554-86-DK (EUCTR)	19/08/2020	27/03/2020	A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes	A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 3	Germany;United Kingdom;Switzerland;France;Canada;Spain;Australia;Denmark;Israel;Netherlands
106	NCT04381429 (ClinicalTrials.gov)	August 17, 2020	30/4/2020	Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes	Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE Trial	Cystic Fibrosis-related Diabetes	Drug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP);Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)	University Hospital, Strasbourg, France	NULL	Recruiting	10 Years	N/A	All	40	Phase 4	France
107	EUCTR2019-003554-86-DE (EUCTR)	14/08/2020	12/03/2020	A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes	A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 3	France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland
108	NCT04375514 (ClinicalTrials.gov)	August 10, 2020	30/4/2020	Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis	A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-ENaC in Normal Healthy Volunteers and Safety, Tolerability and Efficacy in Patients With Cystic Fibrosis	Cystic Fibrosis, Pulmonary	Drug: ARO-ENaC;Drug: Placebo	Arrowhead Pharmaceuticals	NULL	Terminated	18 Years	55 Years	All	43	Phase 1	Australia;New Zealand
109	EUCTR2019-003554-86-NL (EUCTR)	28/07/2020	01/05/2020	A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes	A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 3	France;Canada;Spain;Denmark;Australia;Israel;Germany;Netherlands;United Kingdom;Switzerland
110	EUCTR2016-004558-13-PT (EUCTR)	27/07/2020	20/04/2020	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	France;United States;Portugal;Greece;Canada;Argentina;Poland;Germany;Italy
111	NCT04458129 (ClinicalTrials.gov)	July 8, 2020	30/6/2020	Polyethylene Glycol and Intestinal Inflammation in Cystic Fibrosis	EFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN	Cystic Fibrosis	Drug: Treatment with polyethylene glycol (Macrogol 4000)	University Hospital, Bordeaux	NULL	Not yet recruiting	4 Years	17 Years	All	23	Phase 2	NULL
112	EUCTR2016-004558-13-GR (EUCTR)	07/07/2020	14/05/2020	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;France;United States;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;Italy;New Zealand
113	NCT04461561 (ClinicalTrials.gov)	July 1, 2020	28/6/2020	Using NPT to Evaluate Providing PPC as ELNEC-PPC WBT for Nurses	Using Normalization Process Theory to Evaluate Providing Pediatric Palliative Care at End-of-Life as Web-Based Training Intervention for Nurses:	Cancer;Cardiac Anomaly;Cystic Fibrosis;Muscular Dystrophy;HIV/AIDS;Batten's Disease;Cerebral Palsy	Genetic: end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care	Altoosi University College	Babylon University	Recruiting	20 Years	65 Years	All	172	N/A	Iraq
114	NCT04315311 (ClinicalTrials.gov)	May 6, 2020	18/3/2020	Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer	A Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer	Exocrine Pancreatic Insufficiency (EPI)	Drug: CREON	AbbVie	NULL	Withdrawn	18 Years	N/A	All	0	Phase 4	United States
115	ChiCTR2000031817	2020-04-30	2020-04-11	Evaluation and comparison of quality of life between acetylcysteine tablets and placebo in patients with non cystic fibrosis bronchiectasis	A Randomized, Double-Blinded, Placebo-Controlled, Multiple-Center Clinical Trial to Compare the Quality of Life of Acetylcysteine Tablets 600 Mg BID Treatment With Placebo in Patients With Non-Cystic Fibrosis Bronchiectasis	bronchiectasia	experimental group:Acetylcysteine;control group:placebo;	West China Hospital, Sichuan University	NULL	Pending	18		Both	experimental group:79;control group:40;	Phase 4	China
116	EUCTR2019-003455-11-DE (EUCTR)	08/04/2020	09/12/2019	Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects	A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Trikafta Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: Ivacaftor Product Code: VX-770	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	158	Phase 3	Belgium;Australia;Germany;United Kingdom
117	EUCTR2019-003501-10-SE (EUCTR)	08/04/2020	07/04/2020	Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study.	Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. - MBWtodetectPEXinCF	Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID INN or Proposed INN: AMOXICILLIN INN or Proposed INN: FLUCLOXACILLIN INN or Proposed INN: DICLOXACILLIN INN or Proposed INN: SULFAMETHOXAZOLE INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: RIFAMPICIN INN or Proposed INN: DOXYCYCLINE INN or Proposed INN: Fusidic acid Other descriptive name: FUSIDIC ACID INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN INN or Proposed INN: Linezolid Other descriptive name: LINEZOLID INN or Proposed INN: CLINDAMYCIN Other descriptive name: CLINDAMYCIN INN or Proposed INN: Cefuroxim Other descriptive name: CEFUROXIME INN or Proposed INN: CEFALEXIN	Västra Götalandsregionen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	Denmark;Norway;Sweden
118	EUCTR2019-004940-31-DK (EUCTR)	24/03/2020	24/03/2020	Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial	Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial	GI pains and fat malabsorption in cysticfibrosis patients with pancreas insufficiency MedDRA version: 20.1;Level: LLT;Classification code 10025479;Term: Malabsorption syndrome;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Creon 10.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN Trade Name: Creon 25.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN Trade Name: Creon 40.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN	Terese Katzenstein	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 4	Denmark
119	EUCTR2018-000378-30-DE (EUCTR)	04/03/2020	06/06/2019	A dose finding study of OligoG in patients with CF.	A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF).	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: OligoG CF-5/20, 17,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20, 27,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20, 37,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20	AlgiPharma AS	NULL	Not Recruiting			Female: yes Male: yes	168	Phase 2	Poland;Ireland;Austria;Germany;United Kingdom
120	NCT04235140 (ClinicalTrials.gov)	February 24, 2020	15/1/2020	Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation	A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation	Cystic Fibrosis	Drug: LUM/IVA	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	12 Months	N/A	All	52	Phase 3	United States;Canada
121	NCT04183790 (ClinicalTrials.gov)	February 17, 2020	28/11/2019	Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older	Cystic Fibrosis	Drug: ELX/TEZ/IVA;Drug: IVA	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	6 Years	N/A	All	64	Phase 3	United States;Australia;Canada;Ireland;United Kingdom
122	EUCTR2018-003831-31-ES (EUCTR)	24/01/2020	02/12/2019	MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis.	A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs	Exocrine Pancreatic Insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MS1819-SD INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica Other descriptive name: LIPASE LIP2	AzurRx	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Hungary;Poland;Spain
123	EUCTR2019-000833-37-DE (EUCTR)	23/01/2020	27/06/2019	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Trikafta Product Name: 100-mg ELX (VX-455) / 50-mg TEZ / 75-mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
124	EUCTR2019-000833-37-NL (EUCTR)	22/01/2020	17/09/2019	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy
125	EUCTR2018-002835-76-NL (EUCTR)	22/01/2020	17/09/2019	A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy
126	EUCTR2019-003455-11-GB (EUCTR)	17/01/2020	09/12/2019	Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects	A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	158	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Belgium;Australia;Germany;United Kingdom
127	NCT04259970 (ClinicalTrials.gov)	January 13, 2020	15/1/2020	Hyperpolarized Imaging for New Treatments	Hyperpolarized Imaging for New Treatments (HyPOINT) Study	Cystic Fibrosis	Drug: Initiation of CFTR Modulator	Children's Hospital Medical Center, Cincinnati	University of Virginia;University of Wisconsin, Madison;The Hospital for Sick Children	Active, not recruiting	6 Years	18 Years	All	64	Phase 4	United States;Canada
128	NCT03988816 (ClinicalTrials.gov)	December 6, 2019	14/6/2019	Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis	Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis: a Cross-over, Unicentric, Double-blind and Placebo-controlled Study	Bronchiectasis Adult	Drug: Roflumilast;Drug: Placebo oral tablet	University of Sao Paulo General Hospital	FAPESP - Fundação de Apoio à Pesquisa do Estado de São Paulo	Recruiting	18 Years	N/A	All	30	Phase 2	Brazil
129	NCT04135495 (ClinicalTrials.gov)	November 25, 2019	16/8/2019	A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele	A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients With Cystic Fibrosis With at Least One G542X Allele	Cystic Fibrosis	Drug: ELX-02;Drug: Ivacaftor	Eloxx Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All	17	Phase 2	United States;Canada
130	EUCTR2019-003178-25-HU (EUCTR)	19/11/2019	20/11/2019	A study of safety, tolerability and effect of SNSP113 in Cystic Fibrosis	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Effect of Inhaled SNSP113 in Adult Subjects with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: SNSP113 Product Code: SNSP113 INN or Proposed INN: not assigned Other descriptive name: PAAG15	Synspira Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	56	Phase 2	Hungary
131	EUCTR2019-000833-37-ES (EUCTR)	19/11/2019	09/08/2019	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
132	EUCTR2018-000966-12-DE (EUCTR)	18/11/2019	25/06/2019	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic Fibrosis	A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic Fibrosis with at Least One G542X Allele	Cystic fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Code: ELX-02 INN or Proposed INN: Not Assigned Trade Name: Kalydeco Product Name: Kalydeco INN or Proposed INN: Ivacaftor	Eloxx Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	16	Phase 2	Australia;Israel;Germany
133	EUCTR2019-000750-63-FR (EUCTR)	15/11/2019	22/08/2019	Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation	A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067	AbbVie Deutschland	NULL	Not Recruiting			Female: yes Male: yes	189	Phase 2	Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Romania;Netherlands
134	NCT03924947 (ClinicalTrials.gov)	November 6, 2019	18/4/2019	A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis	A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis	Cystic Fibrosis	Drug: Pancrelipase	AbbVie	NULL	Completed	12 Years	N/A	All	36	Phase 4	United States;Spain
135	EUCTR2019-000261-21-GB (EUCTR)	05/11/2019	05/06/2019	A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM) 1	A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM) 1	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
136	NCT04126473 (ClinicalTrials.gov)	November 5, 2019	16/8/2019	A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele	A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients With Cystic Fibrosis With at Least One G542X Allele	Cystic Fibrosis	Drug: ELX-02	Eloxx Pharmaceuticals, Inc.	NULL	Recruiting	16 Years	N/A	All	16	Phase 2	Australia;Germany;Israel
137	EUCTR2018-000378-30-AT (EUCTR)	04/11/2019	05/07/2019	A dose finding study of OligoG in patients with CF.	A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF).	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20	AlgiPharma AS	NULL	Not Recruiting			Female: yes Male: yes	168	Phase 2	Poland;Ireland;Austria;Germany;United Kingdom
138	EUCTR2019-000750-63-NL (EUCTR)	31/10/2019	05/08/2019	Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation	A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 INN or Proposed INN: TBD Other descriptive name: ABBV-3067	AbbVie Deutschland	NULL	Not Recruiting			Female: yes Male: yes	189	Phase 2	Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Netherlands
139	EUCTR2018-002835-76-GB (EUCTR)	29/10/2019	27/06/2019	A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
140	EUCTR2018-002835-76-IE (EUCTR)	21/10/2019	28/06/2019	A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
141	EUCTR2019-000833-37-IE (EUCTR)	21/10/2019	27/06/2019	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Canada;Netherlands;Belgium;United States;Ireland;Denmark;Italy;United Kingdom;Australia;France;Germany;Spain
142	EUCTR2018-002835-76-DE (EUCTR)	21/10/2019	03/07/2019	A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
143	EUCTR2019-000833-37-DK (EUCTR)	17/10/2019	09/07/2019	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	France;United States;Canada;Spain;Belgium;Ireland;Australia;Denmark;Netherlands;Germany;United Kingdom;Italy
144	EUCTR2018-002835-76-DK (EUCTR)	16/10/2019	09/07/2019	A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	France;United States;Canada;Belgium;Spain;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom
145	EUCTR2019-000261-21-ES (EUCTR)	10/10/2019	05/07/2019	A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler	A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162	Boehringer Ingelheim, S.A.	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	Spain;United States;France;Canada;Belgium;Ireland;Germany;United Kingdom;Sweden
146	EUCTR2018-001695-38-GB (EUCTR)	09/10/2019	19/08/2019	Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years	A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Trade Name: Kalydeco 150 mg film-coated tablets Product Name: IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Product Name: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 3	United States;Canada;Ireland;Australia;United Kingdom
147	EUCTR2019-000261-21-SE (EUCTR)	08/10/2019	29/04/2019	A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler	A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162	Boehringer Ingelheim	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
148	EUCTR2019-000261-21-BE (EUCTR)	07/10/2019	29/05/2019	A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1	A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis – BALANCE – CF(TM)1	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162	SCS Boehringer Ingelheim Comm.V	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
149	EUCTR2018-002835-76-IT (EUCTR)	04/10/2019	12/02/2021	A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF)Subjects Heterozygous for F508del and a Gating or Residual FunctionMutation (F/G and F/RF Genotypes)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating theEfficacy and Safety of VX-445 Combination Therapy in Subjects With CysticFibrosis Who Are Heterozygous for the F508del Mutation and a Gating orResidual Function Mutation (F/G and F/RF Genotypes) - NA	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75- mg IVA FDC Product Code: [VX-445/TEZ/IVA] INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: VX-661 / VX-770 Product Code: [VX-661 / VX-770] INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	VERTEX PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
150	NCT04090294 (ClinicalTrials.gov)	October 1, 2019	21/8/2019	Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis	Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis	Bronchiectasis	Drug: Roflumilast	Assiut University	NULL	Not yet recruiting	18 Years	75 Years	All	35	Early Phase 1	NULL
151	EUCTR2019-000750-63-BE (EUCTR)	27/09/2019	07/08/2019	Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation	A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067	AbbVie Deutschland	NULL	Not Recruiting			Female: yes Male: yes	189	Phase 2	Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Romania;Netherlands
152	EUCTR2019-001735-31-GB (EUCTR)	13/09/2019	24/06/2019	A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic Fibrosis	A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: ELEXACAFTOR Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	158	Phase 3	Belgium;Australia;Germany;United Kingdom
153	EUCTR2018-003970-28-NL (EUCTR)	12/09/2019	09/05/2019	A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis	A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom
154	NCT04006873 (ClinicalTrials.gov)	September 3, 2019	2/7/2019	Gut Imaging for Function & Transit in Cystic Fibrosis Study 2	A Randomised Crossover Pilot Study of the Effects of Tezacaftor/Ivacaftor and Ivacaftor on Gastrointestinal Function Using Magnetic Resonance Imaging Parameters in People With Cystic Fibrosis	Cystic Fibrosis	Drug: Tezacaftor/Ivacaftor + Ivacaftor;Drug: Placebo oral tablet	Nottingham University Hospitals NHS Trust	Vertex Pharmaceuticals Incorporated;Cystic Fibrosis Foundation;Cystic Fibrosis Trust;University of Nottingham;Nottingham University Hospitals Charity	Completed	12 Years	40 Years	All	12	Phase 2	United Kingdom
155	NCT04302428 (ClinicalTrials.gov)	August 29, 2019	6/3/2020	Zinc Status and Growth in Cystic Fibrosis	Zinc Status and Growth in Cystic Fibrosis	Cystic;Fibrosis	Biological: Serum Zn;Biological: Red Blood Cell Zn	Indiana University	NULL	Active, not recruiting	3 Months	3 Years	All	35		United States
156	EUCTR2018-003970-28-DE (EUCTR)	12/08/2019	21/05/2019	A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis	A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
157	EUCTR2019-000261-21-DE (EUCTR)	12/08/2019	16/05/2019	A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler	A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
158	NCT03903913 (ClinicalTrials.gov)	August 8, 2019	15/2/2019	Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis	A Phase IIa Open Label Study to Evaluate the Safety, Tolerability and Efficacy of S-1226 Administered by Nebulization in Subjects With Mild to Moderate Cystic Fibrosis and Non CF Bronchiectasis	Cystic Fibrosis;Bronchiectasis	Drug: S-1226	SolAeroMed Inc.	NULL	Recruiting	14 Years	50 Years	All	12	Phase 2	Canada
159	EUCTR2019-000261-21-IE (EUCTR)	26/07/2019	30/05/2019	A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM)1	A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM)1	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162	Boehringer Ingelheim Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Canada;Belgium;Spain;Ireland;Germany;United Kingdom;Sweden
160	EUCTR2019-000261-21-FR (EUCTR)	19/07/2019	21/05/2019	A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler	A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162	Boehringer Ingelheim France	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
161	EUCTR2017-004134-29-DE (EUCTR)	12/07/2019	05/03/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
162	EUCTR2018-002496-18-NL (EUCTR)	08/07/2019	13/02/2019	A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 2	United States;Portugal;Germany;Netherlands;United Kingdom
163	EUCTR2018-003970-28-BE (EUCTR)	04/07/2019	23/04/2019	A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis	A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
164	NCT04302662 (ClinicalTrials.gov)	June 27, 2019	4/3/2020	Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs	A Multicenter, Open-label Phase 2 Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs, to Investigate the Efficacy and Safety of This Combination for the Compensation of Severe Exocrine Pancreatic Insufficiency in CF Patients Not Fully Compensated With Only PPEs	Cystic Fibrosis;Cystic Fibrosis Gastrointestinal Disease;Cystic Fibrosis of Pancreas	Drug: MS1819-SD	AzurRx SAS	NULL	Completed	12 Years	N/A	All	20	Phase 2	Hungary;Turkey
165	NCT03597347 (ClinicalTrials.gov)	June 20, 2019	12/7/2018	Trial of Inhaled Molgramostim in CF Subjects With NTM Infection	An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection	Mycobacterium Infections, Nontuberculous;Cystic Fibrosis (CF)	Drug: Molgramostim nebulizer solution;Device: PARI eFlow nebulizer system	Savara Inc.	NULL	Terminated	18 Years	N/A	All	14	Phase 2	United States
166	EUCTR2017-003723-29-RO (EUCTR)	18/06/2019	24/05/2022	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
167	EUCTR2018-003970-28-GB (EUCTR)	18/06/2019	17/04/2019	A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis	A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
168	NCT04010799 (ClinicalTrials.gov)	May 27, 2019	10/6/2019	A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis	A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Patients Affected by Cystic Fibrosis and Non Cystic Fibrosis Bronchiectasis	Cystic Fibrosis;Non-Cystic Fibrosis Bronchiectasis	Drug: CHF 6333;Drug: Placebo	Chiesi Farmaceutici S.p.A.	NULL	Completed	18 Years	N/A	All	68	Phase 1	Germany
169	EUCTR2018-002496-18-PT (EUCTR)	20/05/2019	05/02/2019	A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 2	United States;Portugal;Netherlands;Germany;United Kingdom
170	NCT03822455 (ClinicalTrials.gov)	May 16, 2019	29/1/2019	A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis	A Phase 2b Randomised, Double-blind, Parallel-group Study of Alginate Oligosaccharide (OligoG) Dry Powder Inhalation in Addition to Standard of Care Compared to Placebo in Addition to Standard of Care in Patients With Cystic Fibrosis (CF)	Cystic Fibrosis	Drug: OligoG DPI	AlgiPharma AS	AlgiPharma Australia Pty. Ltd.	Active, not recruiting	18 Years	N/A	All	20	Phase 2	Australia
171	EUCTR2017-003723-29-PL (EUCTR)	09/05/2019	07/11/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
172	EUCTR2019-001314-41-NL (EUCTR)	06/05/2019	06/05/2019	This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor.	Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS	Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Orkambi: contains lumacaftor and ivacaftor Product Name: Orkambi Trade Name: Symkevi Product Name: Symkevi Trade Name: Kalydeco Product Name: Kalydeco		NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Netherlands
173	EUCTR2018-002496-18-DE (EUCTR)	02/05/2019	28/01/2019	A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	108	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Portugal;United States;Netherlands;Germany;United Kingdom
174	EUCTR2018-003831-31-HU (EUCTR)	28/03/2019	09/10/2018	MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis.	A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs - MS1819/18/02	Exocrine Pancreatic Insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MS1819-SD	AzurRx	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Hungary;Poland;Spain
175	EUCTR2017-001259-29-GB (EUCTR)	12/03/2019	21/12/2018	A study to establish the tolerabilty and adverse effects in people with a severe form of Cystic Fibrosi (delta F 508 homozygous) when using a combination of two products - cyteamine (a licensed medicine being used in a new disease) and EGCG (a food supplement).	A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE (CYSTAGON) IN ADULTS AND CHILDREN WITH HOMOZYGOUS ?F508 CYSTIC FIBROSIS, IN PATIENTS TAKING EPIGALLOCATECHIN-3-GALLATE (EGCG, EPINERVE) FOOD SUPPLEMENTATION - Delta Dose Study	DeltaF508 Homozygous Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cystagon Product Name: Cystagon INN or Proposed INN: cysteamine bitartrate Other descriptive name: 2-aminoethanethiol;2,3-dihydroxybutanedioic acid	University of LIverpool	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 1;Phase 2	United Kingdom
176	EUCTR2018-002496-18-GB (EUCTR)	08/03/2019	30/01/2019	A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 2	Portugal;United States;Netherlands;Germany;United Kingdom
177	EUCTR2017-003723-29-NL (EUCTR)	25/02/2019	20/06/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
178	EUCTR2017-002533-32-BE (EUCTR)	17/01/2019	28/09/2018	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
179	EUCTR2018-000185-11-GR (EUCTR)	20/12/2018	28/11/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Czechia;United Kingdom;Greece;Canada;Austria;Sweden;Netherlands;Czech Republic;Belgium;Italy;Australia;France;Germany
180	EUCTR2015-004143-39-IT (EUCTR)	19/12/2018	20/09/2018	Saline hypertonic in preschoolers and lung structure as measured by computed tomography.	A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%	Erasmus MC	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy
181	EUCTR2015-002743-33-NL (EUCTR)	14/12/2018	18/07/2018	A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM	Zambon S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Netherlands;Germany;New Zealand
182	NCT03624101 (ClinicalTrials.gov)	December 1, 2018	7/8/2018	Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations	Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations	Cystic Fibrosis	Drug: Trikafta;Drug: symdeko/Trikafta;Drug: Ivacaftor/Trikafta	University of Alabama at Birmingham	NULL	Recruiting	18 Years	N/A	All	2	Phase 4	United States
183	EUCTR2015-002743-33-GR (EUCTR)	27/11/2018	14/11/2018	A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM	Zambon S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	New Zealand;Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands
184	NCT03756922 (ClinicalTrials.gov)	November 27, 2018	27/11/2018	A DDI Study of FDL169 and FDL176 in Healthy Subjects	A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation	Cystic Fibrosis	Drug: FDL169;Drug: FDL176	Flatley Discovery Lab LLC	NULL	Suspended	18 Years	55 Years	All	78	Phase 1/Phase 2	United Kingdom
185	EUCTR2017-003723-29-CZ (EUCTR)	27/11/2018	09/07/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
186	EUCTR2018-000243-87-GB (EUCTR)	19/11/2018	21/08/2018	A study in people with cystic fibrosis who have a fungal lung infection, looking at the safety of inhaled PC945, it's effect on the body and how the body affects the drug.	An open-label study to assess the safety, pharmacokinetics and pharmacodynamics of inhaled PC945 in adult Cystic Fibrosis (CF) patients with persistent pulmonary Aspergillus fumigatus infection.	Pulmonary aspergillosis MedDRA version: 20.0;Level: LLT;Classification code 10059259;Term: Pulmonary aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: PC945	Pulmocide Ltd	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 2	United Kingdom
187	EUCTR2017-003723-29-DE (EUCTR)	19/11/2018	14/02/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
188	EUCTR2017-003723-29-PT (EUCTR)	19/11/2018	21/03/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden
189	EUCTR2017-003319-21-BE (EUCTR)	08/11/2018	21/08/2018	Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis	A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428	Proteostasis Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 1;Phase 2	United States;France;Canada;Belgium;Denmark;Germany;United Kingdom
190	NCT03748199 (ClinicalTrials.gov)	November 8, 2018	5/11/2018	Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF	Phase-Ib/IIa Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Inhaled Multiple Doses of POL6014 in Patients With Cystic Fibrosis	Cystic Fibrosis	Drug: POL6014;Drug: Placebo	Santhera Pharmaceuticals	NULL	Completed	18 Years	55 Years	All	32	Phase 1/Phase 2	Germany
191	NCT03617718 (ClinicalTrials.gov)	November 1, 2018	19/7/2018	Project 2 Airway Potential Hydrogen (pH) in Asthma	Methods to Identify and Treat Severe Asthma Patients Project 2: Airway pH Phenotyping	Cystic Fibrosis;Asthma;Severe Persistent Asthma;Healthy	Drug: Glycine Buffer	University Hospitals Cleveland Medical Center	National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI)	Recruiting	18 Years	50 Years	All	75	Phase 1/Phase 2	United States
192	EUCTR2017-003723-29-GR (EUCTR)	15/10/2018	08/08/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
193	EUCTR2018-000185-11-CZ (EUCTR)	15/10/2018	09/07/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;United Kingdom;Greece;Canada;Czech Republic;Austria;Netherlands;Sweden;Belgium;Italy;Australia;France;Germany
194	EUCTR2018-000183-28-CZ (EUCTR)	01/10/2018	09/07/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
195	EUCTR2018-000183-28-GR (EUCTR)	01/10/2018	25/07/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
196	EUCTR2018-000183-28-GB (EUCTR)	27/09/2018	04/07/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
197	EUCTR2018-000184-89-GB (EUCTR)	27/09/2018	04/07/2018	A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Product Name: 100 mg TEZ/150 mg IVA FDC Product Code: TEZ/IVA INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Belgium;Netherlands;United Kingdom
198	EUCTR2016-004479-35-PL (EUCTR)	26/09/2018	17/05/2018	A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis	A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation - A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic F	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	65	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
199	EUCTR2017-004134-29-PL (EUCTR)	24/09/2018	13/07/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
200	EUCTR2017-003723-29-BG (EUCTR)	21/09/2018	08/05/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
201	EUCTR2018-000183-28-DE (EUCTR)	20/09/2018	03/07/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
202	EUCTR2018-000183-28-IT (EUCTR)	17/09/2018	09/02/2021	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - NA	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: [VX-445/TEZ/IVA] INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: Ivacaftor	VERTEX PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
203	EUCTR2018-002550-71-DE (EUCTR)	12/09/2018	18/07/2018	A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis	Phase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: POL6014 INN or Proposed INN: lonodelestat Other descriptive name: CYCLO[L-ALANYL-L-SERYL-L-ISOLEUCYL-L-PROLYL-L-PROLYL-L-GLUTAMINYL-L-LYSYL-L-TYROSYL-D-PROLYL-L-PROLYL-(2S)-2-AMINODECANOYL-L-ALPHA-GLUTAMYL-L-THREONYL]	Santhera Pharmaceuticals (Switzerland) Ltd	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 1;Phase 2	Germany
204	EUCTR2018-000184-89-NL (EUCTR)	12/09/2018	16/08/2018	A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Product Name: 100 mg TEZ/150 mg IVA FDC Product Code: TEZ/IVA INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Belgium;Netherlands;United Kingdom
205	EUCTR2017-003723-29-IT (EUCTR)	11/09/2018	12/02/2021	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: [JBT-101] Other descriptive name: Lenabasum Product Name: Lenabasum Product Code: [JBT-101] Other descriptive name: Lenabasum	CORBUS PHARMACEUTICALS, INC	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
206	EUCTR2018-000184-89-BE (EUCTR)	07/09/2018	09/07/2018	A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Product Name: 100 mg TEZ/150 mg IVA FDC Product Code: TEZ/IVA INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Belgium;Netherlands;United Kingdom
207	EUCTR2018-000185-11-BE (EUCTR)	07/09/2018	17/07/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Trikafta Product Name: 100 mg ELX /50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden
208	EUCTR2018-000183-28-BE (EUCTR)	07/09/2018	09/07/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
209	EUCTR2018-000183-28-NL (EUCTR)	03/09/2018	18/07/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden
210	EUCTR2017-004134-29-DK (EUCTR)	29/08/2018	03/07/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Canada;Spain;Poland;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland
211	EUCTR2017-002533-32-DK (EUCTR)	28/08/2018	09/11/2017	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Singapore;United States;United Kingdom;Spain;New Zealand;Netherlands;Sweden;Belgium;Denmark;Korea, Republic of;Poland;Italy;Australia;Bulgaria;Germany
212	EUCTR2018-000183-28-SE (EUCTR)	27/08/2018	29/06/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
213	EUCTR2018-002579-16-SE (EUCTR)	26/08/2018	16/07/2018	Measurement of the posaconazole concentration in exhaled breath in CF patients after a single dose posaconazole to correlate to the concentration in blood and saliva.	Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus spp. related lung-disease. Part 1. Pharmacokinetic single center study.	Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene on chromosome seven, which encodes a chloride channel. In the lung defective channel activity leads to thick, viscous secretion and impaired mucociliary clearance. This causes trapping of mucus, colonization with bacteria and fungi, and a persistent inflammatory response. MedDRA version: 20.0;Level: PT;Classification code 10074549;Term: Cystic fibrosis respiratory infection suppression;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Noxafil®	Karolinska University Hospital, Stockholm CF center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 2	Sweden
214	EUCTR2018-000183-28-AT (EUCTR)	24/08/2018	20/07/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
215	EUCTR2018-002366-39-GB (EUCTR)	23/08/2018	20/06/2019	A pilot trial of intravenous iron for the treatment of low iron levels in adult patients with cystic fibrosis.	A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis - Intravenous iron in adults with cystic fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Ferinject Product Name: Ferinject INN or Proposed INN: Ferric carboxymaltose	University of Oxford / Clinical Trials and Research Governance	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
216	EUCTR2017-004134-29-GB (EUCTR)	22/08/2018	23/02/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom
217	NCT03625466 (ClinicalTrials.gov)	August 10, 2018	7/8/2018	A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del	An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del	Cystic Fibrosis	Drug: LUM;Drug: IVA;Drug: Matched Placebos	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	2 Years	5 Years	All	51	Phase 2	Germany
218	EUCTR2016-004479-35-FR (EUCTR)	08/08/2018	04/06/2018	A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis	A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	65	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
219	NCT03551691 (ClinicalTrials.gov)	August 7, 2018	29/5/2018	PPIs and Fat Absorption in CF and EPI	Proton Pump Inhibitors and Fat Absorption in Subjects With Cystic Fibrosis and Pancreatic Insufficiency	Pancreatic Insufficiency;Cystic Fibrosis	Drug: Omeprazole 40mg Capsule;Drug: Placebo oral capsule	Children's Hospital of Philadelphia	Chiesi USA, Inc.	Active, not recruiting	12 Years	N/A	All	16	Phase 2	United States
220	EUCTR2017-003319-21-DE (EUCTR)	20/07/2018	09/04/2018	Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis	A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428	Proteostasis Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 1;Phase 2	United States;France;Canada;Belgium;Denmark;Germany;United Kingdom
221	EUCTR2017-002968-40-DK (EUCTR)	28/06/2018	24/06/2018	A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	121	Phase 3	France;United States;Canada;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland
222	EUCTR2017-003723-29-BE (EUCTR)	27/06/2018	29/03/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Romania;Bulgaria;Germany;Netherlands;Sweden
223	EUCTR2017-003761-99-DE (EUCTR)	27/06/2018	19/02/2018	A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del	An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Orkambi 100 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Germany
224	EUCTR2016-004479-35-BE (EUCTR)	26/06/2018	30/03/2018	A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis	A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	65	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
225	EUCTR2016-004479-35-DE (EUCTR)	26/06/2018	06/04/2018	A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis	A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	65	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
226	EUCTR2018-000098-61-GB (EUCTR)	22/06/2018	01/06/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in adult patients with cystic fibrosis	A Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG3067 Product Code: G914167 INN or Proposed INN: Not applicable Other descriptive name: GLPG3067 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	144	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;France;United States;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;New Zealand;United Kingdom
227	NCT04278040 (ClinicalTrials.gov)	June 20, 2018	7/2/2020	Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis	Safety, Tolerability and Efficacy of Ultra-low Doses of Alkylating Drug Melphalan Inhalations for the Treatment of Non-cystic Fibrosis Bronchiectasis	Non-cystic Fibrosis Bronchiectasis	Drug: Melphalan	Federal State Budgetary Institution, Pulmonology Scientific Research Institute	Moscow State University of Medicine and Dentistry	Recruiting	18 Years	70 Years	All	7	Phase 2	Russian Federation
228	EUCTR2018-001573-24-BE (EUCTR)	11/06/2018	08/05/2018	Evaluation of the short-term effect of ORKAMBI on lung function in patients with cystic fibrosis who have two copies of the F508del mutation using functional respiratory imaging	Functional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaftor/ ivacaftor) on lung function in ORKAMBI-naive patients with Cystic Fibrosis Homozygous for Phe508del.	Cystic Fibrosis Homozygous (homozygous for the F508del mutation) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Orkambi INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Antwerp University Hospital	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Belgium
229	EUCTR2017-003723-29-SE (EUCTR)	07/06/2018	01/03/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
230	EUCTR2017-003319-21-GB (EUCTR)	04/06/2018	03/07/2018	Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis	A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428	Proteostasis Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 1;Phase 2	France;United States;Canada;Belgium;Denmark;Germany;United Kingdom
231	EUCTR2016-001440-18-NL (EUCTR)	30/05/2018	16/01/2018	The influence of cytochrome P450 3A4 inhibitors on serum levels of Ivacaftor in cystic fibrosis patients and healthy subjects.	Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACI	cystic fibrosis and healthy subjects;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ivacaftor Trade Name: claritromycin 500mg film coated tablets Product Name: Claritromycin Trade Name: Azithromycin 500 mg film-coated tablet Product Name: azithromycin Trade Name: Norvir 100 mg film-coated tablets Product Name: Norvir	university medical center utrecht	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 4	Netherlands
232	NCT03482960 (ClinicalTrials.gov)	May 29, 2018	23/3/2018	Comparison of 129Xe MRI With 19F MRI in CF Lung Disease	Comparison of 129Xe MRI With 19F MRI in CF Lung Disease	Cystic Fibrosis	Drug: Hyperpolarized Xenon gas;Drug: PFP	University of North Carolina, Chapel Hill	Cystic Fibrosis Foundation	Completed	18 Years	N/A	All	11	Early Phase 1	United States
233	EUCTR2017-003723-29-ES (EUCTR)	21/05/2018	09/04/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;Serbia;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
234	EUCTR2017-004133-82-ES (EUCTR)	18/05/2018	15/03/2018	A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Spain;Ireland;Australia;Germany;United Kingdom
235	EUCTR2017-004134-29-ES (EUCTR)	18/05/2018	21/03/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
236	EUCTR2017-004132-11-ES (EUCTR)	18/05/2018	05/03/2018	A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
237	EUCTR2017-003723-29-AT (EUCTR)	17/05/2018	28/03/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
238	EUCTR2017-004134-29-IE (EUCTR)	15/05/2018	05/03/2018	A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 3	United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
239	EUCTR2017-003723-29-GB (EUCTR)	11/05/2018	05/02/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
240	NCT03375047 (ClinicalTrials.gov)	May 10, 2018	7/9/2017	Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis	A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled, Combined Single and Multiple Ascending Dose Study Evaluating the Safety, Tolerability, and Biological Activity of MRT5005 Administered by Nebulization to Adult Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: MRT5005;Drug: Normal saline	Translate Bio, Inc.	NULL	Recruiting	18 Years	N/A	All	40	Phase 1/Phase 2	United States
241	NCT03428334 (ClinicalTrials.gov)	May 10, 2018	26/1/2018	Roflumilast in Non-CF Bronchiectasis Study	A 4-week Single-arm Study of Roflumilast in Stable-state Non-cystic Fibrosis Bronchiectasis	Non-cystic Fibrosis Bronchiectasis	Drug: Oral roflumilast	The University of Hong Kong	NULL	Completed	18 Years	N/A	All	20	Phase 2	Hong Kong
242	EUCTR2016-002749-42-NL (EUCTR)	09/05/2018	29/08/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Netherlands;Germany
243	EUCTR2017-004132-11-DK (EUCTR)	08/05/2018	02/03/2018	A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Canada;Poland;Spain;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland
244	EUCTR2017-004132-11-GB (EUCTR)	02/05/2018	23/02/2018	A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom
245	EUCTR2017-004133-82-GB (EUCTR)	02/05/2018	14/06/2018	A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Australia;Germany;United Kingdom
246	EUCTR2017-004133-82-IE (EUCTR)	01/05/2018	05/03/2018	A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Spain;Ireland;Australia;Germany;United Kingdom
247	NCT03522831 (ClinicalTrials.gov)	May 1, 2018	19/3/2018	CF Bronchodilation	A Double-blind Placebo-controlled Crossover Study to Assess the Effects of Bronchodilation on Dyspnea, Ventilatory Responses, and Exercise Tolerance in Adults With Cystic Fibrosis	Lung Diseases;Cystic Fibrosis	Drug: Salbutamol;Drug: Placebo	University of British Columbia	NULL	Active, not recruiting	19 Years	N/A	All	20	N/A	Canada
248	EUCTR2017-004132-11-IE (EUCTR)	01/05/2018	05/03/2018	A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
249	EUCTR2017-002968-40-IE (EUCTR)	27/04/2018	08/03/2018	A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	121	Phase 3	France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
250	EUCTR2017-002533-32-NL (EUCTR)	26/04/2018	29/11/2017	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
251	EUCTR2017-003723-29-SK (EUCTR)	26/04/2018	23/03/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
252	EUCTR2017-004132-11-DE (EUCTR)	25/04/2018	27/02/2018	A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Germany;United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;United Kingdom;Switzerland
253	NCT03537651 (ClinicalTrials.gov)	April 25, 2018	15/5/2018	A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis	Drug: TEZ/IVA;Drug: IVA	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	6 Years	N/A	All	130	Phase 3	United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom
254	EUCTR2016-004479-35-GB (EUCTR)	24/04/2018	26/04/2018	A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis	A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	France;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom
255	EUCTR2016-004479-35-DK (EUCTR)	18/04/2018	22/02/2018	A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis	A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	65	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland
256	EUCTR2017-003723-29-HU (EUCTR)	16/04/2018	27/02/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
257	NCT03489629 (ClinicalTrials.gov)	April 3, 2018	29/3/2018	STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)	STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)	Cystic Fibrosis	Drug: Trimethoprim Sulfamethoxazole (TMP/SMX);Drug: Minocycline;Drug: Mupirocin;Drug: Chlorhexidine Gluconate;Behavioral: Environmental Decontamination	University of North Carolina, Chapel Hill	University of Washington;Cook Children's Medical Center;Indiana University;University of Michigan;University of Texas Southwestern Medical Center;St. Louis Children's Hospital	Recruiting	2 Years	45 Years	All	42	Phase 2	United States
258	EUCTR2017-002533-32-ES (EUCTR)	29/03/2018	22/11/2017	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
259	EUCTR2017-002533-32-PL (EUCTR)	28/03/2018	18/01/2018	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Italy;United Kingdom;Poland;Belgium;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
260	EUCTR2017-002533-32-BG (EUCTR)	23/03/2018	01/12/2017	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
261	EUCTR2017-002533-32-GB (EUCTR)	22/03/2018	23/10/2017	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United Kingdom;United States;Spain;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
262	EUCTR2017-002533-32-DE (EUCTR)	15/03/2018	03/11/2017	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Korea, Republic of;Sweden
263	EUCTR2018-000126-55-NL (EUCTR)	15/03/2018	15/05/2018	A study to investigate the safety and the movement of the study drug VX-121 around the body in healthy people and patients with cystic fibrosis	A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121 INN or Proposed INN: Not yet assigned Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 1;Phase 2	Netherlands
264	NCT04411901 (ClinicalTrials.gov)	March 1, 2018	22/5/2020	The Role of Vitamin D3 in Pediatric Bronchiectasis Severity	The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)	Cystic Fibrosis and Non CF Bronchiectasis	Drug: Cholecalciferol (vitaminD3)	Heba Omara	NULL	Completed	1 Year	17 Years	All	40	Phase 2/Phase 3	Egypt
265	EUCTR2017-002533-32-SE (EUCTR)	30/01/2018	14/11/2017	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;United Kingdom;Italy;France;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
266	NCT03460704 (ClinicalTrials.gov)	January 29, 2018	14/2/2018	Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS II)	A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa)	Non Cystic Fibrosis Bronchiectasis	Drug: Colistimethate sodium;Drug: Saline Solution	Zambon SpA	NULL	Completed	18 Years	90 Years	All	287	Phase 3	United States;Argentina;Australia;Canada;France;Germany;Greece;Israel;Italy;New Zealand;Poland;Portugal
267	EUCTR2017-002533-32-IT (EUCTR)	23/01/2018	05/11/2020	A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study - N/A	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: INS1007 Product Code: [N/A] Product Name: INS1007 Product Code: [N/A]	INSMED INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
268	EUCTR2016-002749-42-GR (EUCTR)	12/01/2018	03/10/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
269	EUCTR2016-002749-42-DK (EUCTR)	15/12/2017	11/10/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
270	EUCTR2016-002749-42-FR (EUCTR)	12/12/2017	01/08/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
271	NCT03218917 (ClinicalTrials.gov)	December 1, 2017	11/7/2017	Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis	Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study	Non-Cystic Fibrosis Bronchiectasis	Drug: INS1007 10 mg oral tablet;Drug: INS1007 25 mg oral tablet;Drug: Placebo Oral Tablet	Insmed Incorporated	NULL	Completed	18 Years	85 Years	All	256	Phase 2	United States;Australia;Belgium;Bulgaria;Denmark;Germany;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Singapore;Spain;United Kingdom;Sweden
272	NCT03474042 (ClinicalTrials.gov)	November 29, 2017	15/3/2018	GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis	A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del Mutation	Cystic Fibrosis	Drug: GLPG2737;Drug: Placebo	Galapagos NV	NULL	Completed	18 Years	N/A	All	22	Phase 2	Germany
273	NCT03219164 (ClinicalTrials.gov)	November 28, 2017	13/7/2017	Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa Infection	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization	Pseudomonas Aeruginosa Respiratory Tract Infection;Cystic Fibrosis	Drug: AZLI;Drug: Placebo	Gilead Sciences	NULL	Completed	3 Months	18 Years	All	149	Phase 3	United Kingdom;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United States
274	EUCTR2016-002749-42-IT (EUCTR)	24/11/2017	14/09/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
275	EUCTR2016-005110-22-DE (EUCTR)	20/11/2017	23/06/2017	A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis	Phase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis	Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: POL6014	Santhera Pharmaceuticals (Switzerland) Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 1;Phase 2	Germany
276	EUCTR2016-005230-30-IT (EUCTR)	15/11/2017	05/11/2020	A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: SPX-101 Product Code: [SPX-101] INN or Proposed INN: SPX-101	SPYRYX BIOSCIENCES, INC.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Portugal;France;Canada;Australia;United Kingdom;Italy
277	EUCTR2015-004263-36-DE (EUCTR)	13/11/2017	06/09/2017	Study to assess the effects of inhaled RPL554 in adults with cystic fibrosis.	A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis. - Study to assess the effects of inhaled RPL554 in patients with cystic fibrosis.	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: RPL554 Product Code: RPL554 INN or Proposed INN: RPL554 Other descriptive name: RPL554	Verona Pharma plc	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 2	Germany;United Kingdom
278	NCT03206788 (ClinicalTrials.gov)	November 11, 2017	29/6/2017	Losartan and Inflammation in Cystic Fibrosis	Losartan as Anti-inflammatory Therapy to Augment F508del Cystic Fibrosis Transmembrane (CFTR) Recovery	Cystic Fibrosis	Drug: Losartan;Drug: placebo	University of Miami	University of Alabama at Birmingham;Children's Hospital Medical Center, Cincinnati;University of Kansas Medical Center;Cystic Fibrosis Foundation	Terminated	12 Years	N/A	All	7	Phase 2	United States
279	EUCTR2017-000540-18-DE (EUCTR)	08/11/2017	13/09/2017	Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi	Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	90	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Germany
280	EUCTR2017-002181-42-DE (EUCTR)	27/10/2017	28/07/2017	GLPG2737 on top of Orkambi in subjects with cystic fibrosis	A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutation	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 2	Germany
281	EUCTR2017-000797-11-NL (EUCTR)	06/10/2017	30/05/2017	A Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis	A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;Belgium;Australia;Netherlands
282	NCT02566044 (ClinicalTrials.gov)	September 27, 2017	18/9/2015	Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis	A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Inhaled QBW276 in Patients With Cystic Fibrosis	Pulmonary Cystic Fibrosis	Other: Placebo;Drug: QBW276	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	All	16	Phase 1/Phase 2	United States;Germany;United Kingdom
283	EUCTR2016-002749-42-DE (EUCTR)	22/09/2017	02/08/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
284	EUCTR2017-000571-85-GB (EUCTR)	19/09/2017	11/05/2017	Study of Oral Liprotamase Therapy Of Non-Porcine Origin	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment	Pancreatic Exocrine Insufficiency due to Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom
285	EUCTR2016-002749-42-BE (EUCTR)	18/09/2017	24/07/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
286	EUCTR2017-000571-85-LT (EUCTR)	15/09/2017	20/07/2017	Study of Oral Liprotamase Therapy Of Non-Porcine Origin	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment	Pancreatic Exocrine Insufficiency due to Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123 MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United States;Hungary;Poland;Spain;Lithuania;Israel
287	NCT03771313 (ClinicalTrials.gov)	September 1, 2017	11/7/2018	Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis	Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis	Cystic Fibrosis	Drug: Ceftaroline	Children's Hospital Medical Center, Cincinnati	NULL	Active, not recruiting	2 Years	21 Years	All	24	Phase 4	United States
288	EUCTR2015-003040-39-NL (EUCTR)	28/08/2017	23/01/2017	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom;Switzerland
289	EUCTR2016-005230-30-PT (EUCTR)	28/08/2017	31/05/2017	A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: SPX-101 INN or Proposed INN: SPX-101 Product Name: SPX-101 INN or Proposed INN: SPX-101	Spyryx Biosciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	France;Portugal;Canada;Australia;Italy;United Kingdom
290	EUCTR2017-000797-11-BE (EUCTR)	28/08/2017	15/06/2017	A Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis	A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) INN or Proposed INN: VX-561 Other descriptive name: VX-561	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	104	Phase 2	United States;Belgium;Australia;Netherlands
291	NCT03277196 (ClinicalTrials.gov)	August 16, 2017	6/9/2017	A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation	A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation	Cystic Fibrosis	Drug: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Active, not recruiting	0 Months	24 Months	All	86	Phase 3	United States;Australia;Canada;Germany;Ireland;United Kingdom
292	EUCTR2016-004558-13-PL (EUCTR)	14/08/2017	30/06/2017	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Portugal;France;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;New Zealand;Italy
293	EUCTR2016-003585-11-GB (EUCTR)	10/08/2017	10/07/2017	Study to Evaluate the Safety and Efficacy of VX-659 drug in combination with other drugs in Subjects Aged 18 Years and Older With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659 Product Code: VX-659 INN or Proposed INN: VX-659 Other descriptive name: VX-659 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) INN or Proposed INN: Deuterated Ivacaftor Other descriptive name: VX-561 (CTP-656)	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	United States;Ireland;Israel;United Kingdom
294	EUCTR2016-002749-42-AT (EUCTR)	07/08/2017	27/07/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
295	EUCTR2016-002749-42-ES (EUCTR)	04/08/2017	08/08/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
296	EUCTR2016-001214-24-DE (EUCTR)	27/07/2017	10/04/2017	A Multi-center, Randomized, Placebo-Controlled Phase I/II Study Designed to Assess the Safety, Tolerability, and how the body breaks down the drug PTI-428 in Subjects with Cystic Fibrosis	A Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Code: PTI-428 Product Code: PTI-428	Proteostasis Therapeutics	NULL	Not Recruiting			Female: yes Male: yes	132	Phase 1;Phase 2	France;United States;Czech Republic;Canada;Denmark;Germany;Italy;United Kingdom
297	EUCTR2014-004915-35-DE (EUCTR)	26/07/2017	14/10/2015	Safety and effect of QBW276 in patients with cystic fibrosis	A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: QBW276 300mcg Product Code: QBW276 INN or Proposed INN: Not established Other descriptive name: QBW276 Succinate Product Name: QBW276 1500mcg Product Code: QBW276 INN or Proposed INN: Not established Other descriptive name: QBW276 Succinate	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	56	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Germany;United Kingdom
298	EUCTR2016-005230-30-GB (EUCTR)	14/07/2017	03/05/2017	A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: SPX-101 INN or Proposed INN: SPX-101 Product Name: SPX-101 INN or Proposed INN: SPX-101	Spyryx Biosciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Portugal;France;Canada;Australia;Italy;United Kingdom
299	EUCTR2015-002743-33-PT (EUCTR)	13/07/2017	10/07/2017	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
300	EUCTR2016-001214-24-DK (EUCTR)	10/07/2017	28/04/2017	A Multi-center, Randomized, Placebo-Controlled Phase I/II Study Designed to Assess the Safety, Tolerability, and how the body breaks down the drug PTI-428 in Subjects with Cystic Fibrosis	A Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Code: PTI-428 Product Code: PTI-428 Product Code: PTI-428 Product Code: PTI-428	Proteostasis Therapeutics	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 1;Phase 2	United States;France;Czech Republic;Canada;Denmark;Germany;United Kingdom;Italy
301	EUCTR2016-004033-25-ES (EUCTR)	19/06/2017	31/03/2017	Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis	Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial	Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10074550;Term: Preventive antimicrobial therapy in cystic fibrosis;System Organ Class: 100000004865 MedDRA version: 20.0;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Sodium bicarbonate INN or Proposed INN: Sodium Bicarbonate Other descriptive name: SODIUM BICARBONATE BP Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: Water for injections INN or Proposed INN: water for injections Other descriptive name: WATER FOR INJECTIONS, EP	Fundació Parc Taulí	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 2	Spain
302	EUCTR2017-000571-85-HU (EUCTR)	15/06/2017	13/04/2017	Study of Oral Liprotamase Therapy Of Non-Porcine Origin	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment	Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	192	Phase 3	United States;Hungary;Poland;Spain;Lithuania;Israel
303	NCT03093974 (ClinicalTrials.gov)	June 6, 2017	9/3/2017	Long Term Efficacy and Safety of Inhaled Colistimethate Sodium in Bronchiectasis Subjects With Chronic Pseudomonas Aeruginosa Infection.	A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa)	Non Cystic Fibrosis Bronchiectasis	Drug: Colistimethate Sodium;Drug: Saline Solution	Zambon SpA	NULL	Completed	18 Years	N/A	All	377	Phase 3	Australia;Belgium;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Portugal;Spain;Switzerland;United Kingdom
304	EUCTR2017-000571-85-ES (EUCTR)	01/06/2017	21/04/2017	Study of Oral Liprotamase Therapy Of Non-Porcine Origin	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment	Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United States;Hungary;Poland;Spain;Lithuania;Israel
305	EUCTR2016-004477-40-ES (EUCTR)	31/05/2017	10/03/2017	A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles	A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation	Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
306	EUCTR2016-004558-13-FR (EUCTR)	30/05/2017	20/03/2017	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 3	Portugal;United States;France;Greece;Canada;Poland;Germany;Italy
307	EUCTR2015-002743-33-DE (EUCTR)	29/05/2017	01/03/2017	A clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
308	EUCTR2016-004477-40-GB (EUCTR)	26/05/2017	06/02/2017	A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles	A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation	Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	50	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
309	EUCTR2016-004477-40-BE (EUCTR)	08/05/2017	21/02/2017	A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles	A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation	Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	United States;Serbia;Spain;Belgium;Netherlands;United Kingdom
310	EUCTR2016-000454-36-NL (EUCTR)	05/05/2017	02/11/2016	A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
311	EUCTR2016-004996-33-ES (EUCTR)	03/05/2017	10/03/2017	A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del-CFTR Mutation	A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation	Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Orkambi Product Name: Orkambi INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR	Vertex Pharmaceuticals Incoporated	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 4	United States;Canada;Spain;Australia;United Kingdom
312	NCT03051490 (ClinicalTrials.gov)	April 28, 2017	9/2/2017	RESULT: Reliable, Emergent Solution Using Liprotamase Treatment	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency	Exocrine Pancreatic Insufficiency;Cystic Fibrosis	Drug: Liprotamase;Drug: porcine PERT	Anthera Pharmaceuticals	NULL	Unknown status	7 Years	N/A	All	140	Phase 3	United States;Hungary;Israel;Lithuania;Poland;Spain;United Kingdom
313	EUCTR2015-004143-39-ES (EUCTR)	19/04/2017	31/03/2017	Saline hypertonic in preschoolers and lung structure as measured by computed tomography.	A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study	Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Hypertonic saline INN or Proposed INN: HYPERTONIC SALINE Other descriptive name: SALINE Product Name: Isotonic saline INN or Proposed INN: ISOTONIC SALINE Other descriptive name: STERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V)	Erasmus MC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Spain;Denmark;Australia;Netherlands
314	EUCTR2016-004477-40-NL (EUCTR)	10/04/2017	14/02/2017	A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles	A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation	Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
315	NCT03104855 (ClinicalTrials.gov)	April 3, 2017	17/2/2017	Clearance of 25-hydroxyvitamin D in Cystic Fibrosis	Clearance of 25-hydroxyvitamin D in Cystic Fibrosis	Cystic Fibrosis	Drug: d6-25-hydroxyvitamin D3	University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Active, not recruiting	18 Years	N/A	All	10	Phase 1	United States
316	NCT03256799 (ClinicalTrials.gov)	March 17, 2017	18/8/2017	Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense Mutations	An Open Label Study to Investigate the Role of Ivacaftor for the Treatment of Cystic Fibrosis in Combination With Ataluren (PTC124) in Cystic Fibrosis Patients Using Ataluren for Nonsense Mutations	Cystic Fibrosis	Drug: Ivacaftor/Ataluren	University of Alabama at Birmingham	NULL	Completed	19 Years	N/A	All	1	Phase 4	United States
317	EUCTR2015-002743-33-ES (EUCTR)	13/03/2017	10/02/2017	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	264	Phase 3	Portugal;Belgium;Spain;Germany;Italy;United Kingdom
318	EUCTR2015-002743-33-IT (EUCTR)	02/03/2017	25/01/2021	A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis 1	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin/Tadim Product Name: Colistimethate sodium Product Code: [-] INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: - Trade Name: Ventolin¿ Evohaler¿ Product Name: Ventolin Product Code: [Ventolin] INN or Proposed INN: SALBUTAMOL Other descriptive name: Ventolin® Evohaler	ZAMBON SPA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
319	NCT02498535 (ClinicalTrials.gov)	February 22, 2017	12/7/2015	Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients	Prospective, Randomized, Placebo Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients	Cystic Fibrosis	Drug: Nitric Oxide 160 ppm	Novoteris, LLC	Cystic Fibrosis Foundation;Mallinckrodt	Terminated	18 Years	N/A	All	49	Phase 2	United States;Canada
320	EUCTR2015-002743-33-GB (EUCTR)	21/02/2017	13/12/2016	A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)	A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I	Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium	Zambon S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	Portugal;Greece;Spain;Israel;United Kingdom;Italy;Switzerland;France;Belgium;Australia;Germany;Netherlands;New Zealand
321	EUCTR2015-004143-39-DK (EUCTR)	14/02/2017	25/10/2016	Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study.	A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study	Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Hypertonic saline INN or Proposed INN: sodium chloride 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%	Erasmus MC	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	France;United States;Spain;Belgium;Australia;Denmark;Netherlands;Italy
322	NCT02712983 (ClinicalTrials.gov)	February 8, 2017	5/2/2016	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	Non-cystic Fibrosis Bronchiectasis	Drug: TIP;Drug: TIP and placebo;Drug: Placebo	Novartis Pharmaceuticals	Queen's University Belfast, UK;University Hospital Antwerp, BE;University of Milan, IT;Fundacion Clinic per a la Recerca Biomedica;Erasmus Medical Center;Papworth Hospital Cambridge, UK;Royal Brompton Hospital Trust, UK;University of Dundee;University of Edinburgh, UK	Completed	18 Years	N/A	All	107	Phase 2	Belgium;France;Germany;Italy;Spain;United Kingdom;Netherlands
323	NCT03256968 (ClinicalTrials.gov)	January 27, 2017	18/8/2017	PTC Study to Evaluate Ataluren in Combination With Ivacaftor	An Open Label N of 1 Study to Evaluate the Study and Efficacy of Long-Term Treatment With Ivacaftor in Combination With Ataluren (PTC124) in Subjects With Nonsense Mutation Cystic Fibrosis	Cystic Fibrosis	Drug: Ataluren	University of Alabama at Birmingham	NULL	Completed	6 Years	N/A	All	1	Phase 4	United States
324	EUCTR2016-000454-36-BE (EUCTR)	24/01/2017	25/10/2016	A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	United States;Canada;Spain;Belgium;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
325	EUCTR2016-000454-36-ES (EUCTR)	18/01/2017	26/10/2016	A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
326	EUCTR2016-000454-36-IT (EUCTR)	16/01/2017	27/02/2018	A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR	VERTEX PHARMACEUTICALS INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
327	EUCTR2015-003399-58-DK (EUCTR)	14/01/2017	07/01/2016	Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma?	Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? - Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease)	Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Ciprofloxacin INN or Proposed INN: ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Piperacillin/Tazobactam INN or Proposed INN: piperacillin sodium , tazobactam sodium Other descriptive name: PIPERACILLIN SODIUM	COP:TRIN Region Hovedstaden (Gentofte hospital)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Denmark
328	EUCTR2015-004986-99-IT (EUCTR)	11/01/2017	06/09/2016	A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (CF) Being Treated for an Exacerbation of CF-associated Lung Disease.	exacerbation of Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: cysteamine bitartrate	NovaBiotics, Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Netherlands;United Kingdom;Italy
329	EUCTR2016-000454-36-GB (EUCTR)	10/01/2017	07/10/2016	A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	198	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
330	EUCTR2015-004841-13-CZ (EUCTR)	04/01/2017	10/08/2016	A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation	A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	France;United States;Czech Republic;Ireland;United Kingdom
331	EUCTR2016-000454-36-DE (EUCTR)	04/01/2017	12/10/2016	A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
332	EUCTR2016-002837-31-CZ (EUCTR)	04/01/2017	24/10/2016	A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation	A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 2	Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
333	EUCTR2016-000454-36-AT (EUCTR)	03/01/2017	07/10/2016	A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	United States;Canada;Belgium;Spain;Denmark;Australia;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
334	EUCTR2016-002837-31-DE (EUCTR)	29/12/2016	24/10/2016	A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation	A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation - Albatross	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 2	Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
335	EUCTR2015-003040-39-BE (EUCTR)	27/12/2016	01/09/2016	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
336	EUCTR2015-003040-39-DE (EUCTR)	23/12/2016	11/10/2016	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
337	EUCTR2016-001585-29-NL (EUCTR)	21/12/2016	18/07/2016	Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Orkambi 200 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Netherlands
338	EUCTR2016-002837-31-BE (EUCTR)	16/12/2016	24/10/2016	A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation	A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 2	Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
339	EUCTR2015-003040-39-FR (EUCTR)	16/12/2016	21/09/2018	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
340	EUCTR2015-003040-39-IE (EUCTR)	16/12/2016	16/12/2016	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
341	EUCTR2009-012575-10-SE (EUCTR)	08/12/2016	04/10/2016	Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF	Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF		Product Name: Ceftazidime INN or Proposed INN: Ceftazidime Other descriptive name: N/A Product Name: Tobramycin INN or Proposed INN: Tobramycin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A	University Hospitals Bristol NHS Foundation Trust	University of Liverpool	Not Recruiting			Female: yes Male: yes	260	Phase 4	United Kingdom;Sweden
342	EUCTR2015-004263-36-GB (EUCTR)	07/12/2016	30/08/2016	Study to assess the effects of inhaled RPL554 in adults with cystic fibrosis.	A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis. - To assess the effects of inhaled RPL554 in adults with cystic fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: RPL554 Product Code: RPL554 INN or Proposed INN: RPL554 Other descriptive name: RPL554	Verona Pharma plc	NULL	Not Recruiting			Female: yes Male: yes	10	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Germany;United Kingdom
343	EUCTR2016-002837-31-GB (EUCTR)	05/12/2016	17/10/2016	A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation	A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	35	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
344	EUCTR2016-002837-31-IE (EUCTR)	02/12/2016	04/10/2016	A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation	A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 2	Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
345	NCT03000348 (ClinicalTrials.gov)	December 2016	11/12/2016	A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients Being Treated for an Exacerbation of CF-associated Lung Disease	Cystic Fibrosis	Drug: Cysteamine;Drug: Placebo Oral Capsule	NovaBiotics Ltd.	Agility Clinical, Inc.;PSR Group B.V.	Completed	18 Years	N/A	All	91	Phase 2	United States;Italy;United Kingdom
346	EUCTR2015-004143-39-BE (EUCTR)	30/11/2016	13/10/2016	Saline hypertonic in preschoolers and lung structure as measured by computed tomography.	A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%	Erasmus MC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Spain;Belgium;Denmark;Australia;Netherlands
347	EUCTR2016-000454-36-DK (EUCTR)	18/11/2016	10/10/2016	A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis	Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	198	Phase 2	United States;Canada;Belgium;Spain;Austria;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
348	NCT02759562 (ClinicalTrials.gov)	November 4, 2016	29/4/2016	Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis	A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: Andecaliximab;Drug: Placebo	Gilead Sciences	NULL	Terminated	18 Years	N/A	All	6	Phase 2	Australia;France;Germany;Spain;United Kingdom;Belgium;Canada;Ireland;United States
349	NCT02934698 (ClinicalTrials.gov)	November 1, 2016	13/10/2016	An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations	An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations	Cystic Fibrosis	Drug: Ivacaftor	Medical University of South Carolina	Vertex Pharmaceuticals Incorporated	Completed	18 Years	N/A	Female	2	Phase 3	NULL
350	NCT02953314 (ClinicalTrials.gov)	November 2016	18/10/2016	A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)	A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis	Drug: TEZ;Drug: TEZ/IVA;Drug: IVA	Vertex Pharmaceuticals Incorporated	NULL	Completed	6 Years	11 Years	All	83	Phase 3	United States;Canada
351	NCT02613884 (ClinicalTrials.gov)	November 2016	20/11/2015	Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis	Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis	Vitamin D Deficiency	Drug: Treatment	Johns Hopkins All Children's Hospital	NULL	Completed	36 Months	18 Years	All	30	Phase 2	United States
352	NCT02951195 (ClinicalTrials.gov)	November 2016	26/10/2016	A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis	A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis	Cystic Fibrosis	Drug: VX-152;Drug: Tezacaftor;Drug: Ivacaftor;Drug: Triple Placebo;Drug: Placebo for VX-152	Vertex Pharmaceuticals Incorporated	NULL	Completed	18 Years	N/A	All	80	Phase 2	United States
353	NCT03029455 (ClinicalTrials.gov)	November 2016	11/1/2017	A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis	A Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: VX-659;Drug: Tezacaftor;Drug: Ivacaftor;Drug: VX-659 Matching Placebo;Drug: Triple Combination (TC) Matching Placebos	Vertex Pharmaceuticals Incorporated	NULL	Completed	18 Years	N/A	All	163	Phase 1	United Kingdom
354	NCT03056326 (ClinicalTrials.gov)	November 2016	3/2/2017	A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects	A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects	Non-Cystic Fibrosis Bronchiectasis;Cystic Fibrosis	Drug: CHF6333 (Part 1 - SAD);Drug: Placebo (Part 1 - SAD);Drug: CHF6333 (Part 2 - MAD);Drug: Placebo (Part 2 - MAD)	Chiesi Farmaceutici S.p.A.	NULL	Completed	18 Years	55 Years	Male	72	Phase 1	Belgium
355	EUCTR2015-004986-99-GB (EUCTR)	31/10/2016	06/09/2016	A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (CF) Being Treated for an Exacerbation of CF-associated Lung Disease.	exacerbation of Cystic Fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: cysteamine bitartrate	NovaBiotics, Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Netherlands;Italy;United Kingdom
356	EUCTR2015-003040-39-GB (EUCTR)	18/10/2016	30/01/2017	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;Switzerland;United Kingdom
357	EUCTR2016-002851-92-CZ (EUCTR)	05/10/2016	02/08/2016	NA	An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years	Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Liprotamase INN or Proposed INN: NOT ASSIGNED Other descriptive name: LIPASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: PROTEASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: AMYLASE	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 4	United States;Hungary;Czech Republic;Canada;Spain;Poland;Israel
358	EUCTR2015-003040-39-ES (EUCTR)	29/09/2016	30/08/2016	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
359	EUCTR2016-002851-92-ES (EUCTR)	19/09/2016	08/08/2016	NA	An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years	Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Liprotamasa INN or Proposed INN: SIN ASIGNAR Other descriptive name: LIPASA INN or Proposed INN: SIN ASIGNAR Other descriptive name: PROTEASA INN or Proposed INN: SIN ASIGNAR Other descriptive name: AMILASA	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Czech Republic;Hungary;Canada;Poland;Spain;Israel
360	EUCTR2015-003040-39-IT (EUCTR)	14/09/2016	28/09/2018	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection - Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder i	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA	NOVARTIS PHARMA SERVICES AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	France;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy
361	EUCTR2016-002851-92-HU (EUCTR)	08/09/2016	25/07/2016	NA	An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years	Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Liprotamase INN or Proposed INN: NOT ASSIGNED Other descriptive name: LIPASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: PROTEASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: AMYLASE	ANTHERA Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	United States;Hungary;Canada;Spain;Israel
362	EUCTR2015-002192-23-ES (EUCTR)	16/08/2016	09/06/2016	An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis.	A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis.	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	France;United States;Canada;Belgium;Spain;Ireland;Australia;Germany;United Kingdom
363	EUCTR2014-004838-25-DE (EUCTR)	16/08/2016	17/05/2016	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	155	Phase 3	United States;France;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
364	NCT02657473 (ClinicalTrials.gov)	August 13, 2016	13/1/2016	Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis	Long-term Inhaled Nebulized Tobramycin in Patients With Non-cystic Fibrosis Bronchiectasis. A Randomized Placebo Controlled Trial. The BATTLE Study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy.	Non-CF Bronchiectasis	Drug: tobramycin inhalation solution;Drug: Saline 0.9% inhalation solution	Medical Center Alkmaar	NULL	Completed	18 Years	N/A	All	58	Phase 2/Phase 3	Netherlands
365	EUCTR2015-004143-39-NL (EUCTR)	09/08/2016	21/12/2015	Saline hypertonic in preschoolers and lung structure as measured by computed tomography.	A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%	Erasmus MC	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy
366	EUCTR2016-000166-35-NL (EUCTR)	08/08/2016	17/05/2016	Inhaled nebulized tobramycin in non-CF bronchiectasis	Effects of long term ToBrAmycin InhalaTion SoluTion (TIS) once daiLy on Exacerbation rate in patients with non-cystic fibrosis bronchiectasis. A double blind, randomized, placebo and TIS twice daily (open label) controlled trial. The BATTLE study.	Patients with non-cystic fibrosis bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Tobramycin Steri-Neb 300 mg/5 ml, inhalation solution	Noordwest Ziekenhuisgroep	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 2;Phase 3	Netherlands
367	EUCTR2015-004841-13-IE (EUCTR)	08/08/2016	07/06/2016	A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation	A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: VX-371 in hypertonic saline INN or Proposed INN: not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic Saline INN or Proposed INN: 4.2% NaCl/Inhalation solution	Vertex Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	France;United States;Czech Republic;Ireland;United Kingdom
368	NCT02918409 (ClinicalTrials.gov)	August 2016	12/4/2016	IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy	IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy	Cystic Fibrosis	Drug: Colistin;Drug: Tobramycin	National Jewish Health	NULL	Active, not recruiting	18 Years	N/A	All	51	Phase 4	United States
369	EUCTR2015-004841-13-GB (EUCTR)	20/07/2016	09/06/2016	A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation	A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/Inhalation solution	Vertex Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Czech Republic;Ireland;United Kingdom
370	EUCTR2015-002192-23-BE (EUCTR)	18/07/2016	18/05/2016	An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis	A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	France;United States;Canada;Spain;Belgium;Ireland;Australia;Germany;United Kingdom
371	EUCTR2016-000066-34-GB (EUCTR)	24/06/2016	25/07/2017	A Study of the Effects of Lumacaftor/Ivacaftor on Exercise Tolerance in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation	A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation.	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Orkambi Product Name: lumacaftor/ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: lumacaftor Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	66	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Australia;United Kingdom
372	EUCTR2015-001267-39-GB (EUCTR)	20/06/2016	24/08/2015	A study to assess the efficacy and safety of ivacaftor in children aged 3 to 5 with Cystic Fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).	A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	50	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Canada;Australia;United Kingdom
373	EUCTR2015-002192-23-DE (EUCTR)	03/06/2016	11/05/2016	An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis	A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2	France;United States;Canada;Belgium;Spain;Ireland;Australia;Germany;United Kingdom
374	EUCTR2014-004788-18-BE (EUCTR)	03/06/2016	03/03/2016	A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function	Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
375	EUCTR2014-004838-25-AT (EUCTR)	02/06/2016	20/04/2016	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	155	Phase 3	France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
376	EUCTR2013-005357-79-SE (EUCTR)	01/06/2016	02/04/2016	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL	Pharmaxis Limited	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;New Zealand;Sweden
377	EUCTR2015-001644-11-DE (EUCTR)	25/05/2016	31/03/2016	Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.	A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	256	Phase 3	United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
378	EUCTR2015-003291-77-DE (EUCTR)	25/05/2016	11/11/2015	A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation	A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation	Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	Czech Republic;Ireland;Australia;Germany;United Kingdom
379	EUCTR2015-003881-96-IT (EUCTR)	17/05/2016	05/11/2020	Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosis	Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with	cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML Product Name: NA Product Code: [NA] INN or Proposed INN: COLISTIMETATO SODICO Other descriptive name: COLISTIN	AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER	NULL	Not Recruiting			Female: yes Male: yes	112	Phase 3	Italy
380	EUCTR2016-000354-35-DK (EUCTR)	12/05/2016	10/02/2016	High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine	High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine	cystic fibrosis MedDRA version: 19.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Mucolysin INN or Proposed INN: ACETYLCYSTEINE SODIUM Trade Name: AAC Hexal INN or Proposed INN: ACETYLCYSTEINE SODIUM	Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Denmark
381	EUCTR2015-002677-38-BE (EUCTR)	11/05/2016	03/03/2016	An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton	Celtaxsys Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	France;United States;Canada;Belgium;Germany;Italy;United Kingdom
382	EUCTR2015-002677-38-DE (EUCTR)	09/05/2016	03/11/2015	An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton	Celtaxsys Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	France;United States;Canada;Belgium;Germany;Italy;United Kingdom
383	EUCTR2013-004302-26-SK (EUCTR)	22/04/2016	26/01/2016	Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.	A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients.	Glaucoma or Ocular Hypertension MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]	Trade Name: Tafluprost INN or Proposed INN: tafluprost Other descriptive name: TAFLUPROST	Santen Oy	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 1	United States;Hungary;Slovakia;Poland;United Kingdom
384	EUCTR2015-002581-23-DE (EUCTR)	20/04/2016	26/10/2015	A study of safety and efficacy of JBT-101 in cystic fibrosis	A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis	Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	United States;France;Poland;Belgium;Israel;Germany;United Kingdom;Italy
385	EUCTR2015-001644-11-BE (EUCTR)	06/04/2016	08/01/2016	Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.	A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	256	Phase 3	United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
386	EUCTR2014-005355-83-GR (EUCTR)	05/04/2016	08/02/2016	Confirmatory extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
387	NCT02724527 (ClinicalTrials.gov)	April 2016	11/3/2016	Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 for Efficacy and Safety in Patients With CF Heterozygous for F508del-CFTR + Gating Mutation Being Treated With Ivacaftor	Cystic Fibrosis	Drug: Cavosonstat;Drug: Placebo	Nivalis Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	N/A	Both	19	Phase 2	United States
388	EUCTR2014-005355-83-GB (EUCTR)	22/03/2016	15/02/2016	Confirmatory extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 extension Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
389	EUCTR2015-001644-11-FR (EUCTR)	16/03/2016	20/04/2016	Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.	A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	256	Phase 3	United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
390	EUCTR2015-001644-11-DK (EUCTR)	15/03/2016	08/02/2016	Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.	A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	256	Phase 3	United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
391	EUCTR2015-002739-17-CZ (EUCTR)	09/03/2016	13/10/2015	Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: liprotamase INN or Proposed INN: Not assigned Other descriptive name: LIPASE INN or Proposed INN: PROTEASE INN or Proposed INN: Amylase Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: Not assigned Other descriptive name: PANCREATIN	ANTHERA Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United States;Hungary;Czech Republic;Canada;Spain;Israel
392	EUCTR2016-000398-19-BE (EUCTR)	08/03/2016	09/02/2016	Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients.	Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. - pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem	Cystic fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie INN or Proposed INN: Meropenem Fresenius Kabi Other descriptive name: MEROPENEM TRIHYDRATE Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie INN or Proposed INN: Ceftazidim Fresenius Kabi Other descriptive name: CEFTAZIDIME PENTAHYDRATE Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM	Ghent University	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 4	Belgium
393	EUCTR2015-002581-23-IT (EUCTR)	03/03/2016	20/01/2021	A study on safety and efficacy of JBT-101 in cystic fibrosis.	A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis - JBT101 in cystic fibrosis	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: JBT101 Product Code: JBT101 Product Name: JBT101 Product Code: JBT101 Product Name: JBT101 Product Code: JBT101	CORBUS PHARMACEUTICALS, INC	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	France;Belgium;Germany;United Kingdom;Italy
394	NCT02354859 (ClinicalTrials.gov)	March 2016	30/7/2014	A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)	A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)	Cystic Fibrosis	Drug: Gallium nitrate;Drug: Normal Saline	University of Washington	Cystic Fibrosis Foundation	Completed	18 Years	N/A	All	119	Phase 2	United States
395	NCT02848560 (ClinicalTrials.gov)	March 2016	26/7/2016	Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI	Validation of MRI as a Sensitive Tool to Longitudinally Monitor CF Lung Disease Progression and Response to CFTR Modulator Therapy in Young Children With CF	Cystic Fibrosis	Drug: Hyperpolarized Xenon	Children's Hospital Medical Center, Cincinnati	National Heart, Lung, and Blood Institute (NHLBI)	Active, not recruiting	6 Years	12 Years	All	38		United States
396	EUCTR2013-004302-26-HU (EUCTR)	29/02/2016	21/12/2015	Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.	A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients.	Glaucoma or Ocular Hypertension MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]	Trade Name: Tafluprost INN or Proposed INN: tafluprost Other descriptive name: TAFLUPROST	Santen Oy	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 1	United States;Hungary;Slovakia;Poland;United Kingdom
397	EUCTR2015-003292-30-NL (EUCTR)	26/02/2016	02/12/2015	A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutation	A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation.	Cystic fibrosis with the S1251N mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	6	Phase 2	Belgium;Netherlands
398	EUCTR2014-004827-29-DE (EUCTR)	24/02/2016	21/09/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1375	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
399	EUCTR2014-005355-83-BG (EUCTR)	19/02/2016	16/12/2015	Confirmatory extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
400	EUCTR2013-005357-79-BG (EUCTR)	12/02/2016	11/01/2016	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL	Pharmaxis Limited	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
401	EUCTR2015-002677-38-GB (EUCTR)	04/02/2016	27/10/2015	An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton	Celtaxsys Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Canada;Belgium;Germany;Italy;United Kingdom
402	NCT02625246 (ClinicalTrials.gov)	February 4, 2016	4/12/2015	Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non-Cystic Fibrosis Bronchiectasis	A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell (hMSC) Infusion in Patients With Non-Cystic Fibrosis Bronchiectasis	Bronchiectasis	Biological: hMSCs	Marilyn Glassberg	NULL	Completed	30 Years	87 Years	All	6	Phase 1	United States
403	EUCTR2015-003291-77-IE (EUCTR)	03/02/2016	03/12/2015	A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation	A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation	Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	Czech Republic;Ireland;Australia;Germany;United Kingdom
404	EUCTR2013-005357-79-GR (EUCTR)	02/02/2016	17/12/2015	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL	Pharmaxis Limited	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
405	EUCTR2015-003291-77-GB (EUCTR)	02/02/2016	03/11/2015	A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation	A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation	Cystic fibrosis with the G551D mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	32	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Czech Republic;Ireland;Australia;Germany;United Kingdom
406	NCT02840136 (ClinicalTrials.gov)	February 2016	18/7/2016	LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients	Optimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and Validation	Cystic Fibrosis	Drug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: Ceftazidime	University Ghent	King Baudouin Foundation;Belgische Vereniging voor Strijd tegen Mucoviscidose	Suspended	12 Years	N/A	All	40	N/A	Belgium
407	EUCTR2015-003291-77-CZ (EUCTR)	26/01/2016	16/11/2015	A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation	A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation	Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	Czech Republic;Ireland;Australia;Germany;United Kingdom
408	EUCTR2014-005355-83-NL (EUCTR)	22/01/2016	25/11/2015	Confirmatory extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
409	EUCTR2015-001644-11-GB (EUCTR)	22/01/2016	10/11/2015	Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.	A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	256	Phase 3	United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
410	EUCTR2015-003292-30-BE (EUCTR)	18/01/2016	26/11/2015	A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutation	A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation.	Cystic fibrosis with the S1251N mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	6	Phase 2	Belgium;Netherlands
411	NCT02661438 (ClinicalTrials.gov)	January 12, 2016	30/12/2015	Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo	Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo	Bronchiectasis;Pulmonary Disease, Chronic Obstructive	Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)	Bayer	Novartis	Completed	40 Years	N/A	All	46	N/A	United States
412	EUCTR2014-004827-29-ES (EUCTR)	12/01/2016	18/11/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1375	Phase 3	United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
413	EUCTR2015-002739-17-HU (EUCTR)	30/12/2015	13/10/2015	Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: liprotamase INN or Proposed INN: Not assigned Other descriptive name: LIPASE INN or Proposed INN: PROTEASE INN or Proposed INN: Amylase Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: Not assigned Other descriptive name: PANCREATIN	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United States;Czech Republic;Hungary;Canada;Spain;Israel
414	EUCTR2015-002581-23-FR (EUCTR)	23/12/2015	18/01/2016	A study of safety and efficacy of JBT-101 in cystic fibrosis	A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis	Cystic Fibrosis Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;France;Poland;Belgium;Israel;Germany;Italy;United Kingdom
415	EUCTR2015-002581-23-GB (EUCTR)	22/12/2015	21/03/2016	A study of safety and efficacy of JBT-101 in cystic fibrosis	A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis	Cystic Fibrosis Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom
416	EUCTR2015-002739-17-ES (EUCTR)	16/12/2015	03/11/2015	Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: liprotamase INN or Proposed INN: Not assigned Other descriptive name: LIPASE INN or Proposed INN: PROTEASE INN or Proposed INN: Amylase Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: Not assigned Other descriptive name: PANCREATIN	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	United States;Czech Republic;Hungary;Canada;Spain;Israel
417	EUCTR2014-004837-13-DE (EUCTR)	15/12/2015	21/04/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
418	EUCTR2014-004827-29-SE (EUCTR)	09/12/2015	27/08/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1375	Phase 3	United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
419	EUCTR2014-005355-83-FR (EUCTR)	08/12/2015	04/12/2015	Confirmatory extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
420	EUCTR2015-002581-23-BE (EUCTR)	03/12/2015	12/10/2015	A study of safety and efficacy of JBT-101 in cystic fibrosis	A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis	Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom
421	EUCTR2014-004915-35-GB (EUCTR)	02/12/2015	16/10/2015	Safety and effect of QBW276 in patients with cystic fibrosis	A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: QBW276 300mcg Product Code: QBW276 INN or Proposed INN: Not established Other descriptive name: QBW276 Succinate Product Name: QBW276 1500mcg Product Code: QBW276 INN or Proposed INN: Not established Other descriptive name: QBW276 Succinate	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 1;Phase 2	United States;Germany;United Kingdom
422	EUCTR2014-004827-29-DK (EUCTR)	30/11/2015	11/09/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1375	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
423	EUCTR2014-004827-29-AT (EUCTR)	27/11/2015	27/08/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1375	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
424	EUCTR2015-003662-87-DK (EUCTR)	13/11/2015	22/09/2015	Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life	Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin	Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa. MedDRA version: 18.1;Level: LLT;Classification code 10051190;Term: Pneumonia Pseudomonas aeruginosa;System Organ Class: 100000004862 MedDRA version: 18.1;Classification code 10050700;Term: Chronic respiratory disease NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: colistimethate sodium (promixin) INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: Piperacillin with Tazobactam (tazocin) INN or Proposed INN: PIPERACILLIN Other descriptive name: PIPERACILLIN INN or Proposed INN: TAZOBACTAM Other descriptive name: TAZOBACTAM	Aarhus University Hospital, Department of Respiratory Medicine	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Denmark
425	EUCTR2014-004827-29-GB (EUCTR)	03/11/2015	05/08/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Symkevi Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1375	Phase 3	United States;United Kingdom;Switzerland;Spain;Canada;Austria;Netherlands;Sweden;Belgium;Ireland;Denmark;Italy;Israel;Australia;France;Germany
426	EUCTR2014-004827-29-NL (EUCTR)	03/11/2015	21/09/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1375	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
427	NCT02598999 (ClinicalTrials.gov)	November 2015	4/11/2015	Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients	Randomized, Double Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics After Single Ascending Doses or Multiple Ascending Doses of OSCN-, bLF or ALX-009 in Healthy Male and CF and Non-CF Bronchiectasis Patients	Cystic Fibrosis;Bronchiectasis	Drug: ALX-009;Drug: OSCN-;Drug: bLF;Drug: Placebo	Alaxia SAS	NULL	Recruiting	18 Years	50 Years	All	103	Phase 1	France
428	NCT02589236 (ClinicalTrials.gov)	November 2015	26/10/2015	Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/Ivacaftor	Cystic Fibrosis	Drug: Cavosonstat;Drug: Placebo	Nivalis Therapeutics, Inc.	Medidata Solutions	Completed	18 Years	N/A	All	138	Phase 2	United States
429	EUCTR2014-004787-37-ES (EUCTR)	26/10/2015	25/08/2015	A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.	A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)	Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;United States;Canada;Spain;Austria;Australia;Israel;Germany
430	EUCTR2014-004827-29-BE (EUCTR)	21/10/2015	06/08/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1375	Phase 3	United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
431	EUCTR2014-004827-29-IE (EUCTR)	19/10/2015	09/07/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1375	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
432	EUCTR2014-005355-83-IT (EUCTR)	16/10/2015	26/08/2015	Confirmatory extension study of ataluren (PTC124) in patients with Cystic Fibrosis	A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis - NA	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
433	EUCTR2013-004595-35-NL (EUCTR)	15/10/2015	09/07/2015	Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients	Multi-center, randomized, double-blind, placebo-controlled phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients	Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;United States;Canada;Belgium;Germany;Netherlands;United Kingdom
434	EUCTR2015-000543-16-DE (EUCTR)	14/10/2015	18/05/2015	A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
435	EUCTR2014-005355-83-ES (EUCTR)	08/10/2015	02/09/2015	Confirmatory extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
436	EUCTR2014-005355-83-BE (EUCTR)	01/10/2015	24/08/2015	Confirmatory extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
437	EUCTR2013-004581-34-BE (EUCTR)	01/10/2015	31/07/2014	Confirmatory study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
438	EUCTR2014-004787-37-DE (EUCTR)	24/09/2015	19/06/2015	A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.	A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;United States;Canada;Spain;Austria;Australia;Israel;Germany
439	EUCTR2015-000543-16-BE (EUCTR)	24/09/2015	08/06/2015	A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
440	EUCTR2015-000543-16-DK (EUCTR)	23/09/2015	22/05/2015	A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
441	EUCTR2014-004787-37-AT (EUCTR)	21/09/2015	18/06/2015	A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.	A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;United States;Canada;Spain;Australia;Austria;Israel;Germany
442	EUCTR2015-002911-13-FR (EUCTR)	15/09/2015	05/08/2015	A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis.	A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis, homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa, a study involving 36 CF patients (24 treated, 12 controls). - ROSCO-CF	Cystic Fibrosis treated by 'roscovitine' in subjects homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa. MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: SELICICLIB Product Code: CYC202	CHRU de Brest	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	France
443	EUCTR2013-004595-35-BE (EUCTR)	03/09/2015	23/07/2015	Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients	Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521 INN or Proposed INN: RIOCIGUAT Other descriptive name: RIOCIGUAT	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom
444	EUCTR2014-004827-29-IT (EUCTR)	01/09/2015	08/07/2015	A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1375	Phase 3	United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
445	NCT02421120 (ClinicalTrials.gov)	September 2015	13/4/2015	Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients	A Prospective, Multicenter, Open-Label Study to Assess Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients Admitted With Acute Pulmonary Exacerbation	Cystic Fibrosis;Cystic Fibrosis Pulmonary Exacerbation;Pseudomonas Aeruginosa Infection	Drug: Ceftolozane/Tazobactam	Joseph L. Kuti, PharmD	Cubist Pharmaceuticals LLC;Indiana University Health;University of North Carolina;St. Christopher's Hospital for Children	Completed	18 Years	N/A	All	21	Phase 4	United States
446	NCT02456103 (ClinicalTrials.gov)	August 31, 2015	26/5/2015	Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis	Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Cystic Fibrosis	Cystic Fibrosis	Drug: Ataluren	PTC Therapeutics	NULL	Terminated	6 Years	N/A	All	246	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
447	EUCTR2013-005449-35-FR (EUCTR)	25/08/2015	18/06/2015	Extension study of ataluren in patients with Cystic Fibrosis	An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®)	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 3	United States;France;Spain;Belgium;Israel;Germany;Italy;Sweden
448	NCT03497117 (ClinicalTrials.gov)	August 25, 2015	29/3/2018	19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation	19F Magnetic Resonance Imaging of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation	Cystic Fibrosis	Device: Lung Clearance Index;Drug: MRI with PFP	University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Terminated	18 Years	99 Years	All	5	Early Phase 1	United States
449	EUCTR2015-000543-16-SE (EUCTR)	19/08/2015	20/05/2015	A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
450	NCT02531984 (ClinicalTrials.gov)	August 2015	21/8/2015	The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis	Open Trial With Randomized Withdrawal of Treatment, to Evaluate the Efficacy of Azithromycin in the Treatment of Children With Non Cystic Fibrosis Bronchiectasis ( AZI-STOP Study )	Non Cystic Fibrosis Bronchiectasis in Children	Drug: Azithromycin	Assistance Publique Hopitaux De Marseille	NULL	Active, not recruiting	3 Years	17 Years	Both	100	Phase 3	NULL
451	NCT02516410 (ClinicalTrials.gov)	August 2015	28/7/2015	A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)	Cystic Fibrosis	Drug: VX-661 plus ivacaftor combination;Drug: Ivacaftor;Drug: Placebo (matched to VX-661 plus ivacaftor combination);Drug: Placebo (matched to ivacaftor)	Vertex Pharmaceuticals Incorporated	NULL	Completed	12 Years	N/A	All	168	Phase 3	United States;Australia;Austria;Canada;France;Israel;Spain
452	EUCTR2014-004838-25-BE (EUCTR)	31/07/2015	26/05/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive	Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
453	EUCTR2015-001317-28-NL (EUCTR)	30/07/2015	19/05/2015	A B2-agonist as a CFTR activator in CF - Part 2	A B2-agonist as a CFTR activator in CF - Part 2 - ABBA 2	Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Salbutamol	UMC Utrecht	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Netherlands
454	EUCTR2013-004581-34-GR (EUCTR)	29/07/2015	23/07/2015	Confirmatory study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
455	EUCTR2014-004788-18-DE (EUCTR)	24/07/2015	31/03/2015	A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 3	France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
456	EUCTR2014-004837-13-IT (EUCTR)	22/07/2015	27/03/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
457	EUCTR2014-004788-18-IT (EUCTR)	15/07/2015	19/03/2015	A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function	Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy
458	EUCTR2014-004837-13-NL (EUCTR)	10/07/2015	08/04/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	France;United States;Canada;Spain;Ireland;Denmark;Germany;Netherlands;Italy;United Kingdom;Switzerland;Sweden
459	EUCTR2014-004788-18-NL (EUCTR)	10/07/2015	08/04/2015	A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 3	France;United States;Canada;Belgium;Australia;Israel;Germany;Netherlands;Italy;United Kingdom
460	EUCTR2014-004837-13-ES (EUCTR)	02/07/2015	15/06/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
461	NCT03489590 (ClinicalTrials.gov)	July 1, 2015	29/3/2018	19F MRI to Evaluate Regional Ventilation in Healthy Subjects and Subjects With Cystic Fibrosis	19F Magnetic Resonance Imaging to Evaluate Regional Ventilation in Healthy Subjects and Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: PFP	University of North Carolina, Chapel Hill	NULL	Completed	18 Years	99 Years	All	42	Early Phase 1	United States
462	EUCTR2014-004837-13-DK (EUCTR)	24/06/2015	26/03/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
463	EUCTR2014-004838-25-IE (EUCTR)	22/06/2015	10/04/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	155	Phase 3	France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
464	EUCTR2015-000543-16-GB (EUCTR)	19/06/2015	15/05/2015	A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
465	EUCTR2014-004837-13-IE (EUCTR)	11/06/2015	05/03/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
466	EUCTR2014-004788-18-GB (EUCTR)	08/06/2015	08/04/2015	A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	204	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;Switzerland;United Kingdom
467	NCT02279498 (ClinicalTrials.gov)	June 2015	28/10/2014	SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis	A Phase 3, Randomized, Open-Label, Assessor-Blind, Noninferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency	Exocrine Pancreatic Insufficiency;Cystic Fibrosis	Drug: Liprotamase;Drug: porcine (pig) PERT	Anthera Pharmaceuticals	NULL	Completed	7 Years	N/A	All	128	Phase 3	United States;Canada;Czechia;Hungary;Israel;Poland;Spain;Czech Republic
468	NCT02239458 (ClinicalTrials.gov)	June 2015	8/9/2014	DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic Fibrosis		Cystic Fibrosis	Drug: Saxagliptin	Ram Weiss	NULL	Not yet recruiting	18 Years	65 Years	Both	60	N/A	Israel
469	EUCTR2011-005085-37-FR (EUCTR)	21/05/2015	17/06/2015	Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.	A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients	cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	140		United States;France;Belgium;Ireland;Germany;United Kingdom
470	EUCTR2014-004838-25-IT (EUCTR)	20/05/2015	30/03/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive	Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
471	EUCTR2013-005366-19-FR (EUCTR)	19/05/2015	22/06/2015	A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Germany;Netherlands;New Zealand
472	EUCTR2014-004837-13-GB (EUCTR)	12/05/2015	20/03/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	490	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
473	EUCTR2011-005085-37-BE (EUCTR)	06/05/2015	26/03/2015	Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.	A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients	cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	156		France;United States;Belgium;Ireland;United Kingdom
474	NCT02449031 (ClinicalTrials.gov)	May 5, 2015	4/5/2015	Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs	A Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® Podhaler™ (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs	Pseudomonas Aeruginosa in Cystic Fibrosis	Drug: TOBI Podhaler;Drug: TOBI;Drug: Bethkis;Drug: Cayston	Mylan Inc.	Cystic Fibrosis Foundation	Active, not recruiting	6 Years	N/A	All	260		United States
475	EUCTR2014-004837-13-SE (EUCTR)	24/04/2015	06/03/2015	A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	490	Phase 3	United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
476	EUCTR2013-004581-34-NL (EUCTR)	26/02/2015	06/08/2014	Confirmatory study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	United States;Greece;Spain;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Brazil;Poland;Australia;Denmark;Bulgaria;Netherlands;Germany
477	EUCTR2014-004519-35-GB (EUCTR)	23/02/2015	08/12/2014	A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis	A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (PAncreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder)	Abbott Laboratories GmbH	NULL	Not Recruiting			Female: yes Male: yes	78	Phase 2	Czech Republic;Hungary;Spain;United Kingdom
478	EUCTR2014-004519-35-CZ (EUCTR)	18/02/2015	19/11/2014	A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis	A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (PAncreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder)	Abbott Laboratories GmbH	NULL	Not Recruiting			Female: yes Male: yes	78	Phase 2	Hungary;Czech Republic;Spain;United Kingdom
479	EUCTR2013-005366-19-PL (EUCTR)	11/02/2015	26/11/2014	A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis. The study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	Serbia;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand
480	EUCTR2013-005348-28-PL (EUCTR)	11/02/2015	26/11/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open label extension (all patients will receive study drug for the last 28 days of the study).	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany
481	EUCTR2013-004581-34-BG (EUCTR)	05/02/2015	06/01/2015	Confirmatory study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
482	ChiCTR-IPC-15005915	2015-01-31	2014-07-06	A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis	A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis	non-cystic fibrosis bronchiectasis	Experimental group:Routine treatment combining with the therapy of bronchoalveolar lavage and local drug injection (Amikacin);	Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine	NULL	Recruiting	18	80	Both	Experimental group:50;		NULL
483	EUCTR2014-004519-35-ES (EUCTR)	30/01/2015	04/12/2014	A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis	A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: KREON de Liberación Inmediata INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATINA (Páncreas Polvo Trade Name: Kreon 25 000 Product Name: Kreon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATINA (Páncreas Polvo)	Abbott Laboratories GmbH	NULL	Not Recruiting			Female: yes Male: yes	78	Phase 2	Czech Republic;Hungary;Spain;United Kingdom
484	NCT02248922 (ClinicalTrials.gov)	January 27, 2015	22/9/2014	Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa	An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients = 6 Years of Age, Chronically Infected With Pseudomonas Aeruginosa	Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis	Drug: TIS or TIP	Novartis Pharmaceuticals	NULL	Terminated	6 Years	N/A	All	17	Phase 4	Germany
485	EUCTR2014-004519-35-HU (EUCTR)	09/01/2015	12/11/2014	A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis	A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (Pancreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder)	Abbott Laboratories GmbH	NULL	Not Recruiting			Female: yes Male: yes	78	Phase 2	Czech Republic;Hungary;Spain;United Kingdom
486	EUCTR2012-001565-33-IE (EUCTR)	08/01/2015	11/09/2014	An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin	An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 17.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	67	Phase 4	Spain;Ireland;Germany;United Kingdom;Switzerland
487	NCT04122547 (ClinicalTrials.gov)	January 2015	8/10/2019	Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis	Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial	Exacerbation Copd;Bronchiectasis;Lung Function Decreased	Drug: Roflumilast;Drug: Placebo	Prince of Songkla University	NULL	Completed	18 Years	80 Years	All	40	Phase 3	Thailand
488	NCT02507843 (ClinicalTrials.gov)	January 2015	22/7/2015	Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis	Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial	Bronchiectasis	Drug: Cholecalciferol;Drug: Placebo	Shanghai Pulmonary Hospital, Shanghai, China	NULL	Recruiting	18 Years	N/A	Both	200	Phase 4	China
489	EUCTR2014-002125-35-DE (EUCTR)	18/12/2014	21/07/2014	A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.	A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization with Burkholderia spp. - A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20	Algipharma AS	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	Germany
490	EUCTR2013-004659-19-SK (EUCTR)	15/12/2014	06/10/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer Healthcare AG, D-51368 Leverkusen, Germany	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
491	EUCTR2013-002202-31-DE (EUCTR)	03/12/2014	08/10/2014	Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.	A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002	Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: POL7080 Product Code: POL7080 INN or Proposed INN: POL7080	Polyphor Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Spain;Germany;United Kingdom
492	EUCTR2013-004581-34-DE (EUCTR)	25/11/2014	05/08/2014	Confirmatory study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
493	NCT02273661 (ClinicalTrials.gov)	November 19, 2014	22/10/2014	Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).	Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)	Allergic Bronchopulmonary Aspergillosis	Drug: Liposomal amphotericin B (Ambisome®);Drug: placebo	Poitiers University Hospital	NULL	Completed	18 Years	N/A	All	174	Phase 2	France
494	EUCTR2013-005357-79-IT (EUCTR)	18/11/2014	06/06/2014	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 17.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL	Pharmaxis Limited	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Sweden
495	EUCTR2011-004208-39-SK (EUCTR)	18/11/2014	21/10/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1	bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Germany;Latvia;New Zealand;Japan
496	EUCTR2014-001204-21-DE (EUCTR)	17/11/2014	22/08/2014	An open-label clinical trial that evaluates the lung clearance index in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa	An 8 week open-label interventional multicenter study to evaluate the lung clearance index as endpoint for clinical trials in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Germany
497	EUCTR2013-005357-79-HU (EUCTR)	13/11/2014	06/06/2014	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 18.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL	Pharmaxis Limited	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
498	EUCTR2013-004659-19-LV (EUCTR)	11/11/2014	30/09/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer Healthcare AG, D-51368 Leverkusen, Germany	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
499	EUCTR2011-004208-39-LV (EUCTR)	11/11/2014	26/09/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1	bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	400		Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Latvia;Germany;New Zealand;Japan
500	EUCTR2013-005348-28-IE (EUCTR)	07/11/2014	11/09/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
501	NCT03312140 (ClinicalTrials.gov)	November 6, 2014	4/10/2017	Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis	Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis	Cystic Fibrosis Liver Disease	Drug: Choline Chloride	University Hospital Tuebingen	NULL	Completed	18 Years	N/A	Male	10	N/A	NULL
502	EUCTR2014-000844-13-SE (EUCTR)	21/10/2014	21/07/2014	A phase IIb study of OligoG in subjects with cystic fibrosis	A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20	Algipharma AS	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 2	Denmark;Germany;Sweden
503	EUCTR2013-005357-79-CZ (EUCTR)	15/10/2014	04/06/2014	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 19.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL	Pharmaxis Limited	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
504	EUCTR2013-005449-35-DE (EUCTR)	01/10/2014	04/08/2014	Extension study of ataluren in patients with Cystic Fibrosis	An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®)	Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 3	France;United States;Belgium;Spain;Israel;Germany;Italy;Sweden
505	NCT02157922 (ClinicalTrials.gov)	October 2014	4/6/2014	A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis	A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: alginate oligosaccharide	AlgiPharma AS	Eurostars;Smerud Medical Research International AS	Completed	18 Years	N/A	All	65	Phase 2	Denmark;Germany;Norway;Sweden;United Kingdom
506	NCT02372383 (ClinicalTrials.gov)	October 2014	20/6/2014	Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis	Pharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus Controls	Cystic Fibrosis	Drug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: Pancrelipase	University of Colorado, Denver	Cystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences Institute	Completed	16 Years	45 Years	Both	32	N/A	United States
507	EUCTR2013-004659-19-BG (EUCTR)	26/09/2014	05/08/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
508	EUCTR2014-000844-13-DK (EUCTR)	25/09/2014	08/07/2014	A phase IIb study of OligoG in subjects with cystic fibrosis	A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis	Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20	Algipharma AS	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 2	Denmark;Germany;Sweden
509	EUCTR2013-005449-35-IT (EUCTR)	16/09/2014	25/06/2014	An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®)	An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®)	Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 3	United States;France;Spain;Belgium;Israel;Germany;Italy;Sweden
510	EUCTR2013-004581-34-IT (EUCTR)	15/09/2014	10/06/2014	Confirmatory study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands
511	EUCTR2013-004581-34-GB (EUCTR)	12/09/2014	25/09/2014	Confirmatory study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
512	EUCTR2013-005357-79-SK (EUCTR)	11/09/2014	26/08/2014	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL	PHARMAXIS LTD	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Sweden
513	EUCTR2013-004595-35-GB (EUCTR)	11/09/2014	16/05/2014	Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients	Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients	Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom
514	EUCTR2013-004302-26-GB (EUCTR)	05/09/2014	01/05/2014	Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.	A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients.	Glaucoma or Ocular Hypertension MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11]	Trade Name: Tafluprost INN or Proposed INN: tafluprost Other descriptive name: TAFLUPROST	Santen Oy	NULL	Not Recruiting			Female: yes Male: yes	18	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;Poland;United Kingdom
515	EUCTR2013-004659-19-PT (EUCTR)	02/09/2014	03/07/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer Healthcare AG, D-51368 Leverkusen, Germany	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand
516	EUCTR2013-005449-35-ES (EUCTR)	01/09/2014	11/08/2014	Extension study of ataluren in patients with Cystic Fibrosis	An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®)	Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 3	France;United States;Belgium;Spain;Israel;Germany;Italy;Sweden
517	EUCTR2013-004581-34-ES (EUCTR)	01/09/2014	14/08/2014	Confirmatory study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis	Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands
518	EUCTR2013-004595-35-DE (EUCTR)	29/08/2014	29/08/2014	Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients	Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521 INN or Proposed INN: RIOCIGUAT Other descriptive name: RIOCIGUAT	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	63	Phase 2	France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom
519	EUCTR2013-004659-19-CZ (EUCTR)	27/08/2014	20/05/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand
520	EUCTR2013-005449-35-BE (EUCTR)	26/08/2014	04/06/2014	Extension study of ataluren in patients with Cystic Fibrosis	An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®)	Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	France;United States;Spain;Belgium;Israel;Germany;Italy;Sweden
521	EUCTR2013-005357-79-BE (EUCTR)	20/08/2014	01/07/2014	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL	Pharmaxis Limited	NULL	Not Recruiting			Female: yes Male: yes	440	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
522	EUCTR2014-000817-30-NL (EUCTR)	14/08/2014	22/05/2014	Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation	Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation - TICTAC-study	Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Ivacaftor/Kalydeco Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg INN or Proposed INN: curcumin Other descriptive name: CURCUMIN Product Name: Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg INN or Proposed INN: genistein Other descriptive name: GENISTEIN	University Medical Centre Utrecht	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Netherlands
523	EUCTR2013-005449-35-SE (EUCTR)	06/08/2014	05/06/2014	Extension study of ataluren in patients with Cystic Fibrosis	An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®)	Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	France;United States;Spain;Belgium;Israel;Germany;Italy;Sweden
524	EUCTR2014-002387-32-GB (EUCTR)	05/08/2014	27/06/2014	Trial of Rosuvastatin for the Prevention of Kidney Toxicity caused by Tobramycin in Children with Cystic Fibrosis	Phase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis - PROteKT	Aminoglycoside-induced nephrotoxicity MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Classification code 10069022;Term: Kidney injury molecule-1;System Organ Class: 10022891 - Investigations MedDRA version: 18.0;Level: LLT;Classification code 10067571;Term: Nephrotoxicity;System Organ Class: 100000004857;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Trade Name: Crestor Product Name: Crestor INN or Proposed INN: Rosuvastatin calcium	University of Liverpool	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	United Kingdom
525	NCT02139306 (ClinicalTrials.gov)	August 2014	13/5/2014	Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)	A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic Fibrosis	Cystic Fibrosis	Drug: Ataluren (PTC124®);Drug: Placebo	PTC Therapeutics	Cystic Fibrosis Foundation;ECFS-Clinical Trial Network (ECFS-CTN)	Completed	6 Years	N/A	All	279	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
526	EUCTR2013-005348-28-RO (EUCTR)	30/07/2014	30/05/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand
527	EUCTR2013-005366-19-RO (EUCTR)	30/07/2014	30/05/2014	A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand
528	EUCTR2013-005348-28-LV (EUCTR)	28/07/2014	08/05/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany;New Zealand
529	EUCTR2011-000801-39-ES (EUCTR)	25/07/2014	25/04/2014	Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens? eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY	Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY	Mukoviszidose Institute gGmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Belgium;Spain;Ireland;Austria;Germany;Italy;Sweden
530	EUCTR2013-005366-19-ES (EUCTR)	17/06/2014	11/04/2014	A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Pulmaquin®(ARD-3150, dual reléase ciprofloxacin for inhalation)in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with non-cystic fibrosis bronchiectasis (ORBIT 4)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
531	EUCTR2013-004659-19-AT (EUCTR)	17/06/2014	13/05/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
532	EUCTR2013-005348-28-ES (EUCTR)	16/06/2014	11/04/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Latvia;Germany;Netherlands;New Zealand
533	EUCTR2011-000801-39-AT (EUCTR)	11/06/2014	24/04/2014	Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY	Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY	Mukoviszidose Institute gGmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
534	EUCTR2014-000284-40-GB (EUCTR)	05/06/2014	29/04/2014	Cysteamine in Cystic Fibrosis	An open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults with Cystic Fibrosis. - Cysteamine in Cystic Fibrosis (2)	Cystic Fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cystagon (cysteamine bitartrate) immediate-release capsules Product Name: Cystagon (cysteamine bitartrate) immediate-release capsules INN or Proposed INN: cysteamine bitartrate	University of Aberdeen	NHS Grampian	Not Recruiting			Female: yes Male: yes	12	Phase 1;Phase 2	United Kingdom
535	EUCTR2011-005085-37-IE (EUCTR)	05/06/2014	10/04/2014	Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.	A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients	cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	156		France;United States;Belgium;Ireland;United Kingdom
536	NCT02104245 (ClinicalTrials.gov)	May 28, 2014	28/3/2014	Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension	Non Cystic Fibrosis Bronchiectasis	Drug: Ciprofloxacin dispersion for inhalation;Drug: Placebo	Aradigm Corporation	Grifols Therapeutics LLC	Completed	18 Years	N/A	All	304	Phase 3	United States;Australia;Canada;Former Serbia and Montenegro;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Spain;United Kingdom;Germany
537	EUCTR2012-002699-14-IT (EUCTR)	28/05/2014	20/02/2014	Trial of inhaled mannitol in children with cystic fibrosis	A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years	Cystic fibrosis in children aged 6 to 17 years MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A	Pharmaxis Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160		Canada;Argentina;Belgium;Netherlands;United Kingdom;Italy
538	EUCTR2013-005481-19-DK (EUCTR)	27/05/2014	27/05/2014	High Dose Antioxidant Treatment for Patients with Cystic Fibrosis	High Dose Antioxidant Treatment for Patients with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 17.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Mucolysin INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: Mucomyst INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: ACC INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: Tad INN or Proposed INN: GLUTATHIONE Other descriptive name: GLUTATHIONE SODIUM	Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Denmark
539	NCT02107859 (ClinicalTrials.gov)	May 23, 2014	4/4/2014	Study of Ataluren (PTC124) in Cystic Fibrosis	An Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124)	Cystic Fibrosis	Drug: Ataluren	PTC Therapeutics	NULL	Terminated	6 Years	N/A	All	61	Phase 3	United States;Belgium;France;Israel;Italy;Spain;Sweden;Germany
540	EUCTR2011-000801-39-HU (EUCTR)	22/05/2014	03/04/2014	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY	Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY	Mukoviszidose Institute gGmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
541	EUCTR2013-005348-28-IT (EUCTR)	22/05/2014	24/03/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Ireland;Israel;Italy;United Kingdom;Hungary;Canada;Poland;Romania;Australia;Latvia;Netherlands;Germany;New Zealand
542	EUCTR2013-005366-19-IT (EUCTR)	22/05/2014	27/03/2014	A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
543	EUCTR2013-004659-19-LT (EUCTR)	12/05/2014	20/03/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	Serbia;Portugal;United States;Hong Kong;Taiwan;Slovakia;Thailand;Lithuania;Turkey;Austria;Russian Federation;Czech Republic;Argentina;Poland;Brazil;Romania;Australia;South Africa;Bulgaria;Netherlands;Latvia;Germany;China;Korea, Republic of
544	EUCTR2011-005085-37-DE (EUCTR)	09/05/2014	31/03/2014	Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.	A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients	cystic fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 1;Phase 2	France;United States;Belgium;Ireland;Germany;United Kingdom
545	EUCTR2013-005366-19-HU (EUCTR)	08/05/2014	21/03/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Serbia;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand
546	EUCTR2013-005348-28-HU (EUCTR)	06/05/2014	21/03/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
547	EUCTR2013-005348-28-GB (EUCTR)	06/05/2014	12/03/2014	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3)	Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
548	NCT02144246 (ClinicalTrials.gov)	May 2014	19/5/2014	Contraceptive Hormones and Women With Cystic Fibrosis	Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease	Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception	Other: Non-hormonal period;Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg	University of Pennsylvania	Society of Family Planning	Terminated	18 Years	40 Years	Female	5	Phase 1	United States
549	EUCTR2014-000057-37-NL (EUCTR)	30/04/2014	12/02/2014	Bronchodilcation as a CFTR activator in CF	A B2-agonist as a CFTR activator in CF - ABBA study	Cystic Fibrosis;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]	Product Name: Salbutamol Product Code: R03AC02 INN or Proposed INN: SALBUTAMOL Product Name: Salbutamol Product Code: R03CC02 INN or Proposed INN: SALBUTAMOL	University Medical Centre Utrecht	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Netherlands
550	EUCTR2013-004295-35-AT (EUCTR)	30/04/2014	02/04/2014	Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study	Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT	Chronic lung P. Aeruginosa Infection MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler INN or Proposed INN: aztreonam Other descriptive name: AZTREONAM LYSINE Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: TOBI Product Name: Tobi INN or Proposed INN: TOBRAMYCIN SULFATE	Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 4	Austria
551	NCT02106832 (ClinicalTrials.gov)	April 30, 2014	4/4/2014	Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)	Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.	Bronchiectasis	Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation;Drug: Placebo	Bayer	Novartis	Completed	18 Years	N/A	All	521	Phase 3	United States;Argentina;Australia;Austria;Brazil;Bulgaria;China;Czechia;Germany;Hong Kong;Korea, Republic of;Latvia;Lithuania;Netherlands;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Taiwan;Thailand;Turkey;Czech Republic
552	EUCTR2013-005366-19-GB (EUCTR)	29/04/2014	17/03/2014	A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections withPseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)	Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
553	EUCTR2013-004659-19-NL (EUCTR)	23/04/2014	27/02/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
554	EUCTR2013-004659-19-DE (EUCTR)	23/04/2014	03/02/2014	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2	non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;New Zealand
555	NCT02088216 (ClinicalTrials.gov)	April 1, 2014	5/3/2014	Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis	Effect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled Trial	Non-Cystic Fibrosis Bronchiectasis	Drug: N-acetylcysteine;Other: On-demand treatment	Qilu Hospital of Shandong University	NULL	Completed	18 Years	80 Years	All	161	N/A	China
556	NCT02113397 (ClinicalTrials.gov)	April 2014	9/4/2014	Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung	Comparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled Colistimethate	Cystic Fibrosis	Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times daily	Dartmouth-Hitchcock Medical Center	Novartis Pharmaceuticals	Terminated	12 Years	75 Years	All	1		United States
557	NCT01515007 (ClinicalTrials.gov)	March 31, 2014	10/1/2012	Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)	Non Cystic Fibrosis Bronchiectasis	Drug: Ciprofloxacin dispersion for inhalation;Drug: Placebo	Aradigm Corporation	Grifols Therapeutics LLC	Completed	18 Years	N/A	All	278	Phase 3	United States;Australia;Canada;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Poland;Romania;South Africa;Spain;Taiwan;United Kingdom;New Zealand
558	EUCTR2012-002699-14-NL (EUCTR)	10/03/2014	02/10/2013	Trial of inhaled mannitol in children with cystic fibrosis	A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years	Cystic fibrosis in children aged 6 to 17 years MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A	Pharmaxis Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160		Argentina;France;Canada;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
559	EUCTR2013-000604-41-DE (EUCTR)	10/03/2014	20/09/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
560	NCT02084043 (ClinicalTrials.gov)	March 2014	8/3/2014	In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation	In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses.	Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;Asthma	Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)	University Hospital St Luc, Brussels	Université Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, Switzerland	Completed	N/A	N/A	Both	3	N/A	Belgium;Switzerland
561	NCT02081963 (ClinicalTrials.gov)	March 2014	6/3/2014	Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis	A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis	Non-Cystic Fibrosis Bronchiectasis	Drug: Amikacin;Drug: Normal saline	Qilu Hospital of Shandong University	NULL	Completed	18 Years	80 Years	All	178	Phase 4	China
562	EUCTR2013-000604-41-NL (EUCTR)	14/02/2014	26/09/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
563	NCT01937325 (ClinicalTrials.gov)	February 2014	4/9/2013	CPET in CF Patients With One G551D Mutation Taking VX770	Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor)	Cystic Fibrosis	Drug: ivacaftor;Drug: placebo	The Alfred	NULL	Active, not recruiting	16 Years	70 Years	Both	20	Phase 4	Australia
564	NCT01746784 (ClinicalTrials.gov)	February 2014	6/12/2012	Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation	A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of N6022 to Evaluate Safety and Pharmacokinetics in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation (SNO1)	Cystic Fibrosis	Drug: N6022;Drug: Normal saline	Nivalis Therapeutics, Inc.	NULL	Completed	18 Years	N/A	All	66	Phase 1	United States
565	NCT02036879 (ClinicalTrials.gov)	February 2014	26/12/2013	Gender Disparity and Hormones in Cystic Fibrosis	Gender Disparity and Hormones in Cystic Fibrosis	Cystic Fibrosis (CF)	Drug: Loestrin (norethindrone acetate and ethinyl estradiol)	University of Texas Southwestern Medical Center	NULL	Completed	18 Years	N/A	All	55	Early Phase 1	United States
566	EUCTR2013-000604-41-IT (EUCTR)	21/01/2014	14/08/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
567	EUCTR2013-003774-27-GB (EUCTR)	20/01/2014	27/11/2013	A study to investigate lung deposition of radiolabelled OligoG(v1.0)	An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients - A study to investigate lung deposition of radiolabelled OligoG (v1.0)	Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI) INN or Proposed INN: OligoG Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation INN or Proposed INN: OligoG	AlgiPharma AS	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	United Kingdom
568	EUCTR2010-020413-90-IE (EUCTR)	08/01/2014	13/12/2013	Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation	A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	France;United States;Belgium;Ireland;Australia;Germany;United Kingdom
569	EUCTR2010-020413-90-GB (EUCTR)	06/01/2014	10/12/2013	Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation	A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Belgium;Ireland;Australia;Germany;United Kingdom
570	NCT02015663 (ClinicalTrials.gov)	January 2014	13/12/2013	Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles	A 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic Fibrosis	Cystic Fibrosis	Drug: Tobramycin Inhalation Powder	Novartis Pharmaceuticals	NULL	Terminated	6 Years	N/A	All	32	Phase 4	United States
571	EUCTR2013-002819-10-ES (EUCTR)	26/12/2013	12/11/2013	A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis	A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: KREON N 25000 INN or Proposed INN: Not applicable Other descriptive name: PANCREATIN Trade Name: Kreon 25000 INN or Proposed INN: not assigned Other descriptive name: PANCREATINA	Abbott Laboratories GmbH	NULL	Not Recruiting			Female: yes Male: yes	40		Hungary;Spain;Russian Federation
572	EUCTR2013-000604-41-CZ (EUCTR)	18/12/2013	13/09/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
573	EUCTR2013-000604-41-SE (EUCTR)	10/12/2013	13/09/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
574	EUCTR2013-000604-41-IE (EUCTR)	09/12/2013	10/10/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
575	EUCTR2013-000604-41-BE (EUCTR)	04/12/2013	17/09/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
576	EUCTR2013-000604-41-ES (EUCTR)	03/12/2013	08/10/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
577	EUCTR2009-016590-15-PL (EUCTR)	03/12/2013	11/10/2013	A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.	Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI 300 mg / 5 mL nebuliser solution INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	50		United States;Greece;Russian Federation;Switzerland;Italy;France;Egypt;Hungary;Canada;Argentina;Poland;Romania;Germany
578	NCT02096315 (ClinicalTrials.gov)	December 2013	18/3/2014	Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.	A Phase II, Open-label, Multicenter Study to Assess the Tolerance, Safety, Efficacy and Pharmacokinetics/Pharmacodynamics (PK/PD) of POL7080 in the Treatment of Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis Due to Pseudomonas Aeruginosa Infection Requiring Intravenous Treatment	Bronchiectasis;Lower Respiratory Infection	Drug: POL7080	Polyphor Ltd.	NULL	Terminated	18 Years	79 Years	All	20	Phase 2	Spain;United Kingdom
579	EUCTR2013-002819-10-HU (EUCTR)	29/11/2013	14/10/2013	A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis	A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis	Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CREON N 25000 INN or Proposed INN: not applicable Other descriptive name: PANCREATIN Trade Name: Creon 25000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN	Abbott Laboratories GmbH	NULL	Not Recruiting			Female: yes Male: yes	40		Hungary;Spain;Russian Federation
580	EUCTR2013-000604-41-DK (EUCTR)	19/11/2013	19/11/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
581	NCT00924547 (ClinicalTrials.gov)	November 2013	17/6/2009	Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis	Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma	Cystic Fibrosis	Dietary Supplement: Docosahexanoic Acid Supplement;Dietary Supplement: Placebo	Vanderbilt University	NULL	Completed	6 Years	N/A	Both	17	Phase 2	United States
582	EUCTR2013-000604-41-AT (EUCTR)	23/10/2013	16/09/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
583	EUCTR2013-000604-41-GB (EUCTR)	10/10/2013	17/09/2013	A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs	A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
584	NCT02035488 (ClinicalTrials.gov)	October 2013	27/12/2013	Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis	Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis	Bronchiectasis	Drug: Tobramycin	University Medical Centre Groningen	NULL	Completed	18 Years	N/A	Both	8	Phase 1/Phase 2	Netherlands
585	NCT01784419 (ClinicalTrials.gov)	October 2013	3/2/2013	Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients	Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients	Cystic Fibrosis	Drug: ivacaftor;Drug: Placebo	University of California, San Francisco	NULL	Completed	6 Years	N/A	All	10	N/A	United States
586	NCT01702415 (ClinicalTrials.gov)	October 2013	4/10/2012	Zoledronic Acid in Cystic Fibrosis	Randomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.	Cystic Fibrosis	Drug: Zoledronic acid;Drug: Placebo	Papworth Hospital NHS Foundation Trust	Novartis Pharmaceuticals	Withdrawn	18 Years	N/A	Both	0	Phase 4	United Kingdom
587	EUCTR2013-002202-31-ES (EUCTR)	24/09/2013	01/08/2013	Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.	A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002	Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: POL7080 Product Code: POL7080 INN or Proposed INN: POL7080 Other descriptive name: POL7080	Polyphor Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Spain;Germany;United Kingdom
588	EUCTR2013-001258-82-IT (EUCTR)	12/09/2013	29/07/2013	Phase II clinical study for the therapy of cystic fibrosis patients with aspecific mutation	A phase II pilot clinical study of experimental research to evaluate thefunctional rescue of CFTR protein through proteostasis regulators - Proteostasis regulators effect in cystic fibrosis therapy	Cystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II mutations;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]	Trade Name: Cystagon Product Name: Cysteamine bitartrate (Cystagon) Product Code: EMEA/H/C/000125	European Institute for Cystic Fibrosis Research (IERFC)	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Italy
589	EUCTR2013-002202-31-GB (EUCTR)	11/09/2013	19/06/2013	Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.	A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002	Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: POL7080 Product Code: POL7080 INN or Proposed INN: POL7080 Other descriptive name: POL7080	Polyphor Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Spain;Germany;United Kingdom
590	EUCTR2012-003990-24-AT (EUCTR)	26/08/2013	03/04/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	United States;France;Canada;Spain;Belgium;Denmark;Australia;Austria;Germany;United Kingdom
591	EUCTR2012-003990-24-ES (EUCTR)	09/08/2013	16/05/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	United States;France;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
592	NCT01844778 (ClinicalTrials.gov)	August 2013	29/4/2013	Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)	An Open-label, Crossover, Interventional Phase IV Study to Compare the Ease of Use of TIP With Nebulized TIS and Nebulized COLI for the Treatment of Pulmonary Pseudomonas Aeruginosa (P.a) in Patients With Cystic Fibrosis	Cystic Fibrosis	Drug: Tobramycin Inhalation Powder;Drug: Tobramycin inhalation solution;Drug: Colistimethate	Novartis Pharmaceuticals	NULL	Completed	6 Years	N/A	All	60	Phase 4	Germany;Ireland;Spain;Switzerland;United Kingdom
593	NCT01885169 (ClinicalTrials.gov)	August 2013	20/6/2013	LAIV (Flumist®) Administration in CF Patients	Safety of Live-attenuated Influenza Vaccine (LAIV, Flumist®) in Patients With Cystic Fibrosis (CF)	Cystic Fibrosis	Biological: Flumist®	McGill University Health Center	Ministere de la Sante et des Services Sociaux;Canadian Cystic Fibrosis Foundation;PHAC/CIHR Influenza Research Network	Active, not recruiting	2 Years	18 Years	Both	170	N/A	Canada
594	EUCTR2012-000386-20-GB (EUCTR)	31/07/2013	26/04/2013	A Roll-over study in children with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term safety and pharmacodynamics of ivacaftor	A Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation	cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	35	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Canada;United Kingdom
595	EUCTR2012-001565-33-ES (EUCTR)	04/07/2013	16/05/2013	An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin	An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN Trade Name: TOBI 300 mg/5 ml solución para inhalación por nebulizador INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN Trade Name: Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE	Novartis Farmaceutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes	67	Phase 4	Spain;Ireland;Germany;United Kingdom;Switzerland
596	EUCTR2012-000204-15-GB (EUCTR)	28/06/2013	26/04/2013	A study in children aged 2 to 5 with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the safety, pharmacokinetics and pharmacodynamics of ivacaftor	A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who are 2 Through 5 Years of Age and Have a CFTR Gating Mutation	cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	35	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Canada;United Kingdom
597	EUCTR2012-003990-24-DK (EUCTR)	27/06/2013	17/05/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	United States;France;Canada;Spain;Belgium;Austria;Australia;Denmark;Germany;United Kingdom
598	EUCTR2009-012842-21-HU (EUCTR)	27/06/2013	10/05/2013	Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis	Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis	Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN	Aptalis Pharma US Inc.	NULL	Not Recruiting			Female: yes Male: yes	86		Hungary;Bulgaria;Germany;Italy;United Kingdom
599	EUCTR2012-003989-40-CZ (EUCTR)	26/06/2013	26/03/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
600	EUCTR2012-003990-24-BE (EUCTR)	25/06/2013	26/03/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
601	EUCTR2012-001565-33-GB (EUCTR)	21/06/2013	16/04/2013	An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin	An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 17.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	67	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Spain;Ireland;Germany;Switzerland;United Kingdom
602	EUCTR2012-003532-23-DE (EUCTR)	20/06/2013	05/02/2013	An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 15.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 15.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
603	EUCTR2012-003990-24-DE (EUCTR)	20/06/2013	26/03/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
604	EUCTR2012-002699-14-BE (EUCTR)	18/06/2013	15/02/2013	Trial of inhaled mannitol in children with cystic fibrosis	A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years	Cystic fibrosis in children aged 6 to 17 years MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A	Pharmaxis Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160		France;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom;Switzerland
605	EUCTR2012-003989-40-GB (EUCTR)	10/06/2013	13/05/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
606	EUCTR2012-003990-24-GB (EUCTR)	10/06/2013	13/05/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
607	EUCTR2012-003989-40-IE (EUCTR)	07/06/2013	11/04/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
608	EUCTR2012-001565-33-DE (EUCTR)	05/06/2013	18/04/2013	An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin	An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	67	Phase 4	Spain;Ireland;Germany;United Kingdom;Switzerland
609	EUCTR2011-004208-39-GB (EUCTR)	30/05/2013	11/12/2012	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1	bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
610	EUCTR2012-003989-40-IT (EUCTR)	22/05/2013	21/03/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
611	EUCTR2012-003989-40-DE (EUCTR)	17/05/2013	26/03/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	United States;France;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
612	EUCTR2012-004437-16-NL (EUCTR)	15/05/2013	19/03/2013	Pharmacokinetic evaluation and local tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis	Pharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis - Tobra-02	BronchiectasisLung infections;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Dry powder tobramycin Product Code: J01GB01 INN or Proposed INN: Tobramycin dry powder Other descriptive name: TOBRAMYCIN	University Medical Center Groningen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
613	EUCTR2011-000801-39-IE (EUCTR)	07/05/2013	12/02/2013	Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY	Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY	Mukoviszidose Institute gGmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
614	EUCTR2012-004491-18-IT (EUCTR)	07/05/2013	21/07/2016	Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs.	A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BAY 85-8501 Product Code: BAY 85-8501 Other descriptive name: BAY 85-8501	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	90	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom;Italy
615	EUCTR2012-003989-40-SE (EUCTR)	07/05/2013	18/03/2013	A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3	United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
616	NCT01764841 (ClinicalTrials.gov)	May 2, 2013	8/1/2013	Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)	Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.	Bronchiectasis	Drug: Ciprofloxacin DPI (BAYQ3939);Drug: Placebo	Bayer	Novartis	Completed	18 Years	N/A	All	416	Phase 3	United States;Argentina;Australia;Denmark;France;Germany;Israel;Italy;Japan;Latvia;New Zealand;Slovakia;Spain;United Kingdom
617	NCT01710644 (ClinicalTrials.gov)	May 2013	17/10/2012	Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis	A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis	Pancreatic Insufficiency;Cystic Fibrosis;Digestive System Diseases;Lung Diseases;Respiratory Tract Diseases	Drug: Burlulipase;Drug: Placebo (Caramel in sterile water)	Nordmark Arzneimittel GmbH & Co. KG	Parexel	Completed	12 Years	N/A	Both	35	Phase 1/Phase 2	United States
618	EUCTR2011-000443-24-NL (EUCTR)	25/04/2013	06/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
619	NCT01818544 (ClinicalTrials.gov)	April 2013	8/3/2013	Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis	A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis Bronchiectasis	Bronchiectasis	Drug: BAY85-8501;Drug: Placebo	Bayer	NULL	Completed	18 Years	N/A	Both	94	Phase 2	France;Germany;Italy;Spain;United Kingdom
620	EUCTR2011-004208-39-FR (EUCTR)	22/03/2013	27/06/2013	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1	bronchiectasis MedDRA version: 16.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Slovakia;Spain;Israel;United Kingdom;Italy;France;United States;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
621	EUCTR2011-003821-93-DE (EUCTR)	13/03/2013	23/12/2011	A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	United States;Canada;Germany;United Kingdom
622	EUCTR2011-004208-39-DK (EUCTR)	12/03/2013	17/12/2012	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1	bronchiectasis MedDRA version: 17.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	400		Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Denmark;Australia;Latvia;Germany;New Zealand;Japan
623	EUCTR2012-004491-18-ES (EUCTR)	19/02/2013	21/12/2012	Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs.	A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BAY 85-8501 Product Code: BAY 85-8501 INN or Proposed INN: - Other descriptive name: BAY 85-8501	Bayer HealthCare AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Spain;United Kingdom
624	NCT01775137 (ClinicalTrials.gov)	February 2013	22/1/2013	Ext. Long-term Safety Study in CF Patients: Single Arm TIP	A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.	Long-term Safety of TIP	Drug: TBM100	Novartis Pharmaceuticals	NULL	Completed	6 Years	N/A	All	45	Phase 4	United States;Argentina;Australia;Canada;Germany;Hungary;Italy;Mexico;Spain
625	NCT01707290 (ClinicalTrials.gov)	February 2013	9/10/2012	Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation	A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR Mutation	Cystic Fibrosis	Drug: Ivacaftor	Vertex Pharmaceuticals Incorporated	Cystic Fibrosis Foundation Therapeutics	Completed	6 Years	N/A	All	125	Phase 3	United States;Belgium;France;United Kingdom;Ireland
626	EUCTR2012-004491-18-GB (EUCTR)	30/01/2013	18/12/2012	Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs.	A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 15.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: BAY 85-8501 Product Code: BAY 85-8501 INN or Proposed INN: N/A Other descriptive name: BAY 85-8501	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	90	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Spain;Italy;United Kingdom
627	EUCTR2012-003532-23-ES (EUCTR)	29/01/2013	29/11/2012	An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Farmaceutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
628	EUCTR2011-004208-39-ES (EUCTR)	29/01/2013	26/11/2012	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non-CF BE)	Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis. - RESPIRE 1	bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
629	EUCTR2012-002699-14-GB (EUCTR)	28/01/2013	03/07/2012	Trial of inhaled mannitol in children with cystic fibrosis	A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years	Cystic fibrosis in children aged 6 to 17 years MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A	Pharmaxis Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Canada;Argentina;Belgium;Netherlands;Italy;United Kingdom
630	EUCTR2011-004208-39-DE (EUCTR)	21/01/2013	23/10/2012	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1	bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
631	EUCTR2012-003532-23-IT (EUCTR)	18/01/2013	21/12/2012	An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;Level: HLT;Classification code 10037132;Term: Pseudomonal infections;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI PODHALER*448CPS 28MG+10IN INN or Proposed INN: Tobramycin	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
632	EUCTR2011-004208-39-IT (EUCTR)	11/01/2013	11/12/2012	Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)	Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1	bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]	Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: CIPROFLOXACIN	BAYER HEALTHCARE AG	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
633	EUCTR2012-003532-23-HU (EUCTR)	19/12/2012	31/10/2012	An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
634	EUCTR2011-000443-24-DK (EUCTR)	14/12/2012	22/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
635	EUCTR2009-012842-21-BE (EUCTR)	19/11/2012	14/05/2012	Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis	Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis	Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREASLIPASE	Aptalis Pharma US Inc.	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 3	Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
636	NCT01684683 (ClinicalTrials.gov)	November 2012	11/9/2012	The Effect of Theophylline in the Treatment of Bronchiectasis	Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis	Bronchiectasis	Drug: Theophylline;Drug: Placebo(for Theophylline)	The First Affiliated Hospital of Guangzhou Medical University	NULL	Completed	18 Years	70 Years	Both	100	Phase 4	China
637	NCT01721382 (ClinicalTrials.gov)	November 2012	26/10/2012	Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis	Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.	Cystic Fibrosis	Drug: Sitagliptin	Nemours Children's Clinic	NULL	Completed	13 Years	20 Years	Both	6	Phase 1	United States
638	EUCTR2012-003140-68-GB (EUCTR)	29/10/2012	28/09/2012	A Study to Look at the Way the Body Absorbs and Distributes Posaconazole in the Blood and Lungs of Lung Transplant Recipients (PAPAL Study)	A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients	Invasive fungal infection (IFI) in lung transplant patients with and without cystic fibrosis. MedDRA version: 15.0;Level: PT;Classification code 10049085;Term: Antifungal prophylaxis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Noxafil Product Name: Noxafil INN or Proposed INN: Posaconazole	MSD	NULL	Not Recruiting			Female: yes Male: yes	40		United Kingdom
639	EUCTR2012-000389-39-GB (EUCTR)	25/10/2012	20/04/2012	Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR Mutation	A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation	cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Belgium;United Kingdom
640	ChiCTR-TRC-12002470	2012-09-15	2012-08-02	The effect of theophylline in the treatment of bronchiectasis, a random, double blind study	The effect of theophylline in the treatment of bronchiectasis, a random, double blind study.	bronchiectasis not due to cystic fibrosis	1:theophylline;2:theophylline;	The first affiliated hospital of Guangzhou Medical University	NULL	Completed	15	65	Both	1:46;2:46;		China
641	EUCTR2011-000441-20-NL (EUCTR)	11/09/2012	06/07/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom
642	EUCTR2012-000389-39-BE (EUCTR)	03/09/2012	26/04/2012	Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR Mutation	A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-TermIvacaftor Treatment in Subjects 6 Years of Age and Older with CysticFibrosis and a Non-G551D CFTR Mutation	Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	France;United States;Belgium;United Kingdom
643	NCT01667094 (ClinicalTrials.gov)	September 2012	13/8/2012	A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis	Continuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis	Cystic Fibrosis	Drug: Intermittent, short infusion Ceftazidime;Drug: Continuous infusion Ceftazidime;Drug: Intermittent, short infusion Meropenem;Drug: Continuous infusion Meropenem;Drug: Intermittent, short infusion Ticarcillin-clavulanate;Drug: Continuous infusion Ticarcillin-clavulanate;Drug: Intermittent, short infusion Cefepime;Drug: Continuous infusion Cefepime;Drug: Continuous infusion Piperacillin tazobactam;Drug: Intermittent, short infusion Piperacillin tazobactam	The Alfred	NULL	Active, not recruiting	18 Years	N/A	All	50	Phase 4	Australia
644	NCT01652157 (ClinicalTrials.gov)	July 31, 2012	25/7/2012	Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)	A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)	Fibrosing Colonopathy	Biological: ULTRESA;Biological: PANCREAZE;Biological: CREON;Biological: ZENPEP;Biological: other non-sponsor pancreatic enzyme replacement therapy;Biological: PERTZYE;Other: No pancreatic enzyme replacement therapy	AbbVie	Cystic Fibrosis Foundation;Digestive Care, Inc.;Nestle Health Science;VIVUS, Inc.	Terminated	N/A	99 Years	All	17		United States
645	NCT02190604 (ClinicalTrials.gov)	July 31, 2012	11/7/2014	Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients	A Randomized, Double Blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Ascending Doses of QBW251 in Healthy Subjects and Multiple Doses in Cystic Fibrosis Patients	Cystic Fibrosis	Drug: Placebo;Drug: QBW251	Novartis Pharmaceuticals	NULL	Terminated	18 Years	65 Years	All	153	Phase 1/Phase 2	United States;Belgium;France;Germany;Ireland;Romania;United Kingdom;Netherlands
646	EUCTR2012-000388-26-BE (EUCTR)	23/07/2012	20/04/2012	Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation	A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation	Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Kalydeco Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	France;United States;Belgium
647	EUCTR2011-005085-37-GB (EUCTR)	20/07/2012	24/05/2012	Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.	A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients.	cystic fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 1;Phase 2	United States;France;Belgium;Ireland;Romania;Netherlands;Germany;United Kingdom
648	NCT01614470 (ClinicalTrials.gov)	July 2012	5/6/2012	Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation	A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation	Cystic Fibrosis	Drug: Ivacaftor;Drug: Placebo	Vertex Pharmaceuticals Incorporated	Cystic Fibrosis Foundation Therapeutics	Completed	6 Years	N/A	All	39	Phase 3	United States;Belgium;France
649	EUCTR2011-001255-36-AT (EUCTR)	25/06/2012	18/10/2011	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
650	EUCTR2011-000801-39-IT (EUCTR)	20/06/2012	21/06/2012	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY	Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially effects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbility and mortality. PA infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY	MUKOVISZIDOSE E.V.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
651	EUCTR2011-000441-20-BG (EUCTR)	13/06/2012	03/05/2012	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
652	EUCTR2012-000387-19-GB (EUCTR)	11/06/2012	20/04/2012	Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR Mutation	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR Mutation	cystic fibrosis MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 3	United States;United Kingdom
653	EUCTR2011-000443-24-SE (EUCTR)	24/05/2012	07/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
654	EUCTR2011-001916-69-NL (EUCTR)	22/05/2012	07/02/2012	treatment with insulin in patients with cystic fibrosis without diabetes	insulin therapy in non-diabetic adults with cystic fibrosis - insulin in CF without CFRD	cystic fibrosis patients without cystic fibrosis related diabetes;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]	Trade Name: Lantus 100 units/ml solution for injection in a cartridge	HagaZiekenhuis, pulmonary department	NULL	Not Recruiting			Female: yes Male: yes	40		Netherlands
655	EUCTR2011-000441-20-IE (EUCTR)	02/05/2012	26/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Code: TOBI INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
656	EUCTR2011-003821-93-GB (EUCTR)	01/05/2012	19/04/2012	A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation	Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	220	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Canada;Germany;United Kingdom
657	EUCTR2011-000801-39-BE (EUCTR)	26/04/2012	09/01/2012	Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY	Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY	Mukoviszidose Institute gGmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
658	EUCTR2011-000443-24-IT (EUCTR)	10/04/2012	19/03/2012	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin Product Code: NA INN or Proposed INN: AMIKACIN SULFATE	INSMED INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	250		Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
659	EUCTR2011-000441-20-DK (EUCTR)	29/03/2012	22/07/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
660	EUCTR2011-001362-18-DE (EUCTR)	19/03/2012	20/12/2011	Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety)	cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Spain;Poland;Germany;Italy
661	EUCTR2011-001255-36-NL (EUCTR)	13/03/2012	19/10/2011	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	United States;France;Spain;Poland;Belgium;Ireland;Austria;Germany;Netherlands;Italy
662	EUCTR2011-004761-33-GB (EUCTR)	08/03/2012	14/12/2011	Repeated application of gene therapy in patients with cystic fibrosis	A randomised double-blind placebo-controlled Phase 2B clinical trial of repeated application of gene therapy in patients with cystic fibrosis - Repeated application of gene therapy in patients with CF v01-010204	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: pGM169/GL67A Other descriptive name: pGM169/GL67A	Imperial College	NULL	Not Recruiting			Female: yes Male: yes	130	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
663	EUCTR2011-002000-32-IT (EUCTR)	09/02/2012	06/03/2012	A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A single arm, open-label, multicenter, Phase IV trial to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Tobramycin inhalation powder Product Code: TBM100C INN or Proposed INN: TOBRAMYCIN Other descriptive name: NA	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;Hungary;Mexico;Canada;Argentina;Spain;Brazil;Australia;Germany;Italy
664	EUCTR2011-001362-18-IT (EUCTR)	08/02/2012	22/02/2012	Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety)	Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety)	Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa. MedDRA version: 14.1;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM Other descriptive name: NA	GILEAD SCIENCES INC.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Spain;Germany;Italy
665	EUCTR2011-000801-39-SE (EUCTR)	08/02/2012	13/12/2011	Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY	Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY	Mukoviszidose Institute gGmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
666	EUCTR2011-001255-36-BE (EUCTR)	07/02/2012	13/10/2011	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	France;United States;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy
667	EUCTR2011-001255-36-IE (EUCTR)	06/02/2012	24/10/2011	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
668	EUCTR2011-000443-24-BE (EUCTR)	30/01/2012	25/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
669	EUCTR2011-000441-20-BE (EUCTR)	30/01/2012	25/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI Product Code: N/A INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany
670	EUCTR2011-001255-36-IT (EUCTR)	27/01/2012	28/09/2012	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas aeruginosa (PA) Aztreonam Lysine for Pseudomonas Infection Eradication (ALPINE)study - ALPINE	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 15.0;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations MedDRA version: 15.0;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Aztreonam 75 mg powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM	GILEAD SCIENCES INC.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;Spain;Ireland;Austria;Netherlands;Germany;Italy
671	EUCTR2011-001362-18-ES (EUCTR)	25/01/2012	21/12/2011	Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mgPowder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety)	Cystic fibrosis and chronic infection of lower respiratory tract withPseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Name: Aztreonam solución para inhalación Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;France;Poland;Spain;Germany;Italy
672	EUCTR2011-000443-24-PL (EUCTR)	20/01/2012	06/10/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
673	EUCTR2011-001255-36-DE (EUCTR)	16/01/2012	11/10/2011	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	United States;France;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy
674	NCT01731015 (ClinicalTrials.gov)	January 2012	16/11/2012	Imaging Lung Function Using Oxygen Enhanced MRI	A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent	COPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways Disease	Drug: Medical Grade Oxygen	Hal C Charles	NULL	Completed	18 Years	90 Years	Both	15	Phase 1	United States
675	NCT01519661 (ClinicalTrials.gov)	January 2012	24/1/2012	Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis	A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis	Pulmonary Infections;Pseudomonas Aeruginosa in Cystic Fibrosis	Drug: TBM100	Novartis Pharmaceuticals	NULL	Completed	6 Years	N/A	All	157	Phase 4	United States;Argentina;Australia;Canada;France;Germany;Hungary;Italy;Mexico;Spain;Brazil
676	NCT01509339 (ClinicalTrials.gov)	January 2012	9/1/2012	Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis	Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis	Cystic Fibrosis;Methicillin-resistant Staphylococcus Aureus	Drug: Vancomycin	Case Western Reserve University	Cystic Fibrosis Foundation Therapeutics	Active, not recruiting	18 Years	N/A	Both	10	Phase 1	United States
677	EUCTR2011-002719-27-IT (EUCTR)	30/12/2011	13/03/2012	EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUS	GLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSIS	PATIENTS WITH CYSTIC FIBROSIS MedDRA version: 14.1;Level: PT;Classification code 10011766;Term: Cystic fibrosis pancreatic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]	Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML INN or Proposed INN: MECASERMIN	AZIENDA OSPEDALIERA DI PARMA	NULL	Not Recruiting			Female: yes Male: yes	20		Italy
678	EUCTR2011-002000-32-DE (EUCTR)	13/12/2011	31/10/2011	A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation Product Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
679	EUCTR2011-002000-32-HU (EUCTR)	25/11/2011	05/09/2011	A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler 28 mg inhalációs por, kemény kapszula Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
680	EUCTR2011-001255-36-ES (EUCTR)	23/11/2011	18/10/2011	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication)	Cystic fibrosis and new onset lower respiratory tract culture positive for P.aeruginosa. MedDRA version: 14.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Poland;Belgium;Spain;Ireland;Austria;Netherlands;Germany;Italy
681	EUCTR2011-002000-32-ES (EUCTR)	17/11/2011	28/09/2011	A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis - not available	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI PODHALER Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Farmaceutica S. A	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
682	NCT00889434 (ClinicalTrials.gov)	November 1, 2011	20/4/2009	Efficacy and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated Cystic Fibrosis (CF)	Single-site, Open-label, Dose-ranging, Efficacy, and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated CF	Cystic Fibrosis	Dietary Supplement: ECGC;Dietary Supplement: Tocotrienol;Dietary Supplement: EGCG + Tocotrienol	Hadassah Medical Organization	NULL	Completed	18 Years	N/A	All	7	N/A	Israel
683	NCT02276898 (ClinicalTrials.gov)	November 2011	22/10/2014	A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index	A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index as a Short-term Pharmacodynamic Biomarker in Patients With Cystic Fibrosis.	Cystic Fibrosis	Drug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo)	The Hospital for Sick Children	NULL	Completed	6 Years	18 Years	Both	24	Phase 2	Canada
684	NCT01537666 (ClinicalTrials.gov)	November 2011	17/2/2012	Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics	Phase I, Reference-controlled, Dose Escalating Study to Examine the Pharmacokinetics and Safety of AeroVanc Inhalation Powder.	Healthy;Cystic Fibrosis	Drug: AeroVanc;Drug: IV vancomycin hydrochloride	Savara Inc.	INC Research Limited	Completed	18 Years	50 Years	All	25	Phase 1	Australia
685	EUCTR2011-001821-26-IT (EUCTR)	18/10/2011	20/03/2012	Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis	Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis: pilot study of antimicrobial activity	Adult patient with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: BRAMITOB*NEBUL 28F 300MG/4ML INN or Proposed INN: TOBRAMYCIN	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO	NULL	Not Recruiting			Female: yes Male: yes			Italy
686	EUCTR2011-000443-24-DE (EUCTR)	11/10/2011	30/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
687	EUCTR2011-000442-38-BG (EUCTR)	03/10/2011	05/07/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
688	EUCTR2011-000443-24-BG (EUCTR)	03/10/2011	28/07/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
689	EUCTR2011-000441-20-IT (EUCTR)	01/10/2011	08/03/2012	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE Trade Name: Tobi INN or Proposed INN: TOBRAMYCIN	INSMED INCORPORATED	NULL	Not Recruiting			Female: yes Male: yes	300		Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy
690	NCT01002534 (ClinicalTrials.gov)	October 2011	26/10/2009	Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients?	Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind, Placebo-controlled Study.	Cystic Fibrosis	Drug: Vardenafil;Drug: Placebo	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	NULL	Terminated	14 Years	N/A	All	5	Phase 2	Belgium
691	EUCTR2011-000443-24-ES (EUCTR)	22/09/2011	03/11/2011	Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta Arikace en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa	Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta de amicacina liposomal para inhalación (Arikace) en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa - NCT0131627	Infeccion pulmonar por Pseudomonas Aeruginosa/ colonizacion en pacientes con fibrosis quistica MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace TM) INN or Proposed INN: Sulfato de amikacina	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
692	EUCTR2011-000442-38-ES (EUCTR)	21/09/2011	11/11/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden
693	EUCTR2011-000441-20-ES (EUCTR)	21/09/2011	11/11/2011	ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	ESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108	Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Amikacina liposomal (Arikace?) INN or Proposed INN: Sulfato de amikacina Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador INN or Proposed INN: tobramicina	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands
694	EUCTR2011-000441-20-DE (EUCTR)	19/09/2011	30/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
695	EUCTR2010-019692-30-ES (EUCTR)	07/09/2011	29/07/2011	Extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Belgium;Spain;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden
696	EUCTR2011-000801-39-DE (EUCTR)	31/08/2011	04/04/2011	Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis	Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY	Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY	Mukoviszidose Institute gGmbH	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
697	EUCTR2010-019692-30-GB (EUCTR)	22/08/2011	23/08/2011	Extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom;Sweden
698	EUCTR2010-019634-26-GB (EUCTR)	18/08/2011	07/02/2011	Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients	A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients	Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: Tobi 300 mg/5 ml Nebuliser Solution INN or Proposed INN: TOBRAMYCIN	Mpex Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Ireland;Israel;Germany;United Kingdom
699	EUCTR2011-000443-24-GR (EUCTR)	09/08/2011	23/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
700	EUCTR2011-000443-24-IE (EUCTR)	05/08/2011	26/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
701	EUCTR2011-000441-20-GB (EUCTR)	03/08/2011	24/05/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
702	EUCTR2011-000443-24-GB (EUCTR)	03/08/2011	24/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
703	EUCTR2011-000443-24-FR (EUCTR)	28/07/2011	31/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
704	EUCTR2005-003772-37-IE (EUCTR)	26/07/2011	08/07/2008	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003	Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762	Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom
705	EUCTR2011-000443-24-AT (EUCTR)	22/07/2011	27/06/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
706	EUCTR2011-000441-20-AT (EUCTR)	19/07/2011	21/06/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
707	EUCTR2011-000441-20-GR (EUCTR)	15/07/2011	22/06/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
708	EUCTR2011-000192-13-PL (EUCTR)	08/07/2011	31/05/2011	A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosis	A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study	systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Colobreathe Product Code: N/A INN or Proposed INN: Colistimethate sodium Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate	Forest Laboratories UK Ltd.	NULL	Not Recruiting			Female: yes Male: yes	28		Poland;Ukraine;Germany;United Kingdom
709	EUCTR2011-000441-20-SK (EUCTR)	04/07/2011	25/11/2014	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
710	EUCTR2011-000443-24-SK (EUCTR)	04/07/2011	20/02/2014	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands
711	EUCTR2009-016590-15-IT (EUCTR)	01/07/2011	14/03/2012	Evaluation of the efficacy and safety of tobramycin for the treatment of early infections of P. aeruginosa in cystic fibrosis subjects aged from 3 months to less than 7 years.	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.	Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients. MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: TOBRAMYCIN Other descriptive name: NA	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	72		France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Switzerland;Italy
712	EUCTR2011-000441-20-HU (EUCTR)	29/06/2011	20/04/2011	Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300		Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
713	EUCTR2011-000443-24-HU (EUCTR)	29/06/2011	11/05/2011	Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250		United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
714	NCT02782312 (ClinicalTrials.gov)	June 2011	17/5/2016	Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis	Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective Study	Bronchiectasis	Drug: ICS+LABA;Other: routine therapy	Shanghai Pulmonary Hospital, Shanghai, China	NULL	Completed	18 Years	N/A	Both	120	Phase 4	China
715	EUCTR2010-019634-26-DE (EUCTR)	24/05/2011	25/01/2011	Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients	A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients	Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI 300 mg/5 ml Lösung für einen INN or Proposed INN: TOBRAMYCIN	Mpex Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	France;United States;Canada;Ireland;Israel;Germany;United Kingdom
716	EUCTR2010-019692-30-DE (EUCTR)	11/05/2011	13/04/2011	Extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden
717	EUCTR2011-000192-13-DE (EUCTR)	05/05/2011	05/04/2011	A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosis	A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study	systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Colobreathe Product Code: N/A INN or Proposed INN: Colistimethate sodium Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate	Forest Laboratories UK Ltd.	NULL	Not Recruiting			Female: yes Male: yes	40		Poland;Ukraine;Germany;United Kingdom
718	EUCTR2010-019634-26-IE (EUCTR)	03/05/2011	15/02/2011	Trial of Aeroquin versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients	A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients	Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI INN or Proposed INN: TOBRAMYCIN	Mpex Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	France;United States;Canada;Ireland;Israel;Germany;United Kingdom
719	NCT02295566 (ClinicalTrials.gov)	May 2011	20/8/2014	RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot Study	RATNO (Reducing Antibiotic Tolerance Using NO) Reducing Antibiotic Tolerance Using Low Dose Nitric Oxide in Cystic Fibrosis - a Phase 2 Pilot Study	Cystic Fibrosis	Drug: Nitric Oxide;Drug: Control	University Hospital Southampton NHS Foundation Trust.	University of Southampton	Completed	12 Years	N/A	Both	12	Phase 2	United Kingdom
720	NCT01355796 (ClinicalTrials.gov)	May 2011	16/5/2011	Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis	Randomized Cross Over Study of Inhaled Hypertonic Xylitol Versus Hypertonic Saline in Stable Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: Xylitol;Drug: Hypertonic saline	Joseph Zabner	Ann & Robert H Lurie Children's Hospital of Chicago;Northwestern University	Completed	16 Years	N/A	All	30	Phase 1/Phase 2	United States
721	EUCTR2011-000192-13-GB (EUCTR)	28/04/2011	17/03/2011	A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study	A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study	cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders	Product Name: Colobreathe Product Code: N/A INN or Proposed INN: Colistimethate sodium Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate	Forest Laboratories UK Ltd.	NULL	Not Recruiting			Female: yes Male: yes	28		Germany;United Kingdom;Poland
722	EUCTR2010-023090-19-IE (EUCTR)	08/04/2011	15/02/2011	A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa	A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis	Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: OligoG (60 mg/ml) Product Code: OligoG INN or Proposed INN: Sodium alginate Other descriptive name: SODIUM ALGINATE	AlgiPharma AS	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Ireland;United Kingdom
723	NCT01313624 (ClinicalTrials.gov)	April 2011	10/3/2011	Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis	A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection	Bronchiectasis	Drug: AZLI;Drug: Placebo	Gilead Sciences	NULL	Completed	18 Years	N/A	All	266	Phase 3	United States;Australia;Canada
724	NCT01349192 (ClinicalTrials.gov)	April 2011	4/5/2011	Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)	Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)	Cystic Fibrosis;Methicillin-resistant Staphylococcus Aureus	Drug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole;Drug: Minocycline;Drug: Mupirocin;Drug: chlorhexidine gluconate oral rinse;Drug: 2% Chlorhexidine solution wipes;Behavioral: Environmental Decontamination	University of North Carolina, Chapel Hill	CF Therapeutics Development Network Coordinating Center;Seattle Children's Hospital;Washington University School of Medicine;University of Washington;University of Colorado, Denver;Baylor College of Medicine;University of Alabama at Birmingham;Cook Children's Medical Center;University of Michigan;University of Florida;University of Texas Southwestern Medical Center;Children's Hospital Medical Center, Cincinnati;St. Louis Children's Hospital	Terminated	4 Years	45 Years	All	47	Phase 2	United States
725	NCT01314716 (ClinicalTrials.gov)	April 2011	11/3/2011	Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis	A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)	Bronchiectasis	Drug: AZLI;Drug: Placebo	Gilead Sciences	NULL	Completed	18 Years	N/A	All	274	Phase 3	United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
726	EUCTR2010-023090-19-GB (EUCTR)	29/03/2011	11/02/2011	A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa	A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis	Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: OligoG (60 mg/ml) Product Code: OligoG INN or Proposed INN: OligoG Other descriptive name: OligoG-CF5/20, Alginate oligosaccharide (G-block) fragment	AlgiPharma AS	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Ireland;United Kingdom
727	EUCTR2009-012842-21-BG (EUCTR)	24/02/2011	28/09/2010	Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis	Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis	Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN	Aptalis Pharma US Inc.	NULL	Not Recruiting			Female: yes Male: yes	86		France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy
728	EUCTR2010-023529-39-GB (EUCTR)	18/02/2011	31/12/2010	Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0	Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0	Cystic Fibrosis	Trade Name: INOmax 400ppm mol/mol inhalation gas Product Name: Nitric Oxide Product Code: NO	Southampton University Hopsitals NHS Trust	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	United Kingdom
729	EUCTR2010-020413-90-BE (EUCTR)	08/02/2011	15/10/2010	Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation	A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	293	Phase 2	United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand
730	EUCTR2009-012842-21-DE (EUCTR)	13/01/2011	13/07/2010	Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic Fibrosis	Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis	Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN	Aptalis Pharma US Inc.	NULL	Not Recruiting			Female: yes Male: yes	86		Hungary;Bulgaria;Germany;Italy;United Kingdom
731	EUCTR2010-020413-90-DE (EUCTR)	06/01/2011	15/10/2010	Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation	A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	293	Phase 2	United States;Belgium;Australia;Germany;United Kingdom;New Zealand
732	NCT02163681 (ClinicalTrials.gov)	January 1, 2011	10/6/2014	MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children		Healthy;Cystic Fibrosis (CF);Asthma;Bronchopulmonary Dysplasia (BPD)	Drug: Hyperpolarized Helium-3 MRI of the chest	University of Virginia	Xemed LLC	Completed	4 Months	65 Years	All	77	N/A	United States
733	NCT01494909 (ClinicalTrials.gov)	January 2011	15/12/2011	Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function	Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function	Cystic Fibrosis	Dietary Supplement: Ensure plus	Texas A&M University	Arkansas Children's Hospital Research Institute;University of Arkansas	Active, not recruiting	10 Years	N/A	All	31	N/A	United States
734	EUCTR2010-023030-23-GB (EUCTR)	24/12/2010	23/11/2010	Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1	Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1	Cystic fibrosis	Trade Name: Nebcin (tobramycin) Product Name: Tobramycin injection 40mg/1ml INN or Proposed INN: Tobramcyin	The Univeristy of Nottingham	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
735	EUCTR2010-022042-24-GB (EUCTR)	24/12/2010	25/10/2010	A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with Pseudomonas	A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with Pseudomonas	The aim of this randomized double blind controlled study is to evaluate the efficacy of a 3 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis. MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Lipitor Product Name: Atorvastatin INN or Proposed INN: Atorvastatin Other descriptive name: Lipitor	NHS Lothian	University of Edinburgh	Not Recruiting			Female: yes Male: yes	32	Phase 4	United Kingdom
736	EUCTR2010-022040-20-GB (EUCTR)	17/12/2010	21/10/2010	A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in Bronchiectasis	A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in Bronchiectasis	The aim of this randomised double blind controlled study to evaluate the efficacy of 6 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Lipitor Product Name: Atorvastatin INN or Proposed INN: Atorvastatin Other descriptive name: Lipitor	NHS Lothian	University of Edinburgh	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
737	EUCTR2010-019692-30-SE (EUCTR)	16/12/2010	11/10/2010	Extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden
738	EUCTR2010-019802-17-IE (EUCTR)	15/12/2010	09/09/2010	Tiotropium-bromide in cystic fibrosis	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. -	Cystic Fibrosis MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	440		Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;United Kingdom;Slovakia;Russian Federation;Czech Republic;Canada;Belgium;Spain;United States;Poland
739	NCT01100892 (ClinicalTrials.gov)	December 2010	31/3/2010	Cystic Fibrosis - Insulin Deficiency, Early Action	Cystic Fibrosis - Insulin Deficiency, Early Action	Cystic Fibrosis;Diabetes	Drug: Once-daily insulin detemir	Sydney Children's Hospitals Network	John Hunter Children's Hospital;Lady Cilento Children's Hospital, Brisbane;Women's and Children's Hospital, Adelaide;Children's Hospital Colorado	Active, not recruiting	5 Years	19 Years	All	100	Phase 3	United States;Australia
740	EUCTR2010-019802-17-ES (EUCTR)	29/11/2010	22/09/2010		Ensayo clínico aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para confirmar eficacia y seguridad del tratamiento durante 12 semanas con tiotropio 5mcg una vez al día inhalado via Respimat® en pacientes con fibrosis quística.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 mcg administered once daily via the Respimat® device in patients with cystic fibrosis. -	Fibrosis QuísticaCystic Fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim España, S.A	NULL	Not Recruiting			Female: yes Male: yes	360		Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Ireland;Spain;Italy;Austria
741	EUCTR2010-019802-17-DE (EUCTR)	25/11/2010	04/08/2010	Clinical trial to confirm the efficacy and safety of tiotropium 5 microgram administered via Respimat device, in patients with cystic fibrosis.	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.	Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat INN or Proposed INN: Tiotropium Bromide (monohydrate)	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	372		Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany
742	EUCTR2010-019802-17-BE (EUCTR)	23/11/2010	11/08/2010	Tiotropium-bromide in cystic fibrosic	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.	Cystic Fibrosis MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	SCS Boehringer Ingelheim Comm.V	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;South Africa;Germany
743	EUCTR2010-019692-30-NL (EUCTR)	04/11/2010	24/06/2010	Extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden
744	NCT01180634 (ClinicalTrials.gov)	November 2010	10/8/2010	MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis	A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients	Cystic Fibrosis	Drug: MP-376 (Levofloxacin solution for Inhalation);Drug: Placebo	Horizon Pharma USA, Inc.	Forest Laboratories	Completed	12 Years	N/A	All	330	Phase 3	United States;Australia;Canada;Israel;New Zealand
745	NCT01299194 (ClinicalTrials.gov)	November 2010	21/10/2010	Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa	A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in Patients With Pseudomonas Aeruginosa	BRONCHIECTASIS	Drug: ATORVASTATIN	University of Edinburgh	NHS Lothian	Completed	18 Years	80 Years	All	32	Phase 4	United Kingdom
746	NCT01299181 (ClinicalTrials.gov)	November 2010	21/10/2010	A Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis	A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis	Bronchiectasis	Drug: Atorvastatin	University of Edinburgh	NHS Lothian	Completed	18 Years	75 Years	Both	60	Phase 4	United Kingdom
747	EUCTR2010-018454-13-DK (EUCTR)	27/10/2010	13/08/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn®	Laboratoires SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
748	EUCTR2010-019802-17-GB (EUCTR)	22/10/2010	10/08/2010	Tiotropium-bromide in cystic fibrosis	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. -	Cystic Fibrosis MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	471		Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;Slovakia;Russian Federation;United Kingdom;Czech Republic;Canada;Belgium;Spain;United States;Poland
749	EUCTR2010-019802-17-AT (EUCTR)	20/10/2010	09/09/2010		A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. -	Cystic Fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 12.1;Level: PT;Term: Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim RCV GmbH & Co KG	,NULL	Not Recruiting			Female: yes Male: yes			Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
750	EUCTR2010-020546-96-GB (EUCTR)	08/10/2010	17/08/2010	Study of the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects with Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted -	Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	16	Phase 2	United Kingdom;Canada;United States
751	EUCTR2010-019692-30-IT (EUCTR)	06/10/2010	02/11/2010	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009e-CF	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009e-CF	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC THERAPEUTICS, INC.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Spain;Belgium;Germany;Netherlands;United Kingdom;Italy;Sweden
752	EUCTR2010-019692-30-FR (EUCTR)	05/10/2010	17/06/2010	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Spain;Belgium;Germany;Netherlands;United Kingdom;Italy;Sweden
753	EUCTR2010-019802-17-CZ (EUCTR)	01/10/2010	16/08/2010	Tiotropium-bromide in cystic fibrosic	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.	Cystic Fibrosis MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim	NULL	Not Recruiting			Female: yes Male: yes	360		Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany
754	EUCTR2010-019802-17-HU (EUCTR)	30/09/2010	23/07/2010		A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. -	Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 microgram Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	360		Portugal;Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
755	EUCTR2009-012997-11-DE (EUCTR)	27/09/2010	25/06/2010	Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and Older	An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST	Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	217		France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
756	EUCTR2009-012842-21-GB (EUCTR)	20/09/2010	17/06/2010	Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis	Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis	Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREASLIPASE	Aptalis Pharma US Inc.	NULL	Not Recruiting			Female: yes Male: yes	86	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
757	EUCTR2010-019802-17-FR (EUCTR)	14/09/2010	23/07/2010	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.	Cystic Fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	Ireland;Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Germany;Italy;United Kingdom
758	EUCTR2010-019802-17-SK (EUCTR)	13/09/2010	03/08/2010	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.	A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.	Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim RCV GmbH&Co KG	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
759	EUCTR2010-019802-17-PT (EUCTR)	13/09/2010	07/07/2010		A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. -	Cystic Fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE	Boehringer Ingelheim France	NULL	Not Recruiting			Female: yes Male: yes	360		Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
760	EUCTR2010-018454-13-ES (EUCTR)	06/09/2010	31/05/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado	Cystic fibrosisFibrosis quistica MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine- N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine- N-acetylcysteinate Other descriptive name: Nacystelyn®	Laboratoires SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	France;Czech Republic;Hungary;Belgium;Spain;Denmark;Germany;United Kingdom;Italy
761	EUCTR2010-018454-13-GB (EUCTR)	01/09/2010	18/06/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn®	Laboratoires SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	Hungary;Czech Republic;Germany;United Kingdom;France;Spain;Italy
762	NCT01208285 (ClinicalTrials.gov)	September 2010	22/9/2010	Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects	A Phase 1 Non-Randomized, Open-Label Study to Assess the Safety and Pharmacokinetics of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects	In Development for Cystic Fibrosis	Drug: VX-770	Vertex Pharmaceuticals Incorporated	NULL	Completed	18 Years	65 Years	Both	24	Phase 1	Czech Republic;Slovakia
763	EUCTR2010-018454-13-DE (EUCTR)	31/08/2010	21/05/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn®	Laboratoires SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
764	EUCTR2010-018454-13-CZ (EUCTR)	27/08/2010	21/06/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn®	Laboratoires SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	Hungary;United Kingdom;Germany;Czech Republic;France;Spain;Italy
765	EUCTR2009-012997-11-FR (EUCTR)	25/08/2010	27/04/2010	An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST	An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST	Cystic Fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: VX-770 Product Code: VX-770, VRT-8130077 Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	217	Phase 3	France;Czech Republic;Ireland;Germany;United Kingdom
766	EUCTR2010-018454-13-HU (EUCTR)	17/08/2010	17/06/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn®	Laboratoires SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
767	NCT01140451 (ClinicalTrials.gov)	August 12, 2010	7/6/2010	Extension Study of Ataluren (PTC124) in Cystic Fibrosis	A Phase 3 Extension Study of Ataluren (PTC124®) in Subjects With Nonsense-Mutation-Mediated Cystic Fibrosis	Cystic Fibrosis	Drug: Ataluren	PTC Therapeutics	Cystic Fibrosis Foundation	Completed	6 Years	N/A	All	191	Phase 3	United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom
768	EUCTR2010-019692-30-BE (EUCTR)	10/08/2010	25/05/2010	Extension study of ataluren in patients with Cystic Fibrosis	A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden
769	EUCTR2009-012842-21-IT (EUCTR)	10/08/2010	23/08/2010	A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND	A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND	exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) MedDRA version: 9.1;Level: HLGT;Classification code 10015674 MedDRA version: 9.1;Level: LLT;Classification code 10011762	Trade Name: ZENPEP INN or Proposed INN: Multienzymes (lipase, protease etc.) Trade Name: CREON 10000 Capsules INN or Proposed INN: Multienzymes (lipase, protease etc.)	EURAND SPA	NULL	Not Recruiting			Female: yes Male: yes	86		Hungary;Bulgaria;Germany;United Kingdom;Italy
770	EUCTR2010-018454-13-FR (EUCTR)	10/08/2010	28/05/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn®	Laboratoires SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
771	EUCTR2010-019802-17-IT (EUCTR)	27/07/2010	20/08/2010		A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 micrograms administered once daily via the Respimat device in patients with cystic fibrosis. - ND	Patients with cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: Tiotropium bromide	BOEHRINGER ING.	NULL	Not Recruiting			Female: yes Male: yes	440		Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
772	EUCTR2009-016590-15-DE (EUCTR)	19/07/2010	15/04/2010	A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.	Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI 300 mg/5 ml Lösung für einen Vernebler Product Name: TOBI Product Code: TBM100 INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	50		France;Egypt;Hungary;Greece;Canada;Argentina;Poland;Romania;Russian Federation;Germany;Switzerland;Italy
773	EUCTR2010-018454-13-IT (EUCTR)	15/07/2010	15/06/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND	Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011762	Product Name: Nacystelyn Product Code: NAL INN or Proposed INN: L-Lysine N acetylcysteinate Product Name: Nacystelyn Product Code: NAL INN or Proposed INN: L-Lysine N-acetylcysteinate	LABORATOIRES SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
774	EUCTR2008-005045-34-IE (EUCTR)	09/07/2010	18/05/2010	A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis	A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis	non-CF bronchiectasis (CF = cystic fibrosis) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis	Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution Other descriptive name: colistimethate sodium	Profile Pharma Ltd	NULL	Not Recruiting			Female: yes Male: yes	260		United Kingdom;Ireland
775	EUCTR2009-012997-11-GB (EUCTR)	08/07/2010	21/06/2010	Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6 and Older	An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST	Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	217	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
776	EUCTR2009-012997-11-IE (EUCTR)	06/07/2010	05/05/2010	Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and Older	An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST	Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	217		France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
777	EUCTR2009-016734-26-BG (EUCTR)	01/07/2010	15/06/2010	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Estonia;Lithuania;Bulgaria;Latvia
778	EUCTR2009-012997-11-CZ (EUCTR)	22/06/2010	12/05/2010	Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and Older	An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects with Cystic Fibrosis - PERSIST	Cystic Fibrosis MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	217		France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
779	EUCTR2009-016590-15-GR (EUCTR)	15/06/2010	31/12/2009	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.	Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization	Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	72		France;Hungary;Greece;Poland;Germany;Italy
780	EUCTR2010-018738-27-DE (EUCTR)	02/06/2010	16/03/2010	A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic Fibrosis	A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic Fibrosis	Cystic fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: SB-656933 Tablets Product Code: SB-656933-AAA Product Name: SB-656933 Tablets Product Code: SB-656933-AAA	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	100		Germany
781	NCT01149005 (ClinicalTrials.gov)	June 2010	9/6/2010	Cystic Fibrosis (CF) Exacerbation and Insulin Treatment	Evaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation	Cystic Fibrosis;Impaired Glucose Tolerance;Pulmonary Exacerbation	Drug: novorapid / humalog short acting insulin;Drug: Novo Rapid Insulin (Novonordisk)	Hadassah Medical Organization	NULL	Not yet recruiting	10 Years	N/A	Both	30	N/A	Israel
782	EUCTR2007-001401-15-DK (EUCTR)	21/05/2010	14/04/2010	Treatment of patients with cystic fibrosis with N-acetylcysteine	Treatment of patients with cystic fibrosis with N-acetylcysteine	Patients with cystic fibrosis and chronic Pseudomonas lung infection MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: ACC600Tabs Product Name: N-acetylcystein Product Code: R05C B01 INN or Proposed INN: ACETYLCYSTEINE	Rigshospitalet	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Denmark
783	EUCTR2007-006276-11-IT (EUCTR)	18/05/2010	07/05/2010	A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - ND	A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - ND	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763	Product Name: heparin 25mg inhalation powder, hard capsule Product Code: VR496	VECTURA LIMITED	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 1/2	Ireland;Italy
784	EUCTR2009-016590-15-FR (EUCTR)	15/04/2010	14/12/2009	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.	Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization	Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 3	France;Hungary;Greece;Poland;Germany;Italy
785	NCT01082367 (ClinicalTrials.gov)	April 2010	5/3/2010	Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years	Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients	Drug: TOBI;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	3 Months	6 Years	All	50	Phase 3	Canada;Egypt;France;Germany;Greece;Hungary;Italy;Romania;Russian Federation;Switzerland;Poland;United States
786	NCT01460836 (ClinicalTrials.gov)	April 2010	25/10/2011	Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis	Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis	Cystic Fibrosis	Drug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalation	Novartis Pharmaceuticals	NULL	Completed	6 Years	N/A	Both		N/A	NULL
787	EUCTR2009-016734-26-LT (EUCTR)	23/03/2010	20/01/2010	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Estonia;Lithuania;Bulgaria;Latvia
788	NCT02198079 (ClinicalTrials.gov)	March 2010	21/2/2014	A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida	A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida	Cystic Fibrosis;Pediatrics	Biological: Sputum	University of Miami	University of Florida	Completed	N/A	18 Years	Both	85	N/A	United States
789	EUCTR2009-014412-35-GB (EUCTR)	23/02/2010	01/10/2009	An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A	An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A	Non-cystic fibrosis bronchiectasis MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS	Product Name: Ciprofloxacin for Inhalation Product Code: None assigned INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	96		Germany;United Kingdom
790	EUCTR2009-016734-26-LV (EUCTR)	17/02/2010	11/01/2010	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Bulgaria;Estonia;Latvia;Lithuania
791	NCT00889967 (ClinicalTrials.gov)	February 2010	27/4/2009	Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis ORBIT-1	An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis	Non-Cystic Fibrosis Bronchiectasis	Drug: Ciprofloxacin for Inhalation;Drug: Placebo	Aradigm Corporation	NULL	Completed	18 Years	80 Years	All	95	Phase 2	United States;Canada;Germany;United Kingdom
792	NCT01069705 (ClinicalTrials.gov)	February 2010	15/2/2010	Second Open Label Extension to Bridging Study CTBM100C2303	A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Completed Participation in Study CTBM100C2303E1.	Pulmonary Infections;Pseudomonas Aeruginosa	Drug: Tobramycin inhalation powder	Novartis Pharmaceuticals	NULL	Completed	6 Years	21 Years	All	49	Phase 3	Bulgaria;Estonia;Latvia;Lithuania;Romania;Russian Federation;South Africa
793	EUCTR2009-014412-35-DE (EUCTR)	27/01/2010	09/10/2009	An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A	An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A	Non-cystic fibrosis bronchiectasis MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS	Product Name: Ciprofloxacin for Inhalation Product Code: None assigned INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE	Aradigm Corporation	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 2	Germany;United Kingdom
794	EUCTR2009-013340-36-IT (EUCTR)	25/01/2010	31/12/2009	PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - ND	PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - ND	cystic fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: reparixin INN or Proposed INN: Reparixin	IST. DI RICERCHE FARMACOLOG. M. NEGRI	NULL	Not Recruiting			Female: yes Male: yes			Italy
795	EUCTR2007-004277-26-AT (EUCTR)	21/01/2010	21/04/2009	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	273	Phase 3	Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
796	EUCTR2009-016734-26-EE (EUCTR)	08/01/2010	15/12/2009	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Estonia;Lithuania;Bulgaria;Latvia
797	NCT00996424 (ClinicalTrials.gov)	January 2010	15/10/2009	The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function	The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function.	Cystic Fibrosis	Drug: Acetylcysteine;Drug: normal saline	University Hospital, Ghent	BVSM	Terminated	6 Years	64 Years	Both	19	Phase 4	Belgium
798	NCT01044719 (ClinicalTrials.gov)	January 2010	14/12/2009	Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis	What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa	Cystic Fibrosis	Drug: Ceftazidime;Drug: Tobramycin;Drug: Meropenem	Imperial College London	NULL	Not yet recruiting	16 Years	N/A	Both	240	Phase 4	United Kingdom
799	EUCTR2009-016590-15-HU (EUCTR)	29/12/2009	25/11/2009	A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included	A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.	Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI 300 mg / 5 mL nebuliser solution Product Name: TOBI Product Code: TBM100 INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	50		France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland
800	EUCTR2007-006648-23-IE (EUCTR)	11/12/2009	15/04/2009	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA	Trade Name: Xolair	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 4	Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom
801	EUCTR2009-012575-10-GB (EUCTR)	16/11/2009	11/09/2009	Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF	Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF		Product Name: Ceftazidime INN or Proposed INN: Ceftazidime Other descriptive name: N/A Product Name: Tobramycin INN or Proposed INN: Tobramycin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A	University Hospitals Bristol NHS Foundation Trust	University of Liverpool	Not Recruiting			Female: yes Male: yes	260	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom;Sweden
802	EUCTR2008-008317-20-BE (EUCTR)	13/11/2009	21/09/2009	The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function	The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function	Cystic Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Lysomucil 10 % Product Name: N-acetylcysteine INN or Proposed INN: Acetylcysteine	University Hospital Ghent	NULL	Not Recruiting			Female: yes Male: yes			Belgium
803	NCT01499914 (ClinicalTrials.gov)	November 2009	21/11/2011	Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination	Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1)	Cystic Fibrosis With Gastrointestinal Manifestation	Biological: influenza vaccination	Assistance Publique - Hôpitaux de Paris	NULL	Completed	6 Months	N/A	Both	439	Phase 4	France
804	NCT01018368 (ClinicalTrials.gov)	November 2009	19/11/2009	Study of VX-770 and Rifampin in Healthy Male Subjects	An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects	Cystic Fibrosis	Drug: VX-770;Drug: Rifampin	Vertex Pharmaceuticals Incorporated	NULL	Completed	18 Years	55 Years	Male	24	Phase 1	United States
805	NCT01094704 (ClinicalTrials.gov)	November 2009	19/3/2010	Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis	Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis	Cystic Fibrosis	Drug: sodium chloride (7%)	University of North Carolina, Chapel Hill	Johns Hopkins University;Novartis Pharmaceuticals	Completed	18 Years	N/A	All	16	Phase 1	United States
806	EUCTR2009-009869-34-SE (EUCTR)	12/10/2009	29/07/2009	Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939	Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939	Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis	Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	122		United Kingdom;Germany;Spain;Sweden
807	EUCTR2008-003924-52-NL (EUCTR)	06/10/2009	05/02/2009	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
808	EUCTR2008-007479-26-DE (EUCTR)	25/09/2009	26/06/2009	Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D Mutation	A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION	Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	United States;France;Canada;Ireland;Australia;Germany;United Kingdom
809	EUCTR2006-006215-68-FR (EUCTR)	21/09/2009	06/08/2009	A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA	A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA	cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin	Chiesi Farmaceutici S.p.A	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 3	France;Hungary;Czech Republic;Spain;Germany
810	EUCTR2009-014050-15-BE (EUCTR)	18/09/2009	14/09/2009	Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XL	Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XL	Stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant MedDRA version: 12.0;Level: LLT;Classification code 10025127;Term: Lung transplant	Trade Name: Prograft capsules Product Name: Tacrolimus capsules INN or Proposed INN: TACROLIMUS INN or Proposed INN: TACROLIMUS INN or Proposed INN: TACROLIMUS Trade Name: Advagraf prolonged-release hard capsules Product Name: Tacrolimus prolonged-release hard capsules	Hopital Erasme - Chest service	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium
811	EUCTR2008-007416-15-FR (EUCTR)	14/09/2009	04/06/2009	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - REACH	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - REACH	cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: VX-770 Product Code: VX-770, VRT-813077 Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France;Czech Republic;Ireland;Germany;United Kingdom
812	NCT00803205 (ClinicalTrials.gov)	September 8, 2009	4/12/2008	Study of Ataluren (PTC124™) in Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Cystic Fibrosis	Drug: Ataluren;Drug: Placebo	PTC Therapeutics	Cystic Fibrosis Foundation	Completed	6 Years	N/A	All	238	Phase 3	United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom
813	EUCTR2008-007479-26-FR (EUCTR)	07/09/2009	07/07/2009	A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION	A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION	cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: VX-770 Product Code: VX-770, VRT-813077 Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	France;Ireland;Germany;United Kingdom
814	EUCTR2008-004764-39-LT (EUCTR)	07/09/2009	22/01/2009	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 13.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Bulgaria;Estonia;Latvia;Lithuania
815	EUCTR2008-002318-22-LT (EUCTR)	07/09/2009	22/01/2009	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin Other descriptive name: TBM100C	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Bulgaria;Estonia;Latvia;Lithuania
816	EUCTR2009-009869-34-GB (EUCTR)	02/09/2009	09/04/2009	Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939	Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939	Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis	Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	122		Germany;United Kingdom;Spain;Sweden
817	NCT01710449 (ClinicalTrials.gov)	September 2009	17/10/2012	Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen	Evaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen.	COPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways Diseases	Drug: perfluorinated gas/oxygen mixture	Hal C Charles	NULL	Completed	18 Years	N/A	Both	44	Phase 1	United States
818	NCT01031706 (ClinicalTrials.gov)	September 2009	11/12/2009	Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis	Sustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic Fibrosis	Cystic Fibrosis	Drug: Hypertonic Saline;Drug: Placebo	University of North Carolina, Chapel Hill	National Heart, Lung, and Blood Institute (NHLBI)	Completed	5 Years	12 Years	All	23	N/A	United States
819	EUCTR2008-003924-52-GB (EUCTR)	26/08/2009	09/04/2009	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	208	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
820	EUCTR2008-006446-25-NL (EUCTR)	26/08/2009	10/03/2009	A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101	A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS	Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	90		Germany;Netherlands;Belgium
821	EUCTR2008-004764-39-BG (EUCTR)	20/08/2009	28/08/2009	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Estonia;Bulgaria;Latvia;Lithuania
822	EUCTR2008-002318-22-BG (EUCTR)	20/08/2009	28/08/2009	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Estonia;Bulgaria;Latvia;Lithuania
823	EUCTR2008-003924-52-DE (EUCTR)	17/08/2009	10/07/2009	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom;Sweden
824	EUCTR2008-007416-15-IE (EUCTR)	11/08/2009	14/05/2009	Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D Mutation	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE	Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
825	EUCTR2008-007479-26-IE (EUCTR)	11/08/2009	14/05/2009	Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D Mutation	A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION	Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 3	Germany;United Kingdom;Canada;France;Ireland;United States;Australia
826	EUCTR2008-002740-42-NL (EUCTR)	10/08/2009	25/03/2009	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study	Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: MTT INN or Proposed INN: Mannitol	Pharmaxis Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	300		Germany;Netherlands;Belgium;France
827	EUCTR2007-006648-23-IT (EUCTR)	06/08/2009	22/05/2009	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - ND	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - ND	Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: XOLAIR INN or Proposed INN: Omalizumab	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	60		United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
828	EUCTR2008-007416-15-CZ (EUCTR)	05/08/2009	04/06/2009	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE	cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: VX-770 Product Code: VX-770, VRT-813077 Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France;Czech Republic;Ireland;Germany;United Kingdom
829	NCT00982930 (ClinicalTrials.gov)	August 2009	21/9/2009	Open Label Extension to Bridging Study CTBM100C2303	A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	Pseudomonas Aeruginosa;Cystic Fibrosis	Drug: Tobramycin inhalation powder	Novartis Pharmaceuticals	NULL	Completed	6 Years	21 Years	Both	57	Phase 3	Estonia;Russian Federation
830	EUCTR2008-004764-39-EE (EUCTR)	30/07/2009	23/07/2009	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Bulgaria;Estonia;Latvia;Lithuania
831	EUCTR2008-007416-15-GB (EUCTR)	27/07/2009	22/05/2009	Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D Mutation	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE	Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
832	EUCTR2008-007479-26-GB (EUCTR)	27/07/2009	22/05/2009	Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D Mutation	A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION	Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Ireland;Australia;Germany;United Kingdom
833	EUCTR2008-001156-43-IT (EUCTR)	27/07/2009	28/07/2009	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis	cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: Tiotropium bromide Product Name: Tiotropium Respimat 1.25 micrograms solution for inhalation Product Code: NA INN or Proposed INN: Tiotropium bromide	BOEHRINGER ING.	NULL	Not Recruiting			Female: yes Male: yes	600		Portugal;France;Belgium;Netherlands;Germany;United Kingdom;Italy
834	EUCTR2008-006446-25-BE (EUCTR)	08/07/2009	12/05/2009	A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101	A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS	Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809 Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	90		Germany;Netherlands;Belgium
835	EUCTR2009-009869-34-ES (EUCTR)	03/07/2009	06/05/2009	Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística.	Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística.	Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of greater than or equal to 35 % and less than or equal to 80 percent of predicted) Bronquiectasias idiopática y post-neumónica no debidas a fibrosis quística en pacientes en situación pulmonar estable (definida como mayor o igual al 35% y menor o igual al 80%) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis	Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Spain;Germany;United Kingdom;Sweden
836	NCT00945347 (ClinicalTrials.gov)	July 2009	23/7/2009	Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients ?	Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind Placebo-controlled Study.	Cystic Fibrosis	Drug: Miglustat;Drug: Placebo	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	NULL	Completed	14 Years	N/A	Both	10	Phase 2	Belgium
837	EUCTR2008-003924-52-IT (EUCTR)	26/06/2009	22/06/2009	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009-CF	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009-CF	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: PTC124 Product Name: PTC124 Product Name: PTC124	PTC THERAPEUTICS, INC.	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
838	EUCTR2008-001156-43-PT (EUCTR)	23/06/2009	05/05/2009	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: Tiotropium Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation INN or Proposed INN: Tiotropium	Boehringer Ingelheim Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	596		Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy
839	EUCTR2008-008314-40-DE (EUCTR)	22/06/2009	03/03/2009	Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis	Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis	Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	276		Denmark;Germany;United Kingdom;Sweden
840	EUCTR2008-004764-39-LV (EUCTR)	19/06/2009	08/05/2009	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Bulgaria;Estonia;Latvia;Lithuania
841	EUCTR2008-007877-19-DE (EUCTR)	15/06/2009	28/05/2009	Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot	Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot	subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Colistin CF Product Name: Colistin CF INN or Proposed INN: Colistimethat-Natrium	University of Jena	NULL	Not Recruiting			Female: yes Male: yes	14		Germany
842	EUCTR2008-003924-52-FR (EUCTR)	12/06/2009	17/03/2009	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
843	EUCTR2009-009869-34-DE (EUCTR)	08/06/2009	17/03/2009	Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939	Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939	Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis	Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	122		Spain;Germany;United Kingdom;Sweden
844	EUCTR2007-006648-23-NL (EUCTR)	08/06/2009	03/09/2008	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA	Trade Name: Xolair INN or Proposed INN: omalizumab Other descriptive name: Recombinant humanized monoclonal antibody omalizumab to IgE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60		United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
845	EUCTR2006-003275-12-NO (EUCTR)	03/06/2009	27/03/2009	Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study	Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study	Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Zitromax Product Name: Zitromax Product Code: Zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN	Copenhagen CF-centre	NULL	NA			Female: yes Male: yes	250	Phase 4	Denmark;Norway;Sweden
846	EUCTR2008-008314-40-DK (EUCTR)	02/06/2009	16/04/2009	Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis	Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis	Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	276		United Kingdom;Germany;Denmark;Sweden
847	NCT00918957 (ClinicalTrials.gov)	June 2009	4/6/2009	A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).	Cystic Fibrosis	Drug: Tobramycin Inhalation Powder;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	6 Years	21 Years	All	62	Phase 3	Bulgaria;Egypt;Estonia;India;Latvia;Lithuania;Romania;Russian Federation;South Africa
848	NCT00930982 (ClinicalTrials.gov)	June 2009	30/6/2009	Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis	Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis	Bronchiectasis	Drug: Ciprofloxacin (Cipro, BAYQ3939);Drug: Placebo	Bayer	Novartis	Completed	18 Years	N/A	All	124	Phase 2	United States;Australia;Germany;Spain;Sweden;United Kingdom
849	EUCTR2008-008314-40-GB (EUCTR)	18/05/2009	09/04/2009	Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis	Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis	Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin	Bayer Healthcare AG	NULL	Not Recruiting			Female: yes Male: yes	276		Germany;United Kingdom;Denmark;Sweden
850	EUCTR2008-003924-52-ES (EUCTR)	18/05/2009	09/03/2009	Estudio de fase 3 sobre la eficacia y la seguridad de PTC124 como tratamiento oral para la fibrosis quística mediada por mutación terminadora	Estudio de fase 3 sobre la eficacia y la seguridad de PTC124 como tratamiento oral para la fibrosis quística mediada por mutación terminadora	Fibrosis quística mediada por mutación terminadora MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: no asignado Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: no asignado Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: no asignado Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Belgium;Spain;Germany;Netherlands;Italy;United Kingdom;Sweden
851	EUCTR2008-008314-40-SE (EUCTR)	15/05/2009	25/03/2009	Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis	Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis	Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	276		United Kingdom;Germany;Denmark;Sweden
852	EUCTR2008-006446-25-DE (EUCTR)	14/05/2009	14/04/2009	A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101	A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS	Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809 Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	90		Belgium;Netherlands;Germany
853	EUCTR2008-002318-22-LV (EUCTR)	13/05/2009	28/01/2009	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Bulgaria;Estonia;Latvia;Lithuania
854	ChiCTR-TRC-13003979	2009-05-07	2013-10-28	Application of roxithromycin in patients with bronchiectasis in stable condition	Effect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis	Bronchietasis	Roxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group;	First Affiliated Hospital of Guangxi Medical University	NULL	Completed	18	70	Both	Roxithromycin group:26;Control group:26;		China
855	EUCTR2008-002318-22-EE (EUCTR)	06/05/2009	27/02/2009	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Bulgaria;Estonia;Latvia;Lithuania
856	EUCTR2008-003924-52-BE (EUCTR)	08/04/2009	20/02/2009	Study of ataluren in patients with Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom;Sweden
857	EUCTR2008-003924-52-SE (EUCTR)	08/04/2009	17/12/2008	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844	PTC Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	208	Phase 3	France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
858	EUCTR2007-004277-26-GB (EUCTR)	12/03/2009	08/02/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	273	Phase 3	Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
859	EUCTR2009-009875-37-NL (EUCTR)	11/03/2009	21/01/2009	A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRD	A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRD	Cystic fibrosis-related diabetes MedDRA version: 9.1;Level: HLT;Classification code 10012602;Term: Diabetes mellitus (incl subtypes) MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Metformine HCL 500 PCH	Staf Longziekten	NULL	Not Recruiting			Female: yes Male: yes	25		Netherlands
860	EUCTR2008-002740-42-FR (EUCTR)	11/03/2009	12/03/2009	Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study	Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: MTT INN or Proposed INN: Mannitol	Pharmaxis Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;Belgium;Netherlands;Germany
861	EUCTR2008-001530-27-GB (EUCTR)	11/03/2009	18/04/2008	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	Germany;United Kingdom;Denmark;Sweden
862	EUCTR2007-006648-23-GB (EUCTR)	27/02/2009	09/10/2008	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA	Trade Name: Xolair INN or Proposed INN: Omalizumab	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60		Germany;United Kingdom;Netherlands;Belgium;Ireland;Italy
863	EUCTR2008-002740-42-BE (EUCTR)	13/02/2009	17/11/2008	Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study	Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: MTT INN or Proposed INN: Mannitol	Pharmaxis Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	300		Germany;Netherlands;Belgium;France
864	EUCTR2008-001530-27-DK (EUCTR)	02/02/2009	20/11/2008	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	Germany;United Kingdom;Denmark;Sweden
865	EUCTR2008-008228-34-GB (EUCTR)	28/01/2009	29/07/2010	Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients	Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients	Cystic Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: IDPM: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: MANNITOL	Pharmaxis Ltd	NULL	Not Recruiting			Female: yes Male: yes	18		United Kingdom
866	EUCTR2008-001156-43-NL (EUCTR)	15/01/2009	15/09/2008	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CF	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CF	Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Other descriptive name: TIOTROPIUM Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Other descriptive name: TIOTROPIUM	Boehringer Ingelheim bv	NULL	Not Recruiting			Female: yes Male: yes	596		Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy
867	EUCTR2007-001412-23-GB (EUCTR)	09/01/2009	19/02/2008	Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study	Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study	Cystic Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: IDPM: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: MANNITOL	Pharmaxis Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	340		United Kingdom;Ireland
868	NCT03905642 (ClinicalTrials.gov)	January 8, 2009	2/4/2019	Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase	Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) in Cystic Fibrosis Patients With Chronic Infections Due to Pseudomonas Aeruginosa	Cystic Fibrosis	Drug: Arikayce™	Insmed Incorporated	NULL	Completed	6 Years	N/A	All	49	Phase 2	Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Macedonia, The Former Yugoslav Republic of
869	EUCTR2008-004699-34-ES (EUCTR)	16/12/2008	25/09/2008	A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBER	A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBER	Cystic FibrosisFibrosis quística MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Code: AZD1236	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Netherlands;Spain
870	EUCTR2008-005045-34-GB (EUCTR)	15/12/2008	17/10/2008	A clinical study to investigate the effect and safety of up to 6 months of treatment with inhaled Promixin in the treatment of chest infections causeed by Pseudomonas in people with a lung disease called bronchiectasis	A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis	non-CF bronchiectasis (CF = cystic fibrosis) MedDRA version: 14.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution Other descriptive name: colistimethate sodium	Profile Pharma Ltd	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 3	Ukraine;Ireland;Russian Federation;United Kingdom
871	EUCTR2007-004277-26-PT (EUCTR)	12/12/2008	17/10/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
872	EUCTR2008-002740-42-DE (EUCTR)	13/11/2008	31/07/2008	Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study	Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: MTT INN or Proposed INN: Mannitol	Pharmaxis Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	300		Germany;Netherlands;Belgium;France
873	EUCTR2007-006648-23-DE (EUCTR)	12/11/2008	15/08/2008	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA	Trade Name: Xolair 150 mg Pulver und Injektionslösung zur Herstellung einer Injektionslösung Product Name: Xolair Product Code: IGE025 INN or Proposed INN: Omalizumab	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60		United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
874	EUCTR2007-006276-11-IE (EUCTR)	11/11/2008	11/02/2008	A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in adults with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in adults with Cystic Fibrosis	A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in adults with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in adults with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Heparin 25mg inhalation powder, hard capsule INN or Proposed INN: HEPARIN SODIUM	Vectura Limited	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 1/2	Ireland;Italy
875	NCT00789867 (ClinicalTrials.gov)	November 2008	11/11/2008	Single Dose of pGM169/GL67A in CF Patients	Evaluation of Safety and Gene Expression With a Single Dose of pGM169/GL67A Administered to the Nose and Lung of Individuals With Cystic Fibrosis	Cystic Fibrosis	Drug: pGM169/GL67A	Imperial College London	Royal Brompton & Harefield NHS Foundation Trust;University of Oxford;University of Edinburgh;Cystic Fibrosis Trust;University of Pennsylvania	Completed	16 Years	70 Years	All	35	Phase 1/Phase 2	United Kingdom
876	NCT00809094 (ClinicalTrials.gov)	November 2008	15/12/2008	NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients	A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients	Cystic Fibrosis	Drug: N-acetylcysteine (NAC);Drug: Placebo	Stanford University	Cystic Fibrosis Foundation Therapeutics	Completed	7 Years	N/A	All	70	Phase 2	United States
877	NCT00803179 (ClinicalTrials.gov)	November 2008	4/12/2008	Growth Hormone Therapy for Wasting in Cystic Fibrosis	Growth Hormone Therapy for Wasting in Cystic Fibrosis	Cystic Fibrosis	Drug: Nutropin AQ	University of Massachusetts, Worcester	NULL	Terminated	18 Years	N/A	All	5	Phase 1	United States
878	NCT00800579 (ClinicalTrials.gov)	November 2008	21/11/2008	Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers	A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers	Cystic Fibrosis	Drug: GS-9411;Drug: Placebo	Gilead Sciences	NULL	Completed	18 Years	45 Years	Male	12	Phase 1	Australia
879	NCT01112059 (ClinicalTrials.gov)	November 2008	20/4/2010	Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients	A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations	Cystic Fibrosis	Drug: Doxycycline;Other: placebo	University of Alabama at Birmingham	Cystic Fibrosis Foundation Therapeutics	Completed	19 Years	N/A	All	40	N/A	United States
880	NCT00787917 (ClinicalTrials.gov)	November 2008	7/11/2008	An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)	An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)	Cystic Fibrosis;Allergic Bronchopulmonary Aspergillosis	Drug: Omalizumab;Drug: Placebo;Drug: Itraconazole	Novartis Pharmaceuticals	NULL	Terminated	12 Years	N/A	All	14	Phase 4	Belgium;Germany;Italy;Netherlands;United Kingdom
881	NCT00794586 (ClinicalTrials.gov)	November 2008	18/11/2008	Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection	A Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa	Cystic Fibrosis	Drug: FTI, AZLI;Drug: Placebo, AZLI	Gilead Sciences	NULL	Completed	18 Years	N/A	Both	120	Phase 2	United States
882	NCT00846573 (ClinicalTrials.gov)	November 2008	16/2/2009	Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders	Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders	COPD;Cystic Fibrosis;Asthma;Healthy	Drug: Hyperpolarized Helium-3	University of Massachusetts, Worcester	NULL	Terminated	5 Years	N/A	All	14	N/A	United States
883	EUCTR2008-004699-34-NL (EUCTR)	28/10/2008	29/08/2008	A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis. - CYBER	A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis. - CYBER	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Code: AZD1236	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	Netherlands;Spain
884	EUCTR2008-001156-43-DE (EUCTR)	15/10/2008	18/07/2008	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: tiotropium bromide monohydrate Product Name: Tiotropium Respimat 1.25 microgram, solution for inhalation Product Code: N/A INN or Proposed INN: tiotropium bromide monohydrate	Boehringer Ingelheim Pharma GmbH & Co.KG	NULL	Not Recruiting			Female: yes Male: yes	596		Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom
885	EUCTR2007-004277-26-DE (EUCTR)	14/10/2008	29/05/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	273	Phase 3	Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
886	NCT00934362 (ClinicalTrials.gov)	October 2008	6/7/2009	Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease	A Double Blind, Cross-Over Study Comparing Aerosolized Lucinactant and Vehicle on Mucociliary Clearance for Cystic Fibrosis Lung Disease	Cystic Fibrosis	Drug: Lucinactant first;Drug: Placebo first	University of North Carolina, Chapel Hill	Cystic Fibrosis Foundation Therapeutics;Windtree Therapeutics	Completed	14 Years	N/A	All	16	Phase 2	United States
887	EUCTR2007-006648-23-BE (EUCTR)	30/09/2008	28/08/2008	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis	Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA	Trade Name: Xolair INN or Proposed INN: omalizumab	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	60		United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
888	EUCTR2008-001769-27-GB (EUCTR)	29/09/2008	09/10/2008	Microbiological assessment of prophylactic ciprofloxacin therapy for children with cystic fibrosis during viral respiratory viral infection to prevent Pseudomonas aeruginosa colonisation – a randomised control study (Prevent Pseudomonas Aeruginosa Colonisation- PREPAC) - PREPAC	Microbiological assessment of prophylactic ciprofloxacin therapy for children with cystic fibrosis during viral respiratory viral infection to prevent Pseudomonas aeruginosa colonisation – a randomised control study (Prevent Pseudomonas Aeruginosa Colonisation- PREPAC) - PREPAC	Cystic FibrosisSpecifically the trial will include children aged 2-14 years with a diagnosis of cystic fibrosis and not chronically infected with pseudomonas aeruginosa in their lungs.	Trade Name: Ciproxin Suspension Product Name: Ciproxin Product Code: PL 0010/0211	Southampton University Hospital Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45		United Kingdom
889	EUCTR2008-001156-43-FR (EUCTR)	19/09/2008	13/06/2008	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Other descriptive name: TIOTROPIUM Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Other descriptive name: TIOTROPIUM	Boehringer Ingelheim France	NULL	Not Recruiting			Female: yes Male: yes	596	Phase 2	Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom
890	EUCTR2007-004050-85-GB (EUCTR)	15/09/2008	13/10/2008	Evaluation of safety and gene expression with a single dose of pGM169/GL67A administered to the nose and lung of individuals with cystic fibrosis - Single dose of pGM169/GL67A in CF patients	Evaluation of safety and gene expression with a single dose of pGM169/GL67A administered to the nose and lung of individuals with cystic fibrosis - Single dose of pGM169/GL67A in CF patients	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: pGM169/GL67A Product Code: pGM169/GL67A	Imperial College	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
891	EUCTR2008-001156-43-GB (EUCTR)	11/09/2008	14/10/2008	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Other descriptive name: TIOTROPIUM Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Other descriptive name: TIOTROPIUM	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	596		Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Italy
892	EUCTR2007-006276-11-GB (EUCTR)	01/09/2008	26/11/2007	A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis	A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Heparin 25mg inhalation powder, hard capsule INN or Proposed INN: HEPARIN SODIUM	Vectura Limited	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 1/2	Ireland;Italy;United Kingdom
893	EUCTR2007-004956-35-GB (EUCTR)	27/08/2008	26/11/2007	The effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards	The effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards	Acute exacerbations of chronic obstructive pulmonary disease. Stress hyperglycaemia. Insulin-induced hypoglycaemia. Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10010953;Term: COPD exacerbation MedDRA version: 9.1;Classification code 10060439;Term: Stress induced hyperglycaemia MedDRA version: 9.1;Classification code 10022484;Term: Insulin hypoglycaemia MedDRA version: 9.1;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Actrapid 100 IU/ml, Solution for injection in a vial Trade Name: Levemir 100 U/ml solution for injection in a cartridge, Levemir 100 U/ml solution for injection in a pre-filled pen Trade Name: NovoRapid 100 U/ml, solution for injection in a vial. NovoRapid Penfill 100 U/ml, solution for injection in a cartridge. NovoRapid FlexPen 100 U/ml, solution for injection in a pre-filled pen. Trade Name: Lantus® 100 Units/ml solution for injection in a vial. Lantus® 100 Units/ml solution for injection in a cartridge. Lantus® 100 Units/ml solution for injection in a pre-filled pen	St George's, University of London	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
894	EUCTR2008-001728-30-DE (EUCTR)	26/08/2008	07/05/2008	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients	Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: MP-376 Product Code: MP-376 INN or Proposed INN: levofloxacin	Mpex Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	Netherlands;Germany
895	EUCTR2007-004277-26-ES (EUCTR)	25/08/2008	24/01/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA). MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Portugal;France;Belgium;Spain;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
896	EUCTR2006-006215-68-ES (EUCTR)	22/08/2008	27/06/2008	ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	Infección pulmonar crónica por P. aeruginosa en pacientes con fibrosis quística MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramicina Trade Name: Tobi 300mg/5ml Solución para inhalación por nebulizador. Product Name: Tobi INN or Proposed INN: tobramycin	Chiesi Farmaceutici S.p.A	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 3	France;Hungary;Czech Republic;Spain;Germany
897	EUCTR2007-004507-36-DE (EUCTR)	19/08/2008	19/10/2007	A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects.	A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects.	patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin	Novartis Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes			Germany
898	EUCTR2008-001728-30-NL (EUCTR)	18/08/2008	30/05/2008		A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients -	Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa	Product Name: MP-376 Product Code: MP-376 INN or Proposed INN: levofloxacin	Mpex Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	190	Phase 2	Germany;Netherlands
899	EUCTR2006-006215-68-DE (EUCTR)	14/08/2008	18/12/2008	A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA	A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA	cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin	Chiesi Farmaceutici S.p.A	NULL	Not Recruiting			Female: yes Male: yes	320		France;Hungary;Czech Republic;Spain;Germany
900	EUCTR2006-006215-68-HU (EUCTR)	13/08/2008	25/06/2008	A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA	A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA	cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin	Chiesi Farmaceutici S.p.A	NULL	Not Recruiting			Female: yes Male: yes	320		Hungary;Germany;Czech Republic;France;Spain
901	EUCTR2008-000164-17-DE (EUCTR)	13/08/2008	26/05/2008	Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot	Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot	subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways	Trade Name: Gernebcin 80 mg Product Name: Gernebcin 80 mg INN or Proposed INN: tobramycin	University of Jena	NULL	Not Recruiting			Female: yes Male: yes	14		Germany
902	EUCTR2008-002352-20-BE (EUCTR)	11/08/2008	17/07/2008	Single center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic fibrosis homozygous for the F508del mutation	Single center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic fibrosis homozygous for the F508del mutation	Cystic fibrosis homozygous for the F508del mutation MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Zavesca INN or Proposed INN: miglustat	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes			Belgium
903	EUCTR2008-001530-27-SE (EUCTR)	06/08/2008	17/06/2008	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	Germany;United Kingdom;Denmark;Sweden
904	NCT00744250 (ClinicalTrials.gov)	August 2008	28/8/2008	Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control	Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency	Exocrine Pancreatic Insufficiency;Chronic Pancreatitis;Cystic Fibrosis	Drug: Pancrelipase	Digestive Care, Inc.	University of North Carolina, Chapel Hill	Terminated	18 Years	N/A	Both	3	Phase 4	United States
905	NCT00639626 (ClinicalTrials.gov)	August 2008	14/3/2008	Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)	Use of Levemir® Improves Metabolic and Clinical Status in CFRD	Cystic Fibrosis Related Diabetes	Drug: insulin detemir [rDNA origin] injection	Nationwide Children's Hospital	Novo Nordisk A/S	Terminated	16 Years	45 Years	All	6	Phase 2/Phase 3	United States
906	EUCTR2006-006215-68-CZ (EUCTR)	29/07/2008	16/06/2008	A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA	A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA	cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin	Chiesi Farmaceutici S.p.A	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 3	France;Hungary;Czech Republic;Spain;Germany
907	EUCTR2007-004063-21-NL (EUCTR)	24/07/2008	31/10/2007	An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency. - N/A	An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency. - N/A	Cystic fibrosis and pancreatic insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: rhBSSL Product Code: rhBSSL INN or Proposed INN: Bucelipase alfa Trade Name: Nexium 20 Product Name: Nexium INN or Proposed INN: Esomeprazole	Biovitrum AB	NULL	Not Recruiting			Female: yes Male: yes	18		Netherlands
908	EUCTR2008-001156-43-BE (EUCTR)	22/07/2008	16/06/2008	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.	Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Other descriptive name: TIOTROPIUM Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Other descriptive name: TIOTROPIUM	SCS Boehringer Ingelheim Comm.V	NULL	Not Recruiting			Female: yes Male: yes	596		Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy
909	EUCTR2006-006693-24-CZ (EUCTR)	16/07/2008	09/05/2007	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	160		Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
910	EUCTR2008-001530-27-DE (EUCTR)	08/07/2008	26/05/2008	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis	A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 2	United Kingdom;Germany;Denmark;Sweden
911	EUCTR2007-006204-37-GB (EUCTR)	03/07/2008	09/05/2008	Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CF	Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CF	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Glutamine Product Code: none Other descriptive name: L-Glutamine	University of Nottingham	NULL	Not Recruiting			Female: yes Male: yes	44	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
912	NCT00706004 (ClinicalTrials.gov)	July 2008	25/6/2008	Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis	Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis	Constipation;Cystic Fibrosis	Drug: lubiprostone	University of Arkansas	Takeda Pharmaceuticals North America, Inc.	Completed	18 Years	N/A	All	9	N/A	United States
913	EUCTR2007-004277-26-IE (EUCTR)	19/06/2008	27/02/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
914	EUCTR2007-004277-26-NL (EUCTR)	10/06/2008	29/05/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
915	EUCTR2005-003772-37-GR (EUCTR)	03/06/2008	21/01/2008	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE II	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE II	Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762	Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom
916	NCT00411736 (ClinicalTrials.gov)	May 2008	14/12/2006	Scandinavian Cystic Fibrosis Azithromycin Study	Supplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study.	Cystic Fibrosis	Drug: Study medication, azithromycin or placebo;Drug: Azithromycin or placebo tablets	Rigshospitalet, Denmark	Cystic Fibrosis Foundation Therapeutics	Completed	1 Year	N/A	Both	45	Phase 4	Denmark;Norway;Sweden
917	NCT00645788 (ClinicalTrials.gov)	May 2008	26/3/2008	Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis	Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939);Drug: Placebo	Bayer	Novartis	Completed	12 Years	N/A	All	288	Phase 2	United States;Australia;Canada;Denmark;Germany;Israel;Norway;Sweden;United Kingdom
918	EUCTR2007-004277-26-FR (EUCTR)	30/04/2008	21/01/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
919	EUCTR2007-004277-26-BE (EUCTR)	29/04/2008	20/12/2007	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	273	Phase 3	Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
920	EUCTR2007-004277-26-IT (EUCTR)	23/04/2008	17/06/2008	An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND	An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: aztreonan lysine Product Code: AZLI INN or Proposed INN: Aztreonam Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
921	EUCTR2007-004277-26-DK (EUCTR)	16/04/2008	12/03/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Not Recruiting			Female: yes Male: yes	273	Phase 3	Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
922	NCT00700050 (ClinicalTrials.gov)	April 2008	16/6/2008	Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways	Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot Study	Cystic Fibrosis	Drug: Hypertonic saline	The Hospital for Sick Children	Unity Health Toronto	Active, not recruiting	14 Years	28 Years	All	80		Canada
923	NCT01323101 (ClinicalTrials.gov)	April 2008	15/2/2011	Doxycycline Effects on Inflammation in Cystic Fibrosis	Effect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis.	Cystic Fibrosis	Drug: Doxycycline;Other: No doxycycline	University of Southern California	NULL	Completed	18 Years	N/A	All	21	Phase 4	United States
924	NCT00635141 (ClinicalTrials.gov)	March 2008	4/3/2008	The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis	The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis	Cystic Fibrosis	Drug: hypertonic saline (7 %) and isotonic saline (0.9%)	The Hospital for Sick Children	Canadian Cystic Fibrosis Foundation	Completed	6 Years	18 Years	Both	20	Phase 3	Canada
925	NCT00762918 (ClinicalTrials.gov)	March 2008	26/9/2008	Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis	Vitamin D and Its Non-Classic Roles in Cystic Fibrosis	Cystic Fibrosis;Vitamin D Deficiency	Dietary Supplement: cholecalciferol	Children's Hospital of Philadelphia	NULL	Withdrawn	10 Years	25 Years	Both	0	Phase 3	United States
926	EUCTR2007-004004-12-BG (EUCTR)	28/02/2008	05/02/2008	A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY	A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY	Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc. MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy	Trade Name: Creon 10000 Product Name: Pancrelipase Delayed Release Capsule Other descriptive name: Pancrelipase/Pancreas Powder Trade Name: Creon 25000 Product Name: Pancrelipase Delayed Release Capsule Other descriptive name: Pancrelipase/Pancreas Powder	Solvay Pharmaceuticals GmbH	NULL	Not Recruiting			Female: yes Male: yes	52		Bulgaria
927	NCT00634192 (ClinicalTrials.gov)	February 2008	4/3/2008	Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin	A Multicenter, Open Label, 2 Period Cross-over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis (CF) Subjects	Pseudomonas Infections	Drug: tobramycin	Novartis	NULL	Completed	6 Years	N/A	All	50	Phase 3	Germany
928	EUCTR2006-006693-24-IT (EUCTR)	31/01/2008	12/11/2007	A randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND	A randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND	Cystic fibrosis MedDRA version: 6.1;Level: PT;Classification code 10011763	Product Name: DURAMYCIN Product Code: MOLI 1901	AOP ORPHAN PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes	160		Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
929	EUCTR2006-006693-24-ES (EUCTR)	21/01/2008	14/09/2007	Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y la seguridad de Moli1901 aerosol en adolescentes (12 años de edad o más) y adultos con fibrosis quística - MOLI	Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y la seguridad de Moli1901 aerosol en adolescentes (12 años de edad o más) y adultos con fibrosis quística - MOLI	La FQ es la enfermedad hereditaria mortal más frecuente en la población caucásica, afectando a unos 4 de cada 10.000 niños. En la fibrosis quística, el transporte de cloro a través del epitelio respiratorio es deficiente, de manera que la mucosidad contiene menos agua y su viscosidad está aumentada de manera anormal. Se puede suponer que Moli1901 corrige el transporte anormal de cloro y agua en los pulmones y de ese modo reduce la formación de tapones de mucosidad y aumenta el aclaramiento. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2;Phase 3	France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
930	EUCTR2007-000171-41-IT (EUCTR)	31/12/2007	07/01/2008	A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND	A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND	Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic	Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTUS-135 Product Code: ALTUS-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.)	ALTUS PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 3	Italy
931	EUCTR2007-000178-21-IT (EUCTR)	31/12/2007	07/01/2008	An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND	An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND	Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic	Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.)	ALTUS PHARMACEUTICALS INC	NULL	Not Recruiting			Female: yes Male: yes	200		Italy
932	EUCTR2007-005346-20-GB (EUCTR)	04/12/2007	28/11/2007	Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF	Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF	Children with cystic fibrosis	Trade Name: Tobi 300 mg/5 ml Nebuliser Solution Product Name: TOBI INN or Proposed INN: tobramycin	Leeds Teaching Hospitals NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	30		United Kingdom
933	NCT00484263 (ClinicalTrials.gov)	December 2007	7/6/2007	The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis	The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.	Bronchiectasis	Drug: Hypertonic saline 6% -	The Alfred	NULL	Completed	18 Years	N/A	Both	40	Phase 3	Australia
934	EUCTR2007-003628-39-IT (EUCTR)	22/11/2007	08/04/2008	Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND	Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND	Rhinosinusal infection by Pseudomonas a. e/o Staphylococcus a. in patients with Cystic Fibrosis MedDRA version: 9.1;Level: HLGT;Classification code 10024970;Term: Respiratory tract infections	Product Code: TNSE INN or Proposed INN: TOBRAMYCIN	ECUPHARMA S.R.L.	NULL	Not Recruiting			Female: yes Male: yes			Italy
935	EUCTR2005-003772-37-HU (EUCTR)	08/11/2007	03/07/2007	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003	Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762	Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Germany;United Kingdom;Spain;Italy;Greece
936	NCT00537602 (ClinicalTrials.gov)	November 2007	28/9/2007	Miglustat / OGT 918 in the Treatment of Cystic Fibrosis	Single Center, Double-blind, Randomized, Placebo-controlled, 2-period/2-treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the ?F508 Mutation	Cystic Fibrosis	Drug: miglustat;Drug: placebo	Actelion	NULL	Terminated	12 Years	N/A	Both	6	Phase 2	Spain
937	NCT00510484 (ClinicalTrials.gov)	November 2007	1/8/2007	Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis	A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis	Cystic Fibrosis	Drug: Pancrelipase Delayed Release;Drug: Placebo Comparator	Solvay Pharmaceuticals	NULL	Completed	12 Years	N/A	All	35	Phase 3	United States;Hungary;Israel;South Africa;Spain
938	EUCTR2007-002912-24-DE (EUCTR)	30/10/2007	05/09/2007	Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years	Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years	long term treatment of chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Ciprofloxacin Product Code: BAY q 3939 INN or Proposed INN: CIPROFLOXACIN Other descriptive name: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[1-piperazinyl]-3-quinoline carboxylic acid	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	16		Germany
939	EUCTR2007-002657-23-DE (EUCTR)	01/10/2007	09/07/2007	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects with Genotype G551D	A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects with Genotype G551D	cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: NA Other descriptive name: VRT-813077 Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: NA Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Germany
940	EUCTR2007-001412-23-IE (EUCTR)	27/09/2007	11/07/2007	Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study	Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol	Pharmaxis Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	250		United Kingdom;Ireland
941	EUCTR2007-000724-40-BE (EUCTR)	27/09/2007	27/04/2007	A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Code: PTC124	PTC Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Belgium
942	EUCTR2006-006693-24-DE (EUCTR)	29/08/2007	29/05/2007	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2;Phase 3	France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
943	EUCTR2006-006693-24-FR (EUCTR)	23/08/2007	16/05/2007	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In Cystic Fibrosis chloride transport accross the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli 1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.	Product Name: Moli 1901 (2622U90, duramycin) Product Code: Moli 1901	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2;Phase 3	France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
944	EUCTR2006-006693-24-SE (EUCTR)	16/08/2007	02/07/2007	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	160		Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
945	EUCTR2007-000959-33-DE (EUCTR)	16/08/2007	04/04/2007	Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF	Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF	Cystic Fibrosis with Pseudomonas aeruginosa infection	Product Name: Tobramycin 100 PARI Product Code: T100 PARI INN or Proposed INN: Tobramycin Trade Name: TOBI® INN or Proposed INN: Tobramycin	PARI GmbH	NULL	Not Recruiting			Female: yes Male: yes	25		Germany
946	NCT01018303 (ClinicalTrials.gov)	August 2007	19/11/2009	Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic Fibrosis	Safety and Efficacy of a Novel Antioxidant-rich Multivitamin Supplement for Persons With Cystic Fibrosis	Cystic Fibrosis	Dietary Supplement: AquADEK	University of Colorado, Denver	Cystic Fibrosis Foundation Therapeutics;Yasoo Health;National Institutes of Health (NIH)	Completed	10 Years	40 Years	Both	17	Phase 1/Phase 2	United States
947	EUCTR2006-006693-24-HU (EUCTR)	27/07/2007	18/06/2007	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	160		Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
948	EUCTR2006-002049-35-ES (EUCTR)	22/07/2007	28/05/2007	Estudio unicéntrico, a doble ciego, aleatorizado y controlado con placebo, cruzado de 2 brazos, para investigar el efecto de miglustat sobre la diferencia de potencial nasal en pacientes con fibrosis quística homocigotos para la mutación ?F508	Estudio unicéntrico, a doble ciego, aleatorizado y controlado con placebo, cruzado de 2 brazos, para investigar el efecto de miglustat sobre la diferencia de potencial nasal en pacientes con fibrosis quística homocigotos para la mutación ?F508	fibrosis quística MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Zavesca Product Name: miglustat Product Code: OGT 918 INN or Proposed INN: Miglustat Other descriptive name: 1,5 (Butylimino)-1,5-dideoxy-D-glucitol	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 2	Spain
949	EUCTR2007-000171-41-SK (EUCTR)	16/07/2007	10/04/2008	A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency	A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency	Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic	Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease	Altus Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	176	Phase 3	Slovakia;Italy
950	EUCTR2007-000178-21-SK (EUCTR)	16/07/2007	10/04/2008	An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency	An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency	Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas	Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease	Altus Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Slovakia;Italy
951	NCT00506792 (ClinicalTrials.gov)	July 2007	22/7/2007	Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis	A Two-part, Randomized, Double-blind, Placebo-controlled, Ascending Single-dose, Adaptive Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAU145 Administered Via a Nasal Spray Pump to Patients With Cystic Fibrosis	Cystic Fibrosis	Drug: QAU145;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	50 Years	Both	9	Phase 2	United States
952	NCT00506688 (ClinicalTrials.gov)	July 2007	24/7/2007	Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients	Randomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis Patients	Cystic Fibrosis	Drug: reduced glutathione sodium salt;Drug: 0.9% normal saline (control)	Mukoviszidose Institut gGmbH	Cystic Fibrosis Foundation Therapeutics	Completed	8 Years	N/A	Both	153	Phase 2	Germany
953	NCT01293084 (ClinicalTrials.gov)	July 2007	9/2/2011	Hypertonic Saline and Mucociliary Clearance in Children	Acute Inhalation of Hypertonic Saline Does Not Improve Mucociliary Clearance in All Children With Cystic Fibrosis	Cystic Fibrosis	Drug: 0.12% saline;Drug: 7% saline	Johns Hopkins University	Cystic Fibrosis Foundation Therapeutics	Completed	7 Years	12 Years	All	17	Phase 2	NULL
954	EUCTR2007-002707-40-BE (EUCTR)	28/06/2007	04/06/2007	The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients	The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients	Mucoviscidose MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Hypertonic saline solution INN or Proposed INN: Sodium Chloride Product Name: Normal saline solution INN or Proposed INN: Sodium Chloride	University Hospital Ghent	NULL	Not Recruiting			Female: yes Male: yes	60		Belgium
955	EUCTR2006-006980-22-BE (EUCTR)	27/06/2007	19/07/2007	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin sulfate	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60		Hungary;Belgium
956	EUCTR2006-006980-22-HU (EUCTR)	14/06/2007	03/04/2007	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Liposomal Amikacin (Arikace™)	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60		Hungary;Belgium
957	EUCTR2006-003275-12-DK (EUCTR)	23/05/2007	17/04/2007	Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study	Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study	Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN	Copenhagen CF-centre	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Denmark
958	EUCTR2006-006980-22-SK (EUCTR)	17/05/2007	23/04/2007	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Liposomal Amikacin (Arikace™)	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Hungary;Slovakia;Poland;Belgium
959	EUCTR2006-006693-24-AT (EUCTR)	09/05/2007	11/01/2007	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	160		Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
960	EUCTR2006-006362-41-GB (EUCTR)	05/04/2007	28/03/2007	An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CF	An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CF	Adult patients with cystic fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Vfend Product Name: Vfend INN or Proposed INN: VORICONAZOLE	Leeds Teaching Hospital NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	12	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
961	NCT00458341 (ClinicalTrials.gov)	March 23, 2007	6/4/2007	A Study of Ataluren in Pediatric Participants With Cystic Fibrosis	A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Cystic Fibrosis	Drug: Ataluren	PTC Therapeutics	NULL	Completed	6 Years	18 Years	All	30	Phase 2	Belgium;France;Israel
962	EUCTR2006-004078-28-GB (EUCTR)	14/03/2007	15/02/2012	Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study	Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study	Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders	Product Name: IDPM: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: MANNITOL	Pharmaxis UK Limited	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United Kingdom
963	NCT00777296 (ClinicalTrials.gov)	February 22, 2007	15/10/2008	Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)	Phase 2a Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) In Cystic Fibrosis Patients With Chronic Infections Due To Pseudomonas Aeruginosa.	Cystic Fibrosis	Drug: ARIKACE™;Drug: Placebo	Insmed Incorporated	NULL	Completed	6 Years	N/A	All	66	Phase 1/Phase 2	Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Bulgaria;Macedonia, The Former Yugoslav Republic of
964	NCT00431964 (ClinicalTrials.gov)	February 2007	2/2/2007	Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa	Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa	Cystic Fibrosis	Drug: azithromycin 250 mg tablets;Drug: placebo tablets	CF Therapeutics Development Network Coordinating Center	Cystic Fibrosis Foundation Therapeutics	Completed	6 Years	18 Years	All	263	Phase 4	United States;Canada
965	EUCTR2006-005180-25-DE (EUCTR)	15/12/2006	31/10/2006	A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design	A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design	Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study. MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Code: LU 70274	Nordmark Arzneimittel GmbH	NULL	Not Recruiting			Female: no Male: yes	20		Germany
966	NCT00351078 (ClinicalTrials.gov)	December 2006	11/7/2006	PTC124 for the Treatment of Cystic Fibrosis	A Phase 2b Extension Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Cystic Fibrosis	Drug: PTC124	PTC Therapeutics	NULL	Completed	18 Years	N/A	All	19	Phase 2	Israel
967	EUCTR2006-001254-27-FR (EUCTR)	30/11/2006	25/08/2006	Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus	Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus	Patients atteints de mucoviscidose, chez lesquels un diagnostic de diabète a été fait par hyperglycémie provoquée orale (HGPO) MedDRA version: 8.1;Level: PT;Classification code 10012594;Term: DIABETES	Trade Name: NovoNorm 0.5 mg Product Name: NovoNorm 0.5 mg INN or Proposed INN: Répaglinide Trade Name: Actrapid Penfill 100UI/ml Product Name: Actrapid Penfill 100UI/ml INN or Proposed INN: Insuline humaine recombinante Trade Name: NovoNorm 1 mg Product Name: NovoNorm 1 mg INN or Proposed INN: Répaglinide Trade Name: NovoNorm 2 mg Product Name: NovoNorm 2 mg INN or Proposed INN: Répaglinide	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
968	NCT00408317 (ClinicalTrials.gov)	November 2006	4/12/2006	Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)	A Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of Ultrase® MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF)	Cystic Fibrosis;Exocrine Pancreatic Insufficiency	Drug: Ultrase® MT20;Drug: Placebo	Forest Laboratories	NULL	Completed	7 Years	N/A	All	36	Phase 3	United States
969	NCT00763412 (ClinicalTrials.gov)	November 2006	29/9/2008	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Cystic Fibrosis Related Diabetes;Pancreatic Insufficiency	Drug: placebo;Drug: repaglinide	Arbelaez, Ana Maria	Washington University School of Medicine;National Institutes of Health (NIH);Novo Nordisk A/S;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	12 Years	24 Years	All	31	N/A	United States
970	NCT00405665 (ClinicalTrials.gov)	November 2006	28/11/2006	The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis	Pilot Study of the Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis	Cystic Fibrosis	Drug: L-arginine	The Hospital for Sick Children	NULL	Completed	14 Years	N/A	Both	20	Phase 2	Canada
971	NCT00450073 (ClinicalTrials.gov)	November 2006	19/3/2007	Improving Vitamin D Status In Cystic Fibrosis	Desktop Tanning Unit to Improve Vitamin D Status in Patients With Cystic Fibrosis and Short Bowel Syndrome: A Pilot Study	Cystic Fibrosis	Drug: ergocalciferol (vitamin D2);Device: Sperti Del Sol Lamp;Drug: Vitamin D3	Atlanta VA Medical Center	Emory University	Completed	18 Years	60 Years	All	30	N/A	United States
972	EUCTR2005-005594-29-HU (EUCTR)	31/10/2006	19/06/2006	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic Fibrosis	Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2;Phase 3	Czech Republic;Hungary;Slovakia
973	EUCTR2005-003870-88-DE (EUCTR)	20/10/2006	28/08/2006	Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4	Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4	Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction.	Product Name: GSH (Glutathione) Product Code: TAD 600 INN or Proposed INN: Glutathione Other descriptive name: reduced glutathione	Mukoviszidose Institut gGmbH i. G.	NULL	Not Recruiting			Female: yes Male: yes	160		Germany
974	EUCTR2006-002259-33-DE (EUCTR)	10/10/2006	11/07/2006	Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study -	Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study -	CF-patients develop a chronic pulmonary infection with Pseudomonas aeruginosa (P. aeruginosa). At present it is unknown why CF-patients are highly sensitive to P. aeruginosa infections and, most important, no curative treatment for cystic fibrosis is available. This Study should provide a novel anti-inflammatory treatment for cystic fibrosis, which reduces pulmonary complications, progression of the disease and may possibly increase the life-expectance of the patients.	Trade Name: Amitriptylin-ct Tabletten Product Name: Amitriptyline INN or Proposed INN: AMITRIPTYLINE Trade Name: Amitriptylin-ct Tabletten Product Name: Amitriptyline INN or Proposed INN: AMITRIPTYLINE Trade Name: Amitriptylin-ct Tabletten Product Name: Amitriptyline INN or Proposed INN: AMITRIPTYLINE	Paediatrisches Sekretariat fuer Klinische Studien	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 2	Germany
975	EUCTR2005-005594-29-CZ (EUCTR)	04/10/2006	02/08/2006	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic Fibrosis	Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2;Phase 3	Hungary;Czech Republic;Slovakia
976	NCT00671723 (ClinicalTrials.gov)	October 2006	30/4/2008	Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients	Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis	Atelectasis	Drug: Normal saline:;Drug: Hypertonic Saline;Drug: Dornase alpha	University of Oklahoma	NULL	Completed	18 Years	90 Years	All	33	N/A	United States
977	NCT01463371 (ClinicalTrials.gov)	October 2006	28/10/2011	Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis	Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis	Bronchiectasis	Drug: Azithromycin	Instituto de Investigacion Sanitaria La Fe	Sociedad Valenciana de Neumología	Completed	16 Years	80 Years	Both	30	N/A	Spain
978	EUCTR2005-005594-29-SK (EUCTR)	14/09/2006	11/08/2006	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic Fibrosis	Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2;Phase 3	Czech Republic;Hungary;Slovakia
979	EUCTR2006-000945-20-GB (EUCTR)	22/08/2006	18/09/2006	To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis - Vitamin K supplementation in Cystic Fibrosis	To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis - Vitamin K supplementation in Cystic Fibrosis	Cystic Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Trade Name: Menadiol Diphosphate Product Name: Menadiol Diphosphate Product Code: Menadiol Diphosphate INN or Proposed INN: Menadiol sodium diphosphate	Barts and the London NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United Kingdom
980	EUCTR2005-002997-31-GB (EUCTR)	10/08/2006	09/11/2005	A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes	A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes	Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes.	Product Name: Levemir Penfill	Sheffield Children's NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
981	EUCTR2005-004344-30-HU (EUCTR)	10/05/2006	23/12/2005	An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease	An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.	Product Name: Moli1901 (2622U90, duramycin) Product Code: EU Orphan Designation Number EU/3/02/120 Other descriptive name: Duramycin, 2622U90	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	18		Hungary
982	EUCTR2005-004103-10-DE (EUCTR)	03/05/2006	30/01/2006	Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections	Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections	Cystic Fibrosis with Pseudomoas aeuriginosa infection MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Tobramycin 100 PARI Product Code: T100 PARI INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: TOBI® INN or Proposed INN: Tobramycin	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60		Germany
983	NCT00399945 (ClinicalTrials.gov)	May 2006	14/11/2006	Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study	A Phase 1, Single-Dose, Open-Label, Two-Way Crossover, Pharmacoscintigraphy Study of Aerosol Delivery Characteristics (Measured by In Vivo Lung Deposition, Nebulization Time, Serum Tobramycin Concentrations, and Pharmacokinetic Parameters) and Safety of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (No Compressor) vs. PARI LC PLUS (TM) Jet Nebulizer (With Compressor) in Healthy Subjects and in Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: Tobramycin	Novartis	NULL	Completed	18 Years	65 Years	Both	12	Phase 1	United Kingdom
984	NCT00420836 (ClinicalTrials.gov)	April 2006	10/1/2007	Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study	Crossover Pharmacokinetic Study of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (no Compressor) vs. PARI LC PLUSTM Jet Nebulizer (With Compressor) in Cystic Fibrosis Subjects	Cystic Fibrosis	Drug: Tobramycin	Novartis	NULL	Completed	6 Years	N/A	Both	20	Phase 1	NULL
985	EUCTR2005-003772-37-IT (EUCTR)	28/02/2006	23/06/2006	A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003	A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003	Cystic Fibrosis with presence of Pseudomonas aeruginosa infection MedDRA version: 6.1;Level: PT;Classification code 10011763	INN or Proposed INN: Tobramycin Product Name: Tobramycin Inhalation Powder TIP delivered by the T-326 Inhaler Product Code: T-326 INN or Proposed INN: Tobramycin	CHIRON CORPORATION LIMITED	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Germany;United Kingdom;Spain;Italy;Greece
986	EUCTR2005-003772-37-ES (EUCTR)	09/02/2006	20/01/2006	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística.	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística.	Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762	Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycin Trade Name: TOBI 300mg/5mL Nebuliser Solution Product Name: TOBI INN or Proposed INN: Tobramycin	Chiron Corporation Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Greece;Spain;Germany;Italy;United Kingdom
987	NCT00298922 (ClinicalTrials.gov)	February 2006	2/3/2006	Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex	Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Azithromycin in Patients With CF, Chronically Infected With Burkholderia Cepacia Complex	Cystic Fibrosis	Drug: Azithromycin;Drug: Placebo	St. Michael's Hospital, Toronto	Cystic Fibrosis Foundation Therapeutics;Pfizer	Active, not recruiting	19 Years	N/A	Both	45	Phase 2	Canada
988	NCT00388505 (ClinicalTrials.gov)	February 2006	16/10/2006	Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis	A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects	Cystic Fibrosis	Drug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for Inhalation	Novartis Pharmaceuticals	NULL	Completed	6 Years	N/A	All	517	Phase 3	United States;Australia;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom
989	EUCTR2005-003772-37-GB (EUCTR)	06/01/2006	09/11/2005	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003	Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762	Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Greece;Spain;Germany;Italy;United Kingdom
990	EUCTR2005-004389-17-HU (EUCTR)	28/12/2005	24/10/2005	SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA	SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA	Cystic Fibrosis with mild to moderate obstructive lung disease and chronic infection with Pseudomonas aeruginosa	Product Name: SLIT Amikacin Product Code: TR02 INN or Proposed INN: amikacin Other descriptive name: amikin, amiklin, amicacin, BB-K8, Biklin, Fabianol, Kaminax, Mikavir, Novamin, Pierami	Transave, Inc	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 2	Hungary
991	EUCTR2005-004899-21-BE (EUCTR)	22/12/2005	12/01/2006	Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA	Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA	Cystic Fibrosis	Product Name: SLIT(TM) Amikacin Product Code: TR02 INN or Proposed INN: Amikacin Other descriptive name: amikin®, amiklin, amicacin, BB-K8, Biklin®, Fabianol®, Kaminax, Mikavir, Novamin®, Pierami	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	15		Belgium
992	NCT00237380 (ClinicalTrials.gov)	November 30, 2005	7/10/2005	Safety and Efficacy of Ataluren (PTC124) for Cystic Fibrosis	A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Cystic Fibrosis	Drug: Ataluren	PTC Therapeutics	NULL	Completed	18 Years	N/A	All	24	Phase 2	Israel
993	EUCTR2005-000311-98-GB (EUCTR)	09/11/2005	14/09/2005	A randomised controlled trial (pilot study) of the use of macerated garlic oil in patients with cystic fibrosis who have pulmonary infection with Pseudomonas aeruginosa - GAP pilot study	A randomised controlled trial (pilot study) of the use of macerated garlic oil in patients with cystic fibrosis who have pulmonary infection with Pseudomonas aeruginosa - GAP pilot study	Chronic pulmonary infection with Pseudomonas aeruginosa in patients with cystic fibrosis	Product Name: Boots High Strength Garlic Odour Controlled Product Code: SE10599	University of Nottingham	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
994	NCT00117208 (ClinicalTrials.gov)	November 2005	30/6/2005	Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis	A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis	Cystic Fibrosis	Drug: mannitol;Drug: mannitol + pulmozyme;Drug: Dornase alpha	Pharmaxis	NULL	Completed	8 Years	18 Years	Both	20	Phase 2	United Kingdom
995	EUCTR2005-004344-30-AT (EUCTR)	31/10/2005	26/09/2005	An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease	An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.	Product Name: Moli1901 (2622U90, duramycin) Product Code: EU Orphan Designation Number EU/3/02/120 Other descriptive name: Duramycin, 2622U90	AOP Orphan Pharmaceuticals AG	NULL	Not Recruiting			Female: yes Male: yes	18		Hungary;Austria
996	EUCTR2004-003675-36-BE (EUCTR)	27/10/2005	13/10/2005	A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection	A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection	Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.	Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Trade Name: TOBI 300 mg/5 ml Nebuliser Solution Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI®	Forest Laboratories UK Ltd	NULL	Not Recruiting			Female: yes Male: yes	360		Denmark;Belgium
997	EUCTR2005-003837-42-GB (EUCTR)	26/09/2005	24/08/2005	CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis	CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis	infection - ciprofloxacin is used to treat various infections, for example respiratory tract infections, ear, nose and throat infections, eye infections, urinary tract infections. The main indication that is relevant to this application is its use in the treatment of chest infections in patients with cystic fibrosis. I have included the ICD classification for chest infection below.	Trade Name: Ciprofloxacin (ciproxin) Product Name: N/A Product Code: N/A	Belfast City Hospital Trust	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
998	EUCTR2005-002035-28-LT (EUCTR)	19/09/2005	24/08/2005	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects	pulmonary P aeruginosa infection in patient with cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycine	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Lithuania
999	NCT00125346 (ClinicalTrials.gov)	September 2005	28/7/2005	Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects	Cystic Fibrosis	Drug: Tobramycin Inhalation Powder	Novartis	NULL	Terminated	6 Years	21 Years	Both	98	Phase 3	United States;Argentina;Brazil;Bulgaria;Canada;Chile;Lithuania;Mexico;Former Serbia and Montenegro
1000	NCT00234663 (ClinicalTrials.gov)	September 2005	5/10/2005	PTC124 for Cystic Fibrosis	A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis	Cystic Fibrosis	Drug: PTC124	PTC Therapeutics	Cystic Fibrosis Foundation Therapeutics;FDA Office of Orphan Products Development	Completed	18 Years	N/A	Both	24	Phase 2	United States
1001	EUCTR2004-002341-12-BE (EUCTR)	05/08/2005	25/08/2005	Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients	Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients	Cystic fibrosis MedDRA version: 7.0;Level: PT;Classification code 10011762	Product Name: Depelestat Product Code: EPI-hNE4 DX-890 INN or Proposed INN: Depelestat Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase INN or Proposed INN: Depelestat Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase	Debiopharm SA	NULL	Not Recruiting			Female: yes Male: yes	90		United Kingdom;Germany;Belgium;Italy
1002	NCT00687466 (ClinicalTrials.gov)	August 2005	27/5/2008	Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay	Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay	Cystic Fibrosis;Glucose Intolerance	Drug: Insulin	Fondazione per la ricerca sulla Fibrosi Cistica	NULL	Active, not recruiting	10 Years	70 Years	Both	70	Phase 3	Italy
1003	EUCTR2005-002135-27-IT (EUCTR)	06/07/2005	28/06/2005	Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration	Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration	Cystic Fibrosis patients with glucose intolerance MedDRA version: 6.1;Level: PT;Classification code 10011762	Trade Name: LANTUS*SC 5CAR3ML100UI/ML Product Name: NA Product Code: NA INN or Proposed INN: Insulin glargine	ISTITUTO GIANNINA GASLINI	NULL	Not Recruiting			Female: yes Male: yes			Italy
1004	EUCTR2004-005019-28-GB (EUCTR)	09/05/2005	19/04/2005	Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose	Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose	Cystic fibrosis related diabetes mellitus	Trade Name: NovoRapid Aspartate INN or Proposed INN: Novo Rapid Trade Name: Rapeglinide INN or Proposed INN: Rapeglinide	Papworth Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	6	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
1005	EUCTR2004-003675-36-DK (EUCTR)	28/04/2005	06/12/2004	A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection	A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection	Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.	Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI®	Forest Laboratories UK Ltd	NULL	Not Recruiting			Female: yes Male: yes	360		Belgium;Denmark
1006	EUCTR2004-003675-36-AT (EUCTR)	19/04/2005	15/03/2005	A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection	A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection	Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.	Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Trade Name: TOBI 300 mg/5 ml Nebuliser Solution Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI®	Forest Laboratories UK Ltd	NULL	Not Recruiting			Female: yes Male: yes	360		Belgium;Denmark;Austria
1007	EUCTR2004-002341-12-GB (EUCTR)	15/04/2005	10/02/2005	Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients	Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients	Cystic fibrosis MedDRA version: 7.0;Level: PT;Classification code 10011762	Product Name: Depelestat Product Code: EPI-hNE4 DX-890 INN or Proposed INN: Depelestat Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase INN or Proposed INN: Depelestat Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase	Debiopharm SA	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Belgium;Germany;Italy;United Kingdom
1008	EUCTR2005-000313-35-GB (EUCTR)	13/04/2005	17/03/2005	A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study	A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study	Cystic Fibrosis MedDRA version: 7.1;Level: LLT;Classification code 10011762	Product Name: Recombinant truncated SPINT2 protease inhibitor Product Code: AER002	Aerovance Inc	NULL	Not Recruiting			Female: yes Male: yes	106	Phase 1;Phase 2	United Kingdom
1009	EUCTR2004-004334-13-IE (EUCTR)	08/04/2005	06/12/2004	A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Talniflumate in Cystic Fibrosis Subjects	A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Talniflumate in Cystic Fibrosis Subjects	Cystic Fibrosis	Trade Name: Somalgen Product Name: Talniflumate Product Code: MSI-1995 INN or Proposed INN: Talniflumate	Genaera Corporation	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Ireland
1010	EUCTR2004-002341-12-DE (EUCTR)	14/02/2005	24/09/2004	Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients	Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients	Cystic fibrosis MedDRA version: 7.0;Level: PT;Classification code 10011762	Product Name: Depelestat Product Code: EPI-hNE4 DX-890 INN or Proposed INN: Depelestat Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase INN or Proposed INN: Depelestat Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase	Debiopharm SA	NULL	Not Recruiting			Female: yes Male: yes	90		United Kingdom;Germany;Belgium;Italy
1011	EUCTR2004-002341-12-IT (EUCTR)	12/01/2005	16/03/2005	Multicenter, 8-week, Randomised,Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients	Multicenter, 8-week, Randomised,Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients	cystic fibrosis MedDRA version: 6.1;Level: PT;Classification code 10011762	Product Name: DEPELESTAT Product Code: DX-890 INN or Proposed INN: Other respiratory system products Product Name: DEPELESTAT Product Code: DX-890 INN or Proposed INN: Other respiratory system products	DEBIOPHARM S.A.	NULL	Not Recruiting			Female: yes Male: yes	90		United Kingdom;Germany;Belgium;Italy
1012	EUCTR2004-001888-21-GB (EUCTR)	03/12/2004	22/02/2005	A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis	A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis	Cystic fibrosis (CF)	Product Name: DP Mannitol INN or Proposed INN: Mannitol Trade Name: Pulmozyme (dornase alfa) Product Name: Pulmozyme (dornase alfa) INN or Proposed INN: Dornase alfa Other descriptive name: rhDNAse	Pharmaxis Ltd	NULL	Not Recruiting			Female: yes Male: yes	42	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
1013	NCT00823238 (ClinicalTrials.gov)	July 2004	29/12/2008	Comparison of Antibiotics for Pseudomonas in Early CF	Comparison of Antibiotics for Pseudomonas in Early CF	Cystic Fibrosis	Drug: ceftazidime and tobramycin;Drug: inhaled tobramycin	University of North Carolina, Chapel Hill	Cystic Fibrosis Foundation Therapeutics	Completed	3 Months	16 Years	Both	21	Phase 1	United States
1014	NCT00163852 (ClinicalTrials.gov)	February 2004	12/9/2005	Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis	Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis	Cystic Fibrosis	Drug: Normal saline IV, salt tablets	Bayside Health	National Health and Medical Research Council, Australia;Monash University;Cystic Fibrosis Australia	Recruiting	18 Years	75 Years	Both	40	Phase 2/Phase 3	Australia
1015	NCT00728715 (ClinicalTrials.gov)	January 2004	31/7/2008	Efficacy of Budesonide-Formoterol in Bronchiectasis	Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis	Bronchiectasis	Drug: budesonide-formoterol single inhaler;Drug: High dose of budesonide;Drug: A;Drug: B	Hospital General de Requena	Esteve Labs (Grant)	Completed	18 Years	80 Years	Both	40	N/A	Spain
1016	NCT00633191 (ClinicalTrials.gov)	November 2003	4/3/2008	Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis	Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients	Cystic Fibrosis;Infection;Pseudomonas Aeruginosa	Drug: Anti-pseudomonas IgY gargle	Immunsystem AB	NULL	Completed	N/A	N/A	Both	14	Phase 1/Phase 2	Sweden
1017	NCT00391976 (ClinicalTrials.gov)	November 2003	19/10/2006	Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis	The Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution (TNS) for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic Fibrosis	Cystic Fibrosis	Drug: Tobramycin solution for inhalation 300 mg	Novartis	NULL	Completed	6 Months	N/A	All	123	Phase 3	NULL
1018	NCT00662714 (ClinicalTrials.gov)	September 2001	17/4/2008	Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis	Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus	Cystic Fibrosis;Diabetes Mellitus	Drug: Repaglinide;Drug: short-acting Insulin (Actrapid)	Mukoviszidose Institut gGmbH	Novo Nordisk A/S;Mucoviscidose-ABCF2;Assistance Publique - Hôpitaux de Paris	Completed	10 Years	N/A	Both	73	Phase 3	Austria;France;Germany;Italy
1019	NCT00274391 (ClinicalTrials.gov)	July 2001	9/1/2006	Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis	Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis	Cystic Fibrosis	Drug: 7% NaCl;Drug: Amiloride HCl	University of North Carolina	Cystic Fibrosis Foundation Therapeutics	Completed	14 Years	N/A	Both	24	Phase 2	United States
1020	NCT00072904 (ClinicalTrials.gov)	June 2001	12/11/2003	Diabetes Therapy to Improve BMI and Lung Function in CF	Diabetes Therapy to Improve BMI and Lung Function in CF	Cystic Fibrosis;Diabetes Mellitus	Drug: Insulin Asparte;Drug: Repaglinide	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Cystic Fibrosis Foundation Therapeutics;Novo Nordisk A/S	Completed	16 Years	N/A	Both	108	Phase 3	United States;Canada
1021	NCT00004489 (ClinicalTrials.gov)	October 1998	18/10/1999	Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis		Osteoporosis;Cystic Fibrosis	Drug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferol	University of North Carolina	NULL	Completed	18 Years	45 Years	Both	60	N/A	United States
1022	NCT00004705 (ClinicalTrials.gov)	September 1996	24/2/2000	Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis		Cystic Fibrosis	Drug: amiloride;Drug: uridine	FDA Office of Orphan Products Development	University of North Carolina	Completed	4 Years	N/A	Both		N/A	NULL
1023	NCT00004315 (ClinicalTrials.gov)	November 1995	18/10/1999	Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease		Cystic Fibrosis;Gastrointestinal Diseases;Cholestasis	Drug: ursodiol	National Center for Research Resources (NCRR)	Children's Hospital Medical Center, Cincinnati	Active, not recruiting	4 Months	N/A	Both	20	Phase 2	United States
1024	NCT00004287 (ClinicalTrials.gov)	November 1995	18/10/1999	Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients With Cystic Fibrosis		Cystic Fibrosis	Genetic: H5.001CBCFTR	National Center for Research Resources (NCRR)	University of Pennsylvania	Completed	18 Years	N/A	Both	14	Phase 1	NULL
1025	NCT00004779 (ClinicalTrials.gov)	January 1993	24/2/2000	Phase I Pilot Study of Ad5-CB-CFTR, an Adenovirus Vector Containing the Cystic Fibrosis Transmembrane Conductance Regulator Gene, in Patients With Cystic Fibrosis		Cystic Fibrosis	Genetic: Ad5-CB-CFTR	National Center for Research Resources (NCRR)	University of North Carolina	Completed	N/A	N/A	Both	12	Phase 1	NULL
1026	EUCTR2016-001840-20-Outside-EU/EEA (EUCTR)		18/05/2016	Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients	A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules.	cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler	Novartis Pharmaceuticals Corporation	NULL	NA			Female: yes Male: yes	45	Phase 4	United States
1027	EUCTR2012-002699-14-FR (EUCTR)		20/09/2012	Trial of inhaled mannitol in children with cystic fibrosis	A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years	Cystic fibrosis in children aged 6 to 17 years MedDRA version: 15.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A	Pharmaxis Ltd.	NULL	Not Recruiting			Female: yes Male: yes	160	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Canada;Argentina;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom
1028	EUCTR2021-000694-85-IE (EUCTR)		29/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden
1029	EUCTR2018-002624-16-FR (EUCTR)		21/11/2018	NA	Validation of respiratory epithelial functional assessment to predict clinical efficacy of Orkambi®. Pathway to personalized therapy in Cystic Fibrosis PREDICT-CF - PREDICT-CF	Homozygous F508del patient aged 12 years or older MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Orkambi® Product Name: Orkambi®	ASSISTANC-PUBLIQUE-HOPITAUX DE PARIS (AP-HP)	NULL	NA			Female: yes Male: yes	104	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France
1030	EUCTR2020-001762-11-DE (EUCTR)		17/09/2020	A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.	An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials	Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2;Phase 3	Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
1031	EUCTR2019-004511-31-FR (EUCTR)		01/04/2021	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil	Bambino Gesù Children's Hospital	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2;Phase 3	Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
1032	EUCTR2019-004511-31-GB (EUCTR)		06/10/2020	Prospective validation and clinical evaluation of a new posaconazole dosingregimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus Infection MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: Noxafil - oral suspension 40 mg/ml Product Name: Noxafil - oral suspension 40 mg/ml Trade Name: Noxafil 100 mg Product Name: Noxafil 100 mg	Bambino Gesù Children's Hospital	NULL	NA			Female: yes Male: yes	135	Phase 2;Phase 3	Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden
1033	EUCTR2015-000543-16-FR (EUCTR)		07/07/2015	A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs	A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
1034	EUCTR2020-001762-11-SE (EUCTR)		17/07/2020	A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.	An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials	Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2;Phase 3	United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
1035	EUCTR2021-000712-31-IE (EUCTR)		29/09/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	400	Phase 3	United States;Portugal;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden
1036	EUCTR2010-018454-13-BE (EUCTR)		25/05/2010	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®	Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate Other descriptive name: Nacystelyn®	Laboratoires SMB S.A.	NULL	Not Recruiting			Female: yes Male: yes	552	Phase 3	France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
1037	EUCTR2017-000571-85-PL (EUCTR)		08/05/2017	Study of Oral Liprotamase Therapy Of Non-Porcine Origin	A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment	Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	192	Phase 3	United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom
1038	EUCTR2011-002000-32-FR (EUCTR)		22/09/2011	A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100 INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	NA			Female: yes Male: yes	150	Phase 4	United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
1039	EUCTR2020-001762-11-AT (EUCTR)		10/08/2020	A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.	An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials	Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2;Phase 3	United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
1040	EUCTR2018-003831-31-PL (EUCTR)		01/12/2020	MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis.	A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs	Exocrine Pancreatic Insufficiency due to Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000004856 MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: MS1819-SD INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica Other descriptive name: LIPASE LIP2	AzurRx SAS	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Hungary;Spain;Poland;Turkey
1041	EUCTR2008-002673-13-DE (EUCTR)		27/08/2008	Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo	Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo	Deficiency of the Cftr-molecule results in accumulation of ceramide in respiratory epithelial cells. Ceramide triggers a pro-inflammatory and -apoptotic status in cystic fibrosis patients. Amitriptyline reduces ceramide levels in the lung tissue, normalises the activity of cytokines and prevents constitutive cell death of epithelial cells. Amitriptyline prevents pulmonary infections of CF-mice with P. aeruginosa. Amitriptyline may result in an improved lung function of cystic fibrosis patients.	Trade Name: Amitriptylin-CT Product Name: Amitriptyline INN or Proposed INN: Amitriptyline	PSKS	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Germany
1042	EUCTR2010-019267-11-DE (EUCTR)		19/10/2010	AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI)	AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI)	Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: LLT;Classification code 10041968;Term: Steatorrhea;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders	Trade Name: PANZYTRAT 25000 Product Name: PANZYTRAT 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: KREON 25000 Product Name: KREON 25000 Other descriptive name: PANCREATIN	Axcan Pharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	68		Germany
1043	EUCTR2018-002835-76-BE (EUCTR)		25/07/2019	A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
1044	EUCTR2017-004132-11-PL (EUCTR)		18/04/2018	A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	360	Phase 3	United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
1045	EUCTR2010-023235-41-PL (EUCTR)		28/01/2011	A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE	A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE	Cystic fibrosis with bronchopulmonary chronic Pseudomonas aeruginosa infection MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Tobramycin Product Code: T100 INN or Proposed INN: Tobramycin Other descriptive name: Tobramycinum Trade Name: TOBI® INN or Proposed INN: TOBRAMYCIN	PARI Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 1	Poland
1046	EUCTR2018-000378-30-PL (EUCTR)		01/06/2020	A dose finding study of OligoG in patients with CF.	A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF).	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20	AlgiPharma AS	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Poland;Ireland;Austria;Germany;United Kingdom
1047	EUCTR2007-001548-36-DE (EUCTR)		27/07/2009	Nasale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cf	Nasale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cf	Cystic Fibrosis with chronic rhinosinusitis	Trade Name: Pulmozyme Product Name: Pulmozyme INN or Proposed INN: Dornase alfa Other descriptive name: recombiant human Desoxyribonuclease ( rhDNase)	University of Jena	NULL	Not Recruiting			Female: yes Male: yes	16	Phase 3	Germany
1048	EUCTR2018-000183-28-FR (EUCTR)		12/12/2018	A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)	MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
1049	EUCTR2021-005320-38-BE (EUCTR)		05/01/2022	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	270	Phase 3	France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
1050	EUCTR2011-000442-38-PL (EUCTR)		01/08/2011	Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa	Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate	Insmed Incorporated	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
1051	EUCTR2019-001735-31-BE (EUCTR)		08/07/2019	A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic Fibrosis	A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: ELEXACAFTOR Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	158	Phase 3	Belgium;Australia;Germany;United Kingdom
1052	EUCTR2021-005320-38-NO (EUCTR)		15/03/2022	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	270	Phase 3	Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Hungary;Belgium;Poland;Norway;Germany;Netherlands;Sweden
1053	EUCTR2017-001379-21-IE (EUCTR)		26/07/2017	A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).	A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 3	Canada;United States;Ireland;United Kingdom;Germany
1054	EUCTR2016-004479-35-IE (EUCTR)		19/02/2018	A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis	A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	65	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
1055	EUCTR2019-003052-36-GB (EUCTR)		28/02/2020	Magnetic Resonance Imaging (MRI) in Bronchiectasis	Triple Modality Functional Magnetic Resonance Lung Imaging in Cystic Fibrosis and Non-CF Bronchiectasis - MRI in Bronchiectasis	Cystic fibrosis (CF) Non-CF Bronchiectasis MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: hyperpolarized xenon-129 Product Name: hyperpolarized xenon-129	The University of Nottingham	NULL	NA			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
1056	EUCTR2020-003688-25-PL (EUCTR)		30/11/2020	A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study	Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986	Insmed Incorporated	NULL	NA			Female: yes Male: yes	1660	Phase 3	Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Bulgaria;Germany;New Zealand;Japan
1057	EUCTR2008-007416-15-DE (EUCTR)		29/05/2009	Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D Mutation	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE	Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
1058	EUCTR2018-001695-38-IE (EUCTR)		28/08/2019	Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years	A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Trade Name: Kalydeco 150 mg film-coated tablets Product Name: IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Product Name: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 3	United States;Canada;Ireland;Australia;United Kingdom
1059	EUCTR2007-006276-11-PL (EUCTR)		06/05/2009	A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis	A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Heparin 25mg inhalation powder, hard capsule INN or Proposed INN: HEPARIN SODIUM	Vectura Limited	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Poland;Ireland;Italy;United Kingdom
1060	EUCTR2015-004841-13-FR (EUCTR)		23/06/2016	A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation	A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi	Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution	Vertex Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;France;Czech Republic;Ireland;United Kingdom
1061	EUCTR2014-003023-22-FR (EUCTR)		22/06/2015	Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study)	Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP study	bronchiectasis excluding cystic fibrosis in children;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: ZITHOMAX 40 mg/ml ENFANTS Product Name: zithromax INN or Proposed INN: AZITHROMYCIN DIHYDRATE Trade Name: ZITHROMAX 250 mg Product Name: ZITHROMAX INN or Proposed INN: AZITHROMYCIN DIHYDRATE	ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France
1062	EUCTR2021-000694-85-BE (EUCTR)		21/10/2021	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	550	Phase 3	United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
1063	EUCTR2016-004318-82-Outside-EU/EEA (EUCTR)		15/05/2017	A study comparing Tobramycin Inhalation Powder (TIP) administered once daily continuously versus TIP administered BID in 28 day on / 28 day off cycles for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis	Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: TOBI Podhaler INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN	Novartis Pharmaceuticals Corporation	NULL	NA			Female: yes Male: yes	200	Phase 4	United States
1064	EUCTR2006-006980-22-PL (EUCTR)		22/08/2007	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA	Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE	Transave, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Slovakia;Belgium;Poland
1065	EUCTR2016-002851-92-PL (EUCTR)		02/08/2016	NA	An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years	Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Liprotamase INN or Proposed INN: NOT ASSIGNED Other descriptive name: LIPASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: PROTEASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: AMYLASE	ANTHERA Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 3	United States;Czech Republic;Hungary;Canada;Spain;Poland;Israel
1066	EUCTR2019-001827-11-GB (EUCTR)		11/12/2019	Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Trade Name: Kalydeco 150 mg film-coated tablets Product Name: IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445 / TEZ / IVA	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	56	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Canada;Ireland;Australia;United Kingdom
1067	EUCTR2017-004133-82-DE (EUCTR)		08/03/2018	A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)	Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Ireland;United Kingdom;Australia;Germany;Spain
1068	EUCTR2017-001379-21-DE (EUCTR)		01/08/2017	A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).	A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 3	Canada;United States;Ireland;United Kingdom;Germany
1069	EUCTR2021-005914-33-SE (EUCTR)		16/05/2022	Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor Long-term Safety and Efficacy in Subjects Without F508del	A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes - Study to Evaluate Elx/Tez/Iva Long-term Safety and Efficacy in Subjects Without F508del	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Kaftrio Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: 150mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: 75-mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kaftrio Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	270	Phase 3	Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Norway;Netherlands;Germany;Sweden
1070	EUCTR2021-005320-38-CZ (EUCTR)		11/03/2022	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	270	Phase 3	Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany;Netherlands;Norway;Sweden
1071	EUCTR2016-002749-42-IE (EUCTR)		26/07/2017	Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria	Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2)	Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	140	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
1072	EUCTR2017-000540-18-FR (EUCTR)		01/08/2017	Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi	Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	90	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;France;Germany
1073	EUCTR2021-000713-17-DE (EUCTR)		29/08/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	850	Phase 3	Portugal;United States;Czechia;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
1074	EUCTR2017-002968-40-DE (EUCTR)		05/04/2018	A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis	A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Symdeko Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symdeko Product Name: Ivacaftor 75 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor 150 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	121	Phase 3	France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
1075	EUCTR2019-003455-11-BE (EUCTR)		23/12/2019	Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects	A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Trikafta Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	158	Phase 3	Belgium;United Kingdom;Australia;Germany
1076	EUCTR2019-004511-31-IE (EUCTR)		21/05/2021	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.	Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF	Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: NOXAFIL - 40 mg/ml oral suspension Product Name: Noxafil INN or Proposed INN: POSACONAZOLE Other descriptive name: POSACONAZOLE Trade Name: Noxafil 100 mg Tablets Gastro-Resistant Product Name: Noxafil INN or Proposed INN: POSACONAZOLE Other descriptive name: POSACONAZOLE	Bambino Gesù Children's Hospital	NULL	Not Recruiting			Female: yes Male: yes	135	Phase 2;Phase 3	Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
1077	EUCTR2021-000713-17-PT (EUCTR)		19/10/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	850	Phase 3	Portugal;United States;Czechia;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
1078	EUCTR2006-003275-12-SE (EUCTR)		07/07/2009	Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study	Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study	Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders	Trade Name: Azithromycin Product Name: azithromycin Product Code: azithromycin INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN	Copenhagen CF-centre	NULL	NA			Female: yes Male: yes	250	Phase 4	Denmark;Norway;Sweden
1079	EUCTR2015-004143-39-FR (EUCTR)		30/03/2017	Saline hypertonic in preschoolers and lung structure as measured by computed tomography.	A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Hypertonic saline 7% INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE PH. EUR. Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE PH. EUR.	Erasmus MC	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 3	United States;France;Spain;Belgium;Denmark;Australia;Netherlands;Italy
1080	EUCTR2018-000378-30-IE (EUCTR)		26/06/2019	A dose finding study of OligoG in patients with CF.	A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF).	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: OligoG CF-5/20 - 17.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 27.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 37.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20	AlgiPharma AS	NULL	Not Recruiting			Female: yes Male: yes	168	Phase 2	Poland;Ireland;Austria;Germany;United Kingdom
1081	EUCTR2007-000178-21-PL (EUCTR)		04/09/2007	An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency	An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency	Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas	Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease	Altus Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	Slovakia;Poland;Italy
1082	EUCTR2021-000713-17-CZ (EUCTR)		23/09/2022	A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	850	Phase 3	Portugal;United States;Czechia;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
1083	EUCTR2006-006693-24-PL (EUCTR)		11/10/2007	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis	Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung	Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin	AOP Orphan Pharmaceuticals AG	NULL	NA			Female: yes Male: yes	160	Phase 2	France;Hungary;Czech Republic;Spain;Poland;Austria;Germany;Italy;Sweden
1084	EUCTR2018-004652-38-PL (EUCTR)		06/09/2019	A Study Evaluating the Long-term Safety of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy	Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	458	Phase 3	United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom;Switzerland
1085	EUCTR2007-001412-23-DE (EUCTR)		26/01/2009	Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study	Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study	Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Trade Name: Aridol or Osmohale INN or Proposed INN: Mannitol	Pharmaxis Pharmaceuticals Limited	NULL	Not Recruiting			Female: yes Male: yes	340	Phase 3	Ireland;Germany;United Kingdom
1086	EUCTR2017-003723-29-FR (EUCTR)		14/03/2018	A study of safety and efficacy of lenabasum in Cystic Fibrosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis	Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	415	Phase 2	United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden
1087	EUCTR2005-003772-37-DE (EUCTR)		05/12/2005	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects	Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762	Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycin Product Name: TOBI INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;United Kingdom;Germany;Spain;Italy;Greece
1088	EUCTR2021-005320-38-DE (EUCTR)		16/12/2021	Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation	A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	270	Phase 3	Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Norway;Germany;Netherlands;Sweden
1089	EUCTR2018-000185-11-FR (EUCTR)		24/01/2019	A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy	A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	NA			Female: yes Male: yes	460	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
1090	EUCTR2020-004885-21-BE (EUCTR)		15/09/2021	A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis	A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis	Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	143	Phase 3	Czechia;Czech Republic;Canada;Spain;Belgium;Australia;Netherlands
1091	EUCTR2015-001997-16-DE (EUCTR)		24/04/2017	A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).	A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have a CFTR Gating Mutation	Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR	Vertex Pharmaceuticals Incorporated	NULL	Not Recruiting			Female: yes Male: yes	35	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Canada;Ireland;Germany;United Kingdom

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321. 非ケトーシス型高グリシン血症

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臨床試験数 : 1 /  薬物数 : 2 - (DrugBank : 2) / 標的遺伝子数 : 0 - 標的パスウェイ数 : 0

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR2100047891	2021-07-01	2021-06-27	A multicentre clinical study of the effect of different gene mutation types on the prognosis of non-ketotic hyperglycinemia	A multicentre clinical study of the effect of different gene mutation types on the prognosis of non-ketotic hyperglycinemia	Nonketotic hyperglycinemia	GLDC group:NO;AMT group:NO ;GCSH group:No ;	Department of Pediatrics, The Seventh Medical Center, PLA General Hospital	NULL	Pending	0	18	Both	GLDC group:20;AMT group:5;GCSH group:5;	N/A	China

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