EN ( DrugBank: - )

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3 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
6	パーキンソン病	254
46	悪性関節リウマチ	434
97	潰瘍性大腸炎	312

6. パーキンソン病

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

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05543252 (ClinicalTrials.gov)	August 29, 2022	13/9/2022	An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of UCB0599 in Study Participants With Parkinson's Disease	A Dose-Blinded Extension Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson's Disease	Parkinson's Disease	Drug: UCB0599	UCB Biopharma SRL	NULL	Enrolling by invitation	40 Years	78 Years	All	270	Phase 2	United States;France;Germany;Netherlands;Poland
2	NCT05542576 (ClinicalTrials.gov)	August 24, 2022	7/9/2022	AMDX-2011P Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy	Prospective Randomized Open, Blinded Endpoint (PROBE) Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy	Parkinson Disease;Amyotrophic Lateral Sclerosis	Drug: AMDX2011P	Amydis Inc.	NULL	Recruiting	18 Years	N/A	All	36	Phase 1/Phase 2	United States
3	JPRN-jRCTs041220054	15/08/2022	15/08/2022	The effects of prebiotics on Parkinson's disease patients with wearing-off	The effects of prebiotics on wearing-off and intestinal environment in patients with Parkinson's disease	Parkinson's disease patients with wearing-off over 20 years old	administration of kestose and inulin Dose / Usage) Kestose: 6 g (3 g in the morning, 3 g in the evening) / 2 times a day, orally Inulin: 6g (3g in the morning, 3g in the evening) / 2 times a day, orally Administration period) 8 weeks	Hirooka Yoshiki	Watanabe Hirohisa	Recruiting	>= 20age old	Not applicable	Both	20	Phase 1-2	Japan
4	NCT04858074 (ClinicalTrials.gov)	January 3, 2022	7/4/2021	Study to Investigate the Effect of Hypoestes Rosea Powder in Parkinson's Disease	A Proof of Concept (POC) Study to Investigate the Effect of 100% Hypoestes Rosea Powder in Parkinson's Disease Using ActiGraph Wearable as a Quantitative Assessment Tool.	Parkinson Disease	Drug: Hypoestoxide	University of Ibadan	NULL	Enrolling by invitation	30 Years	85 Years	All	30	Phase 1/Phase 2	Nigeria
5	NCT05173701 (ClinicalTrials.gov)	November 22, 2021	8/11/2021	Effects of Probiotics on Peripheral Immunity in Parkinson's Disease	Effects of Probiotics on Peripheral Immunity in Parkinson's Disease	Parkinson's Disease	Dietary Supplement: Probiotics;Dietary Supplement: Placebo	Franca Marino	Università degli Studi del Piemonte Orientale Amedeo Avogadro;Università degli Studi dell'Insubria	Enrolling by invitation	N/A	N/A	All	88	N/A	Italy
6	NCT04871464 (ClinicalTrials.gov)	November 11, 2021	29/4/2021	Role and Mechanism of Probiotics in Improving Motor Symptoms in Mild to Moderate Parkinson's Disease	Role and Mechanism of Bifidobacterium Triple Viable Capsules in Improving Motor Symptoms in Patients With Mild to Moderate Parkinson's Disease: a Multicenter Randomized Clinical Study	Parkinson Disease;Parkinsonian Disorders;Basal Ganglia Diseases;Brain Diseases;Movement Disorders;Neurodegenerative Diseases;Central Nervous System Diseases;Nervous System Diseases	Drug: Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules;Other: Placebo	Beijing Friendship Hospital	NULL	Recruiting	40 Years	85 Years	All	240	Phase 4	China
7	NCT04986995 (ClinicalTrials.gov)	June 9, 2021	27/7/2021	OpicApone Sleep dISorder	Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders	Parkinson Disease	Drug: Opicapone	Bial - Portela C S.A.	NULL	Recruiting	30 Years	N/A	All	30	Phase 4	Portugal
8	NCT04919356 (ClinicalTrials.gov)	June 8, 2021	4/6/2021	Parkinson's Disease G2019S LRRK2 Genetic Testing Program	G2019S LRRK2 Parkinson's Disease: Increasing Awareness and Genetic Testing Program	Parkinson's Disease	Genetic: G2019S LRRK2	Escape Bio, Inc.	Engage Health Inc.;Sano	Terminated	18 Years	N/A	All	836		United States
9	EUCTR2020-004997-23-ES (EUCTR)	25/05/2021	01/09/2021	A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease	A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE	Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody	Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 2	France;United States;Canada;Poland;Spain;Austria;United Kingdom;Italy
10	EUCTR2020-001176-15-DE (EUCTR)	07/05/2021	17/12/2020	Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease.	Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS)	Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ongentys Product Name: Ongentys 50 mg hard capsules INN or Proposed INN: OPICAPONE Other descriptive name: OPICAPONE	Bial - Portela & Ca, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Portugal;Germany
11	EUCTR2021-000826-89-FR (EUCTR)	23/04/2021	25/03/2021	Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement	Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement	Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: APOKINON Product Name: APOKINON Product Code: N04BC07	CHU Rennes	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	20	Phase 4	France
12	EUCTR2020-001176-15-PT (EUCTR)	19/03/2021	04/01/2021	Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease.	Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS)	Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ongentys Product Name: Ongentys 50 mg hard capsules INN or Proposed INN: OPICAPONE Other descriptive name: OPICAPONE	Bial - Portela & Ca, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Portugal;Germany
13	NCT04322461 (ClinicalTrials.gov)	March 15, 2021	24/3/2020	Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population	Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKA	Parkinson Disease;Alzheimer Disease	Dietary Supplement: Betaquik MCT supplement	Université de Sherbrooke	Nestlé	Not yet recruiting	60 Years	N/A	All	20	N/A	NULL
14	NCT04986982 (ClinicalTrials.gov)	February 25, 2021	27/7/2021	OpiCapone Effect on Motor Fluctuations and pAiN	Randomised, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Pain.	Parkinson Disease	Drug: Opicapone 50 mg;Other: Matching placebo	Bial - Portela C S.A.	NULL	Recruiting	30 Years	N/A	All	140	Phase 4	United Kingdom
15	NCT04760769 (ClinicalTrials.gov)	February 24, 2021	12/2/2021	Open-label Trial in Parkinson's Disease (PD)	58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)	Parkinson Disease	Drug: Tavapadon	Cerevel Therapeutics, LLC	NULL	Enrolling by invitation	40 Years	80 Years	All	800	Phase 3	United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Serbia;Spain;Ukraine
16	NCT04750226 (ClinicalTrials.gov)	February 18, 2021	10/2/2021	Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease	An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease	Parkinson's Disease (PD)	Drug: ABBV-951	AbbVie	NULL	Enrolling by invitation	30 Years	N/A	All	130	Phase 3	United States;Australia
17	NCT04593511 (ClinicalTrials.gov)	February 2, 2021	21/9/2020	to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers	An Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular Injection	Parkinson's Disease	Drug: LY03009 F1;Drug: LY03009 F2;Drug: LY03009 F3;Drug: LY03009 F4	Luye Pharma Group Ltd.	NULL	Enrolling by invitation	18 Years	65 Years	All	40	Phase 1	Australia
18	EUCTR2020-001175-32-PT (EUCTR)	15/01/2021	30/09/2020	Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson’s disease	Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN)	Parkinson's disease patients with wearing-off motor fluctuations and associated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ongentys Product Name: Opicapone 50 mg hard capsules INN or Proposed INN: Opicapone	Bial - Portela & Ca, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	176	Phase 4	Portugal;Spain;Germany;United Kingdom;Italy
19	JPRN-jRCT2051200104	06/01/2021	24/12/2020	A Phase 1 Study of KK6483 in Healthy Male Volunteers	A Phase 1 Study of KK6483 in Healthy Male Volunteers	Parkinson's disease	A single oral administration of the investigational product, KK6483C in combination with the existing levodopa (LD)/carbidopa (CD)/entacapone (ET)	Yagi Michio	NULL	Complete	>= 20age old	< 45age old	Male	40	Phase 1	Japan
20	JPRN-jRCTs031200172	23/12/2020	26/10/2020	Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipation	Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. - CONST-PD	Parkinson's disease, chronic constipation Parkinson's syndrome,chronic constipation,Symptomatic constipation	Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment.	Hatano Taku	Mochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd.	Not Recruiting	>= 20age old	Not applicable	Both	100	N/A	Japan
21	EUCTR2020-001175-32-IT (EUCTR)	17/12/2020	15/06/2021	Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson's disease	Randomized, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson's disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN)	Parkinson's disease patients with wearing-off motor fluctuations and associated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ongentys Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone	BIAL-Portela & Ca, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	176	Phase 4	Portugal;Spain;Germany;United Kingdom;Italy
22	ChiCTR2000038937	2020-11-01	2020-10-10	Clinical study of early diagnosis of Parkinson's disease based on substantia nigra-striatal axis multimodal imaging	Clinical study of early diagnosis of Parkinson's disease based on substantia nigra-striatal axis multimodal imaging	Parkinson's disease	Gold Standard:Clinical diagnosis by experienced movement disorder specialists after 2 years of follow-up.;Index test:Including traditional imaging feature algorithms (SUVR value, total cortical volume, bilateral cortical surface area, cortical thickness, etc.), high-dimensional imaging omics feature algorithms (energy entropy, gray-level co-occurrence matrix, and mutual information, etc.), and brain connection group Learning feature algorithm.;	Huashan Hospital, Fudan University	NULL	Recruiting	45	80	Both	Target condition:105;Difficult condition:0		China
23	ChiCTR2000039050	2020-10-30	2020-10-14	Efficacy of levodopa/carbidopa/entacapone in the replacement of Levodopa /dopa decarboxylase inhibitor in the treatment of 'Wearing-off' in Patients with Parkinson's disease in China: a multicenter, randomized controlled, open study	Efficacy of levodopa/carbidopa/entacapone in the replacement of Levodopa /dopa decarboxylase inhibitor in the treatment of 'Wearing-off' in Patients with Parkinson's disease in China: a multicenter, randomized controlled, open study	Parkinson's Disease	Group 1:adding pramipexole;Group 2:adding LCE;	The Affiliated Brain Hospital of Nanjing Medical University (Nanjing Brain Hospital)	NULL	Pending	30	80	Both	Group 1:175;Group 2:175;	Phase 4	China
24	EUCTR2020-001175-32-GB (EUCTR)	29/09/2020	07/08/2020	Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease.	Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN)	Parkinson's disease patients with wearing-off motor fluctuations andassociated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ongentys Product Name: Ongentys INN or Proposed INN: Opicapone	Bial - Portela & Ca, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	176	Phase 4	Portugal;Spain;Germany;Italy;United Kingdom
25	NCT04483479 (ClinicalTrials.gov)	July 30, 2020	20/7/2020	Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover)	A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period	Parkinson Disease;Constipation	Drug: Active Investigational Treatment ENT-01	Enterin Inc.	NULL	Completed	30 Years	90 Years	All	28	Phase 2	United States
26	NCT04246437 (ClinicalTrials.gov)	February 4, 2020	25/1/2020	[18F]F-DOPA Imaging in Patients With Autonomic Failure	[18F]F-DOPA Imaging in Patients With Autonomic Failure	Autonomic Failure;Pure Autonomic Failure;Parkinson Disease;Multiple System Atrophy;Dementia With Lewy Bodies	Drug: [18F]FDOPA;Drug: Carbidopa 200mg oral dose;Drug: Entacapone 400mg oral dose	Daniel Claassen	NULL	Recruiting	18 Years	N/A	All	40	Phase 1	United States
27	NCT04768023 (ClinicalTrials.gov)	November 18, 2019	14/2/2021	12 Weeks Vitamin D Supplementation and Physical Activity in PD Patients With DBS	Influence of 12 Weeks Vitamin D Supplementation Combined With Physical Activity on Blood and Functional Parameters and Quality of Life in Parkinson's Disease Patients Treated With Deep Brain Stimulation	Vitamin D Deficiency;Parkinson Disease	Drug: Juvit D3;Behavioral: steps per day;Drug: Placebo	Medical University of Gdansk	NULL	Enrolling by invitation	40 Years	90 Years	All	72	N/A	Poland
28	NCT04477161 (ClinicalTrials.gov)	September 5, 2019	22/6/2020	Effect of Ketone Esters in Parkinson's Disease	Effect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.	Parkinson Disease;Ketosis	Dietary Supplement: Ketone Ester Elite endurance Nutrition Drink;Other: Stool Sample	University of Florida	NULL	Completed	40 Years	75 Years	All	10	N/A	United States
29	JPRN-UMIN000037390	2019/07/01	16/07/2019	An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy	An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy - Levodopa pharmacokinetics on concomitant use of LCIG therapy and COMT inhibitor	Parkinson's disease	Entacapone 100mg	Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine	Saiseikai Matsuyama Hospital	Pending	20years-old	Not applicable	Male and Female	10	Not selected	Japan
30	NCT03938922 (ClinicalTrials.gov)	June 13, 2019	18/4/2019	A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease Dementia	A Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.	Parkinson Disease;Dementia	Drug: Active Investigational Treatment ENT-01	Enterin Inc.	NULL	Active, not recruiting	30 Years	90 Years	All	40	Phase 1	United States
31	ChiCTR1900022534	2019-06-01	2019-04-15	Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial	Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial	non-motor symptoms of Parkinson’s disease	entacapone group:Patients in the entacapone group will be administered entacapone (Novartis; import drug registration certificate number: H20160680), 10 times per day, 200 mg each time, for 3 weeks. ;pramipexole group:Patients in the pramipexole group will be administered pramipexole (Boehringer-Ingelheim; import drug registration certificate number: 20140918) , 3 times per day, 1 mg each time, for 3 weeks.;	Geriatric Hospital of Hainan	NULL	Pending	40	75	Both	entacapone group:194;pramipexole group:194;	N/A	China
32	JPRN-UMIN000036908	2019/05/31	31/05/2019	A dementia study by 11C-PiB, 18F-FDG PET	A dementia study by 11C-PiB, 18F-FDG PET - A dementia study by 11C-PiB, 18F-FDG PET	mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc.	11C-PiB, 18F-FDG PET	Nagoya City Rehabilitation Agency	NULL	Recruiting	20years-old	Not applicable	Male and Female	150	Not applicable	Japan
33	NCT04293159 (ClinicalTrials.gov)	May 14, 2019	19/2/2020	Effect of Probiotic on Constipation in Patients With Parkinson's Disease	Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease	Parkinson Disease;Constipation	Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)	University of Salerno	Roberto Erro;Maria Teresa Pellecchia;Antonella Santonicola;Carolina Ciacci	Recruiting	18 Years	75 Years	All	30	N/A	Italy
34	NCT03968744 (ClinicalTrials.gov)	February 18, 2019	19/4/2019	Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease	A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study	Idiopathic Parkinson's Disease (at Later Stage)	Drug: Safinamide	Alain Kaelin	Clinical Trial Unit Ente Ospedaliero Cantonale	Recruiting	18 Years	N/A	All	23	Phase 4	Switzerland
35	NCT03702816 (ClinicalTrials.gov)	December 13, 2018	1/10/2018	The Relationship Between Neuropsychological Testing and MRI, PET and COBRE - Project 1: AIM 2 (GE-180)	The Relationship Between Neuropsychological Testing and MRI, PET and Blood Biomarkers in Neurodegenerative Disease (COBRE - Project 1): AIM 2	Alzheimer Disease;Parkinson Disease;Inflammation	Drug: GE180 PET Scan	Aaron Ritter, MD	NULL	Enrolling by invitation	55 Years	90 Years	All	70	Phase 2	United States
36	NCT03781791 (ClinicalTrials.gov)	December 10, 2018	27/11/2018	Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)	Constipation;Parkinson Disease	Drug: Active Investigational Treatment ENT-01;Drug: Placebo Treatment	Enterin Inc.	NULL	Completed	30 Years	90 Years	All	144	Phase 2	United States
37	NCT03944447 (ClinicalTrials.gov)	December 1, 2018	3/5/2019	Outcomes Mandate National Integration With Cannabis as Medicine	Outcomes Mandate National Integration With Cannabis as Medicine	Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus	Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler	OMNI Medical Services, LLC	OMNI Medical Services Inc	Recruiting	7 Years	N/A	All	200000	Phase 2	United States
38	NCT03582137 (ClinicalTrials.gov)	September 17, 2018	17/4/2018	A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease	A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease	Parkinson Disease	Drug: Cannabidiol;Other: Placebo	University of Colorado, Denver	Colorado Department of Public Health and Environment	Completed	40 Years	85 Years	All	74	Phase 2	United States
39	NCT04730245 (ClinicalTrials.gov)	June 1, 2018	25/1/2021	Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease	Targeting Gut Microbiota for Motor Complications in Parkinson´s Disease	Parkinson's Disease Aggravated	Drug: sodium phosphate enema, oral rifaximin and polyethylene glycol	Torre Médica Santé	NULL	Completed	18 Years	N/A	All	14	Phase 1	Mexico
40	EUCTR2017-002780-17-ES (EUCTR)	21/05/2018	12/02/2018	Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa.	A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension	Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	France;United States;Spain;Austria;Netherlands;Italy
41	EUCTR2017-004475-31-CZ (EUCTR)	09/05/2018	09/05/2018	Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.	Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease	Excessive daytime sleepiness associated with Parkinson’s disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Trade Name: Modiodal Product Name: over-encapsulated Modafinil INN or Proposed INN: MODAFINIL	Theranexus S.A.	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Hungary;Czech Republic;Germany
42	EUCTR2017-002780-17-FR (EUCTR)	26/04/2018	27/02/2018	-	A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension	Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa	NeuroDerm Ltd.	NULL	Not Recruiting			Female: yes Male: yes	50	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;France;Spain;Austria;Netherlands;Italy
43	NCT03374917 (ClinicalTrials.gov)	April 18, 2018	8/12/2017	A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment	An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment	Parkinson's Disease (PD)	Drug: ABBV-951	AbbVie	NULL	Completed	30 Years	85 Years	All	20	Phase 1	United States
44	EUCTR2017-004475-31-HU (EUCTR)	17/04/2018	09/02/2018	Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.	Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease	Excessive daytime sleepiness associated with Parkinson’s disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Trade Name: Modiodal Product Name: over-encapsulated Modafinil INN or Proposed INN: MODAFINIL	Theranexus S.A.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Czech Republic;Hungary;United States;France;Germany
45	EUCTR2017-002780-17-IT (EUCTR)	10/04/2018	04/11/2020	study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion	A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered	Parkinson¿s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa INN or Proposed INN: LEVODOPA Other descriptive name: levodopa	NEURODERM LTD.	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	United States;France;Spain;Austria;Netherlands;Italy
46	EUCTR2016-001403-23-HU (EUCTR)	23/01/2018	22/01/2018	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
47	NCT03550183 (ClinicalTrials.gov)	January 10, 2018	11/5/2018	Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease	Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells	Parkinson's Disease	Biological: mesenchymal stem cells	Hebei Newtherapy BIo-Pharma technology Co., Ltd.	NULL	Enrolling by invitation	40 Years	80 Years	All	20	Phase 1	China
48	NCT03769896 (ClinicalTrials.gov)	October 3, 2017	6/12/2018	Nabilone for Non-motor Symptoms in Parkinson's Disease	Nabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal Study	Parkinson Disease	Drug: Nabilone 0.25 mg;Drug: Placebo	Medical University Innsbruck	NULL	Completed	30 Years	100 Years	All	48	Phase 2	Austria
49	EUCTR2017-000192-86-AT (EUCTR)	15/09/2017	10/08/2017	Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...)	Nabilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study	Subjects with non-motor symptoms of Parkinson´s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Nabilone INN or Proposed INN: NABILONE	Medizinische Universität Innsbruck, Universitätsklinik für Neurologie	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Austria
50	EUCTR2016-003961-25-CZ (EUCTR)	07/09/2017	15/05/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Hungary;Czech Republic;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
51	EUCTR2017-000135-14-ES (EUCTR)	07/07/2017	09/06/2017	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E	Prexton Therapeutics B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	Spain;Austria;Germany;Italy;United Kingdom
52	NCT03162874 (ClinicalTrials.gov)	July 4, 2017	19/5/2017	Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)	Parkinson Disease	Drug: Placebo oral capsule;Drug: PXT002331 - dose 1;Drug: PXT002331 - dose 2	Prexton Therapeutics	NULL	Completed	35 Years	85 Years	All	157	Phase 2	Austria;France;Germany;Italy;Spain;United Kingdom
53	EUCTR2016-003961-25-DE (EUCTR)	30/06/2017	01/02/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
54	NCT04403399 (ClinicalTrials.gov)	June 29, 2017	21/5/2020	Crossover Target Engagement Study of Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease (Project #3 - Experiment 3 [UdallP3E3])	Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiment 3 - Project #3	Parkinson's Disease	Drug: Varenicline;Drug: Placebo	University of Michigan	NULL	Completed	45 Years	N/A	All	34	Phase 2	United States
55	EUCTR2017-000135-14-GB (EUCTR)	15/06/2017	17/03/2017	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E	Prexton Therapeutics B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	Spain;Austria;Germany;United Kingdom
56	EUCTR2016-003961-25-ES (EUCTR)	08/06/2017	27/04/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
57	EUCTR2017-000135-14-DE (EUCTR)	06/06/2017	10/03/2017	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E	Prexton Therapeutics B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	Spain;Austria;Germany;Italy;United Kingdom
58	EUCTR2016-003961-25-HU (EUCTR)	31/05/2017	03/04/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
59	EUCTR2017-000135-14-AT (EUCTR)	26/05/2017	08/03/2017	A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa	A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E	Prexton Therapeutics B.V.	NULL	Not Recruiting			Female: yes Male: yes	165	Phase 2	Spain;Austria;Germany;United Kingdom
60	NCT03047629 (ClinicalTrials.gov)	May 11, 2017	3/2/2017	Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation	A Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related Constipation	Parkinson's Disease;Constipation	Drug: ENT-01;Other: Placebo	Enterin Inc.	NULL	Completed	30 Years	86 Years	All	50	Phase 1/Phase 2	United States
61	EUCTR2015-004507-23-FI (EUCTR)	08/05/2017	30/03/2017	Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.	Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC	Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Finland;Latvia;Germany
62	NCT03128450 (ClinicalTrials.gov)	April 15, 2017	9/2/2017	A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient	A Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's Disease	Parkinson Disease	Biological: human neural stem cell	Second Affiliated Hospital of Soochow University	NULL	Enrolling by invitation	35 Years	70 Years	All	12	Phase 2/Phase 3	China
63	NCT03051607 (ClinicalTrials.gov)	April 10, 2017	9/2/2017	Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off	Idiopathic Parkinson Disease	Drug: Tozadenant	Biotie Therapies Inc.	Acorda Therapeutics	Terminated	30 Years	80 Years	All	66	Phase 3	United States;Canada;United Kingdom
64	EUCTR2016-003961-25-GB (EUCTR)	04/04/2017	16/02/2017	A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off	A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off”	Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT	Biotie Therapies	NULL	Not Recruiting			Female: yes Male: yes	450	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
65	EUCTR2016-001403-23-GR (EUCTR)	31/03/2017	14/10/2016	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
66	EUCTR2015-004507-23-HU (EUCTR)	24/02/2017	04/01/2017	Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.	Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC	Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Finland;Latvia;Germany
67	EUCTR2016-001403-23-FI (EUCTR)	22/02/2017	31/08/2016	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
68	NCT02799381 (ClinicalTrials.gov)	February 9, 2017	10/6/2016	A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)	Parkinson's Disease (PD)	Drug: Optimized antiparkinsonian treatment;Drug: Levodopa-Carbidopa Intestinal Gel (LCIG);Device: CADD-Legacy ambulatory infusion pump;Device: Percutaneous endoscopic gastrostomy tube;Device: Jejunal extension tube	AbbVie	NULL	Completed	30 Years	N/A	All	63	Phase 3	United States;Finland;Greece;Hungary;Italy;Slovakia;Spain
69	NCT02879136 (ClinicalTrials.gov)	December 2016	23/6/2016	TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease	TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study	Parkinson's Disease, Idiopathic	Drug: Methylphenidate;Other: Physical Therapy;Drug: Atomoxetine	Hubert Fernandez	NULL	Recruiting	18 Years	90 Years	All	42	Early Phase 1	United States
70	EUCTR2016-001403-23-SK (EUCTR)	29/11/2016	07/09/2016	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Hungary;European Union;Slovakia;Greece;Finland;Spain
71	EUCTR2016-001403-23-ES (EUCTR)	14/11/2016	15/11/2016	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
72	NCT02818777 (ClinicalTrials.gov)	October 2016	6/5/2016	A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease	A Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease	Parkinson's Disease	Drug: cannabidiol	University of Colorado, Denver	Colorado Department of Public Health and Environment;GW Research Ltd	Completed	40 Years	80 Years	All	13	Phase 2	United States
73	EUCTR2016-001403-23-IT (EUCTR)	13/09/2016	06/09/2021	12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease.	An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparativeinterventional trial on Duodopa VERsus oral medication) - DYSCOVER Study	Dyskinesia in advanced Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Duodopa Product Name: na Product Code: [na] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE	ABBVIE DEUTSCHLAND GMBH & CO. KG	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;Hungary;Slovakia;European Union;Greece;Finland;Spain;Italy
74	NCT02785978 (ClinicalTrials.gov)	June 2016	11/5/2016	Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers	Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers	Parkinson Disease;Healthy Volunteers	Drug: Levodopa acute challenge;Other: Controlled environment tests (series of tasks of everyday life);Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS;Device: ActiMyo recording;Other: Diary completion	Institut de Myologie, France	NULL	Completed	18 Years	N/A	All	30	N/A	France
75	JPRN-UMIN000022022	2016/05/10	10/05/2016	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease	Parkinson diseaseChronic constipation	Study drug group: A 12-week administration of lubiprostone 24 microrgrum (adjustable) twice daily after switching from magnesium oxide Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollment	Dokkyo Medical University	NULL	Complete: follow-up complete	20years-old	90years-old	Male and Female	64	Not selected	Japan
76	JPRN-UMIN000022023	2016/05/10	10/05/2016	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-	A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora- - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora-	Parkinson diseaseChronic constipation	Study drug group: A 12-week administration of lubiprostone 24 microgrum (adjustable) twice daily after switching from magnesium oxide Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollmen	Dokkyo Medical University	NULL	Complete: follow-up complete	20years-old	90years-old	Male and Female	64	Not selected	Japan
77	EUCTR2015-004507-23-DE (EUCTR)	25/04/2016	13/01/2016	Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.	Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC	Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Finland;Latvia;Germany
78	EUCTR2014-005630-60-AT (EUCTR)	12/04/2016	04/12/2015	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT	Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.)	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
79	NCT02764125 (ClinicalTrials.gov)	April 8, 2016	13/1/2016	Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)	Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off	Parkinson's Disease	Drug: Stalevo;Drug: levodopa MR	Orion Corporation, Orion Pharma	NULL	Completed	30 Years	N/A	All	84	Phase 2	Finland;Germany;Hungary;Latvia
80	EUCTR2015-004507-23-LV (EUCTR)	15/03/2016	13/01/2016	Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.	Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC	Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]	Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Hungary;Finland;Germany;Latvia
81	NCT02683629 (ClinicalTrials.gov)	February 2016	8/2/2016	Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease	A Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease	Parkinson's Disease	Biological: NTCELL Implantation;Other: Sham Surgery	Living Cell Technologies	Statistecol Consultants Limited	Completed	40 Years	65 Years	All	18	Phase 2	New Zealand
82	NCT03258294 (ClinicalTrials.gov)	January 13, 2016	20/8/2017	Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease	Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial	Parkinson's Disease	Drug: Melatonin(Circadin®);Drug: Placebo Oral Tablet	KIMJisun	Kuhnil Pharmaceutical Co., Ltd.	Enrolling by invitation	55 Years	N/A	All	82	Phase 4	NULL
83	NCT02549573 (ClinicalTrials.gov)	January 2016	9/9/2015	Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®	Outpatient Physical Therapy Intervention in Subjects With Parkinson's DiseaseCurrently Using APOKYN®: A Phase IV Study of Outcome Assessments of Physical Therapy in Subjects in an On Versus End-of-Dose-Off Motor State	Parkinson's Disease;Motor Symptoms	Drug: APOKYN;Behavioral: Physical Therapy	US WorldMeds LLC	NULL	Terminated	18 Years	78 Years	All	13	Phase 4	United States
84	NCT02768077 (ClinicalTrials.gov)	January 2016	9/5/2016	Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease	Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial	Parkinson's Disease	Drug: Melatonin(Circadin®);Drug: Placebo	Kuhnil Pharmaceutical Co., Ltd.	NULL	Enrolling by invitation	55 Years	N/A	Both	100	Phase 4	NULL
85	EUCTR2014-005630-60-ES (EUCTR)	11/12/2015	05/10/2015	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD	Parkinson´s Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT	Biotie Therapies Inc.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
86	EUCTR2014-005630-60-DE (EUCTR)	29/10/2015	07/07/2015	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT	Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.)	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
87	NCT02549092 (ClinicalTrials.gov)	October 26, 2015	11/9/2015	A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)	An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS Study	Advanced Parkinson's Disease	Drug: Optimized Medical Treatment;Drug: Levodopa-Carbidopa Intestinal Gel;Device: Nasojejunal (NJ) tube;Device: Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube	AbbVie	NULL	Completed	30 Years	N/A	All	89	Phase 3	United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden
88	EUCTR2015-003045-26-SE (EUCTR)	23/10/2015	15/09/2015	Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease.	[18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease.	Patients with newly clinically diagnosed untreated idiopathic parkinsonism MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: [18F]FE-PE2I INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane Trade Name: DaTSCAN INN or Proposed INN: IOFLUPANE (123I) Product Name: 15O H2O INN or Proposed INN: [15O]H2O	Umeå University Hospital	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	Sweden
89	EUCTR2014-005630-60-CZ (EUCTR)	23/09/2015	10/07/2015	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD	Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT	Biotie Therapies Inc. (a wholly owned subsidiary of Acorda Therapeutics Inc.)	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
90	EUCTR2014-005630-60-IT (EUCTR)	23/09/2015	17/01/2022	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD)	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD	Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Tozadenant Product Code: SYN115 Other descriptive name: TOZADENANT	BIOTIE THERAPIES INC.	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Czech Republic;Canada;Spain;Austria;Germany;Italy
91	NCT02554734 (ClinicalTrials.gov)	August 2015	10/6/2015	Pharmacokinetic Study in Healthy Volunteers	Pharmacokinetics of Levodopa After Repeated Doses of Carbidopa, ODM-104 and Levodopa: an Open, Randomised Study With Crossover Design in Healthy Males and Females	Parkinson's Disease	Drug: levodopa, carbidopa, ODM-104;Drug: levodopa, carbidopa, entacapone	Orion Corporation, Orion Pharma	NULL	Completed	18 Years	65 Years	Both	15	Phase 1	Finland
92	NCT02453386 (ClinicalTrials.gov)	July 2015	21/5/2015	Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD)	Idiopathic Parkinson's Disease	Drug: tozadenant;Drug: placebo	Biotie Therapies Inc.	NULL	Terminated	30 Years	80 Years	All	449	Phase 3	United States;Austria;Canada;Czechia;Germany;Italy;Spain;Czech Republic
93	NCT02448914 (ClinicalTrials.gov)	May 2015	12/5/2015	A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients	A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease	Parkinson's Disease	Drug: TRIGEL;Drug: Duodopa	LobSor Pharmaceuticals AB	TFS Trial Form Support	Completed	30 Years	N/A	All	11	Phase 1	Sweden
94	NCT02418598 (ClinicalTrials.gov)	April 14, 2015	12/4/2015	AADC Gene Therapy for Parkinson's Disease	A Phase I /II Study of Intra-putaminal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase in Subjects With Parkinson's Disease	Parkinson Disease	Genetic: Cohort1;Genetic: Cohort2	Jichi Medical University	Takara Bio Inc.;Gene Therapy Research Institution,Co.,Ltd.	Terminated	35 Years	75 Years	All	2	Phase 1/Phase 2	Japan
95	NCT02066571 (ClinicalTrials.gov)	March 2015	18/2/2014	Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease	A Phase II, Double-Blind, Placebo-Controlled, Crossover Study to Assess Clinical Benefit and Safety of Droxidopa in the Treatment of Parkinson's Disease	Parkinson's Disease;Freezing of Gait;Cognitive Ability, General	Drug: Droxidopa;Drug: sugar pill	Henry Ford Health System	NULL	Enrolling by invitation	30 Years	N/A	Both	20	Phase 2	United States
96	NCT02452606 (ClinicalTrials.gov)	March 2015	14/5/2015	Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease	Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease	Parkinson Disease;Sleep Disorders	Drug: Stalevo®	Asan Medical Center	NULL	Recruiting	20 Years	79 Years	Both	100	N/A	Korea, Republic of
97	NCT02138682 (ClinicalTrials.gov)	July 2014	24/4/2014	Validation of DaTscan for Detection of Parkinson Disease Related Disorders	Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue	Parkinson Disease;Movement Disorders	Drug: l-123 Ioflupane	Wisconsin Institute for Neurologic and Sleep Disorders S.C.	Wisconsin Parkinson Association;Medical College of Wisconsin;GE Healthcare	Enrolling by invitation	75 Years	N/A	Both	20		United States
98	NCT02174250 (ClinicalTrials.gov)	June 2014	24/6/2014	The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.	Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects	Parkinson's Disease	Drug: Istradefylline 40 mg;Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 only	Kyowa Hakko Kirin Pharma, Inc.	NULL	Completed	18 Years	65 Years	Both	20	Phase 1	United States
99	NCT02103894 (ClinicalTrials.gov)	February 2014	12/2/2014	Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects	Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy Subjects	Alzheimer's Disease (AD);Parkinson's Disease (PD);Chronic Traumatic Encephalopathy (CTE);Progressive Supranuclear Palsy (PSP);Frontal Temporal Dementia (FTD);Pick's Disease;Tauopathies	Drug: [18F]T807 ([18F]MNI-777)	Molecular NeuroImaging	Institute for Neurodegenerative Disorders	Completed	18 Years	85 Years	Both	16	Phase 1	United States
100	EUCTR2013-002545-10-SE (EUCTR)	08/01/2014	11/11/2013	An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.	An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. - OSU6162Open1309	Parkinsons diseaseHuntingtons diseaseMultiple sclerosBrain traumaStrokeMyalgic encephalomyelitisNarcolepsy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: OSU6162 similar to (-)-OSU 6162	A. Carlsson Research AB	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Sweden
101	NCT04928079 (ClinicalTrials.gov)	January 1, 2014	9/6/2021	6-year Follow-up of Dysphagia in Patients With Parkinson's Disease	6-year Follow-up of Dysphagia in Patients With Parkinson's Disease	Parkinson Disease;Dysphagia	Procedure: deep brain stimulation;Drug: Anti-Parkinsonian Drugs	Second Affiliated Hospital, School of Medicine, Zhejiang University	NULL	Enrolling by invitation	N/A	N/A	All	116		NULL
102	EUCTR2011-004438-32-DE (EUCTR)	23/10/2013	13/08/2013	The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying	A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC	Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 16.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040	GlaxoSmithKline Research and Development Limited	NULL	Not Recruiting			Female: yes Male: yes	70		Australia;Germany;United Kingdom;Sweden
103	NCT02263235 (ClinicalTrials.gov)	October 8, 2013	18/9/2014	In Vivo Alzheimer Proteomics	Use of Targeted Quantitative Proteomics and Metabolic Labelling With Stable Isotopes for the Diagnosis and the Investigation of Neurological Disorders and in Particular Alzheimer Disease	Probable Alzheimer Disease;Parkinson Disease;Neurological Disease Without Cognitive Degradation;Brain Trauma;Acute Hydrocephaly	Biological: administration of stable isotope-labelled leucine-;Other: collection of CSF, blood, urine, saliva	University Hospital, Montpellier	Assistance Publique - Hôpitaux de Paris;University Hospital, Clermont-Ferrand;International Atomic Energy Agency	Terminated	55 Years	85 Years	All	89	N/A	France
104	EUCTR2013-001881-40-GB (EUCTR)	16/09/2013	05/08/2013	Extension study to Assess the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD)	An Extension Study to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via onvection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease	Parkinson's disease MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Glial Cell Line-Derived Neurotrophic Factor (GDNF) INN or Proposed INN: Liatermin Other descriptive name: r-metHuGDNF	North Bristol NHS Trust (NBT)	NULL	Not Recruiting			Female: yes Male: yes	42	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
105	EUCTR2011-004438-32-SE (EUCTR)	26/08/2013	01/07/2013	The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying	A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC	Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 16.0;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040	GlaxoSmithKline Research and Development Limited	NULL	Not Recruiting			Female: yes Male: yes	70		Australia;Germany;United Kingdom;Sweden
106	NCT01621581 (ClinicalTrials.gov)	March 13, 2013	14/6/2012	AAV2-GDNF for Advanced Parkinson s Disease	A Phase 1 Open-Label Dose Escalation Safety Study of Convection Enhanced Delivery (CED) of Adeno-Associated Virus Encoding Glial Cell Line-Derived Neurotrophic Factor (AAV2-GDNF) in Subjects With Advanced Parkinson's Disease.	Parkinson's Disease	Genetic: Convection enhanced delivery/AAV2-GDNF	National Institute of Neurological Disorders and Stroke (NINDS)	NULL	Completed	18 Years	N/A	All	25	Phase 1	United States
107	NCT01736176 (ClinicalTrials.gov)	March 2013	27/11/2012	A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease	An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease	Advanced Parkinson's Disease	Drug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets	AbbVie (prior sponsor, Abbott)	NULL	Completed	30 Years	N/A	All	39	Phase 3	United States
108	NCT03652363 (ClinicalTrials.gov)	October 25, 2012	21/8/2018	GDNF in ideopathicParkinsons Disease	A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal (GDNF) Infusions Administered Via Convection Enhanced Delivery (CED) in Subjects With Parkinson&Apos;s Disease	Idiopathic Parkinson Disease	Drug: glial cell line-derived neurotrophic factor	North Bristol NHS Trust	NULL	Completed	35 Years	75 Years	All	42	Phase 2	NULL
109	EUCTR2011-003866-34-GB (EUCTR)	24/09/2012	01/05/2012	Assessing the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD)	A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease	Parkinson's disease MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Glial Cell Line-Derived Neurotrophic Factor (GDNF) INN or Proposed INN: Liatermin Other descriptive name: r-metHuGDNF	North Bristol NHS Trust (NBT)	NULL	Not Recruiting			Female: yes Male: yes	42	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
110	EUCTR2011-003053-25-GB (EUCTR)	18/06/2012	01/05/2012	The ReSPonD Study -Rivastigmine to Stabilise gait in Parkinson’s Disease. A study looking at whether Rivastigmine, a drug that can augment mental function, can stabilise walking in people with Parkinson's disease who have fallen.	A randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen. - ReSPonD Study - Rivastigmine to Stabilise gait in Parkinson’s Disease	Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Exelon ® Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine	Research and Enterprise Department	NULL	Not Recruiting			Female: yes Male: yes	130	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
111	JPRN-UMIN000008057	2012/06/01	06/06/2012	Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease	Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease - Effect of enteral formula enriched with omega-3 fatty acid in patients with Parkinson's Disease	Parkinson's Disease	Daily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively.	St. Mariannna University School of Medicine	NULL	Complete: follow-up complete	35years-old	80years-old	Male and Female	25	Not applicable	Japan
112	EUCTR2011-004438-32-GB (EUCTR)	25/04/2012	18/04/2012	The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying	A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC	Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 20.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040	GlaxoSmithKline Research and Development Limited	NULL	Not Recruiting			Female: yes Male: yes	70	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	Germany;United Kingdom;Sweden
113	EUCTR2011-005054-59-RO (EUCTR)	21/02/2012	13/06/2013	SYN115 in Parkinson’s disease	A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off - (none)	Parkinson’s disease MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: SYN115 Tablets, 60 mg Product Code: SYN115 INN or Proposed INN: tozadenant Other descriptive name: tozadenant	Biotie Therapies Inc.	NULL	Not Recruiting			Female: yes Male: yes	400		United States;Canada;Argentina;Ukraine;Romania;Chile
114	NCT02170376 (ClinicalTrials.gov)	September 2011	19/6/2014	The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics	The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects	Parkinson's Disease (PD)	Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa/carbidopa	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	80	Phase 1	France
115	EUCTR2010-021860-13-BG (EUCTR)	04/08/2011	02/06/2011	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
116	EUCTR2010-021860-13-IT (EUCTR)	25/07/2011	29/03/2012	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF` PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF`PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson`s Disease (PD) and end-of-dose motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Comtan® INN or Proposed INN: NA	BIAL - PORTELA & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina
117	EUCTR2010-021860-13-CZ (EUCTR)	24/06/2011	09/11/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
118	EUCTR2010-022200-46-LV (EUCTR)	21/06/2011	01/04/2011	Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease.	Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC	Parkinson's disease MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Finland;Lithuania;Germany;Latvia
119	EUCTR2009-015162-57-ES (EUCTR)	23/05/2011	31/03/2011	Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153)	Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153)	Enfermedad de Parkinson MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	750	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Czech Republic;Poland;Bulgaria;Latvia;Netherlands;Sweden
120	EUCTR2010-022200-46-FI (EUCTR)	13/05/2011	23/03/2011	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC	Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Finland;Germany;Latvia;Lithuania
121	EUCTR2010-022200-46-LT (EUCTR)	09/05/2011	05/04/2011	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC	Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Finland;Lithuania;Germany;Latvia
122	NCT01766258 (ClinicalTrials.gov)	May 2011	22/11/2012	Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations	Efficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations	Parkinson's Disease	Drug: ODM-101 65mg Carbidopa;Drug: ODM-101 105mg Carbidopa;Drug: Stalevo	Orion Corporation, Orion Pharma	NULL	Completed	30 Years	N/A	Both	117	Phase 2	NULL
123	EUCTR2010-021860-13-DE (EUCTR)	09/03/2011	18/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
124	NCT01283594 (ClinicalTrials.gov)	March 2011	24/1/2011	Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off	A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off	Parkinson's Disease	Drug: Tozadenant (SYN115) 60 mg BID;Drug: Placebo;Drug: Levodopa (L-dopa);Drug: Tozadenant (SYN115) 120 mg BID;Drug: Tozadenant (SYN115) 180 mg BID;Drug: Tozadenant (SYN115) 240 mg BID	Biotie Therapies Inc.	NULL	Completed	30 Years	80 Years	All	420	Phase 2/Phase 3	United States;Argentina;Canada;Chile;Romania;Ukraine
125	NCT01568073 (ClinicalTrials.gov)	March 2011	29/3/2012	Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon	Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study	Parkinson's Disease	Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide	Bial - Portela C S.A.	NULL	Completed	30 Years	83 Years	All	600	Phase 3	Portugal;Austria
126	EUCTR2010-021394-37-ES (EUCTR)	17/02/2011	22/12/2010	Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976	Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976	Enfermedad de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: NEUPRO 2 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 4 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 6 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 8 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	345	Phase 4	Czech Republic;Hungary;Slovakia;Belgium;Spain;Austria;Bulgaria;Germany;Italy
127	EUCTR2010-021860-13-SK (EUCTR)	17/02/2011	09/12/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
128	NCT01296464 (ClinicalTrials.gov)	February 2011	14/2/2011	Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens	Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms	Parkinson's Disease	Drug: Carbidopa	Orion Corporation, Orion Pharma	NULL	Completed	30 Years	N/A	Both	27	Phase 2	Finland;Sweden
129	NCT02880033 (ClinicalTrials.gov)	February 2011	3/8/2016	Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes	Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis	Parkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron Overload	Drug: deferiprone;Drug: placebo	University Hospital, Lille	NULL	Completed	18 Years	80 Years	All	90	N/A	France
130	EUCTR2010-021860-13-AT (EUCTR)	27/01/2011	11/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Germany;Latvia;Netherlands;Bosnia and Herzegovina
131	EUCTR2010-021860-13-RO (EUCTR)	27/01/2011	25/07/2011	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
132	EUCTR2010-021860-13-ES (EUCTR)	24/01/2011	27/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
133	EUCTR2010-022915-21-SE (EUCTR)	12/01/2011	18/11/2010	Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST	Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST	Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	27		Finland;Sweden
134	EUCTR2010-022915-21-FI (EUCTR)	10/01/2011	11/11/2010	Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST	Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST	Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	27		Finland;Sweden
135	EUCTR2010-021860-13-LV (EUCTR)	22/12/2010	14/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
136	EUCTR2010-021860-13-PT (EUCTR)	22/12/2010	08/11/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
137	NCT01244269 (ClinicalTrials.gov)	December 2010	18/11/2010	The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.	Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease.	Parkinson's Disease	Drug: Methylphenidate;Drug: Placebo 10;Drug: Placebo 20	Laval University	Fonds de la Recherche en Santé du Québec;Quebec Memory and Motor Skills Disorders Research Center	Terminated	N/A	75 Years	Both	6	Phase 4	Canada
138	EUCTR2010-021860-13-LT (EUCTR)	30/11/2010	28/09/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina
139	EUCTR2010-020109-34-ES (EUCTR)	29/11/2010	23/09/2010	Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.	Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.	Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamida Product Code: NW-1015 Other descriptive name: Safinamida	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Spain;Italy
140	EUCTR2010-021860-13-HU (EUCTR)	11/11/2010	27/09/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
141	EUCTR2009-013552-72-ES (EUCTR)	26/10/2010	27/07/2010	Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE	Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE	Enfermendad de Parkinson MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagilina mesilato Other descriptive name: RASAGILINA MESILATO	Schering Corporation, división Schering-Plough Research	NULL	Not Recruiting			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
142	EUCTR2009-017238-39-DE (EUCTR)	16/09/2010	28/07/2010	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease	Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 3	France;Belgium;Germany;Italy
143	EUCTR2009-017238-39-FR (EUCTR)	15/09/2010	09/07/2010	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease	Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 3	France;Belgium;Germany;Italy
144	EUCTR2009-017238-39-BE (EUCTR)	27/08/2010	14/07/2010	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease	Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Nacom 100 INN or Proposed INN: CARBIDOPA	Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 3	France;Belgium;Germany;Italy
145	EUCTR2010-020769-25-FR (EUCTR)	10/08/2010	09/07/2010	Evaluation médico-économique de l’infusion continue intra-duodénale d’une forme gélifiée de levodopa dans le traitement des formes avancées et sévères de maladie de parkinson par l’intermédiaire d’un dispositif médical	Evaluation médico-économique de l’infusion continue intra-duodénale d’une forme gélifiée de levodopa dans le traitement des formes avancées et sévères de maladie de parkinson par l’intermédiaire d’un dispositif médical	Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated	Trade Name: DUODOPA INN or Proposed INN: LEVODOPA/CARBIDOPA INN or Proposed INN: LEVODOPA/BENZERASIDE INN or Proposed INN: PERGOLIDE INN or Proposed INN: LISURIDE INN or Proposed INN: BROMOCRIPTINE INN or Proposed INN: ROPINIROLE INN or Proposed INN: PRAMIPEXOLE INN or Proposed INN: IPRONIAZID Other descriptive name: MOCLOBEMIDE INN or Proposed INN: AMANTADINE INN or Proposed INN: CLOZAPINE INN or Proposed INN: SELEGILINE INN or Proposed INN: RASAGILINE INN or Proposed INN: ENTACAPONE INN or Proposed INN: TOLCAPONE	CHU de Poitiers	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
146	EUCTR2009-017182-38-ES (EUCTR)	26/07/2010	25/05/2010	Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease.	Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease.	Enfermedad de Parkinson idiopática (parálisis agitante) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA	Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Estonia;Poland;Spain;Lithuania;Germany;Latvia
147	EUCTR2009-017238-39-IT (EUCTR)	21/06/2010	13/07/2010	A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND	A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND	Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA LEVODOPA Trade Name: NACOM 100 INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone	IMPAX LABORATORIES, INC.	NULL	Not Recruiting			Female: yes Male: yes	56		Germany;France;Italy
148	EUCTR2010-019396-29-IT (EUCTR)	18/05/2010	05/03/2012	Levodopa and Pramipexole dministration modalities in patients affected by parkinson desease.	Levodopa Administration Modalities and Pramipexole in Parkinson's Disease (LAMP-PD study) A multicenter, randomized, four parallel groups, active-controlled, open-label study to evaluate the risk of dyskinesia in early PD. - LAMP-PD	Patients with idiopathic Parkinson's Disease.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: STALEVO*100CPR 50/12,5/200MG INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor Trade Name: STALEVO*100CPR 100/25/200MG INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor	AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO-VITTORIO EMANUELE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
149	JPRN-UMIN000003601	2010/05/01	18/05/2010	Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients	Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients - ROPENT trial	Parkinson's disease	Increase dosage of ropinirole Addition of entacapone	Kansai Medical University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	30	Not selected	Japan
150	NCT01130493 (ClinicalTrials.gov)	May 2010	24/5/2010	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066	A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease	Parkinson's Disease	Drug: IPX066;Drug: CLE	Impax Laboratories, LLC	NULL	Completed	30 Years	N/A	All	110	Phase 3	United States;France;Germany;Italy
151	EUCTR2009-017416-33-DE (EUCTR)	18/01/2010	21/12/2009	Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.	Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.	Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE	Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University	NULL	Not Recruiting			Female: yes Male: yes			Germany
152	EUCTR2009-014688-37-ES (EUCTR)	30/12/2009	21/10/2009	A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada.	A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada.	Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Sinemet-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA	Impax Laboratories, Inc.	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;France;Spain;Poland
153	NCT01070628 (ClinicalTrials.gov)	December 2009	23/11/2009	Levodopa Concentration Profile With Stalevo 75/125 mg	Levodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel Groups	Parkinson's Disease	Drug: Stalevo (levodopa/ carbidopa/ entacapone);Drug: Sinemet (levodopa/carbidopa)	Orion Corporation, Orion Pharma	NULL	Completed	18 Years	70 Years	Both	20	Phase 1	Finland
154	NCT00660387 (ClinicalTrials.gov)	December 2009	15/4/2008	Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects	A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations	Advanced Parkinson's Disease	Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube	AbbVie (prior sponsor, Abbott)	Quintiles, Inc.	Completed	30 Years	N/A	All	35	Phase 3	United States;New Zealand
155	EUCTR2008-005492-94-ES (EUCTR)	23/11/2009	18/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
156	EUCTR2009-013885-14-ES (EUCTR)	12/11/2009	23/09/2009	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.	A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.	Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson. MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism	Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant	BIOPROJET	NULL	Not Recruiting			Female: yes Male: yes	246	Phase 3	France;Spain
157	NCT01519284 (ClinicalTrials.gov)	November 2009	23/1/2012	Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic	A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects	Parkinson Disease	Drug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa/carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mg	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	82	Phase 1	Portugal
158	EUCTR2009-011541-24-ES (EUCTR)	27/08/2009	26/06/2009	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up	An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up	Parkinson's Disease Enfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: AZILECT 1 mg comprimidos INN or Proposed INN: RASAGILINA MESILATO Other descriptive name: RASAGILINA MESILATO	Teva Pharmaceutical Industries Ltd	NULL	Not Recruiting			Female: yes Male: yes	700	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
159	EUCTR2009-011736-35-FR (EUCTR)	27/07/2009	06/08/2009	Etude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYS	Etude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYS	Maladie de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: LODALÈS® Product Code: simvastatine	CHU de Bordeaux	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	10	Phase 2	France
160	EUCTR2008-004146-88-ES (EUCTR)	16/06/2009	16/04/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
161	NCT00921128 (ClinicalTrials.gov)	June 2, 2009	13/6/2009	Convection-Enhanced Delivery to Study the Pathophysiology Underlying the Clinical Features of Parkinson s Disease	Convection Enhanced Delivery of Muscimol to Study the Pathophysiology Underlying the Clinical Features of Parkinson's Disease	Parkinson's Disease	Drug: Muscimol	National Institute of Neurological Disorders and Stroke (NINDS)	NULL	Withdrawn	18 Years	N/A	All	0	Phase 1	United States
162	EUCTR2008-004447-11-GB (EUCTR)	27/03/2009	07/01/2009	A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease	A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease	Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: entered code. Term in E.1.1>	Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride	Vectura Limited	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	Germany;United Kingdom;Italy
163	EUCTR2008-004906-15-FR (EUCTR)	05/01/2009	16/03/2009	EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson	EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson	Maladie de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: DATSCAN	CHU Toulouse	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
164	NCT00357994 (ClinicalTrials.gov)	January 2009	27/7/2006	Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects	A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations	Advanced Parkinson's Disease	Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube	AbbVie (prior sponsor, Abbott)	Quintiles, Inc.	Completed	30 Years	N/A	All	36	Phase 3	United States;Germany
165	EUCTR2007-000350-31-IT (EUCTR)	02/10/2008	11/02/2008	A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND	A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND	mild to moderately severe dementia associated with Parkinson?s disease (PDD) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	550		France;Spain;Italy
166	NCT00906828 (ClinicalTrials.gov)	October 2008	19/5/2009	Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors	Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors	Parkinson Disease	Drug: levodopa/carbidopa;Drug: entacapone;Drug: tolcapone	Uppsala University	Swedish Parkinson's Disease Foundation;Swedish Society for Medical Research	Completed	30 Years	90 Years	Both	10	Phase 4	Sweden
167	EUCTR2008-003225-16-FI (EUCTR)	10/09/2008	30/05/2008	Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla	Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla	Vaikeahoitoinen Parkinsonin tauti potilailla, joille on aiemmin asetettu aivostimulaattori, tai on päädytty päivittäisten oireiden vuoksi aloittamaan Duodopa-infuusio. MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS	Trade Name: Duodopa	Organisation name was not entered	NULL	Not Recruiting			Female: yes Male: yes			Finland
168	EUCTR2004-005234-39-DE (EUCTR)	11/08/2008	02/12/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	244		Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden
169	NCT00601978 (ClinicalTrials.gov)	August 2008	11/1/2008	Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off	A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off	Parkinson's Disease	Drug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/Entacapone	Novartis Pharmaceuticals	NULL	Withdrawn	45 Years	75 Years	Both	0	Phase 4	United States
170	EUCTR2008-003581-26-SE (EUCTR)	18/07/2008	30/05/2008	Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT	Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT	Parkinson's disease (G20.9), advanced, patients presently on Duodopa treatment. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: Duodopa INN or Proposed INN: levodopa INN or Proposed INN: carbidopa Trade Name: Comtess INN or Proposed INN: entacapone Trade Name: Tasmar INN or Proposed INN: tolcapone	Dept of Neuroscience, Uppsala University	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Sweden
171	EUCTR2008-001336-13-FR (EUCTR)	16/07/2008	09/06/2008	Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2	Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2	Maladie Parkinson MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Nicorette 5 mg/ 16 h Product Name: Nicorette 5 mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 10mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 15 mg/ 16 h INN or Proposed INN: Nicotine	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
172	EUCTR2007-003051-36-ES (EUCTR)	01/07/2008	05/05/2008	Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease	Psicosis en la enfermedad de Parkinson.Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS	Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate	Acadia Pharmaceuticals Inc	NULL	Not Recruiting			Female: yes Male: yes	280		Portugal;Spain;Austria;Sweden
173	EUCTR2007-003134-42-DE (EUCTR)	19/06/2008	20/02/2008	A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.	A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.	Idiopathic Parkinson’s disease and end-of-dose wearing off. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten Product Name: Stalevo INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONE Trade Name: Nacom 100 Product Name: Nacom INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	20		Germany
174	NCT00822913 (ClinicalTrials.gov)	June 2008	14/1/2009	Botulinum A Toxin in Patients With Parkinson's Disease	The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.	Parkinson's Disease;Multiple System Atrophy;Detrusor Overactivity	Drug: Intravesical injection of Botulinum A toxin	University Of Perugia	University of Roma La Sapienza	Enrolling by invitation	18 Years	80 Years	Both	20	Phase 4	NULL
175	NCT00642356 (ClinicalTrials.gov)	March 2008	19/3/2008	Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off	An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off	Parkinson's Disease	Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa	Novartis	NULL	Terminated	30 Years	85 Years	All	14	Phase 4	United States
176	EUCTR2007-000350-31-ES (EUCTR)	13/02/2008	21/12/2007	Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP)	Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP)	Demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease	Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine	Novartis Farmacéutica S.A	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 3	France;Spain;Italy
177	EUCTR2007-004235-37-ES (EUCTR)	24/01/2008	08/03/2010	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD	Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD	Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	390	Phase 3	Hungary;Czech Republic;Slovakia;Poland;Spain;Austria;Italy;United Kingdom;Sweden
178	EUCTR2006-005186-18-ES (EUCTR)	23/01/2008	29/11/2007	Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas	Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas	Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severas MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid	Solvay Pharmaceuticals B.V.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
179	EUCTR2007-002964-90-ES (EUCTR)	18/01/2008	30/11/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	1121	Phase 3	France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom
180	EUCTR2007-002963-28-ES (EUCTR)	17/01/2008	16/11/2007	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	1036	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
181	NCT00562198 (ClinicalTrials.gov)	January 2008	19/11/2007	PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding	Effects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg on Striatal 11C-Raclopride Binding Potential in Parkinson's Disease Patients With Wearing-Off Symptoms;an Open, Randomised, Active-Controlled,Two-Period Crossover Study.	Parkinson´s Disease	Drug: entacapone and carbidopa;Drug: Sinemet 200mg/50mg	Orion Corporation, Orion Pharma	NULL	Terminated	45 Years	80 Years	Both	16	Phase 2	Finland
182	EUCTR2007-004400-12-ES (EUCTR)	27/12/2007	03/01/2008	ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy	ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy	Apatía en la Enfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Azilect INN or Proposed INN: RASAGILINE	Institut de Recerca de l'Hospital de la santa Creu i Sant Pau	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
183	EUCTR2004-000185-12-GB (EUCTR)	13/12/2007	11/02/2005	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	740	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Finland;Austria;Italy;United Kingdom;Sweden
184	EUCTR2007-000801-30-ES (EUCTR)	29/11/2007	12/09/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras	Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	726	Phase 3	France;Hungary;Estonia;Czech Republic;Poland;Spain;Lithuania;Latvia;Italy
185	EUCTR2007-002496-14-FI (EUCTR)	05/11/2007	14/09/2007	Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study.	Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study.	Parkinson’s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Stalevo® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Product Name: 11C-Raclopride Other descriptive name: 11C-Raclopride	Orion Corporation Orion Pharma	NULL	Not Recruiting			Female: yes Male: yes			Finland
186	ChiCTR-TRC-07000027	2007-11-01	2007-11-09	A randomized controlled clinical study of Pramipexole for Parkinson's disease	A randomized controlled clinical study of Pramipexole for Parkinson's disease	Primary Parkinson's disease	Group 1:Artane oral 1-2mg, tid,+ Mirapexin, 0.25 mg/d at beginning, and add to 1.0 mg/d at the end of the second week; the dose will be added from the second weekend to the eighth week to 4. 5 mg/d(1.5 mg, tid); maintain the dose during 12 weeks and reduce the dose during 1-4weeks;Group 3:Artane oral 1-2mg, tid + Madopar, 62.5~500 mg, 2~4 times a day depends on the serious of disease + Mirapexin, the dose is same as group 1;Group 2:Artane oral 1-2mg, tid+ Benserazide-Levodopa (Madopar), oral 62.5~500 mg, 2~4 times a day depends on the serious of the disease;	First Affiliated Hospital of Xinjiang Medical University	NULL	Completed	30	80	Both	Group 1:45;Group 3:45;Group 2:45;		China
187	NCT00547911 (ClinicalTrials.gov)	October 2007	19/10/2007	Augmenting Effects of L-DOPS With Carbidopa and Entacapone	L-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and Entacapone	Parkinson Disease;Multiple System Atrophy;Autonomic Nervous System Diseases	Drug: Droxidopa;Drug: Carbidopa;Drug: Entacapone	National Institute of Neurological Disorders and Stroke (NINDS)	NULL	Terminated	18 Years	N/A	All	14	Phase 1/Phase 2	United States
188	EUCTR2006-002937-20-HU (EUCTR)	20/09/2007	17/05/2007	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
189	EUCTR2006-005318-11-FR (EUCTR)	06/07/2007	10/05/2007	Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons.	Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons.	maladie de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Trade Name: APOKINON	CHU Toulouse	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
190	EUCTR2006-006684-22-FR (EUCTR)	08/06/2007	27/03/2007	Evaluation des effets à long terme de l’amantadine chez le parkinsonien souffrant de dyskinésies induites par la lévodopa : Etude randomisée en double-insu versus placebo de l’arrêt d’une prescription chronique. - AMANDYSK	Evaluation des effets à long terme de l’amantadine chez le parkinsonien souffrant de dyskinésies induites par la lévodopa : Etude randomisée en double-insu versus placebo de l’arrêt d’une prescription chronique. - AMANDYSK	maladie de parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10013916;Term: Dyskinesia	Trade Name: MANTADIX	CHU Toulouse	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
191	EUCTR2007-000074-23-ES (EUCTR)	29/05/2007	02/03/2010	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+.	A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+.	Pacientes varones o mujeres, diagnosticados de enfermedad de Parkinson idiopática, al menos dos años antes, con 30 años o más de edad en el momento del diagnóstico, con un estadío entre 2 y 4 en la escala modificada de Hoehn y Yahr en el periodo on.Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	516	Phase 3	Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden
192	EUCTR2006-006907-35-ES (EUCTR)	27/05/2007	27/03/2007	EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER	EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER	Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
193	EUCTR2006-006752-35-ES (EUCTR)	27/05/2007	27/03/2007	RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover	RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover	Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine	Schwarz Biosciences GmbH	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
194	EUCTR2006-002937-20-ES (EUCTR)	27/04/2007	26/04/2007	Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras	Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras	Enfermedad de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
195	EUCTR2006-002339-26-ES (EUCTR)	19/04/2007	30/01/2007	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras.	A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras.	Levodopa treated Parkinson's disease patients with motor fluctuations.Pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: MARS Product Code: E2007	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	1400		Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
196	EUCTR2006-002937-20-FR (EUCTR)	12/03/2007	12/02/2007	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702	Phase 3	France;Hungary;Czech Republic;Estonia;Spain;Lithuania;Latvia;Italy
197	EUCTR2006-005714-12-IT (EUCTR)	27/02/2007	03/08/2007	A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213	A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213	Patients with idiopathic Parkinson's disease who respond to levodopa treatment but who experience peak-effect levodopa-induced dyskinesia and end-of-dose 'wearing-off' motor fluctuations MedDRA version: 6.1;Level: HLT;Classification code 10034005	Product Name: E2007 Product Code: E2007 INN or Proposed INN: OTHER NERVOUS SYSTEM DRUGS Trade Name: SINEMET INN or Proposed INN: levodopa-carbidopa	EISAI LTD UK	NULL	Not Recruiting			Female: yes Male: yes	24		Italy
198	EUCTR2006-002408-32-ES (EUCTR)	27/02/2007	07/02/2007	Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa.	Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa.	Fluctuaciones motoras, cognitivas y del humor en la enfermedad de Parkinson. MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo 150 Product Name: Levodopa-carbidopa-entacapone Trade Name: Sinemet Product Name: Levodopa/Carbidopa	Institut de Recerca del Hospital de la Santa Creu i Sant Pau	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20		Spain
199	NCT00427011 (ClinicalTrials.gov)	February 2007	24/1/2007	A Study of E2007 In Patients With Parkinson's Disease	A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing-Off Motor Fluctuations	Parkinson's Disease	Drug: E2007	Eisai Inc.	NULL	Terminated	18 Years	N/A	All	25	Phase 2	United States
200	EUCTR2005-000314-12-DE (EUCTR)	19/12/2006	25/01/2007	Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI	Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI	Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006	Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil	Institut de Recherches Internationales Servier	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Spain;Germany
201	EUCTR2006-002937-20-CZ (EUCTR)	14/12/2006	24/10/2006	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
202	EUCTR2006-002937-20-EE (EUCTR)	11/12/2006	19/10/2006	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
203	EUCTR2006-002937-20-LT (EUCTR)	04/12/2006	02/11/2006	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
204	EUCTR2006-001755-36-GB (EUCTR)	20/11/2006	29/09/2006	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone	Orion Corporation Orion Pharma	NULL	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Germany;United Kingdom;Sweden
205	EUCTR2006-001793-24-PT (EUCTR)	07/11/2006	31/07/2006	A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available	A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available	Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536	Product Name: Nebicapone Product Code: BIA 3-202 Trade Name: COMTAN® Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202	BIAL - Portela & Cª, SA	NULL	Not Recruiting			Female: yes Male: yes	250		Portugal;Austria
206	EUCTR2006-004582-33-GB (EUCTR)	03/11/2006	23/01/2012	A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease	A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease	Hypomobility (off or freezing) episodes associated with advanced Parkinson's disease	Product Name: Apomorphine hydrochloride Product Code: VR040	Vectura Group plc	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	United Kingdom
207	EUCTR2006-002937-20-LV (EUCTR)	01/11/2006	02/11/2006	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations	Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone	Eisai Limited	NULL	Not Recruiting			Female: yes Male: yes	702		Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
208	NCT00491998 (ClinicalTrials.gov)	November 2006	26/6/2007	PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets	Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets	Parkinson's Disease	Drug: V1512;Drug: V1512 and Entacapone	Vernalis (R&D) Ltd	Cita NeuroPharmaceuticals;INC Research	Completed	30 Years	N/A	Both	27	Phase 1/Phase 2	Italy
209	NCT00360308 (ClinicalTrials.gov)	November 2006	2/8/2006	Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations	A Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations	Parkinson's Disease	Drug: Placebo;Drug: E2007	Eisai Limited	NULL	Terminated	30 Years	N/A	All	723	Phase 3	France
210	NCT00373087 (ClinicalTrials.gov)	October 2006	6/9/2006	COMT Polymorphism and Entacapone Efficacy	Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease	Parkinson's Disease	Drug: entacapone;Drug: l dopa versus placebo	Assistance Publique - Hôpitaux de Paris	NULL	Completed	30 Years	N/A	Both	60	Phase 4	France
211	NCT00391898 (ClinicalTrials.gov)	October 2006	24/10/2006	Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off	A 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With Levodopa	Parkinson's Disease	Drug: Levodopa/carbidopa/entacapone;Drug: Levodopa/carbidopa	Novartis	NULL	Completed	30 Years	80 Years	All	95	Phase 4	Spain
212	EUCTR2004-005234-39-LV (EUCTR)	06/09/2006	29/09/2006	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	244		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
213	EUCTR2006-001755-36-SE (EUCTR)	09/08/2006	30/06/2006	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone	Orion Corporation Orion Pharma, FI-02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	100		United Kingdom;Germany;Sweden
214	EUCTR2006-001793-24-AT (EUCTR)	31/07/2006	24/07/2006	A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available	A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available	Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536	Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202	BIAL - Portela & Cª, SA	NULL	Not Recruiting			Female: yes Male: yes	250		Portugal;Austria
215	EUCTR2006-000680-28-ES (EUCTR)	07/07/2006	22/05/2006	Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI	Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI	Enfermedad de Parkinson (Parkinson Disease)	Trade Name: Stalevo 100 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA Trade Name: Sinemet plus Product Name: Sinemet plus (levodopa/carbidopa) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Stalevo 150 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA	NOVARTIS FARMACEUTICA, S.A	NULL	Not Recruiting			Female: yes Male: yes	200		Spain
216	EUCTR2005-004949-34-ES (EUCTR)	29/05/2006	21/04/2006	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study	A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study	Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536	Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	500		Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
217	EUCTR2004-005234-39-LT (EUCTR)	09/05/2006	24/03/2006	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	244		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania
218	NCT03094156 (ClinicalTrials.gov)	April 26, 2006	23/3/2017	Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics	A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg	Parkinson Disease	Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan®	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	39	Phase 1	Portugal
219	EUCTR2005-001032-72-PT (EUCTR)	23/03/2006	11/11/2005	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step	Parkinson disease	Trade Name: Stalevo Product Code: ELC200 INN or Proposed INN: levodopa/carbidopa/entacapone Trade Name: SINEMET Product Name: sinemet INN or Proposed INN: levodopa/carbidopa	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	424		Portugal;Czech Republic;Italy
220	NCT00141518 (ClinicalTrials.gov)	March 2006	30/8/2005	Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact	A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia	Advanced Idiopathic Parkinson's Disease	Drug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube)	AbbVie (prior sponsor, Abbott)	NULL	Completed	18 Years	99 Years	All	77	Phase 4	Norway;Sweden
221	EUCTR2005-003788-22-ES (EUCTR)	09/02/2006	28/12/2005	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos	A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms	Trade Name: Mirapexin / Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole	Boehringer Ingelheim España S.A.	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 4	Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
222	EUCTR2005-001032-72-IT (EUCTR)	25/11/2005	26/03/2007	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa.	A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa.	Parkinson s Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Trade Name: Stalevo INN or Proposed INN: ENTACAPONE INN INN or Proposed INN: LEVODOPA INN INN or Proposed INN: CARBIDOPA INN Trade Name: Sinemet INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA ANIDRA	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	424		Portugal;Czech Republic;Italy
223	EUCTR2004-005234-39-IE (EUCTR)	20/10/2005	16/08/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
224	EUCTR2005-000314-12-ES (EUCTR)	14/10/2005	08/09/2005	Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI	Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI	Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006	Product Name: piribedil Product Code: S 90049 - F36 INN or Proposed INN: piribedil Product Name: piribedil Product Code: S 90049 - F38 INN or Proposed INN: piribedil	Institut de Recherches Internationales Servier	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Spain;Germany
225	EUCTR2004-005234-39-FI (EUCTR)	22/09/2005	03/06/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA	NULL	Not Recruiting			Female: yes Male: yes	240		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
226	NCT00165789 (ClinicalTrials.gov)	September 2005	12/9/2005	A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations	A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations	Parkinson's Disease	Drug: E2007	Eisai Inc.	NULL	Completed	18 Years	N/A	All	75	Phase 2	United States
227	EUCTR2004-005234-39-DK (EUCTR)	04/08/2005	31/05/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	240		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
228	NCT00125567 (ClinicalTrials.gov)	August 2005	29/7/2005	Stalevo in Early Wearing-Off Patients	Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off	Idiopathic Parkinson's Disease	Drug: Stalevo (levodopa/carbidopa/entacapone);Drug: Levodopa/carbidopa	Orion Corporation, Orion Pharma	NULL	Completed	30 Years	N/A	Both	223	Phase 4	Denmark;Finland;Germany;Ireland;Sweden;United Kingdom
229	NCT00134966 (ClinicalTrials.gov)	August 2005	23/8/2005	A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa	A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa	Parkinson's Disease	Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)	Novartis	NULL	Completed	30 Years	80 Years	All	493	Phase 3	United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic
230	EUCTR2005-001416-42-ES (EUCTR)	28/07/2005	28/06/2005	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO	A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO	Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536	Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate	Teva Pharmaceuticals Industries LtD	NULL	Not Recruiting			Female: yes Male: yes	1100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
231	NCT00143026 (ClinicalTrials.gov)	July 2005	31/8/2005	Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States	Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.	Parkinson's Disease	Drug: carbidopa, levodopa, entacapone	Novartis	NULL	Completed	30 Years	N/A	All	184	Phase 4	Australia;Philippines;Taiwan;Thailand
232	EUCTR2004-005234-39-SE (EUCTR)	08/06/2005	02/05/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	240		Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
233	EUCTR2004-005234-39-GB (EUCTR)	27/05/2005	22/03/2005	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet	Orion Corporation, ORION PHARMA, Finland	NULL	Not Recruiting			Female: yes Male: yes	240	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
234	EUCTR2004-000817-20-IT (EUCTR)	06/04/2005	13/04/2005	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy	Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: istradefylline Product Code: KW-6002 Other descriptive name: NA Trade Name: COMTAN 200* 60 CPR 200 MG Product Name: NA Product Code: NA INN or Proposed INN: Entacapone	KYOWA HAKKO UK LTD	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Italy;Latvia;Lithuania
235	EUCTR2004-000817-20-AT (EUCTR)	02/02/2005	29/12/2004	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Lithuania;Austria;Latvia;Italy
236	NCT00219284 (ClinicalTrials.gov)	January 2005	30/6/2005	Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease	A Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off	Parkinson's Disease With End of Dose Wearing Off	Drug: Carbidopa/levodopa/entacapone	Novartis Pharmaceuticals	NULL	Completed	30 Years	85 Years	All	359	Phase 4	United States;Puerto Rico
237	EUCTR2004-000817-20-ES (EUCTR)	10/12/2004	04/05/2005	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtan Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Italy;Latvia;Lithuania
238	EUCTR2004-000185-12-IT (EUCTR)	02/12/2004	27/06/2005	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease	Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU)	NOVARTIS FARMA	NULL	Not Recruiting			Female: yes Male: yes	740		Finland;United Kingdom;Italy;Sweden
239	EUCTR2004-000185-12-AT (EUCTR)	25/11/2004	21/10/2004	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name:	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	740		Finland;Austria;Italy;United Kingdom;Sweden
240	EUCTR2004-000185-12-SE (EUCTR)	11/11/2004	03/09/2004	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name:	Orion Corporation, ORION PHARMA, 02200 Espoo, Finland	NULL	Not Recruiting			Female: yes Male: yes	740		Finland;United Kingdom;Italy;Sweden
241	EUCTR2004-000817-20-GB (EUCTR)	08/11/2004	11/02/2005	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405	Phase 3	Spain;Lithuania;Austria;Latvia;Italy;United Kingdom
242	NCT03091868 (ClinicalTrials.gov)	November 3, 2004	21/3/2017	Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics	A Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mg	Parkinson Disease	Drug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mg	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	80	Phase 1	Portugal
243	NCT00199394 (ClinicalTrials.gov)	November 2004	12/9/2005	A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Drug: Istradefylline (KW-6002)	Kyowa Hakko Kirin UK, Ltd.	NULL	Completed	30 Years	N/A	Both	405	Phase 3	United Kingdom
244	NCT00229736 (ClinicalTrials.gov)	November 2004	28/9/2005	A Study of AAV-hAADC-2 in Subjects With Parkinson's Disease	A Phase1 Open Label Safety Study of Intrastriatal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase (AAV-hAADC-2) in Subjects With Parkinson's Disease [AAV-hAADC-2-003]	Parkinson's Disease	Genetic: AAV-hAADC-2	Genzyme, a Sanofi Company	NULL	Completed	40 Years	75 Years	Both	10	Phase 1	United States
245	EUCTR2004-000817-20-LV (EUCTR)	22/10/2004	27/10/2004	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Italy;Latvia;Lithuania
246	EUCTR2004-000185-12-FI (EUCTR)	21/09/2004	23/07/2004	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD	Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536	Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa	Orion Corporation, ORION PHARMA	NULL	Not Recruiting			Female: yes Male: yes	740		Finland;United Kingdom;Italy;Sweden
247	EUCTR2004-000817-20-LT (EUCTR)	16/09/2004	07/01/2005	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.	Parkinson's Disease	Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone	Kyowa Hakko U.K. Limited	NULL	Not Recruiting			Female: yes Male: yes	405		Spain;Italy;Latvia;Lithuania
248	NCT00099268 (ClinicalTrials.gov)	September 2004	10/12/2004	Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy	A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy	Parkinson's Disease	Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa	Novartis Pharmaceuticals	Orion Corporation, Orion Pharma	Completed	30 Years	70 Years	All	747	Phase 3	United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom
249	NCT00211588 (ClinicalTrials.gov)	June 2004	13/9/2005	Galantamine Executive Function in Parkinson's Disease	Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease	Parkinson's Disease	Drug: galantamine	Memorial Hospital of Rhode Island	Ortho-McNeil Neurologics, Inc.	Active, not recruiting	60 Years	85 Years	Both	90	N/A	United States
250	NCT00200447 (ClinicalTrials.gov)	March 2004	12/9/2005	An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)	Assessment of Carbidopa/l-Dopa and Carbidopa/l Dopa/Entacapone on Synaptic Dopamine in Parkinson's Patients: An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)	Parkinson's Disease	Drug: carbidopa/l-dopa;Drug: carbidopa/l-dopa/entacapone;Drug: Stalevo;Procedure: [123I]-IBZM imaging	Molecular NeuroImaging	NULL	Completed	30 Years	N/A	Both	3	Phase 2	NULL
251	NCT00237263 (ClinicalTrials.gov)	February 2003	7/10/2005	An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States	An Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off	Parkinson's Disease	Drug: Entacapone	Novartis	NULL	Completed	20 Years	N/A	All	285	Phase 2	United States
252	EUCTR2008-004447-11-DE (EUCTR)		17/10/2008	A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease	A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease	Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: entered code. Term in E.1.1>	Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride	Vectura Limited	NULL	Not Recruiting			Female: yes Male: yes	66	Phase 2	Germany;Italy;United Kingdom
253	EUCTR2006-001755-36-DE (EUCTR)		15/08/2006	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE	Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone	Orion Corporation Orion Pharma	NULL	Not Recruiting			Female: yes Male: yes	100		United Kingdom;Germany;Sweden
254	EUCTR2010-022200-46-DE (EUCTR)		13/04/2011	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease.	Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC	Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na	Orion Corporation	NULL	Not Recruiting			Female: yes Male: yes	100		Finland;Lithuania;Latvia;Germany

先頭へ

46. 悪性関節リウマチ

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

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05392127 (ClinicalTrials.gov)	July 15, 2022	23/5/2022	A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers	A Single-center, Open-label, Single-arm, Fixed-sequence Study to Evaluate the Pharmacokinetic Effects of SHR0302 Tablets on Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19 in Healthy Volunteers	Rheumatoid Arthritis	Drug: SHR0302 Tablets;Drug: Midazolam Maleate Tablets;Drug: Warfarin Sodium Tablets;Drug: Omeprazole Enteric Capsules;Drug: Vitamin K1 Tablets;Drug: Repaglinide Tablets	Jiangsu HengRui Medicine Co., Ltd.	NULL	Completed	18 Years	45 Years	Male	24	Phase 1	China
2	NCT04688398 (ClinicalTrials.gov)	January 20, 2022	14/12/2020	Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis	Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis	Polyarthritis	Dietary Supplement: Seal oil;Dietary Supplement: Control	Laval University	Ministry of Agriculture, Fisheries and Food, Quebec;Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.	Recruiting	18 Years	N/A	All	130	N/A	Canada
3	NCT04885751 (ClinicalTrials.gov)	June 1, 2021	26/4/2021	Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy	Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study	Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis;Other Musculoskeletal Disorder;Gastric Ulcer;Enteritis;NSAID-Associated Gastropathy;NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy	Drug: Eupatilin;Drug: Rebamipide	Seoul National University Boramae Hospital	Dong-A ST Co., Ltd.	Not yet recruiting	19 Years	70 Years	All	50	Phase 4	NULL
4	EUCTR2020-005096-12-SE (EUCTR)	31/05/2021	09/04/2021	Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad ledgångsreumatism: en randomiserad, öppen, non-inferiority klinisk studie	Utvärdering av två kortison behandlingsstrategier hos patienter med nydiagnostiserad, tidigare obehandlad reumatoid artrit: en randomiserad, öppen, non-inferiority klinisk studie	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Prednisolon Pfizer Product Name: Prednisolon Pfizer INN or Proposed INN: PREDNISOLONE	Karolinska Universitetssjukhuset	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	166	Phase 4	Sweden
5	JPRN-jRCTs071200107	25/05/2021	03/03/2021	Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: Comparative study with Filgotinib and Tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial	Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: Comparative study with Filgotinib and Tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial	Rheumatoid arthritis	In patients with active RA for whom continuous MTX treatment (including other concurrent csDMARDs) for at least 8 weeks is ineffective, treatment will be switched to filgotinib monotherapy or tocilizumab monotherapy. MTX (including other concomitant csDMARDs) will be discontinued at baseline. Patients who satisfy the eligibility criteria will be randomly allocated to the filgotinib treatment group or the tocilizumab group (ratio of 1:1). The patients in each group will receive each respective drug for 52 weeks. The proportion of patients who reach an American College of Rheumatology 50% improvement response (ACR50) at 12 weeks after commencement of filgotinib monotherapy or tocilizumab monotherapy will be defined as the primary endpoint, and will serve as evidence of the noninferiority of filgotinib monotherapy compared with tocilizumab monotherapy.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	400	N/A	Japan
6	NCT04559412 (ClinicalTrials.gov)	March 15, 2021	3/9/2020	Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis	Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Device: Sofusa DoseConnect;Drug: Enbrel	Sorrento Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	80 Years	All	11	Phase 1	United States
7	NCT04798287 (ClinicalTrials.gov)	March 10, 2021	11/3/2021	Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints	Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints	Rheumatoid Arthritis	Drug: Tofacitinib;Drug: TNF Inhibitor	Brigham and Women's Hospital	NULL	Completed	18 Years	N/A	All	105711		United States
8	NCT04772248 (ClinicalTrials.gov)	February 22, 2021	23/2/2021	Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints	Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints	Rheumatoid Arthritis	Drug: Tofacitinib;Drug: TNF Inhibitor	Brigham and Women's Hospital	NULL	Completed	18 Years	N/A	All	105711		United States
9	EUCTR2018-004558-30-DK (EUCTR)	18/12/2020	05/10/2020	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Phase 4	Portugal;Spain;Denmark
10	JPRN-jRCTs071200054	17/12/2020	18/11/2020	Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Rheumatoid arthritis	Rheumatoid arthritis patients with moderate or high disease activity will be introduce for etanercept BS MA within 14 days of case enrollment. The etanercept BS MA is given as a weekly subcutaneous injection of 50 mg for 24 weeks.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	40	Phase 4	Japan
11	NCT04638426 (ClinicalTrials.gov)	September 10, 2020	13/11/2020	Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis	For 12 Weeks, the Multi Center, Randomized, Double Blinded, Placebo Controlled, Parallel, Dose-finding Clinical Study for the Therapeutic Exploration of Safety and Efficacy Assessment of HL237 Tablet in Patients With Rheumatoid Arthritis (Phase IIa)	Rheumatoid Arthritis	Drug: HL237 tablet;Drug: Placebo of HL237 tablet	Hanlim Pharm. Co., Ltd.	NULL	Enrolling by invitation	19 Years	N/A	All	196	Phase 2	Korea, Republic of
12	NCT04428424 (ClinicalTrials.gov)	July 5, 2020	10/6/2020	Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients	The Impact of RF, and Anti-CCP on RA Patients in Response to Etanercept	Arthritis, Rheumatoid	Drug: Enbrel	Pfizer	NULL	Completed	18 Years	N/A	All	1		Iraq
13	JPRN-UMIN000040094	2020/07/01	01/07/2020	Development of chronotherapeutics in rheumatoid arthritis	Development of chronotherapeutics in rheumatoid arthritis - Development of chronotherapeutics in rheumatoid arthritis	rheumatoid arthritis	baricitinib 4mg morning baricitinib 4mg evening baricitinib 2mg evening baricitinib 2mg morning	Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo college of Medicine	NULL	Recruiting	18years-old	100years-old	Male and Female	120	Not applicable	Japan
14	JPRN-jRCTs071190046	29/06/2020	20/02/2020	Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with enbrel (Subcutaneous injection of 25 mg once weekly or 25 mg twice weekly or 50 mg once weekly or 50 mg once biweekly) over 24 weeks and persisted with LDA/remission are switched to the same dose of etanercept BS MA from enbrel. In addition, for patients receiving etanercept BS MA 50 mg weekly, the dose will be reduced from 24 weeks to etanercept BS MA 25 mg weekly to test whether LDA/remission persists until week 52.	Kawakami Atsushi	NULL	Not Recruiting	>= 20age old	Not applicable	Both	62	Phase 4	Japan
15	EUCTR2018-003351-37-FR (EUCTR)	19/02/2020	28/05/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	2600	Phase 3;Phase 4	Russian Federation;Romania;Hungary;United States;United Kingdom;Switzerland;Spain;Greece;Austria;Czech Republic;Netherlands;Turkey;Belgium;Denmark;Poland;Italy;South Africa;Israel;Slovakia;France;Australia;Lithuania;Germany
16	EUCTR2018-004558-30-PT (EUCTR)	03/02/2020	21/05/2019	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Phase 4	Portugal;Spain
17	EUCTR2018-003351-37-LT (EUCTR)	13/12/2019	29/08/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
18	EUCTR2019-001754-25-NL (EUCTR)	25/11/2019	25/11/2019	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch)	rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel, Benepali, Erelzi Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab INN or Proposed INN: ETANERCEPT INN or Proposed INN: RITUXIMAB INN or Proposed INN: ABATACEPT INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB INN or Proposed INN: SARILUMAB	Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 4	Netherlands
19	NCT04120831 (ClinicalTrials.gov)	October 7, 2019	4/10/2019	TOLERA: Tolerance Enhancement in RA	Sequential B Cell/T Cell Therapy to Re-induce Humoral Immune TOLErance in ACPA- Positive Rheumatoid Arthritis A Prospective, Randomized Controlled Open Label Single-centre Clinical Trial in Adult Subjects With Active ACPA-positive Rheumatoid Arthritis Failing Methotrexate	Rheumatoid Arthritis	Drug: Abatacept Injection	University of Erlangen-Nürnberg Medical School	NULL	Recruiting	18 Years	N/A	All	20	Phase 2	Germany
20	EUCTR2018-003351-37-HU (EUCTR)	07/10/2019	24/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
21	EUCTR2018-003351-37-GR (EUCTR)	13/09/2019	29/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Czechia;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands
22	EUCTR2018-003351-37-ES (EUCTR)	05/09/2019	16/09/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Lilly S.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
23	EUCTR2018-003351-37-PL (EUCTR)	04/09/2019	09/08/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
24	EUCTR2018-003351-37-DK (EUCTR)	29/08/2019	07/08/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	Russian Federation;Romania;Hungary;United States;United Kingdom;Switzerland;Spain;Greece;Austria;Czech Republic;Netherlands;Turkey;Belgium;Denmark;Poland;Italy;South Africa;Israel;Slovakia;Australia;France;Lithuania;Germany
25	EUCTR2018-003351-37-NL (EUCTR)	29/08/2019	08/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands
26	EUCTR2018-003351-37-IT (EUCTR)	20/08/2019	15/06/2021	Uno studio di fase 3b/4 sull'Artrite Reumatoide	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel Product Code: [Enbrel] INN or Proposed INN: ETANERCEPT Trade Name: Humira Product Name: Humira Product Code: [Humira] INN or Proposed INN: ADALIMUMAB	ELI LILLY & COMPANY, LILLY CORPORATE CENTER	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 4	United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
27	EUCTR2018-003351-37-AT (EUCTR)	13/08/2019	31/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
28	EUCTR2018-003351-37-GB (EUCTR)	08/08/2019	16/05/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
29	EUCTR2018-003351-37-DE (EUCTR)	02/08/2019	24/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Czechia;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Poland;Romania;Denmark;Australia;South Africa;Germany;Netherlands
30	EUCTR2018-004539-54-DE (EUCTR)	03/06/2019	10/04/2019	Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy	Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte	Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz Trade Name: Enbrel Trade Name: Celebrex	Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	192	Phase 4	Germany
31	NCT03882008 (ClinicalTrials.gov)	May 23, 2019	7/11/2018	A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis	Phase IV Open-Label Study to Evaluate Biomarkers to Predict the Efficacy of Abatacept in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Abatacept	University of Washington	Bristol-Myers Squibb	Enrolling by invitation	18 Years	N/A	All	25	Phase 4	United States
32	EUCTR2018-004558-30-ES (EUCTR)	16/05/2019	11/04/2019	Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.	Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Spain
33	NCT03699293 (ClinicalTrials.gov)	September 22, 2018	21/9/2018	NSAIDs vs. Coxibs in the Presence of Aspirin	NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease	Rheumatoid Arthritis;Cardiovascular Diseases	Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet	Inova Health Care Services	NULL	Unknown status	18 Years	75 Years	All	30	Phase 4	United States
34	NCT04079374 (ClinicalTrials.gov)	September 3, 2018	3/9/2019	Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel	Open, Randomized, Comparative, Multicenter Study in Parallel Groups of the Efficacy, Safety, Immunogenicity of Etanercept and Enbrel, Lyophilisates for Solution for Subcutaneous Injection, in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept;Drug: Enbrel	Joint Stock Company Farmak	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	Recruiting	18 Years	75 Years	All	160	Phase 3	Ukraine
35	EUCTR2017-004079-30-PT (EUCTR)	09/08/2018	29/06/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Spain;Belgium;Italy
36	EUCTR2017-004079-30-ES (EUCTR)	10/07/2018	21/03/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rhuematoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
37	EUCTR2017-004079-30-IT (EUCTR)	06/07/2018	10/09/2021	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Spain;Belgium;Italy
38	JPRN-UMIN000031692	2018/03/01	12/03/2018	Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty	Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty - Efficacy of intravenous acetaminophen injection for pain management after TKA	knee osteoarthritis rheumatoid arthritis	Study group:Fentanyl sustained intravenous administration given after operation end. And use the Intravenous acetaminophen 4 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight. Control group:Fentanyl sustained intravenous administration given after operation end.	Yamaguchi University	NULL	Recruiting	20years-old	Not applicable	Male and Female	60	Not selected	Japan
39	EUCTR2017-004079-30-BE (EUCTR)	19/02/2018	19/02/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	219	Phase 3	Portugal;Spain;Belgium;Italy
40	EUCTR2017-001970-41-DK (EUCTR)	21/12/2017	15/09/2017	Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial	Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation)	Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Orencia Product Name: Abatacept Product Code: L04AA24 INN or Proposed INN: ABATACEPT Trade Name: Humira Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: L04AB05 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Enbrel Product Name: Etanercept Product Code: L04AB01 INN or Proposed INN: ETANERCEPT	MD, PhD Salome Kristensen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Denmark
41	NCT03288584 (ClinicalTrials.gov)	October 27, 2017	16/9/2017	Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis	The Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Inflammation	Drug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents.	University of Athens	NULL	Recruiting	18 Years	80 Years	All	60		Greece
42	EUCTR2017-000947-41-FR (EUCTR)	18/08/2017	21/06/2017	ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.	ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR	Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor. MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie Trade Name: RoActemra 162 mg solution injectable en seringue préremplie	Groupement des Hôpitaux de l’Institut Catholique de Lille	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	France
43	EUCTR2016-001987-12-IT (EUCTR)	18/08/2017	05/01/2021	Clinical study aimed to compare tocilizumab to anti-TNF treatment and to discover biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF	Open-label, randomized controlled trial comparing tocilizumab to anti-TNF treatment and discovery of biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF - RAFTING	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039014;Term: Rh arthritis;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINO Product Name: Tocilizumab Product Code: [NA] INN or Proposed INN: Tocilizumab Other descriptive name: Tocilizumab Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: etanercept Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: Infliximab Product Code: [NA] INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI	SOCIETA' ITALIANA DI REUMATOLOGIA - SIR	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	208	Phase 4	Italy
44	NCT03100734 (ClinicalTrials.gov)	June 1, 2017	29/3/2017	Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel	A Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT Study	Rheumatoid Arthritis;Axial Spondyloarthritis	Biological: Benepali;Biological: Enbrel	Biogen	Samsung Bioepis Co., Ltd.	Completed	18 Years	N/A	All	585		Germany
45	NCT02908490 (ClinicalTrials.gov)	April 1, 2017	8/7/2016	Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?	Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?	Arthritis, Rheumatoid;Atherosclerosis	Drug: Sildenafil;Other: Placebo	Kimberly Liang	NULL	Completed	18 Years	N/A	All	26	Phase 2	United States
46	EUCTR2014-004868-38-DE (EUCTR)	23/02/2017	25/05/2016	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
47	NCT03667131 (ClinicalTrials.gov)	February 13, 2017	10/9/2018	Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.	Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients.	Rheumatoid Arthritis	Drug: Enalapril Maleate;Drug: Placebo	University of Guadalajara	NULL	Completed	18 Years	80 Years	Female	59	Phase 2	Mexico
48	NCT03085940 (ClinicalTrials.gov)	January 20, 2017	7/2/2017	Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis	Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Hydroxychloroquine;Drug: Placebo	Indonesia University	NULL	Completed	18 Years	N/A	All	37	N/A	Indonesia
49	EUCTR2016-003129-40-IT (EUCTR)	05/01/2017	10/09/2021	Remission after suspension of TNF alpha therapies in RA	PHASE 4, MULTICENTER RANDOMISED STUDY, AIMED AT EVALUATING THE MAINTENANCE OF REMISSION AFTER 6, 12, 18 AND 24 MONTHS FROM SUSPENSION OF TNF-ALPHA THERAPIES (ADALIMUMAB, ETANERCEPT, INFLIXIMAB, CERTOLIZUMAB PEGOL, GOLIMUMAB) IN RHEUMATOID ARTHRITIS (RA) PATIENTS - NA	RHEUMATOID ARTHRITIS (RA) PATIENTS MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 2 SIRINGHE PRERIEMPITE 0.8 ML + 2 TAMPONI IMBEVUTI DI ALCOL IN 1 BLISTER Product Name: HUMIRA (ADALIMUMAB) Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI ALCOOL Product Name: CIMZIA (Certolizumab Pegol) Product Code: [NA] INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: ENBREL (Etanercept) Product Code: [-] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: REMICADE (INFLIXIMAB) Product Code: [-] INN or Proposed INN: INFLIXIMAB Trade Name: SIMPONI - 50 MG-SOLUZIONE PER INIEZIONE IN PENNA PRERIEMPITA-USO SOTTOCUTANEO-PENNA PRERIEMPITA(VETRO) -0.5 ML 3 (3X1) PENNE PRERIEMPITE	AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	Italy
50	NCT02983227 (ClinicalTrials.gov)	November 30, 2016	29/11/2016	A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350	A Phase II Open-Label Extension Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: GDC-0853	Genentech, Inc.	NULL	Completed	18 Years	76 Years	All	496	Phase 2	United States;Argentina;Brazil;Bulgaria;Colombia;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile;Korea, Republic of
51	JPRN-UMIN000026819	2016/11/21	01/04/2017	A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients.	A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients. - A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients.	osteoarthritis of the hip, osteonecrosis of the femoral head, femoral neck fracture, rheumatoid arthritis, rapidly destructive coxarthropathy, septic arthritis of the hip	Dose: Edoxaban group; Edoxaban 15mg per day Enoxaparin gropu; Enoxaparin 2000 IU per day Intervention period: for 10 days after the surgery	Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	80	Not selected	Japan
52	EUCTR2016-002061-54-IT (EUCTR)	13/10/2016	15/11/2018	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)	Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Italy
53	EUCTR2016-000498-19-BG (EUCTR)	13/10/2016	19/08/2016	A Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Rheumatoid Arthritis	A PHASE II OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA29350 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GDC-0853 Product Code: RO7010939 INN or Proposed INN: not available Other descriptive name: GDC-0853 RO7010939	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	580	Phase 2	United States;Serbia;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of
54	NCT03403140 (ClinicalTrials.gov)	October 6, 2016	30/11/2017	Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )	Multicenter Extension Study To 104 Weeks To Asses The Efficacy, Safety And Immunogenicity Of Enerceptan® In Combination With Methotrexate For The Treatment Of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept	Gema Biotech S.A.	QUID Quality in Drugs and Devices Latin American Consulting SRL	Unknown status	19 Years	99 Years	All	141	Phase 3	Argentina
55	NCT02936180 (ClinicalTrials.gov)	October 2016	7/10/2016	Standard Versus High Dose Inactivated Influenza Vaccine in RA	Improving Influenza Immunization Responses in Rheumatoid Arthritis: A Strategy To Enhance Protection Against A Preventable Cause Of Death In An At Risk Population?	Rheumatoid Arthritis	Biological: HD-TIV;Biological: SD-QIV	McGill University Health Centre/Research Institute of the McGill University Health Centre	The Arthritis Society, Canada	Unknown status	18 Years	N/A	All	280	Phase 4	Canada
56	NCT02666443 (ClinicalTrials.gov)	September 2016	24/1/2016	Low Dose Dexamethasone in Supraclavicular Blocks	Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study	Rheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament Injury	Drug: Control intervention (no dexamethasone);Drug: Peri-neural Dexamethasone 1 mg;Drug: Intravenous Dexamethasone 1 mg	University of Calgary	NULL	Recruiting	18 Years	80 Years	Both	306	N/A	Canada
57	EUCTR2016-002035-15-FI (EUCTR)	20/05/2016	12/05/2016	Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study	Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia	Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee MedDRA version: 19.0;Level: LLT;Classification code 10031174;Term: Osteoarthrosis;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10031158;Term: Osteo arthritis knees;System Organ Class: 100000004859;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]	Trade Name: Bicain spinal INN or Proposed INN: bupivacaine hydrochloride Other descriptive name: BUPIVACAINE HYDROCHLORIDE Trade Name: Propolipid INN or Proposed INN: propofol Other descriptive name: PROPOFOL	Helsinki University Central Hospital	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 4	Finland
58	NCT02538341 (ClinicalTrials.gov)	May 2016	18/8/2015	Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)	Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)	Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease	Biological: Herpes Zoster Vaccine;Drug: Placebo	University of Alabama at Birmingham	Oregon Health and Science University	Active, not recruiting	50 Years	N/A	All	617	Phase 2	United States
59	EUCTR2014-004868-38-IT (EUCTR)	16/04/2016	06/11/2020	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. - A study comparing the use of etanercept and methotrexate, used either alone or in combination, for m	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ENBREL - 50 MG SOLUZIONE INIETTABILE IN SIRINGA (VETRO DA 1 ML) PRERIEMPITA - USO SOTTOCUTANEO 12 SIRINGHE PRERIEMPITE + 24 TAMPONI IMBEVUTI DI ALCOL Product Name: Enbrel Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: METOTREXATO SANDOZ - 2.5 MG COMPRESSE 50 COMPRESSE IN FLACONE PP Product Name: methotrexate Product Code: [NA] INN or Proposed INN: METOTREXATO	AMGEN INC.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	France;Portugal;Hungary;Czech Republic;Greece;Spain;Bulgaria;Germany;United Kingdom;Italy
60	EUCTR2014-004868-38-PT (EUCTR)	07/03/2016	18/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	France;United States;Portugal;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
61	EUCTR2012-002009-23-DE (EUCTR)	22/02/2016	09/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
62	EUCTR2014-004868-38-HU (EUCTR)	09/02/2016	11/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	Greece;Canada;Argentina;Czech Republic;Hungary;United States;Italy;Bulgaria;France;Portugal;Germany;Spain
63	EUCTR2014-004868-38-BG (EUCTR)	02/02/2016	22/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
64	NCT03332719 (ClinicalTrials.gov)	February 2016	21/4/2016	Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis	Multicentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Etanercept;Drug: Methotrexate	Gema Biotech S.A.	QUID-Quality in Drugs and Devices Latin American Consulting SRL	Completed	19 Years	99 Years	All	168	Phase 3	Argentina
65	EUCTR2015-002809-12-BG (EUCTR)	27/01/2016	02/12/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
66	EUCTR2014-004868-38-GR (EUCTR)	26/01/2016	02/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	France;Portugal;United States;Hungary;Czech Republic;Canada;Greece;Argentina;Spain;Bulgaria;Germany
67	EUCTR2014-004868-38-ES (EUCTR)	19/01/2016	13/01/2016	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	720	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
68	EUCTR2014-004868-38-FR (EUCTR)	12/01/2016	18/01/2016	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	720	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;France;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany
69	EUCTR2012-002009-23-HU (EUCTR)	07/01/2016	29/09/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Latvia
70	NCT02878161 (ClinicalTrials.gov)	January 2016	12/7/2016	Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World	Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway	Rheumatoid Arthritis	Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary)	Fen Li	NULL	Enrolling by invitation	18 Years	75 Years	Both	240	Phase 4	NULL
71	EUCTR2015-002809-12-ES (EUCTR)	23/12/2015	30/10/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
72	EUCTR2014-004868-38-CZ (EUCTR)	21/12/2015	03/12/2015	A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	358	Phase 3	Greece;Canada;Czech Republic;Argentina;Hungary;United States;Italy;Bulgaria;France;Portugal;Germany;Spain
73	EUCTR2015-004173-32-DK (EUCTR)	18/12/2015	20/10/2015	Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.	Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.	Rheumatic diseases MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Benepali INN or Proposed INN: ETANERCEPT Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Department of Clinical Biochemestry, Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 4	Denmark
74	EUCTR2012-002009-23-GB (EUCTR)	09/12/2015	07/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
75	EUCTR2015-002809-12-CZ (EUCTR)	27/11/2015	02/10/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
76	EUCTR2012-002009-23-BG (EUCTR)	25/11/2015	15/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
77	EUCTR2012-002009-23-ES (EUCTR)	20/11/2015	15/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
78	EUCTR2015-002809-12-HU (EUCTR)	17/11/2015	26/08/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India
79	EUCTR2015-002809-12-LV (EUCTR)	17/11/2015	21/09/2015	A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT	YL Biologics Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
80	EUCTR2012-002009-23-CZ (EUCTR)	13/11/2015	30/09/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
81	EUCTR2012-002009-23-LT (EUCTR)	06/11/2015	02/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
82	EUCTR2012-002009-23-SK (EUCTR)	27/10/2015	07/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
83	EUCTR2012-002009-23-LV (EUCTR)	23/10/2015	08/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Latvia;Germany
84	EUCTR2012-002009-23-PL (EUCTR)	22/10/2015	08/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
85	EUCTR2012-002009-23-EE (EUCTR)	12/10/2015	06/10/2015	Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis	A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA	Moderate to severe active rheumatoid arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
86	NCT02320630 (ClinicalTrials.gov)	October 2015	16/12/2014	Combination Therapy Prevents the Relapse of RA	The Efficacy, Safety and Cost-effectiveness of Hydroxychloroquine, Sulfasalazine, Methotrexate Triple Therapy in Preventing Relapse Among Patients With Rheumatoid Arthritis Achieving Clinical Remission or Low Disease Activity	Recurrence (Disease Attribute)	Drug: Entanercept;Drug: HCQ;Drug: MTX	Peking University First Hospital	Peking University People's Hospital;Peking University Third Hospital;Beijing Hospital;Beijing Jishuitan Hospital;Peking University Shougang Hospital;Beijing Shijitan Hospital	Recruiting	18 Years	70 Years	All	240	N/A	China
87	EUCTR2015-002284-42-FI (EUCTR)	18/09/2015	28/08/2015	The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit	INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT	rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify	Trade Name: Enbrel Product Name: etanercept Trade Name: Humira Product Name: adalimumab Trade Name: Cimzia Product Name: certolizumab pegol Trade Name: Simponi Product Name: golimumab Trade Name: Remicade Product Name: infliximab	READE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1650	Phase 1	Finland
88	EUCTR2013-003177-99-AT (EUCTR)	17/08/2015	07/05/2015	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
89	EUCTR2013-003177-99-FI (EUCTR)	12/08/2015	12/02/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
90	NCT02481180 (ClinicalTrials.gov)	July 31, 2015	18/6/2015	Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)	An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance?Pharmacokinetics?Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)	Rheumatoid Arthritis	Drug: T0001;Drug: Enbrel	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.	NULL	Terminated	18 Years	65 Years	All	36	Phase 1	China
91	EUCTR2014-004673-16-IT (EUCTR)	27/07/2015	04/06/2021	Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.	PROSPECTIVE, MULTICENTRE, PLACEBO CONTROLLED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY OF MAINTENANCE TREATMENT WITH TOCILIZUMAB WITH OR WITHOUT GLUCOCORTICOID DISCONTINUATION IN RHEUMATOID ARTHRITIS PATIENTS - NA	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE Product Name: NA Product Code: RO487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton, 5 mg, tablets INN or Proposed INN: PREDNISONE	F. HOFFMANN - LA ROCHE LTD.	NULL	Not Recruiting			Female: yes Male: yes	226	Phase 4	France;Serbia;Egypt;Lebanon;Turkey;Russian Federation;Germany;Switzerland;Italy
92	EUCTR2013-004569-16-DE (EUCTR)	07/05/2015	26/11/2014	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany;Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy
93	EUCTR2011-004720-35-NO (EUCTR)	04/05/2015	26/01/2015	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Sweden
94	NCT02486302 (ClinicalTrials.gov)	March 24, 2015	28/6/2015	A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.	A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT	Rheumatoid Arthritis;Psoriatic Arthritis;Axial Spondyloarthritis;Plaque Psoriasis	Drug: Etanercept	Pfizer	NULL	Completed	18 Years	N/A	All	1534		Germany
95	NCT02353780 (ClinicalTrials.gov)	March 2015	30/6/2013	Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept	Mechanistic Studies of B- and T-Cell Function in Rheumatoid Arthritis Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept	Rheumatoid Arthritis (RA)	Drug: TNF Antagonist (enbrel, humire, remicade, cimzia, symponi);Drug: Abatacept;Drug: Tocilizumab	Dr. Larry W. Moreland	Genentech, Inc.;Bristol-Myers Squibb	Terminated	18 Years	64 Years	All	10	Phase 4	United States
96	NCT02638259 (ClinicalTrials.gov)	February 21, 2015	16/12/2015	Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis	A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: GP2015	Sandoz	NULL	Completed	18 Years	N/A	All	376	Phase 3	United States;Bulgaria;Czechia;Estonia;Germany;Hungary;Italy;Latvia;Lithuania;Mexico;Poland;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Czech Republic
97	NCT02357069 (ClinicalTrials.gov)	February 2015	29/1/2015	A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy	Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX	Arthritis, Rheumatoid	Drug: Enbrel;Drug: LBEC0101	LG Life Sciences	Mochida Pharmaceutical Company, Ltd.	Active, not recruiting	20 Years	75 Years	Both	372	Phase 3	Japan;Korea, Republic of
98	EUCTR2014-000443-33-DE (EUCTR)	18/12/2014	07/07/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02) (RApsody) - ETA 302	Rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	620	Phase 3	United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
99	EUCTR2014-003529-16-GB (EUCTR)	16/12/2014	22/06/2015	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	219	Phase 3	United Kingdom
100	JPRN-UMIN000015794	2014/12/15	10/12/2014	Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study )	Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study ) - RISOTTO(sodium RISedrOnate for sTeroid induced osTeOporosis with rheumatoid arthritis)	osteoporosis, rheumatoid arthritis	monthly risedronate sodium 75mg for 6 months monthly placebo for 6 months	Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of Medicine	NULL	Complete: follow-up continuing	20years-old	Not applicable	Male and Female	165	Phase 4	Japan
101	NCT02319642 (ClinicalTrials.gov)	November 2014	15/12/2014	An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044	A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.	Rheumatoid Arthritis	Drug: Certolizumab Pegol	UCB Pharma SA	Parexel	Completed	18 Years	N/A	All	347	Phase 3	China
102	EUCTR2014-000443-33-PL (EUCTR)	29/10/2014	21/07/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302	Rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus BioSciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	620	Phase 3	United States;Belarus;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;South Africa;Germany;Japan
103	EUCTR2014-000443-33-IT (EUCTR)	24/10/2014	24/06/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302	Rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Belarus;Spain;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan
104	EUCTR2014-000443-33-ES (EUCTR)	24/10/2014	04/07/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate - ETA 302	Rheumatoid arthritis MedDRA version: 17.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Belarus;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan
105	EUCTR2014-000443-33-GB (EUCTR)	20/10/2014	26/06/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02)(RApsody) - ETA 302	Rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus BioSciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	620	Phase 3	United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
106	EUCTR2014-000859-91-FR (EUCTR)	03/10/2014	18/06/2015	Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde.	Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. - LYRITUX	Cette étude portera donc sur une population de patients atteints de polyarthrite rhumatoïde (PR) actives et ayant présenté un échec ou une contre-indication à au moins un anti-TNFa, et n’ayant jamais reçu de rituximab. MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB	CHRU de TOURS	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	France
107	JPRN-UMIN000015462	2014/10/01	17/10/2014	Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study)	Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study) - Clinical study on rheumatoid arthritis treated with tofacitinib	Rheumatoid arthritis	Continue current treatment Tofacitinib discontinuation MTX discontinuation	School of Medicine, University of Occupational and Environmental Health, Japan	NULL	Recruiting	18years-old	Not applicable	Male and Female	400	Not selected	Japan
108	NCT02257047 (ClinicalTrials.gov)	October 2014	2/10/2014	Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis		Rheumatoid Arthritis	Dietary Supplement: Tea;Dietary Supplement: RYR	Chengdu PLA General Hospital	NULL	Enrolling by invitation	18 Years	75 Years	All	120	N/A	China
109	NCT02150473 (ClinicalTrials.gov)	October 2014	27/2/2014	The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients	Delayed Gadolinium-enhanced Magnetic Resonance (MR) Imaging of Cartilage - A Pilot Study to Measure the Effect of Adalimumab Plus MTX Versus Placebo Plus MTX on Cartilage in Early RA Patients	Rheumatoid Arthritis	Drug: Adalimumab;Drug: Placebo	Heinrich-Heine University, Duesseldorf	Abbott	Terminated	18 Years	80 Years	All	21	Phase 3	Germany
110	EUCTR2011-004720-35-FI (EUCTR)	10/09/2014	09/09/2014	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Finland;Denmark;Sweden
111	EUCTR2014-000443-33-HU (EUCTR)	09/09/2014	06/06/2014	Coherus RA Study	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02) (RApsody) - ETA 302	Rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CHS-0214 INN or Proposed INN: Etanercept Other descriptive name: CHS-0214 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Coherus Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	620	Phase 3	United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan
112	EUCTR2013-003177-99-NL (EUCTR)	09/09/2014	25/02/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
113	NCT02202837 (ClinicalTrials.gov)	August 12, 2014	15/7/2014	Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice	Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered))	Rheumatoid Arthritis	Drug: etanercept	Pfizer	NULL	Completed	18 Years	N/A	All	157		Belgium
114	EUCTR2013-004604-19-DE (EUCTR)	06/08/2014	03/06/2014	Effect of Adalimumab plus Methortrexat (MTX) versus Placebo plus MTX on cartilage in early RA patients	Delayed Gadolinium-enhanced Magnetic resonance Imaging (MRI) of Cartilage - A pilot study to measure the effect of Adalimumab plus Methotrexat (MTX) versus Placebo plus MTX on cartilage in early rheumatoid arthritis (RA) patients	patients with early progressive rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]	Trade Name: Humira 40mg Injektionslösung Product Name: Humira	Heinrich-Heine-Universität Düsseldorf	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 3	Germany
115	NCT02264301 (ClinicalTrials.gov)	August 2014	3/10/2014	Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis	The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Puerarin injection 400 mg;Drug: Qingkailing injection 40 ml	Chengdu PLA General Hospital	NULL	Enrolling by invitation	18 Years	75 Years	All	150	N/A	China
116	EUCTR2013-003177-99-GB (EUCTR)	17/07/2014	11/03/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
117	EUCTR2013-003177-99-CZ (EUCTR)	10/07/2014	05/02/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	Mexico;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
118	NCT02053727 (ClinicalTrials.gov)	July 2014	6/11/2013	Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background	Pilot Study to Evaluate Subcutaneous Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background- a Pilot, Double-blind, Placebo-controlled, Randomized, Controlled Trial.	Rheumatoid Arthritis;Chronic Hepatitis B	Drug: Abatacept;Drug: Placebo	University of California, Los Angeles	NULL	Withdrawn	18 Years	N/A	All	0	N/A	United States
119	JPRN-JapicCTI-142621	09/6/2014		CHS-0214 Phase III trial	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate	Rheumatoid Arthritis	Intervention name : CHS-0214 Dosage And administration of the intervention : subcutaneous injection Control intervention name : Enbrel INN of the control intervention : Etanercept Dosage And administration of the control intervention : subcutaneous injection	DAIICHISANKYO Co.,Ltd.	Coherus Biosciences, Inc.		20		BOTH	620	Phase 3	NULL
120	EUCTR2013-003177-99-ES (EUCTR)	07/05/2014	17/03/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
121	NCT02115750 (ClinicalTrials.gov)	May 2014	14/4/2014	Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)	A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate	Rheumatoid Arthritis	Drug: Etanercept;Drug: CHS-0214	Coherus Biosciences, Inc.	Daiichi Sankyo Co., Ltd.	Completed	18 Years	N/A	All	647	Phase 3	United States;Belarus;France;Germany;Hungary;Israel;Japan;Poland;Russian Federation;South Africa;Spain;United Kingdom
122	EUCTR2013-003177-99-SK (EUCTR)	28/04/2014	10/03/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
123	EUCTR2013-003177-99-SE (EUCTR)	11/04/2014	05/02/2014	A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: XELJANZ Product Name: Tofacitinib citrate (commercial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE CP-690550 Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: ETANERCEPT	Pfizer Inc. 235 East 42nd Street, New York, 10017	NULL	Not Recruiting			Female: yes Male: yes	4000	Phase 3;Phase 4	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
124	NCT02092467 (ClinicalTrials.gov)	March 14, 2014	3/3/2014	Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis	PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Arthritis, Rheumatoid	Drug: tofacitinib;Biological: adalimumab;Biological: etanercept	Pfizer	NULL	Completed	50 Years	N/A	All	4372	Phase 4	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;Finland;Hong Kong;Israel;Jordan;Lebanon;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;Sweden
125	JPRN-UMIN000012399	2013/10/16	26/11/2013	Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis	Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis - Rheumascan Pilot Study	Rheumatoid arthritis	Patients with active rheumatoid arthritis (1)Assessment of tender and swollen joints by physical examination (2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands (3)Gadolinium-enhanced MRI of the hand with more severe arthritis (4)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG) Healthy subjects (1)Assessment of tender and swollen joints by physical examination (2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands (3)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG)	Tokyo Medical and Dental University	Diagnostic Imaging Center, Ochanomizu Surugadai Clinic	Complete: follow-up complete	20years-old	Not applicable	Male and Female	9	Not applicable	Japan
126	NCT02538757 (ClinicalTrials.gov)	October 2013	18/8/2015	Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE)	Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE)	Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory Arthritis	Biological: Herpes Zoster Vaccine;Drug: Placebo	University of Alabama at Birmingham	Oregon Health and Science University	Active, not recruiting	50 Years	N/A	All	125	Phase 2	United States
127	EUCTR2012-001984-66-NO (EUCTR)	11/09/2013	17/10/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910	Phase 3	United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Germany;Norway;New Zealand
128	NCT01907230 (ClinicalTrials.gov)	September 10, 2013	14/7/2013	Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients	Propylactic Use of Entecavir for Biological Agents Associated Hepatitis B Virus Reactivation in Inflammatory Arthritis Patients: a Randomized Controlled Trial	Rheumatoid Arthritis;Hepatitis B Reactivation;Exposure to Hepatitis B Virus	Drug: Entecavir	Taipei Veterans General Hospital, Taiwan	NULL	Active, not recruiting	20 Years	90 Years	All	115	Phase 4	Taiwan
129	NCT01787149 (ClinicalTrials.gov)	September 2013	6/2/2013	A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis	A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis	Combination With DMARDs	Drug: DMARDs	Mycenax Biotech Inc.	NULL	Unknown status	20 Years	N/A	All	98	Phase 3	Taiwan
130	EUCTR2012-005026-30-HU (EUCTR)	15/08/2013	20/02/2013	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
131	NCT01394913 (ClinicalTrials.gov)	August 2013	12/7/2011	Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis	A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Reumatocept (etanercept);Drug: Enbrel (etanercept)	EMS	NULL	Withdrawn	18 Years	70 Years	All	0	Phase 3	Brazil
132	EUCTR2012-003644-71-BE (EUCTR)	08/07/2013	06/02/2013	Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure	A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	France;Hong Kong;Spain;Poland;Belgium;Australia;Russian Federation;Israel;Chile;Netherlands;Colombia;New Zealand
133	EUCTR2012-001984-66-LV (EUCTR)	03/07/2013	25/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
134	EUCTR2012-001984-66-IT (EUCTR)	02/07/2013	07/05/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
135	NCT02236481 (ClinicalTrials.gov)	July 2013	8/9/2014	Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes	No-profit Study to Ensure Normal Clinical Practice, to Evaluate the Efficacy of Anakinra in Reducing the Glycated Haemoglobin in Patients Affected by Rheumatoid Arthritis and Diabetes; Randomized, Open Label, Parallel Group,Controlled Clinical Study	Diabetes Mellitus, Type 2;Arthritis, Rheumatoid	Drug: Anakinra;Drug: TNF alpha inhibitors	Prof. Roberto Giacomelli	NULL	Terminated	18 Years	N/A	All	41	Phase 4	Italy
136	EUCTR2012-001984-66-DE (EUCTR)	26/06/2013	06/03/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand
137	EUCTR2012-001984-66-LT (EUCTR)	20/06/2013	23/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
138	EUCTR2012-004482-40-ES (EUCTR)	18/06/2013	16/05/2013	Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies	Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.	Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: ENBREL Product Name: Etanercept INN or Proposed INN: ETANERCEPT Trade Name: CIMZIA Product Name: Certolizumab Pegol INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: SIMPONI Product Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: TOCILIZUMAB Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	FRANCISCO J. BLANCO GARCÍA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
139	EUCTR2012-001984-66-HU (EUCTR)	06/06/2013	14/03/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - SARIL-RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
140	NCT02132234 (ClinicalTrials.gov)	June 2013	28/4/2014	Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis	Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis	Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Hypertension	Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab	Jagiellonian University	Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland	Recruiting	18 Years	N/A	Both	100	Phase 4	Poland
141	NCT01895309 (ClinicalTrials.gov)	June 2013	3/7/2013	A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy	Rheumatoid Arthritis	Drug: Enbrel (etanercept);Drug: SB4 (proposed biosimilar to etanercept)	Samsung Bioepis Co., Ltd.	NULL	Completed	18 Years	75 Years	All	596	Phase 3	Poland;United Kingdom
142	EUCTR2012-001984-66-FI (EUCTR)	17/05/2013	24/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
143	EUCTR2012-005026-30-PL (EUCTR)	17/05/2013	08/03/2013	A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	596		Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
144	EUCTR2012-001984-66-GR (EUCTR)	15/05/2013	23/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
145	EUCTR2012-005026-30-CZ (EUCTR)	15/05/2013	22/02/2013	A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	596		Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
146	EUCTR2012-001984-66-CZ (EUCTR)	13/05/2013	27/03/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand
147	EUCTR2012-005026-30-LT (EUCTR)	10/05/2013	21/02/2013	A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Rheumatoid Arthritis (RA) MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	498		Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
148	EUCTR2012-001984-66-ES (EUCTR)	25/04/2013	09/04/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira INN or Proposed INN: ADALIMUMAB	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910		United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
149	EUCTR2012-001984-66-GB (EUCTR)	25/04/2013	04/03/2013	An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate	A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Humira	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	5910	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand
150	EUCTR2012-005026-30-BG (EUCTR)	10/04/2013	05/03/2013	A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy	Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SB4 (etanercept biosimilar) Product Code: SB4 INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc Trade Name: Enbrel® Product Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: TNFR:Fc	Samsung Bioepis Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	596		Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
151	EUCTR2012-003057-29-CZ (EUCTR)	02/04/2013	12/09/2012	A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.	A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients	XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)	Xencor Inc.	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 2	Hungary;Czech Republic;Slovakia
152	EUCTR2012-005275-14-NO (EUCTR)	19/03/2013	04/02/2013	Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs	Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND	Rheumatoid arthritis (RA) MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Methotrexate Pfizer 2,5 mg tabletter Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Salazopyrin EN 500 mg enterotabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Plaquenil 200 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: Arava 20 mg filmdrasjerte tabletter Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte. Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning. Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte	Diakonhjemmet Hospital AS	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 4	Norway
153	EUCTR2012-003644-71-ES (EUCTR)	12/03/2013	21/12/2012	Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure	A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	168		France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia
154	EUCTR2011-006021-23-PL (EUCTR)	05/03/2013	04/01/2013	.	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development Inc. (APGD)	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Hungary;Czech Republic;Mexico;Belgium;Poland;Bulgaria;Germany
155	EUCTR2011-006021-23-CZ (EUCTR)	01/02/2013	06/12/2012	.	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany
156	NCT01742468 (ClinicalTrials.gov)	February 2013	3/12/2012	Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis	Intervention With Products Enriched With Long Chain n-3 Polyunsaturated Fatty Acids (n-3 LC-PUFA) From Microalgae Oil in Patients With Rheumatoid Arthritis - Influence on Disease Activity and Inflammation Status	Rheumatoid Arthritis	Dietary Supplement: long-chain n-3 PUFA;Dietary Supplement: sunflower oil	University of Jena	German Federal Ministry of Education and Research	Completed	40 Years	80 Years	Both	38	N/A	Germany
157	EUCTR2011-006021-23-BG (EUCTR)	25/01/2013	13/12/2012	A two-year, open-label clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who completed a previous study of ASP015K	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany;Colombia
158	EUCTR2012-004631-22-BE (EUCTR)	15/01/2013	11/12/2012	TapERA:Tapering Etanercept in Reumatoid Artritis.	TapERA:Maintaining remission in RA while tapering Etanercept. - TapERA	reumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel Product Name: Enbrel Product Code: EMEA/H/C000262	University Hospitals Leuven	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	Belgium
159	EUCTR2012-003644-71-NL (EUCTR)	07/01/2013	07/01/2013	Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure	A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Pfizer Inc., 235 EAst 42nd Street, New York, NY 10017, United States	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120		France;Hong Kong;Spain;Belgium;Australia;Russian Federation;Israel;Chile;Colombia;Netherlands
160	EUCTR2011-006021-23-HU (EUCTR)	04/01/2013	24/10/2012	.	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Czech Republic;Hungary;Mexico;Poland;Belgium;Bulgaria;Germany
161	EUCTR2011-006021-23-BE (EUCTR)	19/11/2012	25/10/2012	.	A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ASP015K INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide INN or Proposed INN: ASP015K Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide	Astellas Pharma Global Development	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 2	Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany
162	EUCTR2012-003057-29-HU (EUCTR)	13/11/2012	19/09/2012	A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.	A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients	XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.	Xencor Inc.	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 2	Czech Republic;Hungary;Slovakia
163	EUCTR2012-003057-29-SK (EUCTR)	12/11/2012	19/09/2012	A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.	A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients	XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 15.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.	Xencor Inc.	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 2	Hungary;Czech Republic;Slovakia
164	NCT01709760 (ClinicalTrials.gov)	November 2012	16/10/2012	A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA	A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: ENIA11;Drug: Placebo	Mycenax Biotech Inc.	NULL	Unknown status	20 Years	N/A	All	91	Phase 3	Taiwan
165	NCT01636557 (ClinicalTrials.gov)	October 11, 2012	6/7/2012	A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis	A Phase I, Open-label, Drug Interaction Study to Evaluate the Effect of a Single-dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Subjects With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Sirukumab;Drug: Midazolam;Drug: Warfarin;Drug: Vitamin K;Drug: Omeprazole;Drug: Caffeine	Janssen Research & Development, LLC	NULL	Completed	18 Years	65 Years	All	12	Phase 1	Germany;Korea, Republic of;Moldova, Republic of;South Africa
166	JPRN-UMIN000010315	2012/10/01	26/03/2013	Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment	Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment - PROUD study	rheumatoid arthritis	In patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab.	Osaka City University Medical School	Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine.The center for rheumatic diseases. Nara Medical University.Rheumatology. Kitano Hospital.	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
167	NCT01711814 (ClinicalTrials.gov)	September 26, 2012	19/10/2012	A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study	Arthritis, Rheumatoid	Drug: peficitinib	Astellas Pharma Global Development, Inc.	Janssen Biotech, Inc.	Completed	18 Years	N/A	All	611	Phase 2	United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic
168	NCT01694264 (ClinicalTrials.gov)	September 1, 2012	24/9/2012	Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFa	A Randomized, Double-blinded, Phase 3, Multicenter, Investigator-initiated Trial for Entecavir for Prophylaxis of Hepatitis B Virus (HBV) Reactivation in HBV Surface Antigen or Anti-HBc Positive Patients Undergoing Anti-TNFa Treatment	Chronic Hepatitis B;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Juvenile Idiopathic Arthritis	Drug: Entecavir;Drug: Placebo	Seoul National University Hospital	Konkuk University Medical Center;Kyungpook National University;Kyunghee University Medical Center;Kyung Hee University Hospital at Gangdong;Gachon University Gil Medical Center;Daegu Catholic University Medical Center;Eulji University Hospital;SMG-SNU Boramae Medical Center;The Catholic University of Korea;Severance Hospital;Ajou University School of Medicine;Ewha Womans University Mokdong Hospital;Inha University Hospital;Chonnam National University Hospital;Chonbuk National University Hospital;Chungnam National University Hospital;Hallym University Medical Center;Hanyang University;Dong-A University;Korea University Guro Hospital	Terminated	16 Years	85 Years	All	43	Phase 3	Korea, Republic of
169	NCT01635686 (ClinicalTrials.gov)	September 2012	4/7/2012	Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers	A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers	Rheumatoid Arthritis	Drug: DWP422 25mg;Drug: ENBREL 25MG PFS INJ.	Daewoong Pharmaceutical Co. LTD.	NULL	Not yet recruiting	20 Years	45 Years	Male	38	Phase 1	Korea, Republic of
170	EUCTR2011-005204-15-AT (EUCTR)	20/06/2012	15/05/2012	Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?	Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop	biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Simponi INN or Proposed INN: GOLIMUMAB Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT	Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 4	Austria
171	EUCTR2011-005448-87-CZ (EUCTR)	11/06/2012	12/04/2012	A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)	A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	320		United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Hungary;Czech Republic;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China
172	EUCTR2011-005448-87-HU (EUCTR)	14/05/2012	21/03/2012	A STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)	A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® 50 mg Solution for Injection in Pre-filled Syringe INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	320		United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China
173	JPRN-UMIN000018017	2012/04/23	22/06/2015	Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy	Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy - Analysis for the reactivation of hepatitis B virus in patients treated with anti-tumor necrosis factor-alpha therapy	rheumatoid arthritis or psoriasis patients with past hepatitis B virus infection	The effect of preventive lamivudine, adefovir or entecavir on de novo HBV hepatitis.	Department of general internal medicine, Kyushu-University hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	70	Not selected	Japan
174	NCT01579890 (ClinicalTrials.gov)	April 2012	16/4/2012	Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis	A Non-blinded, Non-placebo Controlled, Compassionate Use, Open Treatment, Open-ended Program of the Safety of Pennsaid Topical Lotion (Diclofenac) in the Treatment of Osteo or Rheumatoid Arthritis	Osteoarthritis of the Hand	Drug: Diclofenac	Mallinckrodt	Nuvo Research Inc.	Approved for marketing	N/A	N/A	Both		N/A	NULL
175	NCT01623752 (ClinicalTrials.gov)	February 2012	18/6/2012	Prospective Evaluation of the Radiographic Efficacy of Enbrel	A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS.	Rheumatoid Arthritis;Psoriasis Arthritis	Drug: Etanercept	Pfizer	NULL	Completed	18 Years	N/A	All	1821		NULL
176	EUCTR2011-002849-36-LV (EUCTR)	12/01/2012	22/11/2011	A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid Arthritis	A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: JNJ-39758979-AAC - enteric coated tablet - 10 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned Product Name: JNJ-39758979-AAC - enteric coated tablet - 30 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned Product Name: JNJ-39758979-AAC - enteric coated tablet - 100 mg Product Code: JNJ-39758979 INN or Proposed INN: Not assigned Other descriptive name: Not assigned	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	325	Phase 2	United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Poland;Malaysia;Singapore;Romania;Latvia;Japan
177	EUCTR2010-020065-24-GR (EUCTR)	05/12/2011	04/11/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Greece;Ecuador;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
178	EUCTR2010-020992-21-ES (EUCTR)	17/10/2011	28/05/2012	Comparación de la eficacia de masitinib frente a metotrexato en el tratamiento de la artritis reumatoide	Estudio prospectivo, Fase IIb/III, multicéntrico, randomizado, doble ciego, controlado, de 3 grupos paralelos y 24 semanas de duración con posible extensión, para comparar la eficacia y seguridad de masitinib, a la dosis de 3 y 4,5 mg/kg/día, con metotrexato, con randomización 1:1:1, en el tratamiento de pacientes con artritis reumatoide activa y con una respuesta inadecuada a 1. metotrexato, a 2. cualquier FAME incluido al menos un fármaco biológico si previamente resultó ineficaz en pacientes tratados con metotrexato o a 3. metotrexato en combinación con cualquier FAME incluidos fármacos biológicos - AB1010 en tratamiento de pacientes con artritis reumatoide activa.	Atritis Reumatoide MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: no aplica Trade Name: Methotrexate Product Name: Methotrexate Product Code: no aplica INN or Proposed INN: METHOTREXATE Other descriptive name: no aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: No aplica	AB Science	NULL	Not Recruiting			Female: yes Male: yes	140		Slovakia;Greece;Thailand;Spain;Turkey;Germany;India;United States;Czech Republic
179	EUCTR2010-020065-24-BE (EUCTR)	26/09/2011	16/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	United States;Serbia;Philippines;Greece;Ecuador;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany
180	EUCTR2010-020065-24-DE (EUCTR)	06/09/2011	30/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
181	EUCTR2010-020065-24-NL (EUCTR)	31/08/2011	06/07/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
182	EUCTR2010-020065-24-ES (EUCTR)	25/08/2011	01/07/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Anticuerpo monoclonal anti-humano recombinante humanizado, receptor de IL-6R. Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
183	EUCTR2011-000102-21-ES (EUCTR)	17/08/2011	04/07/2011	Seguridad y Eficacia de secukinumab comparado con placebo y abatacept in pacientes con artritis reumatoide activa que no respodieron a agentes anti- TNFalfa	Estudio aleatorizado, doble ciego, controlado con placebo y con control activo de secukinumab para demostrar la eficacia en 24 semanas y evaluar la seguridad, tolerabilidad y eficacia a largo plazo durante 1 año en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada a anti-TNFalfa	ARTRITIS REUMATOIDE MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Secukinumab Product Code: AIN457 INN or Proposed INN: secukinumab Other descriptive name: NO APLICA Trade Name: ORENCIA 250 mg polvo para concentrado para sol. para perfusión INN or Proposed INN: ABATACEPT Other descriptive name: ABATACEPT	Novartis Farmacéutica S.A.	NULL	Not Recruiting			Female: yes Male: yes	548		United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany
184	EUCTR2010-020065-24-GB (EUCTR)	15/08/2011	08/04/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
185	EUCTR2010-020065-24-AT (EUCTR)	28/07/2011	17/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
186	EUCTR2010-020065-24-CZ (EUCTR)	26/07/2011	27/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
187	EUCTR2010-020065-24-LT (EUCTR)	25/07/2011	25/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080		Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
188	EUCTR2010-019262-86-ES (EUCTR)	22/06/2011	21/04/2010	Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)	Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)	Artritis Reumatoide_______________________Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Netherlands;Germany;Norway;Sweden
189	EUCTR2010-020065-24-HU (EUCTR)	15/06/2011	02/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
190	EUCTR2010-020065-24-LV (EUCTR)	08/06/2011	11/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
191	EUCTR2011-000215-79-FR (EUCTR)	07/06/2011	24/02/2011	Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA	Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA	Polyarthrite rhumatoïde	Trade Name: Roactemra Other descriptive name: TOCILIZUMAB	CHU de Clermont Ferrand	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France
192	EUCTR2009-016266-90-ES (EUCTR)	03/05/2011	16/12/2009	Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY	Artritis Reumatoide_____________________________________Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	1740	Phase 2	Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands
193	EUCTR2010-019871-31-SK (EUCTR)	02/05/2011	28/02/2011	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
194	EUCTR2010-020065-24-IT (EUCTR)	29/04/2011	20/03/2012	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel(etanercept) in Patients With Rheumatoid Arthritis and Increased Riskfor Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptorblockade with tocilizumab (TCZ) in comparison with etanercept (ETA) onthe rate of cardiovascular events in patients with moderate to severerheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: TOCILIZUMAB Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Philippines;Greece;Ecuador;Spain;Chile;Russian Federation;Israel;Italy;India;Malaysia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany
195	EUCTR2010-023587-40-ES (EUCTR)	13/04/2011	17/02/2011	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.	Adult Rheumatoid Arthritis (RA)Artritis reumatoide del adulto (AR) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	Greece;Finland;Spain;Denmark;Netherlands;Germany;Italy;Sweden
196	EUCTR2010-023880-17-GB (EUCTR)	31/03/2011	25/02/2011	SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drug	SWITCH: Randomised-controlled trial of switching to alternative tumour-necrosis factor (TNF)-blocking drugs or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-blocking drug. - SWITCH	Rheumatoid arthritis in patients who have failed to respond to an initial TNF-blocking drug MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Mabthera Product Name: Rituximab Product Code: n/a INN or Proposed INN: Rituximab Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of the world) Trade Name: Orencia Product Name: Abatacept Product Code: n/a INN or Proposed INN: abatacept Other descriptive name: Orencia Trade Name: Remicade Product Name: Infliximab Product Code: n/a INN or Proposed INN: infliximab Other descriptive name: n/a Trade Name: Enbrel Product Name: Etanercept Product Code: n/a INN or Proposed INN: etanercept Other descriptive name: n/a	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	477	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
197	EUCTR2010-023910-30-GB (EUCTR)	23/03/2011	28/02/2011	A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA)	A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA)	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Enbrel 50mg pre-filled pen Product Name: Etanercept (Enbrel) Product Code: EU/1/99/126/020 INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Enbrel 50mg pre-filled syringe Product Name: Etanercept (Enbrel) Product Code: EU/1/99/126/017 INN or Proposed INN: Etanercept	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	United Kingdom
198	EUCTR2010-022207-22-ES (EUCTR)	21/03/2011	29/12/2010	A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfa	A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfa	Rheumatoid Arthritis Artritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	555	Phase 3	Greece;Poland;Spain;Germany;Italy
199	EUCTR2010-022208-36-ES (EUCTR)	21/03/2011	29/12/2010	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR)	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR)	Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: LY2127399 Product Code: LY2127399 Product Name: LY2127399 Product Code: LY2127399	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1505	Phase 3	Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
200	NCT01313208 (ClinicalTrials.gov)	March 2011	10/3/2011	Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy	Rheumatoid Arthritis	Drug: etanercept;Drug: Placebo;Drug: DMARD Therapy	Amgen	NULL	Completed	18 Years	80 Years	All	210	Phase 4	United States;Canada
201	EUCTR2010-020890-18-CZ (EUCTR)	25/02/2011	02/11/2010	AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS	AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: tasocitinib citrate Trade Name: Methotrexate Sodium Tablets 2.5 mg INN or Proposed INN: Methotrexate Sodium	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Czech Republic
202	EUCTR2010-020890-18-HU (EUCTR)	18/02/2011	16/11/2010	Tofacitinib MRI in Early Rheumatoid Arthritis	AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF Tofacitinib (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib Product Code: CP-690,550 INN or Proposed INN: tasocitinib citrate Trade Name: Methotrexate Sodium Tablets 2.5 mg INN or Proposed INN: Methotrexate Sodium	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Czech Republic;Hungary
203	NCT01254331 (ClinicalTrials.gov)	February 2011	3/12/2010	An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment	Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	51	Phase 3	Tunisia
204	EUCTR2010-019514-24-ES (EUCTR)	27/01/2011	30/11/2010	Estudio multicéntrico, doble ciego, aleatorizado, de brazos paralelos para determinar la respuesta a la dosis de metotrexato (MTX) en combinación con adalimumab en sujetos con artritis reumatoide temprana (CONCERTO). A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO	Estudio multicéntrico, doble ciego, aleatorizado, de brazos paralelos para determinar la respuesta a la dosis de metotrexato (MTX) en combinación con adalimumab en sujetos con artritis reumatoide temprana (CONCERTO). A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO	Rheumatoid Arthritis. Artritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB Trade Name: MTX HEXAL Tablets INN or Proposed INN: METOTREXATO Other descriptive name: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE Trade Name: MTX HEXAL Tablets INN or Proposed INN: METHOTREXATE	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	380		Czech Republic;Spain;Austria;Germany
205	EUCTR2010-021577-37-ES (EUCTR)	27/01/2011	23/11/2010	ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	Artritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: N/A Product Code: MLTA3698A Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	GENENTECH, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Germany;Bulgaria;Spain
206	EUCTR2010-019912-18-ES (EUCTR)	17/01/2011	19/01/2011	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	Rheumatoid arthritis (RA)Artritis Reumatoide (AR) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml SC PFS SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Hungary;Greece;Spain;Bulgaria
207	EUCTR2010-019871-31-BE (EUCTR)	11/01/2011	31/08/2010	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin Trade Name: ARCOXIA Product Name: Etoricoxib Product Code: MK-0663 INN or Proposed INN: ETORICOXIB Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
208	EUCTR2010-021283-14-ES (EUCTR)	07/01/2011	05/11/2010	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis.Ensayo de dosis múltiples, aleatorizado, doble ciego y controlado con placebo de anti IL 20 (109 0012) en pacientes con artritis reumatoide.	A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis.Ensayo de dosis múltiples, aleatorizado, doble ciego y controlado con placebo de anti IL 20 (109 0012) en pacientes con artritis reumatoide.	Rheumatoid arthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Anti-IL-20 (109-0012) Product Code: NNC 0109-0000-0012 Other descriptive name: Anti-IL-20	Novo Nordisk A/S	NULL	Not Recruiting			Female: yes Male: yes	66		Hungary;Portugal;United Kingdom;Spain;Italy
209	NCT01411215 (ClinicalTrials.gov)	January 2011	13/5/2011	A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department	A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department	Rheumatoid Arthritis;Ankylosing Spondylitis	Drug: Enbrel	Pfizer	NULL	Terminated	18 Years	N/A	All	160	N/A	China
210	EUCTR2010-021020-94-ES (EUCTR)	21/12/2010	21/10/2010	Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-?	Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-?	artritis reumatoide activa MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191 Trade Name: SIMPONI 50 mg solución inyectable en pluma precargada INN or Proposed INN: GOLIMUMAB Other descriptive name: GOLIMUMAB	Sanofi-aventis Recherche & Développement	NULL	Not Recruiting			Female: yes Male: yes	250		Hungary;Czech Republic;Germany;Spain;Italy
211	EUCTR2010-020892-22-ES (EUCTR)	13/12/2010	05/10/2010	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid ArthritisEstudio de extensión a largo plazo para evaluar la seguridad y la eficacia de fostamatinib disódico (FosD) en el tratamiento de la artritisreumatoide - OSKIRA - X	A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid ArthritisEstudio de extensión a largo plazo para evaluar la seguridad y la eficacia de fostamatinib disódico (FosD) en el tratamiento de la artritisreumatoide - OSKIRA - X	Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	2000		Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Netherlands;Latvia;Germany;Italy;United Kingdom
212	EUCTR2010-020745-27-ES (EUCTR)	13/12/2010	30/09/2010	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonistEstudio en fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas de fostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficiente a un antagonista del TNF-alfa - OSKIRA - 3	A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonistEstudio en fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas de fostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficiente a un antagonista del TNF-alfa - OSKIRA - 3	Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	France;Portugal;Hungary;Czech Republic;Belgium;Spain;Germany;Italy;United Kingdom
213	EUCTR2010-020744-35-ES (EUCTR)	13/12/2010	23/09/2010	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2	Rheumatoid ArthritisArtritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom
214	NCT01270997 (ClinicalTrials.gov)	December 2010	2/1/2011	Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients	A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase ? Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Etanercept	Hanwha Chemical	NULL	Completed	20 Years	N/A	Both	294	Phase 3	Korea, Republic of
215	EUCTR2010-018646-31-ES (EUCTR)	05/11/2010	12/08/2010	Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Artritis reumatoide.Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis	Product Name: CT-P13 Product Code: CT-P13 INN or Proposed INN: Infliximab Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB	CELLTRION, Inc	NULL	Not Recruiting			Female: yes Male: yes	584	Phase 3	Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom
216	JPRN-UMIN000008756	2010/11/01	30/08/2012	Abatacept-based approach to cure of RA	Abatacept-based approach to cure of RA - ACURE study	Rheumatoid Arthritis	Abatacept treatmentat month 12 MTX treatment at month 12	University of Occupational and Environmental Health, Japan	NULL	Recruiting	15years-old	Not applicable	Female	40	Not selected	Japan
217	EUCTR2010-020738-24-GB (EUCTR)	12/10/2010	17/08/2010	To see whether for patients with established rheumatoid arthritis that have already achieved a good response to Tumour Necrosis Factor Inhibitor (TNF inhibitor) treatment, whether the treatment be tapered to a minimum dose without affecting the control of disease activity.	Optimising Treatment With Tumour Necrosis Factor Inhibitors In Rheumatoid Arthritis: Is Dose Tapering Practical In Good Responders? A Proof Of Principle” And Exploratory Trial. (OPTTIRA) - OPTTIRA	Patients with established Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel pre-filled pen Product Name: Etanercept INN or Proposed INN: etanercept Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab Trade Name: Enbrel pre-filled syringe Product Name: Etanercept INN or Proposed INN: etanercept	King's College London	NULL	Not Recruiting			Female: yes Male: yes	99	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
218	NCT01164579 (ClinicalTrials.gov)	October 2010	15/7/2010	Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)	An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tasocitinib plus Methotrexate;Drug: Tofacitinib plus placebo methotrexate;Drug: Placebo tofacitinib plus Methotrexate	Pfizer	NULL	Completed	18 Years	N/A	All	109	Phase 2	United States;Argentina;Chile;Croatia;Czech Republic;Hungary;Mexico;Poland;Puerto Rico
219	EUCTR2010-019935-37-FI (EUCTR)	15/09/2010	02/07/2010	A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis	A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Other descriptive name: TOCILIZUMAB	Roche Oy	NULL	Not Recruiting			Female: yes Male: yes	160		Finland
220	EUCTR2010-018375-22-ES (EUCTR)	03/08/2010	04/06/2010	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	Rheumatoid arthritisArtritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml jeringa SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
221	EUCTR2009-010582-23-GR (EUCTR)	15/06/2010	30/12/2009	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?)	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal Product Name: Golimumab prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
222	EUCTR2010-019873-13-BE (EUCTR)	07/06/2010	14/04/2010	Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA	Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA	early rheumatoid arthritis MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Trade Name: RoActemra Product Name: Tocilizumab	UCL Cliniques Universitaires Saint Luc	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Belgium
223	EUCTR2010-019438-28-SE (EUCTR)	17/05/2010	18/03/2010	Vaccination against TBE in patients who use immunosuppressive drugs	Vaccination against TBE in patients who use immunosuppressive drugs	TBE vaccin in patients using immunosuppressive drugs MedDRA version: 12.1;Level: LLT;Classification code 10046859;Term: Vaccination MedDRA version: 12.1;Classification code 10037153;Term: Psoriasis MedDRA version: 12.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.1;Classification code 10054980;Term: Immunosuppressant drug therapy	Trade Name: FSME-IMMUN Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED)	Mälarsjukhuset Eskilstuna	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Sweden
224	EUCTR2009-015740-42-DE (EUCTR)	12/05/2010	12/01/2010	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO	Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: A	Universitätsklinkum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	318	Phase 3	Germany
225	EUCTR2009-015845-21-ES (EUCTR)	12/05/2010	12/01/2012	A comparison of tocilizumab and adalimumab in patients withrheumatoid arthritis looking at improvement in joint pain, joint swellingand general disease activity.	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	United States;Portugal;Greece;Finland;Spain;Turkey;United Kingdom;Switzerland;Czech Republic;Mexico;Belgium;Brazil;Australia;Germany;Sweden
226	EUCTR2009-010516-15-ES (EUCTR)	11/05/2010	29/07/2009	Ensayo aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de SBI-087 en sujetos seropositivos con artritis reumatoide activa en tratamiento de fondo estable con metotrexatoRandomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Ensayo aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de SBI-087 en sujetos seropositivos con artritis reumatoide activa en tratamiento de fondo estable con metotrexatoRandomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate	Rheumatoid arthritis (seropositive)Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis	Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Greece;Poland;Spain
227	EUCTR2007-000896-41-AT (EUCTR)	06/05/2010	13/05/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
228	NCT01245452 (ClinicalTrials.gov)	May 2010	19/11/2010	Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate	Comparative Study of the Clinical Response and Cardiorespiratory Endurance in Early Rheumatoid Arthritis Patients Treated With Tocilizumab or Methotrexate Addendum Protocol : Global Gene Expression Profiles in Synovial Biopsies	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Methotrexate	Patrick Durez	NULL	Completed	18 Years	70 Years	Both	30	N/A	Belgium
229	EUCTR2009-016987-34-ES (EUCTR)	19/04/2010	12/02/2010	Estudio de fase 3 aleatorizado y doble ciego de la eficacia y la seguridad de 2 dosis de CP-690,550 en comparación con metotrexato en pacientes con artritis reumatoide no tratados previamente con metotrexato PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Estudio de fase 3 aleatorizado y doble ciego de la eficacia y la seguridad de 2 dosis de CP-690,550 en comparación con metotrexato en pacientes con artritis reumatoide no tratados previamente con metotrexato PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS	Artritis Reumatoide activa moderada a grave Moderate to severe active Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550 Product Code: CP-690,550 Trade Name: Methotrexate Sodium Product Name: Metotrexato Sodico INN or Proposed INN: METOTREXATO SODICO	PFIZER	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Czech Republic;Hungary;Slovakia;Poland;Belgium;Spain;Bulgaria;Germany;Sweden
230	EUCTR2009-012118-27-BE (EUCTR)	13/04/2010	23/02/2010	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy - N/A	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy - N/A	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168-AEK - Over Encapsulated Tablet - 50 mg Product Code: JNJ-38518168 INN or Proposed INN: N/A	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	95	Phase 2	Czech Republic;Spain;Belgium;Netherlands;United Kingdom
231	EUCTR2007-006657-63-HU (EUCTR)	26/03/2010	15/02/2010	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel 25 mg powder and solvent for solution for injection Product Name: Enbrel Trade Name: Enbrel 50 mg powder and solvent for solution for injection Product Name: Enbrel	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	186	Phase 4	Hungary;Finland;Denmark;Iceland;Sweden
232	EUCTR2007-006657-63-IS (EUCTR)	10/03/2010	18/02/2010	Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT	Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Finland;Iceland;Denmark;Norway;Sweden
233	EUCTR2009-010582-23-IT (EUCTR)	10/03/2010	08/01/2010	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA) - ND	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA) - ND	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: golimumab Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: golimumab	CENTOCOR	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
234	EUCTR2009-010582-23-BE (EUCTR)	10/02/2010	23/09/2009	Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen or prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
235	NCT00979771 (ClinicalTrials.gov)	February 2010	17/9/2009	A Study to Investigate the Ability of GSK706769 to Maintain Clinical Remission After Withdrawal of Enbrel in Rheumatoid Arthritis Patients	A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Ability of GSK706769 to Maintain Clinical Remission After Withdrawal of Enbrel in Patients With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: GSK706769;Drug: Placebo	GlaxoSmithKline	NULL	Withdrawn	18 Years	N/A	All	0	Phase 2	Netherlands
236	EUCTR2009-010582-23-DE (EUCTR)	04/01/2010	22/09/2009	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
237	EUCTR2009-010582-23-GB (EUCTR)	31/12/2009	28/06/2010	Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab prefilled pen or prefilled syringe Product Code: CNTO 148 INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Greece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden
238	EUCTR2009-011268-13-GB (EUCTR)	31/12/2009	15/03/2010	Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study	Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera Product Name: Rituximab Trade Name: Enbrel Product Name: Etanercept Trade Name: Humira Product Name: Adalimumab	NHS Greater Glasgow and Clyde	University of Glasgow	Not Recruiting			Female: yes Male: yes			United Kingdom
239	EUCTR2009-012204-42-BE (EUCTR)	16/12/2009	28/09/2009	A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis	A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK706769 Product Code: GSK706769	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	50		Belgium;Ireland
240	EUCTR2009-010582-23-SE (EUCTR)	16/12/2009	23/10/2009	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
241	EUCTR2008-002623-85-DE (EUCTR)	16/12/2009	12/06/2009	Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	300		Poland;Romania;Germany;Netherlands;Sweden;Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France
242	EUCTR2009-012759-12-ES (EUCTR)	01/12/2009	23/09/2009	Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Artritis ReumatoideRheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
243	NCT01004432 (ClinicalTrials.gov)	December 2009	29/10/2009	Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA)	Arthritis;Arthritis, Rheumatoid;Autoimmune Diseases	Drug: Golimumab 50 mg SC;Drug: Golimumab 2 mg/kg IV;Drug: Methotrexate (MTX);Drug: Placebo SC;Drug: Placebo IV	Janssen Biotech, Inc.	Merck Sharp & Dohme Corp.	Completed	18 Years	N/A	All	433	Phase 3	United States;Austria;Belgium;Canada;Germany;Greece;Sweden;United Kingdom;France;Spain
244	EUCTR2009-010582-23-AT (EUCTR)	26/11/2009	12/10/2009	Golimumab in Rheumatoid Arthritis Patients With An Inadequate Response to Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen or Prefilled Syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody	Janssen Biologics B.V.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden
245	EUCTR2009-012424-87-GB (EUCTR)	26/11/2009	14/10/2009	T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF	T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF	Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 12.0;Classification code 10037160;Term: Psoriatic arthritis MedDRA version: 12.0;Classification code 10002556;Term: Ankylosing spondylitis	Trade Name: Enbrel INN or Proposed INN: etanercept Trade Name: Humira INN or Proposed INN: adalimumab Trade Name: Enbrel INN or Proposed INN: etanercept Trade Name: Enbrel INN or Proposed INN: Etanercept	Imperial College London South Kensington London	NULL	Not Recruiting			Female: yes Male: yes	55	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
246	EUCTR2009-013223-37-ES (EUCTR)	25/11/2009	17/09/2009	Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS	Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS	ARTRITIS REUMATOIDE MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 Trade Name: DECORTIN (PREDNISONA) 5 MG COMPRIMIDOS INN or Proposed INN: Prednisone Other descriptive name: Decortin®	Pfizer S.A.	NULL	Not Recruiting			Female: yes Male: yes	119	Phase 2	Hungary;Czech Republic;Spain
247	EUCTR2009-014296-40-ES (EUCTR)	20/11/2009	24/09/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS. Estudio de fase 3 aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato y con una respuesta insuficiente a inhibidores del TNF.	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS. Estudio de fase 3 aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato y con una respuesta insuficiente a inhibidores del TNF.	Rheumatoid arthritisArtritis reumatoide MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer S.A.	NULL	Not Recruiting			Female: yes Male: yes	396	Phase 3	France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy
248	EUCTR2009-012204-42-IE (EUCTR)	13/11/2009	09/09/2009	A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis	A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis	Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: GSK706769 Product Code: GSK706769	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	50		Belgium;Ireland
249	EUCTR2008-002623-85-IE (EUCTR)	06/11/2009	15/09/2009	Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	300		Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France;Poland;Romania;Germany;Netherlands;Sweden
250	EUCTR2007-003288-36-GB (EUCTR)	04/11/2009	03/10/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
251	JPRN-UMIN000002687	2009/11/01	16/11/2009	ENBREL Clinical Outcome in RA patients for Growing Evidence	ENBREL Clinical Outcome in RA patients for Growing Evidence - ENCOURAGE	rheumatoid arthritis	MTX/MTX+DMARDs group MTX+ETN group ETN continuation group ETN discontinuation group	TAP Corporation	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	330	Not applicable	Japan,Asia(except Japan)
252	NCT00844714 (ClinicalTrials.gov)	November 2009	12/2/2009	Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy	Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy	Endothelial Function;Rheumatoid Arthritis;Inflammation	Drug: Rituxan	University of California, San Francisco	Genentech, Inc.	Completed	18 Years	N/A	All	20	N/A	United States
253	EUCTR2008-005450-20-BE (EUCTR)	29/10/2009	01/10/2009	The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)	The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)	Rheumatoid arthritis MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade (infliximab) INN or Proposed INN: INFLIXIMAB Other descriptive name: remicade Trade Name: Humira (adalimumab) INN or Proposed INN: ADALIMUMAB Trade Name: Enbrel (etanercept) INN or Proposed INN: ETANERCEPT Other descriptive name: Enbrel Trade Name: Mabthera (rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: Mabthera Trade Name: Orencia (abatacept) INN or Proposed INN: ABATACEPT Other descriptive name: Orencia	Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	261		Belgium
254	EUCTR2009-012118-27-NL (EUCTR)	27/10/2009	27/05/2009	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Czech Republic;United Kingdom;Netherlands;Spain
255	EUCTR2009-011137-26-ES (EUCTR)	23/10/2009	06/08/2009	Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE	Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE	Artritis reumatoide MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab Product Name: Golimumab Product Code: SCH 900259 INN or Proposed INN: Golimumab	Schering-Plough Research Institute, A Division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	3150	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
256	EUCTR2009-012705-19-CZ (EUCTR)	16/10/2009	17/07/2009	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	Rheumatoid Arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305 Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305	Lexicon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Czech Republic;Bulgaria
257	EUCTR2008-002623-85-GB (EUCTR)	01/10/2009	17/08/2009	Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA). (Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel® Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate Trade Name: Methotrexate Sodium Tablets 2.5mg Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Pharmaceuticals Inc. Philadelphia (A Pfizer Company)	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Qatar;Spain;Ireland;Russian Federation;United Kingdom;Switzerland;Italy;France;Poland;Romania;Germany;Netherlands;Sweden
258	EUCTR2009-012705-19-BG (EUCTR)	29/09/2009	06/10/2009	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	Rheumatoid Arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305 Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305	Lexicon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	104	Phase 2	Hungary;Czech Republic;Bulgaria
259	EUCTR2009-012118-27-ES (EUCTR)	28/09/2009	03/07/2009	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy SubstudyEstudio de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos de JNJ 38518168 en pacientes con artritis reumatoide activa a pesar del tratamiento con metotrexato con un sub-estudio de biopsia sinovial	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy SubstudyEstudio de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos de JNJ 38518168 en pacientes con artritis reumatoide activa a pesar del tratamiento con metotrexato con un sub-estudio de biopsia sinovial	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.JNJ-38518168 se está desarrollando para el tratamiento de la Artritis Reumatoide MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Czech Republic;United Kingdom;Netherlands;Spain
260	EUCTR2006-006373-25-FI (EUCTR)	21/09/2009	16/06/2009		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
261	EUCTR2009-012118-27-GB (EUCTR)	04/09/2009	18/06/2009	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	95	Phase 2	Czech Republic;United Kingdom;Netherlands;Spain
262	EUCTR2009-012118-27-CZ (EUCTR)	04/09/2009	25/06/2009	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy	JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis. MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet Product Code: GFI 38518168-AEK-B-007	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	United Kingdom;Czech Republic;Netherlands;Spain
263	EUCTR2006-006373-25-GB (EUCTR)	03/09/2009	16/11/2010	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
264	EUCTR2009-012705-19-HU (EUCTR)	17/08/2009	16/07/2009	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201	Rheumatoid Arthritis (RA) MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305 Product Name: LX3305 Dihydrate Product Code: LX3305 INN or Proposed INN: None as of yet Other descriptive name: LX3305	Lexicon Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	104	Phase 2	Hungary;Czech Republic;Bulgaria
265	EUCTR2008-002623-85-ES (EUCTR)	27/07/2009	19/02/2010	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato.	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato.	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Product Name: Etanercept Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate Product Code: L01BA01 INN or Proposed INN: Methotrexate	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
266	EUCTR2008-002623-85-NL (EUCTR)	27/07/2009	01/05/2009	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE	Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel 25mg PFS Product Name: Enbrel (Etanercept) Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Enbrel 50mg PFS Product Name: Enbrel (Etanercept) Product Code: 0881 INN or Proposed INN: Etanercept Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate 2.5mg Tablets INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	300		France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
267	EUCTR2008-002623-85-IT (EUCTR)	14/07/2009	30/06/2009	A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate - PRIZE	A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate - PRIZE	Moderate to severe early Rheumatoid Arthritis (RA). MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ENBREL*SC 4SIR 25MG 0,5ML+8TAM INN or Proposed INN: Etanercept Trade Name: ENBREL*SC 4SIR 50MG 1ML+8TAMP INN or Proposed INN: Etanercept Trade Name: METHOTREXATE*25CPR 2,5MG INN or Proposed INN: Methotrexate	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development	NULL	Not Recruiting			Female: yes Male: yes	300		France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
268	EUCTR2008-008338-35-ES (EUCTR)	19/06/2009	27/03/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato	CP 690,550 está estudiándose como fármaco antirreumático modificador de la enfermedad (FARME) en el tratamiento de la artritis reumatoide activa moderada o grave en adultosCP-690,550 ins being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550 Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	Pfizer, S.A	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
269	EUCTR2008-008337-11-ES (EUCTR)	19/06/2009	27/03/2009	Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Artritis reumatoide RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP-690,550	Pfizer, S.A.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
270	EUCTR2008-002381-55-ES (EUCTR)	16/06/2009	01/08/2008	Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.	Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.	Pacientes con artritis reumatoide (AR) activa refractarios a uno o más fármacos antiTNF (definido por un DAS28>3,2). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ROCHE FARMA, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain
271	NCT01010503 (ClinicalTrials.gov)	June 2009	9/11/2009	A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.	Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	32	Phase 4	Slovakia
272	EUCTR2007-006657-63-FI (EUCTR)	08/05/2009	27/01/2009	Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT	Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Finland;Iceland;Denmark;Norway;Sweden
273	EUCTR2009-011520-53-SK (EUCTR)	04/05/2009	17/03/2009	Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment	Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment	moderate to severe active rheumatoid arthritis	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	Roche Slovensko s.r.o.	NULL	Not Recruiting			Female: yes Male: yes			Slovakia
274	NCT00279461 (ClinicalTrials.gov)	May 2009	17/1/2006	Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis	Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis: Clinical Trial and Investigations on Dendritic Cells	Arthritis, Rheumatoid;Vitamin D Deficiency	Drug: Placebo in arm A and Vitamin D in arm B;Drug: vitamin D 3 for arm A ,and matching placebo for arm B	Indiana University	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 2	United States
275	EUCTR2007-001625-10-GR (EUCTR)	29/04/2009	06/03/2009	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
276	EUCTR2008-008309-23-FR (EUCTR)	24/04/2009	31/03/2009	Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO	Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO	Polyarthrite rhumatoïde active modérée à sévère de moins de 10 ans d'ancienneté, avec réponse inadéquate au méthotrexate (MTX) et/ou à un autre DMARD et/ou à au moins un anti-TNF MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Code: RO487-7533/F01-F05 INN or Proposed INN: tolicizumab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	118	Phase 4	France
277	EUCTR2007-006657-63-DK (EUCTR)	16/04/2009	20/02/2009	Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT	Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Finland;Denmark;Iceland;Norway;Sweden
278	JPRN-UMIN000004271	2009/04/01	27/09/2010	Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxib	Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxib - The usefulness of switching to celecoxib in patients with NSAIDs-induced gastrointestinal mucosal injury	Rheumatoid arthritis (RA)NSAIDs-induced gastrointestinal mucosal injury	Japanese rheumatic patients who have been treated with NSAIDs for twelve or more weeks are switched to CEL (400mg/day). Upper GI endoscopy is conducted before and after administration of CEL. Patients with ulcers at the enrollment are switched to CEL (400mg/day) with famotidine (20mg/day) after healing of their pre-existing ulcers following treatment.	Hoshigaoka Koseinenkin Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not applicable	Japan
279	EUCTR2007-006657-63-SE (EUCTR)	25/03/2009	06/02/2009	Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)	Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA	Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Enbrel 25 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT	Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom	NULL	Not Recruiting			Female: yes Male: yes	72		Hungary;Finland;Denmark;Norway;Iceland;Sweden
280	EUCTR2008-006443-39-ES (EUCTR)	23/02/2009	09/12/2008	Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos.	Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos.	Pacientes adultos con artritis reumatoide (AR) activa moderada o grave que son respondedores inadecuados a los tratamientos con FAMEs no biológicos o con anti-TNFs. MedDRA version: 9;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO04877533 INN or Proposed INN: Tocilizumab Other descriptive name: RoActemra	Roche Farma, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain
281	EUCTR2008-005320-81-ES (EUCTR)	18/02/2009	20/01/2009	Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2	Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2	Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class	Novartis Farmacéutica S.A.	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	Belgium;Spain;Austria;Germany
282	EUCTR2007-001625-10-GB (EUCTR)	17/02/2009	02/05/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700	Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes	France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
283	EUCTR2008-006924-68-ES (EUCTR)	13/02/2009	19/01/2009	Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573	Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573	Artritis reumatoide/Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
284	EUCTR2008-001523-57-ES (EUCTR)	09/02/2009	22/10/2008	Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate	Sujetos adultos con artritis reumatoide activa, de acuerdo con los criterios de la asociación de reumatismo Americana para la clasificación de la AR y con respuesta al metotrexate inadecuada.Adult subjects with Active Rheumatoid Arthritis, in accordance with the American Rheumatology Association criteria for the classification of AR with inadequate response to Metotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom
285	NCT01172639 (ClinicalTrials.gov)	February 2009	28/7/2010	Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.	A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Prednisone	P. Verschueren	Agentschap voor Innovatie door Wetenschap en Technologie	Completed	18 Years	N/A	All	400	Phase 4	Belgium
286	EUCTR2008-005525-11-ES (EUCTR)	29/01/2009	09/12/2008	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Artritis reumatoideRheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
287	EUCTR2007-000896-41-GB (EUCTR)	12/01/2009	19/01/2009	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France;Czech Republic;Hungary;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
288	EUCTR2007-003288-36-ES (EUCTR)	08/01/2009	09/03/2010	Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART	Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART	Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200		Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
289	EUCTR2007-001625-10-IE (EUCTR)	12/12/2008	07/10/2008	AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RADIOGRAPHIC EFFICACY AND SAFETY OF ENBREL™ (ETANERCEPT) ADDED TO METHOTREXATE IN COMPARISON WITH USUAL TREATMENT IN SUBJECTS WITH MODERATE RHEUMATOID ARTHRITIS DISEASE ACTIVITY	AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RADIOGRAPHIC EFFICACY AND SAFETY OF ENBREL™ (ETANERCEPT) ADDED TO METHOTREXATE IN COMPARISON WITH USUAL TREATMENT IN SUBJECTS WITH MODERATE RHEUMATOID ARTHRITIS DISEASE ACTIVITY	RHEUMATOID ARTHRITIS	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Spain;Ireland;Italy;Greece;Poland;Austria
290	EUCTR2007-003288-36-FR (EUCTR)	08/12/2008	21/10/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom
291	EUCTR2007-003288-36-FI (EUCTR)	28/11/2008	30/09/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
292	EUCTR2007-001625-10-IT (EUCTR)	26/11/2008	01/04/2009	An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) added to Methotrexate in Comparison with Usual Treatment in Subjects with Moderate Rheumatoid Arthritis Disease Activity. - EXTRA	An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) added to Methotrexate in Comparison with Usual Treatment in Subjects with Moderate Rheumatoid Arthritis Disease Activity. - EXTRA	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ENBREL INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;United Kingdom;Italy
293	EUCTR2008-006256-22-FR (EUCTR)	21/11/2008	31/10/2008	Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.	Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.	rheumatoid arthritis requiring anti-TNF alpha treatment MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Trade Name: remicade INN or Proposed INN: infliximab Trade Name: humira INN or Proposed INN: adalimumab Trade Name: enbrel INN or Proposed INN: etanercept	CHU Saint-Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
294	EUCTR2007-003288-36-DE (EUCTR)	10/11/2008	03/09/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
295	EUCTR2008-001847-20-ES (EUCTR)	17/10/2008	11/08/2008	Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX.	Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX.	Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO04877533 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: METOTREXATO SODIO Other descriptive name: METHOTREXATE SODIUM	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
296	EUCTR2007-003288-36-NL (EUCTR)	15/10/2008	11/07/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
297	EUCTR2008-002046-27-ES (EUCTR)	14/10/2008	06/05/2010	Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato.	Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato.	Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20	GlaxoSmithKline S.A.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 1/2	Germany;Belgium;France;Spain
298	EUCTR2007-001625-10-AT (EUCTR)	09/10/2008	04/06/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel 50 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
299	EUCTR2007-003288-36-AT (EUCTR)	01/10/2008	18/08/2008	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Other descriptive name: Chimeric Human-Murine IgG1	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria
300	EUCTR2007-001625-10-DE (EUCTR)	01/10/2008	05/05/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel 50 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;United Kingdom;Germany;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
301	EUCTR2007-001625-10-PL (EUCTR)	10/09/2008	09/06/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Greece;Austria;Poland;Italy;Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain
302	NCT00706797 (ClinicalTrials.gov)	September 2008	25/6/2008	Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects	An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity	Rheumatoid Arthritis	Drug: etanercept (EnbrelTM);Drug: methotrexate	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Terminated	18 Years	N/A	All	141	Phase 4	Czech Republic;France;Germany;Hungary;Italy;Poland;Spain;Turkey;United Kingdom;Austria;Croatia;United States
303	NCT00746512 (ClinicalTrials.gov)	September 2008	3/9/2008	A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)	A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Prednisone 15 mg;Drug: Placebo Tablets;Drug: Prednisone 7.5 mg;Drug: Placebo Over-Encapsulated Tablets	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	N/A	All	45	Phase 1	United Kingdom
304	EUCTR2008-000170-20-ES (EUCTR)	26/08/2008	03/06/2008	A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, para evaluar la eficacia clínica y la seguridad de BMS-582949 administrado por vía oral a sujetos con artritis reumatoide que han mostrado respuesta inadecuada al metotrexato.Protocolo Revisado 01, que incorpora la carta administrativa 01 y la enmienda 03 (version 1.0, de fecha 12-Mar-2008).	A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, para evaluar la eficacia clínica y la seguridad de BMS-582949 administrado por vía oral a sujetos con artritis reumatoide que han mostrado respuesta inadecuada al metotrexato.Protocolo Revisado 01, que incorpora la carta administrativa 01 y la enmienda 03 (version 1.0, de fecha 12-Mar-2008).	subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX)sujetos con artritis reumatoide (AR) que estan recibiendo tratamiento de fondo con metotrexato (MTX). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BMS-582949	Bristol Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	France;Czech Republic;Spain
305	EUCTR2007-007539-14-HU (EUCTR)	15/08/2008	26/08/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
306	EUCTR2007-007539-14-BG (EUCTR)	14/08/2008	06/08/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
307	EUCTR2007-007539-14-PL (EUCTR)	05/08/2008	30/06/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
308	EUCTR2006-006373-25-BG (EUCTR)	04/08/2008	14/09/2009	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Czech Republic;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
309	EUCTR2007-007888-24-FR (EUCTR)	31/07/2008	17/07/2008	Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW	Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW	RHEUMATOID ARTHRITIS	Trade Name: ENBREL INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	101	Phase 4	France
310	EUCTR2008-000587-17-ES (EUCTR)	22/07/2008	26/05/2008	Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Artritis reumatoideRheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
311	EUCTR2007-000896-41-IT (EUCTR)	15/07/2008	30/07/2008	A RANDOMIZED, DOUBLE-BLIND STUDY COMPARING THE SAFETY AND EFFICACY OF ONCE-WEEKLY ADMINISTRATION OF ETANERCEPT 50 MG, ETANERCEPT 25 MG, AND PLACEBO IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE ACHIEVED AN ADEQUATE RESPONSE WITH ETANERCEPT 50 MG ONCE WEEKLY AND METHOTREXATE - ND	A RANDOMIZED, DOUBLE-BLIND STUDY COMPARING THE SAFETY AND EFFICACY OF ONCE-WEEKLY ADMINISTRATION OF ETANERCEPT 50 MG, ETANERCEPT 25 MG, AND PLACEBO IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE ACHIEVED AN ADEQUATE RESPONSE WITH ETANERCEPT 50 MG ONCE WEEKLY AND METHOTREXATE - ND	Moderately Active Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML INN or Proposed INN: ETANERCEPT Trade Name: ENBREL*SC 4FL 50MG+4SIR+4AGHI+ INN or Proposed INN: ETANERCEPT Product Name: metotrexato INN or Proposed INN: Methotrexate	Wyeth Pharmaceuticals France, Wyeth Research Division	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
312	ChiCTR-TCC-12002824	2008-07-10	2012-12-08	Traditional Chinese and anti-rheumatic drugs for the treatment of rheumatoid arthritis	Integration of Traditional Chinese and Western Medicine treat rheumatoid witharthritis: A prospective, randomized, controlled trial	rheumatoid arthritis with peptic ulcer	Acupuncture treatment:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint. ;ARD treatment:esomeprazole magnesium enteric-coated tablets ,celecoxib capsules and methotrexate tablets ;Combined therapy:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint + oral Shanhuang Wuji decoction ;	Hospital of Chengdu Military Area Command PLA	NULL	Completed	45	65	Both	Acupuncture treatment:20;ARD treatment:20;Combined therapy:20;		China
313	EUCTR2007-001625-10-DK (EUCTR)	08/07/2008	18/06/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
314	JPRN-UMIN000001281	2008/07/01	31/07/2008	Strategic reduction of joint destruction in rheumatoid arthritis	Strategic reduction of joint destruction in rheumatoid arthritis - Strategic reduction of joint destruction in rheumatoid arthritis (ZERO-J study)	Rheumatoid arthritis	TNF-inhibitors plus MTX TNF-inhibitors are used for 54 weeks and exchange among them is approved MTX MTX is used for 54 weeks and addition of the other DMARD is approved	School of Medicine, University of Occupational and Environmental Health, Japan	NULL		Not applicable	Not applicable	Male and Female	120	Not selected	Japan
315	NCT00714493 (ClinicalTrials.gov)	July 2008	10/7/2008	RESTART C0168Z05 Rheumatoid Arthritis Study	A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).	Rheumatoid Arthritis	Biological: Infliximab	Centocor Ortho Biotech Services, L.L.C.	Schering-Plough	Completed	18 Years	N/A	All	203	Phase 4	United States;Austria;Canada;Finland;France;Germany;Israel;Netherlands;Spain;United Kingdom;Belgium
316	EUCTR2007-000896-41-DE (EUCTR)	20/06/2008	21/04/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders MedDRA version: 9.1;Classification code 10021428;Term: Immune system disorders	Trade Name: Enbrel 25 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Sodium Tablets 2.5 mg Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Sodium	Wyeth Research Division of Wyeth Pharmceuticals Inc. A Pfizer Company, Philadelphia, PA-19101, USA	NULL	Not Recruiting			Female: yes Male: yes	900		France;Czech Republic;Hungary;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
317	EUCTR2007-001625-10-CZ (EUCTR)	19/06/2008	21/05/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Research Division of Wyeth Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Germany;United Kingdom;Czech Republic;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
318	EUCTR2007-001625-10-HU (EUCTR)	16/06/2008	18/03/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700		Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria
319	EUCTR2007-007539-14-CZ (EUCTR)	12/06/2008	18/04/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
320	EUCTR2007-005464-26-GB (EUCTR)	05/06/2008	11/04/2008	Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body.	The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II	Rheumatoid Arthritis MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL	Kings College London	Guys and St Thomas'NHS Foundation Trust	Not Recruiting			Female: yes Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
321	EUCTR2007-001625-10-FR (EUCTR)	03/06/2008	13/05/2008	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	RHEUMATOID ARTHRITIS	Trade Name: Etanercept INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
322	EUCTR2007-001625-10-ES (EUCTR)	28/05/2008	24/03/2008	Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderadaAn Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderadaAn Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra	Artritis reumatoideRHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom
323	EUCTR2008-000327-25-ES (EUCTR)	19/05/2008	18/03/2008	ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITIS REUMATOIDE EN PACIENTES CON UN CONTROL INADECUADO CON METROTEXATOA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE	ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITIS REUMATOIDE EN PACIENTES CON UN CONTROL INADECUADO CON METROTEXATOA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE	Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CE-224,535	PFIZER S.A.	NULL	Not Recruiting			Female: yes Male: yes	78	Phase 2	Czech Republic;Poland;Spain
324	EUCTR2007-007539-14-SK (EUCTR)	16/05/2008	16/04/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Latvia;Malta;Italy
325	EUCTR2007-000896-41-BE (EUCTR)	16/05/2008	27/02/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 4	France;Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
326	EUCTR2007-007539-14-LV (EUCTR)	07/05/2008	12/05/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
327	EUCTR2007-000896-41-FR (EUCTR)	07/05/2008	29/02/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 4	France;Czech Republic;Hungary;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
328	EUCTR2007-000896-41-SE (EUCTR)	29/04/2008	06/02/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company, Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
329	EUCTR2007-007539-14-MT (EUCTR)	25/04/2008	12/05/2008	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Product Name: AZD5672 Product Code: AZD5672 Other descriptive name: AZD5672 Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland
330	EUCTR2007-005759-41-ES (EUCTR)	23/04/2008	19/02/2008	Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy	Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy	Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	France;Spain;Germany;Italy;United Kingdom
331	EUCTR2007-000896-41-CZ (EUCTR)	14/04/2008	04/03/2008	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
332	EUCTR2007-000593-24-GB (EUCTR)	28/03/2008	01/08/2007	An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.	An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.	Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Humira INN or Proposed INN: adalimumab Other descriptive name: Humira	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	52	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom;Sweden
333	EUCTR2007-000896-41-HU (EUCTR)	27/03/2008	16/10/2007	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 Trade Name: Methotrexate Product Name: Methotrexate	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
334	EUCTR2007-003623-20-ES (EUCTR)	12/03/2008	04/02/2008	Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).	Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).	Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: RITUXIMAB	Dr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
335	EUCTR2006-006373-25-GR (EUCTR)	26/02/2008	20/09/2007		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
336	EUCTR2006-006591-37-GR (EUCTR)	26/02/2008	20/09/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	264		Greece;Austria
337	EUCTR2006-006562-42-GB (EUCTR)	21/02/2008	13/01/2009	An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia	An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia	Cachexia in patients with Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept 50mg	Derby Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	32	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
338	EUCTR2007-000896-41-ES (EUCTR)	06/02/2008	18/12/2007	Estudio aleatorizado doble ciego que compara la seguridad y la eficacia de la administración semanal de 50 mg de etanercept, 25 mg de etanercept y placebo en combinación con metotrexato en pacientes con artritis reumatoide moderadamente activa que han obtenido una respuesta adecuada con 50 mg de etanercept semanal y metotrexatoA Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	Estudio aleatorizado doble ciego que compara la seguridad y la eficacia de la administración semanal de 50 mg de etanercept, 25 mg de etanercept y placebo en combinación con metotrexato en pacientes con artritis reumatoide moderadamente activa que han obtenido una respuesta adecuada con 50 mg de etanercept semanal y metotrexatoA Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	Artritis reumatoideRheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
339	EUCTR2006-006591-37-AT (EUCTR)	25/01/2008	04/01/2008	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	264		Greece;Austria
340	EUCTR2007-002536-29-ES (EUCTR)	18/01/2008	14/02/2008	Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, fase II de atacicept en pacientes con artritis reumatoide moderada a gravemente activa, sin tratamiento previo con anti-TNFa y con respuesta insuficiente a metrotexato.A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti-TNFa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate. - Atacicept en pacientes con AR sin tratamiento previo con anti-TNFa	Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, fase II de atacicept en pacientes con artritis reumatoide moderada a gravemente activa, sin tratamiento previo con anti-TNFa y con respuesta insuficiente a metrotexato.A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti-TNFa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate. - Atacicept en pacientes con AR sin tratamiento previo con anti-TNFa	Artritis ReumatoideRheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	264	Phase 2	Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden
341	EUCTR2007-001420-12-CZ (EUCTR)	16/01/2008	13/11/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Czech Republic;France;Poland;Sweden
342	EUCTR2007-000593-24-SE (EUCTR)	16/01/2008	21/11/2007	An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.	An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Enbrel INN or Proposed INN: Etanercept Other descriptive name: Enbrel Trade Name: Humira INN or Proposed INN: adalimumab Other descriptive name: Humira	F.Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	52		United Kingdom;Sweden
343	EUCTR2006-003577-27-ES (EUCTR)	21/12/2007	09/10/2007	ESTUDIO DE FASE IIA, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO, DE DOCE SEMANAS DE DURACIÓN PARA EVALUAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE PH-797804 ADMINISTRADO POR VIA ORAL UNA VEZ AL DÍA EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - n/a	ESTUDIO DE FASE IIA, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO, DE DOCE SEMANAS DE DURACIÓN PARA EVALUAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE PH-797804 ADMINISTRADO POR VIA ORAL UNA VEZ AL DÍA EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - n/a	Tratamiento de artritis reumatoide (AR) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide Product Code: PH-797804 Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide	Pfizer S.A.	NULL	Not Recruiting			Female: yes Male: yes	290	Phase 2	Czech Republic;Estonia;Spain
344	EUCTR2006-005137-38-GB (EUCTR)	21/12/2007	14/08/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Finland;Denmark;Germany;United Kingdom;Sweden
345	EUCTR2007-001420-12-PL (EUCTR)	20/12/2007	17/10/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Czech Republic;France;Poland;Sweden
346	EUCTR2006-005137-38-DK (EUCTR)	10/12/2007	08/06/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		France;Finland;Denmark;Germany;United Kingdom;Sweden
347	EUCTR2007-002950-42-ES (EUCTR)	27/11/2007	11/10/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX	Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	248	Phase 3	Czech Republic;Hungary;Belgium;Poland;Spain;Lithuania;United Kingdom
348	EUCTR2007-002951-18-ES (EUCTR)	27/11/2007	11/10/2007	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist	Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab	Genmab A/S	NULL	Not Recruiting			Female: yes Male: yes	236	Phase 3	France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
349	EUCTR2007-001585-33-ES (EUCTR)	15/11/2007	13/09/2007	Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE	Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE	Artritis reumatoide (AR)Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
350	EUCTR2006-006373-25-CZ (EUCTR)	14/11/2007	20/09/2007		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
351	EUCTR2007-000896-41-NL (EUCTR)	05/11/2007	17/10/2007	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate	Rheumatoid arthritis	Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	900		Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
352	EUCTR2007-001035-58-ES (EUCTR)	30/10/2007	26/07/2007	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATEESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATEESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A	ARTRITIS REUMATOIDERHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Maraviroc Product Code: UK-427,857 INN or Proposed INN: Maraviroc	Pfizer, S. A.	NULL	Not Recruiting			Female: yes Male: yes	114	Phase 2	Portugal;Spain;Italy
353	EUCTR2006-006591-37-BE (EUCTR)	25/10/2007	12/06/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	264		Greece;Belgium;Austria
354	EUCTR2006-005137-38-DE (EUCTR)	23/10/2007	23/08/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: Enbrel Product Name: Etanercept Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Etanercept Auto-Injector Product Code: L04AA11 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		France;Finland;Denmark;Germany;United Kingdom;Sweden
355	EUCTR2006-003768-67-ES (EUCTR)	19/10/2007	10/09/2007	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate.Estudio de fase IIIB, multicéntrico, aleatorizado, en doble ciego y controlado con placebo, para evaluar los cambios a corto plazo en la sinovitis y el daño estructural en sujetos con artritis reumatoide activa y respuesta inadecuada al metotrexato tratados con abatacept frente a placebo más un tratamiento de fondo de metotrexato+ Protocol Amendment 01 (Version 1.0, Dated 16-May-2007) and Administrative Letter (Version 1.0, Dated 13-Jun-2007).	A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate.Estudio de fase IIIB, multicéntrico, aleatorizado, en doble ciego y controlado con placebo, para evaluar los cambios a corto plazo en la sinovitis y el daño estructural en sujetos con artritis reumatoide activa y respuesta inadecuada al metotrexato tratados con abatacept frente a placebo más un tratamiento de fondo de metotrexato+ Protocol Amendment 01 (Version 1.0, Dated 16-May-2007) and Administrative Letter (Version 1.0, Dated 13-Jun-2007).	RHEUMATOID ARTHRITIS,NOSARTRITIS REUMATOIDE, NOS MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	58	Phase 3	Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
356	EUCTR2007-001420-12-FR (EUCTR)	17/10/2007	23/07/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	France;Czech Republic;Slovakia;Poland;Belgium;Sweden
357	EUCTR2007-001420-12-SK (EUCTR)	15/10/2007	18/04/2008	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	France;Czech Republic;Slovakia;Poland;Belgium;Sweden
358	EUCTR2007-001420-12-SE (EUCTR)	12/10/2007	20/07/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Czech Republic;France;Poland;Sweden
359	EUCTR2007-001665-15-ES (EUCTR)	14/09/2007	27/06/2007	Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide.	Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide.	Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Farmaceutica S.A.	NULL	Not Recruiting			Female: yes Male: yes	179		Belgium;Spain;Netherlands;Germany;Italy
360	EUCTR2007-001420-12-BE (EUCTR)	23/08/2007	09/07/2007	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Product Name: AZD9056 hydrochloride Product Code: AZD9056 Other descriptive name: None Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: Etanercept	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	France;Czech Republic;Poland;Belgium;Sweden
361	NCT00503139 (ClinicalTrials.gov)	July 2007	16/7/2007	Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan	Enbrel Special Use Result Surveillance	Rheumatoid Arthritis	Drug: Enbrel (etanercept)	Pfizer	NULL	Completed	10 Years	N/A	All	684		Japan
362	EUCTR2006-005137-38-FR (EUCTR)	19/06/2007	10/04/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: Enbrel Product Name: Enbrel Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	724	Phase 3	France;Finland;Denmark;Germany;United Kingdom;Sweden
363	EUCTR2006-005137-38-FI (EUCTR)	18/06/2007	15/05/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		Finland;Germany;United Kingdom;Denmark;France;Sweden
364	EUCTR2006-005137-38-SE (EUCTR)	29/05/2007	30/04/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term: entered code. Term in E.1.1>	Trade Name: Enbrel Product Name: Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Enbrel Auto Injector Product Code: Auto Injector INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		Finland;Germany;United Kingdom;Denmark;France;Sweden
365	EUCTR2006-006373-25-SE (EUCTR)	04/05/2007	16/03/2007		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
366	EUCTR2007-000491-16-ES (EUCTR)	30/04/2007	05/03/2007	Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available	Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available	Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Farmacéutica, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Belgium;Spain;Austria;Germany
367	EUCTR2006-004140-23-ES (EUCTR)	24/04/2007	05/03/2007	Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, en fase II para la determinación de la dosis de atacicept, administrado por vía subcutánea, en pacientes con artritis reumatoide y con respuesta insuficiente al tratamiento con antagonistas del TNF - Atacicept en pacientes con AR y fracaso a anti-TNF, Fase II	Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, en fase II para la determinación de la dosis de atacicept, administrado por vía subcutánea, en pacientes con artritis reumatoide y con respuesta insuficiente al tratamiento con antagonistas del TNF - Atacicept en pacientes con AR y fracaso a anti-TNF, Fase II	Pacientes con Artritis Reumatoide. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: Not applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	288	Phase 2	Portugal;Slovakia;Greece;Finland;Spain;Italy;United Kingdom;Czech Republic;Belgium;Bulgaria;Netherlands;Germany;Sweden
368	EUCTR2006-004139-31-ES (EUCTR)	23/04/2007	25/01/2007	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA	A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA	Rheumatoid Arthritis. Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex®	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	1000		France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
369	EUCTR2006-006373-25-SK (EUCTR)	20/04/2007	03/04/2007	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
370	EUCTR2006-004669-32-ES (EUCTR)	09/04/2007	06/02/2007	Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available	Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available	Artritis reumatoide establecida MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance	Novartis Farmacéutica S.A	NULL	Not Recruiting			Female: yes Male: yes	80		Spain
371	NCT00414661 (ClinicalTrials.gov)	April 2007	19/12/2006	Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550	A Prospective Observational Study To Evaluate Long-Term Safety And Functional Status Of Subjects With Rheumatoid Arthritis Previously Enrolled In Studies Of CP-690,550	Arthritis, Rheumatoid	Drug: CP-690,550	Pfizer	NULL	Completed	18 Years	N/A	All	162	N/A	United States;Argentina;Brazil;Bulgaria;Canada;Chile;Czech Republic;Dominican Republic;Finland;Greece;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;Spain;Ukraine;Australia;Austria;Belgium;Costa Rica;Romania;Sweden
372	EUCTR2006-006373-25-ES (EUCTR)	23/03/2007	24/01/2007		ESTUDIO OBSERVACIONAL PROSPECTIVO PARA EVALUAR LA SEGURIDAD A LARGO PLAZO Y EL ESTADO FUNCIONAL DE SUJETOS CON ARTRITIS REUMATOIDE INCLUIDOS PREVIAMENTE EN ESTUDIOS DE CP-690,550A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	CP-690,550 se está desarrollando como fármaco antirreumático modificador de la enfermedad (FARME) para el tratamiento de la artritis reumatoide (AR).CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer, S.A.	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
373	EUCTR2006-006373-25-AT (EUCTR)	15/02/2007	12/02/2007		A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP-690,550	Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
374	EUCTR2006-006275-21-GB (EUCTR)	10/01/2007	18/10/2011	A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RA	A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RA	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Humira Trade Name: Enbrel	University Hospital Birmingham NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	124	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
375	EUCTR2006-004673-98-HU (EUCTR)	16/10/2006	08/09/2006	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.	Trade Name: MabThera 500 mg concentrate for solution for infusion	Roche (Hungary) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20		Hungary
376	EUCTR2006-000363-28-GB (EUCTR)	03/10/2006	28/04/2006	DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study	DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study	Rheumatoid arthritis and Psoriatic arthritis	Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Enbrel Product Name: Etanercept INN or Proposed INN: Etanercept	Greater Glasgow Health Board	Glasgow University	Not Recruiting			Female: yes Male: yes	40	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
377	EUCTR2006-001428-38-GB (EUCTR)	18/09/2006	29/09/2006	Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA	Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA	Patients with early inflamatory arthritis (duration of symptoms of < 12 weeks) who are at very high risk of the development of rheumatoid arthritis (seropositivity for Rheumatoid factor and anti-CCP antibody)	Trade Name: Enbrel Trade Name: Methorexate Trade Name: Depo-Medrone Trade Name: Salazopyrin En-Tabs Trade Name: Plaquenil	University Hospitals Birmingham NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	United Kingdom
378	NCT00588393 (ClinicalTrials.gov)	September 2006	22/12/2007	FolateScan in Autoimmune Disease	Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases	Rheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus Erythematosus	Drug: FolateScan (Technetium Tc 99mEC20)	Mayo Clinic	Endocyte	Completed	18 Years	N/A	Both	75	Phase 2	United States
379	NCT00361634 (ClinicalTrials.gov)	September 2006	4/8/2006	Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis	DCE-MRI of the Wrist to Measure Short-Term Responses in Rheumatoid Arthritis Subjects Treated With Etanercept	Rheumatoid Arthritis	Drug: Etanercept	Amgen	NULL	Completed	18 Years	N/A	All	14	Phase 1	United States;United Kingdom
380	NCT00488475 (ClinicalTrials.gov)	September 2006	18/6/2007	Observational Trial With Enbrel	A 1 Year Observational Study of the Use of Etanercept in Routine German Clinical Practice to Treat Rheumatoid Arthritis Patients: a Health Economic, Safety and Effectiveness Evaluation	Rheumatoid Arthritis	Drug: etanercept	Pfizer	NULL	Completed	18 Years	N/A	All	4945	N/A	Germany
381	EUCTR2005-001742-16-ES (EUCTR)	02/06/2006	19/04/2006	Estudio múlticéntrico, aleatorio, doble ciego, controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFalfa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa tratados previamente con agentes biológicos anti-TNFalfa.	Estudio múlticéntrico, aleatorio, doble ciego, controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFalfa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa tratados previamente con agentes biológicos anti-TNFalfa.	Active rheumatoid arthritis (RA)Artritis Reumatoide activa	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor B.V.	NULL	Not Recruiting			Female: yes Male: yes	420		Germany;United Kingdom;Netherlands;Spain;Austria
382	NCT00298272 (ClinicalTrials.gov)	May 2006	1/3/2006	Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis	A Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: IDEC-C2B8 (rituximab);Drug: Placebo;Drug: Methotrexate;Drug: Etanercept;Drug: Adalimumab;Drug: Methylprednisolone;Dietary Supplement: Folate	Biogen	Hoffmann-La Roche;Genentech, Inc.	Terminated	18 Years	65 Years	All	54	Phase 2	United States
383	EUCTR2004-003295-10-ES (EUCTR)	25/04/2006	17/02/2006	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid ArthritisEnsayo múlticéntrico, aleatorizado, en doble ciego y controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa no tratados previamente con metotrexato	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid ArthritisEnsayo múlticéntrico, aleatorizado, en doble ciego y controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa no tratados previamente con metotrexato	Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)Artritis Reumatoide activa (no tratada previamente con metotrexato)	Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium tablets 2.5 mg INN or Proposed INN: Methotrexate sodium Other descriptive name: Methylaminopterin Product Name: Golimumab Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa	Centocor BV	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;United Kingdom;Spain;Italy
384	EUCTR2005-003558-83-ES (EUCTR)	04/04/2006	16/02/2006	Estudio aleatorizado, doble ciego, controlado con placebo, y de dosis múltiple, para evaluar la eficacia, seguridad y farmacocinética de AMG 108 subcutáneo en sujetos con artritis reumatoide. (A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis).	Estudio aleatorizado, doble ciego, controlado con placebo, y de dosis múltiple, para evaluar la eficacia, seguridad y farmacocinética de AMG 108 subcutáneo en sujetos con artritis reumatoide. (A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis).	Artritis Reumatoide (Rheumatoid arthritis - RA)	Product Code: AMG 108	Amgen Inc.	NULL	Not Recruiting			Female: yes Male: yes	784	Phase 2	Estonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden
385	EUCTR2005-003694-25-ES (EUCTR)	27/01/2006	28/11/2005	Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR)A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).	Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR)A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).	Artritis ReumatoideRheumatoid Arthritis	Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Product Name: P38 (4) Map Kinase Inhibitor Product Code: RO4402257 Other descriptive name: P38(4) Map Kinase Inhibitor Trade Name: Methotrexate Sodium 2.5mg Tablets Product Name: Methotrexate Sodium 2.5mg Tablets Product Code: PL 00095/5079R Other descriptive name: Methotrexate Sodium 2.5mg Tablets	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Czech Republic;Spain;Italy
386	NCT00346294 (ClinicalTrials.gov)	January 2006	27/6/2006	An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis	An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept	Amgen	Immunex Corporation	Completed	18 Years	N/A	All	115	Phase 4	United States
387	EUCTR2005-002395-15-ES (EUCTR)	29/12/2005	31/10/2005	Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”	Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”	Artritis reumatoide / Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853		Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
388	EUCTR2005-002396-33-ES (EUCTR)	27/12/2005	28/10/2005	Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Artritis Reumatoide (Rheumatoid arthritis)	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
389	EUCTR2005-002969-37-ES (EUCTR)	25/11/2005	19/10/2005	A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship.Estudio aleatorizado, de grupos paralelos y controlado con placebo de la administración de una dosis única de GW856553 en pacientes con Artritis Reumatoide activa para investigar la relación entre la dosis y respuesta sobre la proteína C reactiva - GM2005/00244/00	A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship.Estudio aleatorizado, de grupos paralelos y controlado con placebo de la administración de una dosis única de GW856553 en pacientes con Artritis Reumatoide activa para investigar la relación entre la dosis y respuesta sobre la proteína C reactiva - GM2005/00244/00	Rheumatoid Arthritis	Product Code: GW856553 Product Code: GW856553 Product Code: GW856553	GlaxoSmithKline S.A.	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	Spain;Germany;Sweden
390	EUCTR2005-001319-23-ES (EUCTR)	14/10/2005	22/06/2005	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy.Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, dirigido a evaluar la eficacia y la seguridad de 3 dosis orales distintas de ERB-041 en sujetos con artritis reumatoide en tratamiento de fondo con metotrexato	A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy.Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, dirigido a evaluar la eficacia y la seguridad de 3 dosis orales distintas de ERB-041 en sujetos con artritis reumatoide en tratamiento de fondo con metotrexato	Rheumatoid arthritis	Product Name: ERB-041 Product Code: ERB-041 Product Name: ERB-041 Product Code: ERB-041 Product Name: ERB-041 Product Code: ERB-041	Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 2	Hungary;Spain;Italy
391	NCT00249041 (ClinicalTrials.gov)	October 2005	3/11/2005	Enbrel Liquid Immunogenicity Protocol	Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: 50 mg Etanercept;Drug: Enbrel liquid	Amgen	Immunex Corporation	Completed	18 Years	N/A	Both	447	Phase 3	United States;Canada
392	EUCTR2005-002909-23-ES (EUCTR)	21/09/2005	08/09/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
393	EUCTR2005-001977-82-GB (EUCTR)	09/09/2005	14/07/2005	A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects	A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects	Rheumatoid arthritis	Product Name: GW274150 Tablets Product Code: GW274150 Trade Name: Deltacortril Enteric Product Name: Prednisolone INN or Proposed INN: Prednisolone	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	45	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
394	EUCTR2005-000551-15-GB (EUCTR)	05/09/2005	05/08/2005	Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate	Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate	Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory polyarthritis associated with excess cardiovascular (CV) mortality. Hyperhomocysteinaemia is recognized as an independent CV risk factor and homocysteine levels are frequently elevated in RA patients.Endothelial dysfunction is considered a marker of early atherosclerotic disease and seems to correlate well with future increase CV risk. RA patients are known to have endothelial dysfunction.	Product Name: Allopurinol Product Code: Allopurinol INN or Proposed INN: Allopurinol Product Name: Folic acid Product Code: Folic acid INN or Proposed INN: Folic acid	University of Dundee	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	United Kingdom
395	EUCTR2005-001350-24-FI (EUCTR)	04/08/2005	23/06/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Hungary;Finland;Czech Republic;Estonia;Latvia;Lithuania
396	EUCTR2005-001350-24-HU (EUCTR)	01/08/2005	19/05/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
397	EUCTR2005-001350-24-EE (EUCTR)	18/07/2005	14/06/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Hungary;Czech Republic;Estonia;Finland;Lithuania;Latvia
398	EUCTR2005-001350-24-LT (EUCTR)	14/07/2005	08/06/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
399	EUCTR2005-001350-24-LV (EUCTR)	21/06/2005	21/06/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
400	NCT00175877 (ClinicalTrials.gov)	June 2005	9/9/2005	A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis	A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Certolizumab Pegol	UCB Pharma	NULL	Completed	18 Years	N/A	All	857	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Croatia;Czechia;Estonia;Finland;France;Hungary;Israel;Latvia;Lithuania;Mexico;New Zealand;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro;Netherlands;Spain;Sweden
401	EUCTR2005-001350-24-SK (EUCTR)	31/05/2005	21/04/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Celltech	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Latvia
402	EUCTR2005-001350-24-CZ (EUCTR)	27/05/2005	04/05/2005	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027	Rheumatoid arthritis Classification code 10039073	Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania
403	EUCTR2004-000563-96-FI (EUCTR)	08/03/2005	11/10/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Hungary;Finland;Denmark;Norway;Ireland;Spain;Italy;Sweden
404	NCT00503503 (ClinicalTrials.gov)	March 2005	16/7/2007	Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan	Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan	Rheumatoid Arthritis	Drug: Enbrel (etanercept)	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	11 Years	90 Years	Both			NULL
405	EUCTR2004-000563-96-AT (EUCTR)	19/01/2005	15/12/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: METHOTREXAT Lederle - Tabletten Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: METHOTREXAT Lederle - Tabletten Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden
406	EUCTR2004-000563-96-ES (EUCTR)	22/12/2004	26/10/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: METOTREXATO-LEDERLE 2,5 MG COMPRIMIDOS Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: METOTREXATO-LEDERLE 2,5 MG COMPRIMIDOS Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
407	EUCTR2005-000492-18-IT (EUCTR)	16/12/2004	09/11/2007	Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome	Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome	Metabolic Syndrome and Rheumatoid Arthritis MedDRA version: 6.1;Level: SOC;Classification code 10021428	Trade Name: REMICADE*EV F 100MG+F 2ML INN or Proposed INN: Infliximab	POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI	NULL	Not Recruiting			Female: yes Male: yes			Italy
408	EUCTR2004-000563-96-IE (EUCTR)	26/11/2004	29/01/2007	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Trade Name: Enbrel Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Methotrexate sodium tablets 2.5mg Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: Methotrexate sodium tablets 2.5mg Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Spain;Ireland;Italy;Sweden
409	EUCTR2004-000563-96-DK (EUCTR)	23/11/2004	28/08/2007	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
410	EUCTR2004-002006-30-GB (EUCTR)	17/11/2004	17/02/2005	Triple therapy in early active rheumatoid arthritis - TEAR	Triple therapy in early active rheumatoid arthritis - TEAR	Rheumatoid arthritis	Product Name: Methotrexate INN or Proposed INN: Methotrexate Trade Name: Salazopyrin En-Tabs Product Name: sulfasalazine INN or Proposed INN: Sulfasalazine Trade Name: Plaquenil Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine	North Glasgow NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	96		United Kingdom
411	EUCTR2004-000563-96-SE (EUCTR)	17/11/2004	15/09/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
412	EUCTR2004-000563-96-HU (EUCTR)	12/11/2004	13/09/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Trade Name: Enbrel (etanercept) Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Trade Name: Methotrexate-Lachema Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Trade Name: Methotrexate-Lachema Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
413	NCT00094341 (ClinicalTrials.gov)	October 2004	16/10/2004	Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes	An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes	Rheumatoid Arthritis	Drug: Etanercept	Amgen	NULL	Completed	18 Years	N/A	Both	215	Phase 4	United States
414	EUCTR2004-000563-96-IT (EUCTR)	13/09/2004	14/03/2007	A 24-Month, Randomized, Double-Blind, Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects with Active Early Rheumatoid Arthritis COMET	A 24-Month, Randomized, Double-Blind, Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects with Active Early Rheumatoid Arthritis COMET	Active Early Rheumatoid Arthritis MedDRA version: 6.1;Level: SOC;Classification code 10028395	Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML Product Name: ETANERCEPT INN or Proposed INN: Etanercept	WYETH LEDERLE	NULL	Not Recruiting			Female: yes Male: yes	540		Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden
415	EUCTR2004-000612-54-SE (EUCTR)	11/09/2004	07/07/2004	A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study	A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study	Osteoarthritis (OA) ICD: M19.9 MedDRA: 10031161Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037	Product Name: L-001069957 Product Code: L-001069957 INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate Product Name: L-001069957 Product Code: L-001069957 INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate Trade Name: Aspirin Tablets Product Name: Acetylsalicylic acid INN or Proposed INN: Acetylsalicylic acid Other descriptive name: Acetylsalicylic Acid Trade Name: Celebrex Product Name: Celecoxib INN or Proposed INN: Celecoxib	Merck Sharp & Dohme (Sweden) AB	NULL	Not Recruiting			Female: yes Male: yes	1360	Phase 2	Sweden
416	EUCTR2004-000106-41-SE (EUCTR)	07/09/2004	03/08/2004	A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis - GW406381 and methotrexate	A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis - GW406381 and methotrexate	The patients entering the trial have rheumatoid arthritis although treatment of the disease itself is not under investigation in this study.	Product Name: GW406381 Product Code: GW406381	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes			Sweden
417	NCT00273533 (ClinicalTrials.gov)	June 2004	6/1/2006	Ramipril in Rheumatoid Arthritis	Effects of Ramipril on Endothelial Function in Patients With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Ramipril	University of Zurich	Sanofi	Completed	18 Years	60 Years	Both	13	Phase 2/Phase 3	Switzerland
418	NCT00291915 (ClinicalTrials.gov)	May 2004	14/2/2006	Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis	Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis	Rheumatoid Arthritis;Arthritis	Drug: Adalimumab;Drug: Methotrexate	Goupe d'Etudes et de Recherche Clinique En Rhumatologie	NULL	Recruiting	18 Years	N/A	Both	80	Phase 4	France
419	NCT00099554 (ClinicalTrials.gov)	May 2004	16/12/2004	Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)	A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)	Rheumatoid Arthritis	Drug: Etanercept	Amgen	NULL	Completed	18 Years	N/A	Both	200	Phase 4	United States;Canada
420	NCT00195403 (ClinicalTrials.gov)	May 2004	12/9/2005	A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA	A Drug Use Investigation of Enbrel for Post-Marketing Surveillance	Rheumatoid Arthritis	Drug: Etanercept	Pfizer	NULL	Completed	4 Years	N/A	All	1014	N/A	Korea, Republic of
421	NCT00195338 (ClinicalTrials.gov)	May 2004	12/9/2005	Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg	A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg	Rheumatoid Arthritis	Drug: etanercept	Pfizer	Innovex, Inc	Completed	17 Years	N/A	All	25	N/A	Luxembourg
422	NCT00484809 (ClinicalTrials.gov)	March 2004	8/6/2007	Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children	A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).	Rheumatoid Arthritis	Drug: Enbrel (Etanercept)	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	4 Years	N/A	Both	100		NULL
423	NCT00245934 (ClinicalTrials.gov)	June 2003	26/10/2005	Study Evaluating Enbrel in Patients With Rheumatoid Arthritis	Observational Study With Enbrel in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Enbrel	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	Both	1500	N/A	NULL
424	NCT00244556 (ClinicalTrials.gov)	March 2003	12/10/2005	Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy	A Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate Therapy	Rheumatoid Arthritis	Drug: Methotrexate plus ENBREL or ENBREL alone	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	N/A	Both	300	Phase 4	NULL
425	NCT00116727 (ClinicalTrials.gov)	October 2002	30/6/2005	Rheumatoid Arthritis DMARD Intervention and UtilizationStudy	Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)	Rheumatoid Arthritis	Drug: ENBREL®	Amgen	Immunex Corporation;Wyeth is now a wholly owned subsidiary of Pfizer	Completed	18 Years	N/A	Both	5103	N/A	United States
426	NCT00121056 (ClinicalTrials.gov)	September 2002	30/6/2005	REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations	Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)	Rheumatoid Arthritis	Drug: Enbrel®;Drug: Kineret®	Amgen	NULL	Completed	18 Years	N/A	Both		N/A	NULL
427	NCT00078806 (ClinicalTrials.gov)	June 4, 2001	5/3/2004	Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis	A Phase 3 Safety and Efficacy Study of Etanercept In Children With Systemic Onset Juvenile Rheumatoid Arthritis	Juvenile Rheumatoid Arthritis	Drug: Etanercept;Drug: Placebo	Amgen	Immunex Corporation	Terminated	2 Years	18 Years	All	19	Phase 3	Canada;United States
428	NCT03781375 (ClinicalTrials.gov)	August 24, 2000	18/12/2018	Etanercept Plus Methotrexate Versus Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis	A Phase III Double Blind Randomized Study Comparing Etanercept (Enbrel) Combined With Methotrexate vs Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis	Juvenile Rheumatoid Arthritis	Drug: Etanercept;Drug: Placebo to Etanerceot;Drug: Methotrexate	Amgen	NULL	Terminated	N/A	N/A	All	25	Phase 3	NULL
429	NCT00078793 (ClinicalTrials.gov)	June 2000	5/3/2004	Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis	Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis	Juvenile Rheumatoid Arthritis	Drug: Enbrel®	Amgen	Immunex Corporation	Completed	2 Years	18 Years	Both	600	Phase 4	United States;Canada
430	NCT00132418 (ClinicalTrials.gov)	April 2000	19/8/2005	Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders	Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders	Rheumatoid Arthritis	Drug: Enbrel;Drug: Placebo	Amgen	Immunex Corporation	Completed	18 Years	N/A	Both	564	Phase 4	United States
431	NCT00001862 (ClinicalTrials.gov)	February 1999	3/11/1999	TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis	The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis	Juvenile Rheumatoid Arthritis;Uveitis	Drug: Enbrel	National Eye Institute (NEI)	NULL	Completed	N/A	N/A	Both	15	Phase 2	United States
432	EUCTR2012-001171-37-Outside-EU/EEA (EUCTR)		07/03/2012	Study evaluating safety and effectiveness in children with childhood arthritis	A Phase IV Registry of Etanercept in Children With Juvenile Rheumatoid Arthritis	Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel (Etanercept) INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel (Etanercept) INN or Proposed INN: ETANERCEPT	Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320	NULL	NA			Female: yes Male: yes	594	Phase 4	Canada;United States
433	EUCTR2004-000563-96-NO (EUCTR)		06/10/2004	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET	Rheumatoid Arthritis	Product Name: Enbrel (etanercept) Product Code: 0881 INN or Proposed INN: etanercept Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate Product Name: methotrexate sodium tablets 2.5 mg INN or Proposed INN: methotrexate Other descriptive name: methotrexate	Wyeth Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	580	Phase 4	Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden
434	EUCTR2012-001145-40-Outside-EU/EEA (EUCTR)		07/03/2012	Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritis	Open-label Extension Treatment with TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials	Rheumatoid arthritis (RA) in adults and juvenile idiopathic arthritis (JIA) for subjects who did not respond to conventional DMARDS;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel Product Name: Enbrel (Etanercept) INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel (Etanercept) INN or Proposed INN: ETANERCEPT	Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320	NULL	NA			Female: yes Male: yes	783		Canada;United States

先頭へ

97. 潰瘍性大腸炎

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

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05771155 (ClinicalTrials.gov)	May 2023	1/3/2023	Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®	A Randomized, Double-blind, Multicenter Phase 3 Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC) to Compare the Efficacy, Safety and Immunogenicity of PB016 and Entyvio® for the Induction and Maintenance of Clinical Response and Remission	Ulcerative Colitis	Biological: Intravenous (IV) infusions	Polpharma Biologics S.A.	NULL	Not yet recruiting	18 Years	75 Years	All	750	Phase 3	NULL
2	NCT05202990 (ClinicalTrials.gov)	March 2023	10/1/2022	Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis	Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.	Pediatric Ulcerative Colitis in Remission	Drug: Fecal Microbiota Transplantation by Stool capsules;Drug: Fecal Microbiota Transplantation by Intra-rectal enemas	Assistance Publique - Hôpitaux de Paris	MRSU 938 - Research Center of Saint Antoine	Not yet recruiting	8 Years	17 Years	All	26	Phase 2	France
3	NCT05507931 (ClinicalTrials.gov)	February 2023	17/8/2022	Broccoli Sprouts for Mild Ulcerative Colitis	A Pilot Feasibility Study to Develop a Broccoli Sprouts-enriched Diet in the Management of Ulcerative Colitis	Ulcerative Colitis;Ulcerative Colitis Chronic Mild	Dietary Supplement: 1 Serving of broccoli sprouts;Dietary Supplement: 3 Servings of broccoli sprouts	University of Michigan	University of Maine	Not yet recruiting	18 Years	N/A	All	40	N/A	United States
4	EUCTR2021-000630-34-GR (EUCTR)	13/01/2023	11/11/2022	A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease	A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease	Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of
5	EUCTR2021-000630-34-HR (EUCTR)	27/12/2022	05/01/2023	A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease	A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease	Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of
6	EUCTR2022-000837-17-NL (EUCTR)	07/12/2022	29/09/2022	Lengthening of vedolizumab injections based on drug concentrations in patients with inflammatory bowel disease	Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study - SILVER-study	Inflammatory bowel diseases (Crohn's disease, ulcerative colitis);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Vedolizumab, Entyvio	Amsterdam UMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 4	Netherlands
7	NCT05561062 (ClinicalTrials.gov)	December 1, 2022	27/9/2022	Atorvastatin in Patients With Ulcerative Colitis	Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis	Inflammatory Bowel Diseases	Drug: Atorvastatin 80mg	Tanta University	NULL	Not yet recruiting	18 Years	75 Years	All	50	Phase 2	NULL
8	JPRN-jRCT2031220308	01/11/2022	01/09/2022	A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC	Colitis, Ulcerative	Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip	Nishikawa Kazuko	NULL	Pending	>= 18age old	<= 65age old	Both	550	Phase 2	Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;NewZealand;Poland;Portugal;Serbia;Japan
9	JPRN-jRCT2031220186	10/08/2022	06/07/2022	A Basket Long-term Extension Study of Ustekinumab in Pediatric Participants	A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)	Crohn Disease, Ulcerative Colitis, Psoriatic Arthritis	Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004 & CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Ustekinumab will be administered as a SC injection.	Nishikawa Kazuko	NULL	Pending	>= 2age old	< 18age old	Both	151	Phase 3	France;Poland;United States Of America;Japan
10	JPRN-jRCTs052210199	22/03/2022	22/03/2022	Comparison of GI tract pH and motility between patients with ulcerative colitis and healthy controls	Comparison of total gastrointestinal pH and motility between healthy subjects and patients with ulcerative colitis using wireless motility/pH capsule	Ulcerative colitis	arm UC arm Health control In each case, the SmartPill motility capsule is orally taken with 50 ml of water. The temperature, pH and pressure of the entire digestive tract are measured in real time. Also, the transit time of each of the stomach, small intestine, and large intestine is calculated from the transit time of the capsule.	Nakamura Shiro	Higuchi Kazuhide	Pending	>= 20age old	<= 79age old	Both	25	N/A	Japan
11	JPRN-jRCTs031210326	28/02/2022	21/09/2021	Evaluation of biomarkers in BF treatment	A multicenter study to evaluate the effectiveness of budesonide enema foam treatment and the usefulness ofserum biomarker measurement for active ulcerative colitis - BF-LRG	Ulcerative colitis Ulcerative colitis	Budesonide foam was administered as a study drug	Matsuoka Katsuyoshi	EA Pharma Co., Ltd.	Recruiting	>= 16age old	Not applicable	Both	20	N/A	Japan
12	JPRN-jRCT1051210145	28/12/2021	28/12/2021	Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial	Efficacy of therapeutic intervention with vedolizumab for ulcerative colitis patients with no or mild symptom and uncontrolled endoscopic activity: A multicenter- non-randomized trial	ulcerative colitis ulcerative colitis;D003093	Administration of vedolizumab 300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 weeks	ooi makoto	NULL	Recruiting	>= 18age old	<= 80age old	Both	150	Phase 3	Japan
13	NCT05404074 (ClinicalTrials.gov)	November 22, 2021	17/5/2022	Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis	Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis	Ulcerative Colitis	Drug: Cobitolimod 500mg	InDex Pharmaceuticals	NULL	Recruiting	18 Years	N/A	All	6	Phase 1	Sweden
14	EUCTR2020-004300-34-IT (EUCTR)	13/10/2021	30/08/2021	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - NA	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab Product Code: [NA] INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	TAKEDA DEVELOPMENT CENTER AMERICAS INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
15	NCT03843385 (ClinicalTrials.gov)	October 2021	14/2/2019	Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis	Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Drug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: Placebo	Jena University Hospital	German Federal Ministry of Education and Research	Not yet recruiting	18 Years	75 Years	All	174	Phase 2/Phase 3	NULL
16	EUCTR2019-002485-12-IT (EUCTR)	23/09/2021	22/10/2020	Determination of the Optimal Treatment Target in Ulcerative Colitis	VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Entyvio Product Code: [NA] Other descriptive name: VEDULIZUMAB Trade Name: Entyvio Product Name: Entyvio Product Code: [NA] Other descriptive name: VEDOLIZUMAB	ALIMENTIV INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	660	Phase 4	United States;France;Belarus;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy
17	EUCTR2020-004300-34-SK (EUCTR)	18/09/2021	28/04/2021	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
18	JPRN-jRCT2051210087	17/09/2021	22/09/2021	Safety and pharmacokinetics study in healthy Japanese volunteers	A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple doses of ABX464 capsules in healthy Japanese volunteers. - Safety and pharmacokinetics study in healthy Japanese volunteers	Ulcerative colitis	Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo - 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen group. Following a blinded review of available safety data by the DSMB after the subjects of the first dose regimen have received the study treatment (ABX464, 9 subjects and placebo, 3 subjects), the 50 mg dose regimen group will open for enrolment and receive the study treatment. For each dose regimen group, subjects will be admitted to the study center on D?1, administered the study treatment on D1, orally in the morning in the standardized fed conditions, and discharged from the study center on D4 after completion of study assessments. Subjects will visit the study center on D8 and D15 (End of Study [EoS] visit) for PK and safety assessments. Body weight, vital signs, laboratory parameters including renal and hepatic markers, will be evaluated at screening and at each visit to the study center. Part B Following a blinded review of available safety and PK data by the DSMB after the subjects of part A have received the study treatment (ABX464 or placebo), the part B will start for enrolment. Part B includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days - 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen.	Owada Yasuko	NULL	Pending	>= 20age old	<= 45age old	Male	48	Phase 1	Japan
19	EUCTR2021-003023-14-SE (EUCTR)	02/09/2021	23/06/2021	Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis	Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: DIMS0150 INN or Proposed INN: Cobitolimod Other descriptive name: DIMS0150	InDex Pharmaceuticals AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 1;Phase 2	Sweden
20	EUCTR2020-004300-34-HR (EUCTR)	18/08/2021	02/09/2021	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
21	EUCTR2020-004300-34-HU (EUCTR)	06/08/2021	28/04/2021	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
22	EUCTR2020-000609-10-DK (EUCTR)	06/07/2021	23/09/2020	A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patients	A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgeryA clinical safety and proof-of-concept study	A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch. MedDRA version: 20.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Repomol INN or Proposed INN: Molgramostim Trade Name: Metronidazole Product Name: Metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: Metronidazole Trade Name: Fosfomycin Product Name: Infectofos INN or Proposed INN: Fosfomycin disodium Other descriptive name: FOSFOMYCIN DISODIUM	Center for Surgical Science	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	26	Phase 1;Phase 2	Denmark
23	EUCTR2020-004300-34-LT (EUCTR)	25/06/2021	21/04/2021	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of
24	EUCTR2020-004300-34-ES (EUCTR)	02/06/2021	01/09/2021	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
25	NCT04882683 (ClinicalTrials.gov)	June 1, 2021	6/5/2021	Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis	Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis	Ulcerative Colitis	Drug: Prednisone;Drug: Azathioprine;Drug: Adalimumab;Biological: umbilical cord blood mononuclear cells	Shandong Qilu Stem Cells Engineering Co., Ltd.	NULL	Recruiting	18 Years	65 Years	All	50	N/A	China
26	EUCTR2020-004300-34-GR (EUCTR)	01/06/2021	29/04/2021	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of
27	EUCTR2019-002485-12-PL (EUCTR)	05/05/2021	22/09/2020	Determination of the Optimal Treatment Target in Ulcerative Colitis	VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Alimentiv Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	660	Phase 4	Belarus;France;United States;Canada;Belgium;Poland;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy
28	EUCTR2019-002485-12-NL (EUCTR)	23/04/2021	03/08/2020	Determination of the Optimal Treatment Target in Ulcerative Colitis	VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Alimentiv Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	660	Phase 4	France;United States;Belarus;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;United Kingdom;Italy
29	EUCTR2019-001653-99-BE (EUCTR)	26/02/2021	26/02/2021	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Portugal;Serbia;United States;Slovakia
30	EUCTR2019-001653-99-LT (EUCTR)	01/02/2021	23/09/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland
31	EUCTR2019-001653-99-LV (EUCTR)	18/01/2021	26/10/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
32	EUCTR2019-001653-99-AT (EUCTR)	12/01/2021	24/11/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
33	EUCTR2019-001653-99-DE (EUCTR)	08/01/2021	05/10/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Portugal;Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
34	EUCTR2019-001653-99-FR (EUCTR)	26/11/2020	12/10/2020	A placebo-controlled study of mirikizumab and vedolizumab in participants withmoderately to severely active ulcerative colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active-Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants withModerately to Severely Active Ulcerative Colitis - LUCENT-ACT	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Trade Name: Entyvio Product Name: vedolizumab INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1100	Phase 3	Malaysia;Denmark;United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
35	ChiCTR2000039161	2020-10-30	2020-10-20	Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial	A systematic study on the criteria of syndrome differentiation of kidney Yang deficiency in infertility	Ulcerative colitis	control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;	Chengdu University of Traditional Chinese Medicine	NULL	Recruiting	20	45	Female	control group:118;experimental group:118;		China
36	EUCTR2020-004391-18-FR (EUCTR)	28/10/2020	14/09/2020	IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS	IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC	ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Inflectra 100 mg Product Name: Inflectra 100 mg Trade Name: AMGEVITA Product Name: AMGEVITA Trade Name: Simponi Product Name: Simponi Trade Name: Entyvio 300 mg Product Name: Entyvio 300 mg Trade Name: XELJANZ Product Name: XELJANZ	CHU Amiens-Picardie	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	France
37	EUCTR2018-005086-39-BG (EUCTR)	27/10/2020	25/06/2020	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
38	ChiCTR2000038888	2020-10-19	2020-10-09	Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial	A systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility	Ulcerative colitis	control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;	Chengdu University of Traditional Chinese Medicine	NULL	Recruiting	20	45	Female	control group:118;experimental group:118;		China
39	JPRN-UMIN000046650	2020/10/08	18/01/2022	exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis	exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis - exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis	ulcerative colitis	Endoscopy was performed 28 to 32 weeks after the administration of ustekinumab	JUNTENDO UNIVERSITY NERIMA HOSPITAL	NULL	Recruiting	20years-old	100years-old	Male and Female	30	Not selected	Japan
40	NCT05538026 (ClinicalTrials.gov)	September 1, 2020	9/9/2022	Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis	Efficacy and Safety of Fecal Microbiota Transplantation as add-on Therapy in Patients With Mild-To-Moderate Ulcerative Colitis: A Randomized, Clinical Trial	Ulcerative Colitis Chronic Mild;Inflammatory Bowel Diseases	Drug: Mesalazine;Biological: Fecal transplantation	Bogomolets National Medical University	Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine	Completed	18 Years	60 Years	All	53	N/A	Ukraine
41	EUCTR2019-002485-12-GB (EUCTR)	14/07/2020	30/03/2020	Determination of the Optimal Treatment Target in Ulcerative Colitis	VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Alimentiv Inc. (formerly Robarts Clinical Trials)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	660	Phase 4	France;Belarus;United States;Canada;Poland;Belgium;Ukraine;Russian Federation;Netherlands;Italy;United Kingdom
42	NCT05386290 (ClinicalTrials.gov)	July 9, 2020	17/5/2022	A Multicentered Prospective Cohort Study of Chinese IBD Patients	A Multicentered Prospective Cohort Study of Chinese IBD Patients Concerning Cost-effectiveness Analysis, Therapeutic Effect Predictor Exploration and Gut Microbiota Analysis	Ulcerative Colitis;Crohn Disease	Drug: Infliximab;Drug: Vedolizumab;Drug: Ustekinumab;Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)	Peking Union Medical College Hospital	NULL	Enrolling by invitation	14 Years	80 Years	All	200		China
43	NCT04277546 (ClinicalTrials.gov)	March 3, 2020	18/2/2020	Open-label Extension Study of Brazikumab in Ulcerative Colitis	A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)	Ulcerative Colitis	Drug: Brazikumab Maintenance Dose;Drug: Brazikumab Induction Dose	AstraZeneca	NULL	Enrolling by invitation	18 Years	80 Years	All	165	Phase 2	India;Israel;Italy;Japan;Korea, Republic of;Poland;Puerto Rico;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;United States;Belgium;Bulgaria;Romania;Russian Federation;Austria;Canada;Czechia;France;Germany;Hungary
44	NCT04202211 (ClinicalTrials.gov)	February 2020	13/12/2019	FMT for Remission of Active Ulcerative Colitis in Adults	A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Biological: FMT oral;Biological: FMT enema;Other: Placebo oral;Other: Placebo enema	University of British Columbia	Crohn's and Colitis Canada;Vancouver Island Health Authority	Not yet recruiting	18 Years	N/A	All	145	Phase 2	Canada
45	EUCTR2018-005086-39-HR (EUCTR)	16/12/2019	17/01/2020	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
46	JPRN-jRCTs031190156	09/12/2019	09/12/2019	IN for practical use	Study on efficacy and safety of indigo naturalis in patients with intractable ulcerative colitis.	ulcertive colitis	administration of one indigo naturalis FC enteric-coated tablet (including 0.5g indigo naturalis per tablet)twice a day for 4 weeks	Kanai Takanori	NULL	Recruiting	>= 16age old	Not applicable	Both	100	Phase 3	Japan
47	ChiCTR1900025900	2019-12-01	2019-09-13	Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.	Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.	Ulcerative colitis	Experimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion;	Nanjing Hospital of Chinese Medicine	NULL	Pending			Both	Experimental group:200;control group:100;	Phase 3	China
48	ITMCTR1900002594	2019-12-01	2019-09-13	Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.	Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.	Ulcerative colitis	Experimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion;	Nanjing Hospital of Chinese Medicine	NULL	Pending			Both	Experimental group:200;control group:100;	Phase 3	China
49	EUCTR2018-005086-39-HU (EUCTR)	28/10/2019	08/04/2019	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested	Landos Biopharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
50	NCT04131322 (ClinicalTrials.gov)	October 10, 2019	10/10/2019	Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.	Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study	Crohn Disease;Ulcerative Colitis	Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	NULL	Terminated	18 Years	N/A	All	24	Phase 4	Spain
51	EUCTR2018-001605-93-RO (EUCTR)	10/10/2019	15/03/2022	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
52	EUCTR2018-001605-93-BG (EUCTR)	09/10/2019	20/09/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
53	EUCTR2018-005086-39-PL (EUCTR)	07/10/2019	06/05/2019	A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	Russian Federation;Hungary;United States;Moldova, Republic of;Ukraine;Poland;Georgia;Belarus;Serbia;Bulgaria;Bosnia and Herzegovina;Croatia
54	EUCTR2018-001605-93-IT (EUCTR)	26/09/2019	29/01/2021	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFU	ALLERGAN LIMITED	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
55	EUCTR2018-001605-93-BE (EUCTR)	23/09/2019	07/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2b Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
56	EUCTR2018-001605-93-FR (EUCTR)	13/09/2019	25/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
57	EUCTR2019-002070-31-DK (EUCTR)	05/09/2019	24/06/2019	Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial)	Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial)	Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Asacol® INN or Proposed INN: MESALAZINE	Copenhagen University Hospital Hvidovre	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 4	Denmark
58	EUCTR2018-001605-93-ES (EUCTR)	07/08/2019	09/08/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
59	EUCTR2019-001032-54-FR (EUCTR)	23/07/2019	19/06/2019	Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy	Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy - CYTOVEDO	Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058881;Term: Cytomegalovirus viremia;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: valganciclovir Product Name: valganciclovir Trade Name: vedolizumab Product Name: vedolizumab	CHU de Saint Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	France
60	ChiCTR1900024591	2019-07-22	2019-07-18	Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis	Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis	Ulcerative colitis	TCM Group:Prednisone+New Wumeiwan Formula;Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk);	Peking University First Hospital	NULL	Pending	18	65	Both	TCM Group:40;Convenience medicine Group:40;Combined Group:40;		China
61	ITMCTR1900002475	2019-07-22	2019-07-18	Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis	Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis	Ulcerative colitis	Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk);Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);TCM Group:Prednisone+New Wumeiwan Formula;	Peking University First Hospital	NULL	Pending	18	65	Both	Combined Group:40;Convenience medicine Group:40;TCM Group:40;		CHINA
62	EUCTR2018-001605-93-GB (EUCTR)	01/07/2019	04/04/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
63	EUCTR2019-000717-37-ES (EUCTR)	27/06/2019	28/06/2019	Loss of response of the Adalimumba biosimilar compared with the original drug	LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.ADA-SWITCH Study - ADA-SWITCH Study	Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: AMGEVITA® Product Name: AMGEVITA (Adalimumab biosimilar ) Trade Name: HUMIRA ® Product Name: Humira (adalimumab original)	Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 4	Spain
64	ChiCTR1900023159	2019-05-20	2019-05-14	Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial	Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial	Ulcerative colitis	?????????+???????(???)???:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Qingchang Wenzhong Granules Simulator;Combined Group:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk);	Dongfang Hospital of Beijing University of Chinese Medicine	NULL	Recruiting	18	65	Both	?????????+???????(???)???:90;Medical Group:90;Combined Group:90;		China
65	ChiCTR1900023158	2019-05-20	2019-05-14	Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial	Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial	Ulcerative colitis	TCM Group:Hudi Enteric-coated Capsules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Hudi Enteric-coated Capsules Simulator;	Jiangsu Province Hospital of Chinese Medicine	NULL	Recruiting	18	65	Both	TCM Group:120;Medical Group:120;	Phase 4	China
66	ITMCTR1900002335	2019-05-20	2019-05-14	Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial	Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial	Ulcerative colitis	Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Hudi Enteric-coated Capsules Simulator;TCM Group:Hudi Enteric-coated Capsules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;;0201	Jiangsu Province Hospital of Chinese Medicine	NULL	Recruiting	18	65	Both	Medical Group:120;TCM Group:120;	Phase 4	China
67	ITMCTR1900002336	2019-05-20	2019-05-14	Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial	Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial	Ulcerative colitis	Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Qingchang Wenzhong Granules Simulator;Combined Group:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk);TCM Group:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;;020301	Dongfang Hospital of Beijing University of Chinese Medicine	NULL	Recruiting	18	65	Both	Medical Group:90;Combined Group:90;TCM Group:90;		China
68	NCT03917095 (ClinicalTrials.gov)	May 15, 2019	12/4/2019	The Safety and Efficacy of TET Enema in the Treatment of UC	Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail	Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate	Device: The Colonic Transendoscopic enteral Tubing.;Drug: Glutamine;Drug: Mesalazine	The Second Hospital of Nanjing Medical University	NULL	Recruiting	18 Years	65 Years	All	75	N/A	China
69	NCT03884439 (ClinicalTrials.gov)	March 18, 2019	4/3/2019	Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)	Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis)	Crohn's Disease;Ulcerative Colitis	Drug: Infliximab [infliximab biosimilar 3]	Pfizer	NULL	Enrolling by invitation	0 Years	N/A	All	300		Japan
70	JPRN-JapicCTI-194603	01/2/2019	30/01/2019	Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]	Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]	Ulcerative colitis	Intervention name : Vedolizumab INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab intravenous (IV) infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Takeda Pharmaceutical Company Limited	NULL	recruiting			BOTH	1000	NA	Japan
71	NCT03824561 (ClinicalTrials.gov)	February 1, 2019	29/1/2019	Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]	Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]	Ulcerative Colitis	Drug: Vedolizumab	Takeda	NULL	Recruiting	N/A	N/A	All	1000		Japan
72	EUCTR2017-002350-36-GB (EUCTR)	10/12/2018	13/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
73	JPRN-UMIN000034016	2018/12/01	03/09/2018	The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study	The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY study	ulcerative colitis	Additional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema The continuation of concomitant treatment at the remission induction by budesonide form enema (control group)	Hyogo College of Medicine	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	84	Not selected	Japan
74	NCT03944447 (ClinicalTrials.gov)	December 1, 2018	3/5/2019	Outcomes Mandate National Integration With Cannabis as Medicine	Outcomes Mandate National Integration With Cannabis as Medicine	Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus	Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler	OMNI Medical Services, LLC	OMNI Medical Services Inc	Recruiting	7 Years	N/A	All	200000	Phase 2	United States
75	ChiCTR1800019676	2018-12-01	2018-11-22	Diagnostic Value of probe-based Confocal Laser Endomicroscopy Score for assessment of numosal healing of ulcerative colitis	Diagnostic Value of probe-based Confocal Laser Endomicroscopy Score for assessment of numosal healing of ulcerative colitis: a single center, prospective cohort study	ulcerative colitis	Gold Standard:Histopathological examination;Index test:1, Gland density (grade) 2. Gland morphology (grade) 3. Vascular changes (grade);	Peking University First Hospital	NULL	Pending	18	80	Both	Target condition:40;Difficult condition:0		China
76	NCT02201758 (ClinicalTrials.gov)	December 2018	18/7/2014	Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment	Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment.	Ulcerative Colitis	Dietary Supplement: Flaxseed lignan-enriched complex (FLC);Other: Placebo	University of Saskatchewan	Royal University Hospital Foundation	Unknown status	18 Years	N/A	All	56	Phase 2	Canada
77	NCT02921555 (ClinicalTrials.gov)	October 11, 2018	22/9/2016	Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis	Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis.	Ulcerative Colitis	Drug: Methylprednisolone;Drug: Prednisone	Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa	NULL	Completed	18 Years	N/A	All	75	Phase 4	Spain
78	EUCTR2017-002350-36-GR (EUCTR)	03/10/2018	10/09/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
79	EUCTR2017-002350-36-DE (EUCTR)	27/09/2018	13/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
80	EUCTR2018-001051-12-FR (EUCTR)	07/09/2018	19/04/2018	VEDO - PREDIRESPUC project - Vedolizumab and anti-vedolizumab antibody in the prediction of therapeutic response in Ulcerative Colitis	VEDO - PREDIRESPUC project - Value of pharmacokinetic assays (Vedolizumab and anti-vedolizumab antibody) in the prediction of induction and maintenance therapeutic response in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: ENTYVIO Product Code: 1	CHU Saint-Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	125	Phase 4	France
81	EUCTR2018-002673-21-FR (EUCTR)	04/09/2018	06/07/2018	EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.	EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: Remicade Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Entyvio Product Name: Vedolizumab Other descriptive name: VEDOLIZUMAB	Centre Hospitalier Universitaire de Rennes	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	France
82	EUCTR2017-002350-36-IE (EUCTR)	28/08/2018	16/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
83	EUCTR2017-002350-36-NL (EUCTR)	28/08/2018	24/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
84	EUCTR2017-002350-36-BG (EUCTR)	22/08/2018	28/05/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
85	EUCTR2017-002350-36-HU (EUCTR)	14/06/2018	19/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
86	NCT03521232 (ClinicalTrials.gov)	May 15, 2018	17/4/2018	A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis	A Phase I/IIA, Open-Label, Three-Stage Study to Investigate the Safety, the Efficacy and the Pharmacokinetics of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Procto-Sigmoiditis	Ulcerative Colitis;Ulcerative Proctitis;Ulcerative Proctosigmoiditis	Drug: Niclosamide	First Wave Bio, Inc.	NULL	Terminated	18 Years	N/A	All	27	Phase 1/Phase 2	Italy
87	EUCTR2017-002231-41-NL (EUCTR)	14/05/2018	26/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary
88	EUCTR2017-002350-36-IT (EUCTR)	10/05/2018	22/01/2021	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - NA	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio 300mg Product Name: RO7246311 Product Code: [RO7246311] INN or Proposed INN: Vedolizumab Product Name: NA Product Code: [UTTR1147A/RO7021610 (Active)]	GENENTECH, INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
89	EUCTR2017-002350-36-ES (EUCTR)	15/04/2018	06/06/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Roche Farma, S.A por delegación de Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
90	EUCTR2017-002182-21-NL (EUCTR)	20/03/2018	28/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom
91	EUCTR2017-002231-41-PL (EUCTR)	17/01/2018	13/10/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
92	EUCTR2017-002182-21-PL (EUCTR)	17/01/2018	13/10/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
93	EUCTR2017-002231-41-BE (EUCTR)	10/01/2018	14/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
94	EUCTR2017-002182-21-BE (EUCTR)	10/01/2018	14/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
95	ChiCTR2100043797	2018-01-01	2021-02-28	The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis	The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis	Ulcerative colitis	Case series:Single or multiple FMT were performed via the working channel of the colonoscope or transendoscopic enteral tubing in 2 months. All patients were given concomitant oral mesalamine (4g/d) and patients who were taking corticosteroid did a mandatory taper of 2.5 mg per week until it was withdrawn.;	Department of Gastroenterology, Jinan Central Hospital	NULL	Completed	21	81	Both	Case series:28;	N/A	China
96	EUCTR2014-001594-14-DE (EUCTR)	19/12/2017	22/09/2014	Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site	Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgIC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: FITC-Adalimumab Product Code: FITC-Adalimumab INN or Proposed INN: FITC-Adalimumab Other descriptive name: FITC-ADALIMUMAB	Universitätsklinikum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Phase 1;Phase 2	Germany
97	EUCTR2017-002182-21-DE (EUCTR)	18/12/2017	13/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
98	EUCTR2017-002231-41-DE (EUCTR)	18/12/2017	14/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
99	EUCTR2017-002182-21-FR (EUCTR)	18/12/2017	15/12/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
100	JPRN-jRCTs041180035	15/12/2017	31/01/2019	Dual center study of pCLE for UCAN	Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia	suspected ulcerative colitis-associated neoplasia	pCLE after intravenous administration of fluorescein	Ohmiya Naoki	NULL	Complete	>= 20age old	< 80age old	Both	30	N/A	Japan
101	JPRN-UMIN000032250	2017/12/15	14/04/2018	Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia	Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia - Dual center study of pCLE for UCAN	suspected ulcerative colitis-associated neoplasia	pCLE after intravenous administration of fluorescein	Fujita Health University School of Medicine, Department of Gastroenterology	Center for Diagnostic and Therapeutic Endoscopy, School of Medicine KeioUniversity	Recruiting	20years-old	85years-old	Male and Female	40	Not applicable	Japan
102	NCT02559713 (ClinicalTrials.gov)	November 29, 2017	23/9/2015	Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease	An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically	Colitis, Ulcerative;Crohn's Disease	Drug: Vedolizumab	Takeda	NULL	Completed	18 Years	N/A	Female	11	Phase 4	United States
103	EUCTR2015-005753-12-GB (EUCTR)	22/11/2017	02/08/2018	A research study looking at faecal transplant as a treatment for ulcerative colitis, and the best way to use it in children and adults with the condition	Prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis. - STOP-Colitis Pilot Trial	Ulcerative colitis for at least 3 months prior to trial entry;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Faecal Microbiota Transplant Product Code: FMT INN or Proposed INN: faecal matter	University of Birmingham	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 3	United Kingdom
104	EUCTR2017-002182-21-GB (EUCTR)	16/11/2017	11/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
105	EUCTR2017-002231-41-GB (EUCTR)	15/11/2017	11/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
106	EUCTR2017-002182-21-HU (EUCTR)	25/10/2017	12/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
107	EUCTR2017-002231-41-HU (EUCTR)	25/10/2017	19/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
108	EUCTR2016-001170-15-ES (EUCTR)	19/10/2017	02/08/2017	Intravenous corticosteroids in moderate ulcerative colitis	Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM	Moderate flares of Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Urbason INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE	GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	148	Phase 4	Spain
109	EUCTR2014-005443-40-HU (EUCTR)	13/10/2017	30/08/2017	An open-label study to evaluate the efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of ulcerative colitis versus subject with longer exisiting ulcerative colitis	An open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) - LOVE-UC	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio	Academic Medical Center, Gastroenterology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	Hungary;Belgium;Netherlands
110	JPRN-UMIN000026175	2017/06/23	01/03/2017	Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis	Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis	Ulcerative colitis	Time dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa . PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .	Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University	NULL	Complete: follow-up complete	20years-old	99years-old	Male and Female	60	Not applicable	Japan
111	NCT03104036 (ClinicalTrials.gov)	June 19, 2017	27/3/2017	Faecal Bacteriotherapy for Ulcerative Colitis	Faecal Bacteriotherapy for Ulcerative Colitis	Ulcerative Colitis	Other: Faecal bacterial transplantation;Drug: Mesalazine 4G Enema	Institute for Clinical and Experimental Medicine	Institute of Animal Physiology and Genetics Academy of Science Czech Republic	Completed	18 Years	70 Years	All	61	Phase 2	Czechia;Czech Republic
112	NCT03705117 (ClinicalTrials.gov)	May 23, 2017	9/10/2018	Open-label V565 Target Engagement Study	An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565	Ulcerative Colitis	Biological: V565	VHsquared Ltd.	NULL	Completed	18 Years	75 Years	All	5	Phase 1	United Kingdom
113	NCT03151525 (ClinicalTrials.gov)	May 8, 2017	8/5/2017	Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis	Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab	Colitis, Ulcerative	Drug: Azathioprine;Drug: Infliximab	Istituto Clinico Humanitas	Agenzia Italiana del Farmaco	Recruiting	18 Years	65 Years	All	100	Phase 4	Italy
114	NCT03110198 (ClinicalTrials.gov)	May 2017	19/2/2017	Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis	A Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)	Ulcerative Colitis, Unspecified	Drug: Mesalazine;Drug: hydrocortisone sodium succinate;Drug: Mesalazine with hydrocortisone sodium succinate	Xijing Hospital of Digestive Diseases	Shanghai Tongji Hospital, Tongji University School of Medicine;First Affiliated Hospital of Zhongshan Medical University	Recruiting	18 Years	70 Years	All	528	Phase 4	China
115	NCT03415711 (ClinicalTrials.gov)	April 28, 2017	5/1/2018	PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis	A Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UC	Ulcerative Colitis	Dietary Supplement: VSL#3®;Drug: Mesalamine;Drug: Placebo	VSL Pharmaceuticals	Actial Farmaceutica S.r.l.	Terminated	18 Years	85 Years	All	14	N/A	Italy
116	EUCTR2016-002707-25-IT (EUCTR)	31/03/2017	13/01/2021	n.a.	Comparison between two therapeutic strategies for the maintenance of clinical and endoscopic remission in patients with ulcerative colitis treated by infliximab (SCILLA). - n.a.	patients with ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO INN or Proposed INN: INFLIXIMAB Trade Name: AZAFOR - 50 MG COMPRESSE RIVESTITE CON FILM 50 COMPRESSE IN BLISTER PVC/PVDC/AL INN or Proposed INN: AZATIOPRINA	IRCCS ISTITUTO CLINICO HUMANITAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	Italy
117	NCT03029143 (ClinicalTrials.gov)	March 29, 2017	20/1/2017	Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis	A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET)	Colitis, Ulcerative	Drug: Vedolizumab IV	Takeda	NULL	Completed	18 Years	85 Years	All	278	Phase 4	United States;Canada
118	EUCTR2015-002558-11-BG (EUCTR)	14/03/2017	06/01/2017	A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
119	EUCTR2015-002557-35-BG (EUCTR)	14/03/2017	06/01/2017	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
120	NCT02878083 (ClinicalTrials.gov)	January 11, 2017	16/8/2016	Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)	Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)	ULCERATIVE COLITIS	Drug: VEDOLIZUMAB;Drug: ADALIMUMAB	Nantes University Hospital	Takeda;Mauna Kea Technologies;Institut National de la Santé Et de la Recherche Médicale, France	Terminated	18 Years	N/A	All	19	N/A	France
121	EUCTR2016-000678-40-BG (EUCTR)	05/01/2017	01/11/2016	Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe Limited	NULL	Not Recruiting			Female: yes Male: yes	385	Phase 4	Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Serbia;Taiwan;Estonia;Slovakia;Ukraine;Romania;Australia;Bulgaria;South Africa;Latvia;New Zealand;Korea, Republic of
122	NCT02998112 (ClinicalTrials.gov)	December 2016	13/12/2016	Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing		Ulcerative Colitis	Drug: fecal microbiota transplantation;Drug: Saline	The Second Hospital of Nanjing Medical University	Fourth Military Medical University;First Hospital of Guangzhou;Daping Hospital and the Research Institute of Surgery of the Third Military Medical University;Zhongshan Hospital Xiamen University	Recruiting	18 Years	65 Years	Both	188	Phase 4	China
123	NCT02760615 (ClinicalTrials.gov)	November 1, 2016	2/5/2016	Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study	An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease	Colitis, Ulcerative;Crohn Disease	Drug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: Vedolizumab	Takeda	NULL	Withdrawn	18 Years	55 Years	All	0	Phase 4	United States
124	EUCTR2016-002061-54-IT (EUCTR)	13/10/2016	15/11/2018	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.	Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)	Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019	UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Italy
125	NCT02864264 (ClinicalTrials.gov)	September 14, 2016	9/8/2016	Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis	Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis	Healthy Volunteers;Ulcerative Colitis	Drug: BMS-986184;Drug: Placebo matching BMS-986184	Bristol-Myers Squibb	NULL	Terminated	18 Years	75 Years	All	7	Phase 1	Australia;Georgia;Moldova, Republic of;Romania
126	EUCTR2015-002558-11-LV (EUCTR)	01/09/2016	01/07/2016	A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia
127	EUCTR2015-002557-35-LV (EUCTR)	01/09/2016	01/07/2016	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia
128	EUCTR2016-000678-40-EE (EUCTR)	22/08/2016	20/06/2016	Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	385	Phase 4	Serbia;Estonia;Taiwan;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
129	EUCTR2016-000678-40-LV (EUCTR)	19/08/2016	10/05/2016	Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe Limited	NULL	Not Recruiting			Female: yes Male: yes	385	Phase 4	Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
130	NCT02743806 (ClinicalTrials.gov)	August 1, 2016	15/4/2016	Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease	Colitis, Ulcerative;Crohn Disease	Drug: Vedolizumab	Takeda	NULL	Completed	18 Years	90 Years	All	329	Phase 4	Australia;Bulgaria;Czechia;Estonia;Hungary;India;Italy;Korea, Republic of;Latvia;Malaysia;New Zealand;Poland;Romania;Russian Federation;Serbia;South Africa;Turkey;Ukraine;Czech Republic;Slovakia;Taiwan
131	EUCTR2016-000678-40-HU (EUCTR)	07/07/2016	19/05/2016	Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	385	Phase 4	Serbia;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
132	EUCTR2015-000480-14-BE (EUCTR)	30/06/2016	14/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
133	EUCTR2016-000390-20-PL (EUCTR)	28/06/2016	16/06/2016	English A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity	A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity	Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution	TOPIVERT Pharma Limited	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
134	EUCTR2016-000678-40-CZ (EUCTR)	27/06/2016	18/05/2016	Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment	Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: vedolizumab IV Product Code: MLN002 INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	385	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
135	EUCTR2015-000480-14-DE (EUCTR)	14/06/2016	09/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
136	EUCTR2015-000482-31-HR (EUCTR)	13/06/2016	06/07/2016	Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease	A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study	Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	692	Phase 3	United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
137	EUCTR2015-000480-14-HR (EUCTR)	10/06/2016	06/07/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
138	EUCTR2016-001278-13-FI (EUCTR)	08/06/2016	15/04/2016	Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis	Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD	Ulcerative colitis and Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB	Taina Sipponen	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Finland
139	EUCTR2015-000480-14-DK (EUCTR)	31/05/2016	17/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
140	EUCTR2015-000480-14-ES (EUCTR)	29/05/2016	18/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
141	EUCTR2015-000482-31-NL (EUCTR)	25/05/2016	27/01/2016	Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease	A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study	Ulcerative Colitis Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: - Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	692	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
142	EUCTR2015-000480-14-HU (EUCTR)	09/05/2016	22/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
143	EUCTR2015-000480-14-RO (EUCTR)	05/05/2016	22/06/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden
144	EUCTR2015-000480-14-LT (EUCTR)	04/05/2016	18/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
145	EUCTR2015-001555-69-PL (EUCTR)	28/04/2016	22/12/2015	A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis	Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation
146	EUCTR2015-000480-14-IT (EUCTR)	18/04/2016	08/06/2021	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis.	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy. - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ENTYVIO - 300 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	TAKEDA DEVELOPMENT CENTRE EUROPE LTD	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
147	EUCTR2015-000480-14-CZ (EUCTR)	13/04/2016	21/01/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
148	EUCTR2015-000480-14-SE (EUCTR)	04/04/2016	16/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
149	JPRN-UMIN000020029	2016/04/01	01/12/2015	The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection	The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation	Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies.	Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more.	Saitama Medical University	NULL	Recruiting	16years-old	Not applicable	Male and Female	300	Not selected	Japan
150	EUCTR2015-000480-14-NL (EUCTR)	21/03/2016	29/12/2015	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
151	EUCTR2015-000480-14-BG (EUCTR)	17/03/2016	16/02/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
152	EUCTR2015-000480-14-GB (EUCTR)	14/03/2016	07/03/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
153	EUCTR2015-001555-69-CZ (EUCTR)	07/03/2016	14/12/2015	A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis	Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation
154	EUCTR2015-000939-33-HR (EUCTR)	16/02/2016	28/04/2016	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
155	EUCTR2015-002557-35-HU (EUCTR)	09/02/2016	16/11/2015	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
156	EUCTR2015-002558-11-HU (EUCTR)	09/02/2016	16/11/2015	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	United States;Serbia;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
157	EUCTR2015-003270-32-IT (EUCTR)	09/02/2016	20/03/2019	Identification of cells predicting response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis and Crohn’s disease	Identification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD) - Immunological predictors of therapeutic response to vedolizumab	Ulcerative colitis (UC) and Crohn disease (CD) MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: entyvio INN or Proposed INN: VEDOLIZUMAB	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 4	Italy
158	NCT02522780 (ClinicalTrials.gov)	February 1, 2016	12/8/2015	Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative Colitis	Drug: Mesalamine;Drug: Placebo	Ferring Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	276	Phase 3	United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium
159	NCT02579733 (ClinicalTrials.gov)	February 1, 2016	16/10/2015	Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis		Ulcerative Colitis	Drug: Azathioprine;Drug: Placebo	Kyungpook National University Hospital	Celltrion	Terminated	18 Years	80 Years	All	16	Phase 4	Korea, Republic of
160	NCT02683733 (ClinicalTrials.gov)	February 2016	10/2/2016	Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis	The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis	Ulcerative Colitis	Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicylic acid	Asian Institute of Gastroenterology, India	NULL	Recruiting	18 Years	70 Years	Both	50	Phase 3	India
161	NCT02683759 (ClinicalTrials.gov)	February 2016	10/2/2016	Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis	The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis	Ulcerative Colitis	Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicyclic acid	Asian Institute of Gastroenterology, India	NULL	Recruiting	18 Years	70 Years	Both	50	Phase 3	India
162	EUCTR2015-000480-14-SK (EUCTR)	22/01/2016	05/01/2016	Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	400	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden
163	EUCTR2015-000939-33-NL (EUCTR)	21/01/2016	30/09/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	658	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
164	EUCTR2015-001555-69-HU (EUCTR)	15/01/2016	17/11/2015	A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis	Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: KHK4083 Product Code: KHK4083 INN or Proposed INN: Not available	Kyowa Kirin Pharmaceutical Development, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation
165	EUCTR2015-000939-33-PT (EUCTR)	08/01/2016	25/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	658	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
166	EUCTR2015-000939-33-PL (EUCTR)	08/01/2016	24/11/2015	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Phase 3	United States;Serbia;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Denmark;Australia;Latvia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
167	EUCTR2015-000939-33-HU (EUCTR)	05/01/2016	03/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
168	EUCTR2015-000939-33-ES (EUCTR)	05/01/2016	05/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	658	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
169	EUCTR2015-000939-33-SK (EUCTR)	11/12/2015	27/08/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
170	EUCTR2015-000939-33-LT (EUCTR)	08/12/2015	12/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
171	EUCTR2015-002558-11-BE (EUCTR)	07/12/2015	04/11/2015	A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of
172	EUCTR2015-002557-35-BE (EUCTR)	07/12/2015	04/11/2015	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA]	Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia
173	EUCTR2015-000939-33-BE (EUCTR)	07/12/2015	04/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
174	EUCTR2015-000939-33-DK (EUCTR)	04/12/2015	25/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
175	EUCTR2015-000939-33-LV (EUCTR)	27/11/2015	05/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
176	EUCTR2015-000939-33-BG (EUCTR)	26/11/2015	05/10/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
177	EUCTR2015-000939-33-IT (EUCTR)	24/11/2015	08/06/2021	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitiscompared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab IV Product Code: MLN0002 Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 1 SIRINGA PRERIEMPITA 0.8 ML + 1 TAMPONE IMBEVUTO DI ALCOL IN UN BLISTER	TAKEDA DEVELOPMENT CENTRE EUROPE LTD	NULL	Not Recruiting			Female: yes Male: yes	658	Phase 3	Portugal;Serbia;United States;Taiwan;Hong Kong;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
178	EUCTR2015-000939-33-EE (EUCTR)	16/11/2015	10/11/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
179	EUCTR2015-000939-33-CZ (EUCTR)	11/11/2015	18/08/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
180	EUCTR2015-000939-33-DE (EUCTR)	10/11/2015	30/10/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
181	EUCTR2015-000939-33-GB (EUCTR)	06/11/2015	29/10/2015	Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC	A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	758	Phase 3	Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
182	NCT02487238 (ClinicalTrials.gov)	November 2015	25/6/2015	Pediatric FEcal Microbiota Transplant for Ulcerative Colitis	A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified	Inflammatory Bowel Disease;Ulcerative Colitis	Biological: Fecal Microbiota Enema;Biological: Normal Saline Enema	McMaster Children's Hospital	London Health Sciences Centre;St. Justine's Hospital	Completed	3 Years	17 Years	All	35	Phase 1	Canada
183	ChiCTR-ICR-15007188	2015-10-09	2015-10-09	Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial	Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial	Ulcerative colitis	Percutaneous endoscopic mini-colostomy group:Oral steroids (prednisone 1mg.kg-1d-1) +Percutaneous endoscopic mini-colostomy andsubsequent drug delivery (mesalazine 3g / d);Control Group:Oral steroids (prednisone 1mg.kg-1d-1) andmesalazine 3g / d;	Southern Medical University, Nanfang Hospital, Department of Gastroenterology	NULL	Recruiting			Both	Percutaneous endoscopic mini-colostomy group:21;Control Group:21;		China
184	NCT02522767 (ClinicalTrials.gov)	October 2015	12/8/2015	Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Ulcerative Colitis	Drug: Mesalamine;Drug: Placebo	Ferring Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	228	Phase 3	United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium
185	JPRN-JapicCTI-163122	24/9/2015	06/01/2016	A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative, Inflammatory Bowel Diseases	Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : week 0: Participants will be randomized to receive single dose of placebo, Ustekinumab 130mg or Ustekinumab 6 mg/kg as Intravenous (IV: into the vein) infusion at Week 0. At week 8: Participants without clinical response to placebo will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo. Participants without clinical response to ustekinumab (130 mg or 6 mg/kg [IV]) will receive a single dose of ustekinumab 90 mg SC along with matching placebo IV. Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized. Participants in clinical response will be randomized to receive placebo SC, ustekinumab 90 mg SC every 12 weeks or 90 mg subcutaneously every 8 weeks beginning Week 0 of Maintenance study through Week 44. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Janssen Pharmaceutical K.K.	NULL	complete	18		BOTH	92	Phase 3	Japan, Asia except Japan, North America, Europe, Oceania
186	JPRN-UMIN000018745	2015/09/01	01/09/2015	The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy	The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy - The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy	ulcerative colitis	Administration of Infliximab and enteral nutrition Administration of Infliximab	Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatology	NULL	Pending	15years-old	75years-old	Male and Female	40	Not selected	Japan
187	EUCTR2014-005443-40-NL (EUCTR)	15/07/2015	08/01/2015	An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC	An open label observational phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio	Academic Medical Center/ Gastroenterology	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	Hungary;Belgium;Netherlands
188	JPRN-UMIN000018075	2015/06/26	25/06/2015	Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions	Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions - Clinical trial for UC-AC	Ulcerative colitis	normal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA no optimized therapy	Center for Diagnostic and Therapeutic Endoscopy,Keio University	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not selected	Japan
189	EUCTR2014-005443-40-BE (EUCTR)	02/06/2015	03/02/2015	An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC	An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC	Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab	Academic Medical Center/ Gastroenterology	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 4	Hungary;Belgium;Netherlands
190	EUCTR2014-000784-41-DK (EUCTR)	15/04/2015	28/01/2015	Amino acids in j-pouch surgery for ulcerative colitis	Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial - Amino acids in ileal pouch-anal anastomosis	Ileal pouch-anal anastomosis for ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Vaminolac, komb. Product Name: Vaminolac, komb. INN or Proposed INN: Vaminolac, komb. Other descriptive name: Vaminolac, komb.	Department of Medicine and Endocrinology	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 3	Denmark
191	NCT02674308 (ClinicalTrials.gov)	March 24, 2015	29/1/2016	Entyvio (Vedolizumab) Long Term Safety Study	Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease	Ulcerative Colitis and Crohn's Disease	Drug: Vedolizumab;Other: Other Biologic Agents	Takeda	NULL	Completed	18 Years	N/A	All	5302		United States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom
192	EUCTR2013-004435-72-BG (EUCTR)	16/03/2015	06/11/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMab Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
193	EUCTR2014-002579-27-IT (EUCTR)	03/03/2015	19/01/2015	Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone	Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL	active steroid-dependent ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: SIMPONI Product Name: SIMPONI Product Code: NA INN or Proposed INN: GOLIMUMAB	Istituto Clinico Humanitas	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Italy
194	NCT02368717 (ClinicalTrials.gov)	March 2015	16/2/2015	An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase	A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets	Ulcerative Colitis	Drug: Mesalazine Enema;Drug: Placebo Enema	Ferring Pharmaceuticals	NULL	Completed	18 Years	70 Years	All	281	Phase 3	China
195	NCT02412085 (ClinicalTrials.gov)	March 2015	26/3/2015	Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission	Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis	Colitis, Ulcerative	Drug: Golimumab	Istituto Clinico Humanitas	NULL	Recruiting	18 Years	65 Years	Both	100	Phase 4	Italy
196	NCT02318667 (ClinicalTrials.gov)	February 27, 2015	12/12/2014	Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).	An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab.	Colitis, Ulcerative	Biological: Golimumab	Merck Sharp & Dohme Corp.	NULL	Completed	18 Years	65 Years	All	38	Phase 4	Portugal
197	EUCTR2013-004435-72-IT (EUCTR)	27/02/2015	29/09/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ND Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2568	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
198	EUCTR2013-004435-72-DE (EUCTR)	06/02/2015	18/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Malaysia;Viet Nam;Denmark;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
199	NCT02465385 (ClinicalTrials.gov)	February 2015	27/5/2015	Single-dose Linaclotide for Capsule Endoscopy Preparation	Single-dose Linaclotide for Capsule Endoscopy Preparation	Crohn's;Ulcerative Colitis;Gastrointestinal Bleeding	Drug: Linaclotide	University of Virginia	NULL	Completed	18 Years	N/A	Both	30	Phase 4	United States
200	EUCTR2013-004435-72-NL (EUCTR)	28/01/2015	04/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: unknown Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
201	EUCTR2013-004435-72-PT (EUCTR)	09/01/2015	23/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Portugal;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
202	EUCTR2013-004435-72-ES (EUCTR)	22/12/2014	11/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: - Other descriptive name: ETROLIZUMAB	Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2568	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
203	EUCTR2013-004435-72-BE (EUCTR)	22/12/2014	27/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
204	EUCTR2014-003262-25-PT (EUCTR)	12/12/2014	20/11/2014	Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab	An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Simponi INN or Proposed INN: GOLIMUMAB	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.	NULL	Not Recruiting			Female: yes Male: yes	37	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal
205	EUCTR2013-004435-72-FR (EUCTR)	02/12/2014	22/06/2015	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES	Ulcerative colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2568	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
206	EUCTR2013-004282-14-ES (EUCTR)	25/11/2014	06/08/2014	A study of the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS	Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Remicade INN or Proposed INN: INFLIXIMAB	Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 3	Portugal;Philippines;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Vietnam;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Germany;Netherlands;Norway;Sweden;Korea, Republic of
207	EUCTR2013-004435-72-SK (EUCTR)	13/11/2014	20/10/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	United States;Serbia;Portugal;Philippines;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
208	EUCTR2013-004435-72-DK (EUCTR)	07/11/2014	21/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Portugal;Serbia;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
209	EUCTR2013-004435-72-SE (EUCTR)	05/11/2014	16/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Phase 3	Bulgaria;Norway;Germany;New Zealand;Sweden;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico
210	EUCTR2013-004435-72-HU (EUCTR)	29/10/2014	30/10/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
211	EUCTR2013-004435-72-GB (EUCTR)	24/10/2014	15/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
212	ChiCTR1800016668	2014-10-22	2018-06-14	A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome)	A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome)	Active ulcerative colitis	test group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets Simulator;Positive control group:Mesalazine enteric-coated tablets+Hudi Enteric-coated Capsule Simulator;Combined group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets;	Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Province Traditional Chinese Medicine Hospital)	NULL	Completed	18	65	Both	test group:120;Positive control group:120;Combined group:120;		China
213	EUCTR2013-004435-72-NO (EUCTR)	17/10/2014	06/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
214	EUCTR2013-004435-72-CZ (EUCTR)	02/10/2014	21/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
215	EUCTR2013-004435-72-GR (EUCTR)	30/09/2014	20/08/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2568	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
216	EUCTR2013-004435-72-LT (EUCTR)	30/09/2014	22/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
217	EUCTR2013-004435-72-EE (EUCTR)	19/09/2014	29/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
218	NCT02118584 (ClinicalTrials.gov)	September 15, 2014	16/4/2014	Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies	An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies	Ulcerative Colitis	Drug: Etrolizumab	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	N/A	All	1822	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic;Philippines;Sweden;Vietnam
219	JPRN-UMIN000015068	2014/09/05	05/09/2014	An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis		Ulcerative colitis	Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks GMA will be administrated 10 times	Hiroshima University Hospital, Department of Endoscopy	NULL	Enrolling by invitation	20years-old	Not applicable	Male and Female	150	Not applicable	Japan
220	EUCTR2013-004435-72-LV (EUCTR)	05/09/2014	22/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2625	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
221	EUCTR2013-004435-72-AT (EUCTR)	03/09/2014	22/07/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	2100	Phase 3	United States;Serbia;Portugal;Philippines;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
222	EUCTR2013-004435-72-HR (EUCTR)	12/08/2014	05/09/2014	An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studies	AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2100	Phase 3	Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden
223	EUCTR2013-004278-88-ES (EUCTR)	25/07/2014	13/06/2014	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS	Ulcerative colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: - Other descriptive name: ETROLIZUMAB	Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	800	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of
224	ChiCTR-OCH-14004615	2014-05-12	2014-05-07	Prospective cohort study of Qing Chang Wen Zhong decoction in the treatment of patients with mild and moderate ulcerative colitis.	Prospective cohort study of qingchangwenzhong decoction in the treatment of patients with mild and moderate ulcerative colitis.	ulcerative colitis	clinical group:Qing Chang Wen Zhong decoction;control:Mesalazine Enteric-coated Tablets or Medichemie Ettingen;	Dongfang Hospital Affiliated to Beijing University of Traditional Chinese Medicine	NULL	Completed	18	65	Both	clinical group:60;control:60;		China
225	EUCTR2013-004599-36-DE (EUCTR)	23/04/2014	03/02/2014	SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily	SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE	Active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: SB012 INN or Proposed INN: hgd40	sterna biologicals GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	18	Phase 2	Germany
226	NCT02129439 (ClinicalTrials.gov)	April 2014	30/4/2014	Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients	SB012 for Treatment of Active Ulcerative Colitis: Prospective Multi-centre Randomised Double-blind Placebo-controlled Phase IIa Clinical Trial to Evaluate Efficacy, Pharmacokinetics, Tolerability and Safety of SB012 Enema Administered OD	Colitis, Ulcerative	Drug: SB012;Drug: Placebo	Sterna Biologicals GmbH & Co. KG	NULL	Completed	18 Years	75 Years	All	20	Phase 1/Phase 2	Germany
227	JPRN-UMIN000013033	2014/02/01	01/02/2014	Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis.	Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. - Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis	Ulcerative colitis	Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks)	Department of Internal Medicine,Juntendo University	NULL	Pending	20years-old	Not applicable	Male and Female	30	Not selected	Japan
228	EUCTR2012-004768-23-DE (EUCTR)	12/06/2013	06/02/2013	A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis	A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis	Ulcerative Colitis with active endoscopic lesion(s), ranging in severity from moderate to severe in endoscopic score not responding sufficiently to conventional treatment MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: STNM01 1.84 mg Product Code: STNM01 INN or Proposed INN: STNM01	STELIC INSTITUTE & CO.	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Germany
229	NCT01759056 (ClinicalTrials.gov)	February 2013	24/12/2012	Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis	A Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative Colitis	Ulcerative Colitis	Drug: AVX 470;Drug: Placebo	Avaxia Biologics, Incorporated	NULL	Completed	18 Years	75 Years	Both	33	Phase 1	United States;Belgium;Canada;Hungary
230	JPRN-UMIN000009811	2013/01/23	21/01/2013	Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis	Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis - Antibiotics trials for ulcerative colitis	Ulcerative colitis	One group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint). Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months.	Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine	NULL	Complete: follow-up complete	16years-old	75years-old	Male and Female	40	Phase 3	Japan
231	NCT02922374 (ClinicalTrials.gov)	January 2013	28/9/2016	Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis	Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study	Acute Severe Colitis (ASC)	Drug: corticosteroids	Jinling Hospital, China	NULL	Active, not recruiting	18 Years	N/A	Both	117	Phase 1/Phase 2	China
232	NCT01078935 (ClinicalTrials.gov)	December 2012	1/3/2010	The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation	The Effect of Probiotics on Bowel Disease	Crohn's Disease;Ulcerative Colitis	Dietary Supplement: probiotics;Dietary Supplement: placebo	The Baruch Padeh Medical Center, Poriya	Ministry of Health, Israel	Not yet recruiting	18 Years	80 Years	Both	100	Phase 4	NULL
233	NCT01586533 (ClinicalTrials.gov)	June 2012	25/4/2012	Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis	A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis	Ulcerative Colitis;Left-sided Ulcerative Colitis;Distal Ulcerative Colitis	Drug: Zoenasa-1:4;Drug: Mesalamine Enema	Altheus Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	64 Years	Both	120	Phase 2	United States
234	NCT01387594 (ClinicalTrials.gov)	May 2012	30/6/2011	Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs	A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)	Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative Colitis	Procedure: lumbar puncture;Drug: lumbar puncture	Shire	NULL	Completed	18 Years	75 Years	All	49	Phase 1	Austria;Belgium;France;Germany;Netherlands
235	ChiCTR1900023689	2012-03-01	2019-06-07	Comparison of white light endoscopy vs chromoendoscopy in the detection rate of dysplasia and colorectal cancer in ulcerative colitis: A Multicenter Long-term Follow-up Randomized Controlled Trial in China	Comparison of white light endoscopy vs chromoendoscopy in the detection rate of dysplasia and colorectal cancer in ulcerative colitis: A Multicenter Long-term Follow-up Randomized Controlled Trial in China	Ulcerative colitis	Gold Standard:Pathological examination;Index test:1. targeted biopsies were taken from all visible lesions when using white light endoscopy 2. using white light endoscopy, sequential 4-quadrantic random biopsies were taken at every 10-cm intervals colon from disease segments defined by the endoscopist in addition to targeted biopsies from all visible lesions; 3. tar;	Xijing Hospital of Digestive Diseases, Fourth Military Medical University	NULL	Completed	18	70	Both	Target condition:141;Difficult condition:0	N/A	China
236	EUCTR2010-020448-37-NL (EUCTR)	21/12/2011	16/09/2010	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE	Enceladus Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Belgium;Netherlands
237	EUCTR2010-023762-49-ES (EUCTR)	16/05/2011	11/02/2011	ESTUDIO EN FASE 2A, ALEATORIZADO, DOBLE CIEGO, SIN ENMASCARAMIENTO PARA EL PROMOTOR, CONTROLADO CON PLACEBO, DE DOSIS MÚLTIPLES PARA EVALUAR LA FARMACODINÁMICA, LA FARMACOCINÉTICA Y LA SEGURIDAD DE ANRUKINZUMAB EN PACIENTES CON COLITIS ULCEROSA ACTIVAA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS	ESTUDIO EN FASE 2A, ALEATORIZADO, DOBLE CIEGO, SIN ENMASCARAMIENTO PARA EL PROMOTOR, CONTROLADO CON PLACEBO, DE DOSIS MÚLTIPLES PARA EVALUAR LA FARMACODINÁMICA, LA FARMACOCINÉTICA Y LA SEGURIDAD DE ANRUKINZUMAB EN PACIENTES CON COLITIS ULCEROSA ACTIVAA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS	Colitis ulcerosa MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Not Applicable Product Code: PF-05230917 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable	Pfizer, S.L.U.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Hungary;Belgium;Poland;Spain;Bulgaria;Germany
238	NCT01408810 (ClinicalTrials.gov)	February 2011	20/7/2011	Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis	Histological and Endoscopic Evaluation of Remission Induced by Infliximab in Moderately to Severely Active Ulcerative Colitis Patients	Ulcerative Colitis	Drug: Infliximab	Grupo de Estudo da Doença Inflamatória Intestinal	NULL	Completed	18 Years	64 Years	Both	21	Phase 4	Portugal
239	EUCTR2010-020448-37-BE (EUCTR)	10/12/2010	22/12/2010	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.	Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE	Enceladus Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Belgium;Netherlands
240	EUCTR2009-017044-13-DE (EUCTR)	03/11/2010	16/06/2010	A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development Inc	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
241	EUCTR2009-017044-13-BE (EUCTR)	14/09/2010	06/05/2010	A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany
242	EUCTR2009-017044-13-IE (EUCTR)	10/08/2010	20/04/2010	A study to Evaluate the Ability to Maintain Clinical andEndoscopic Remission During a 12-Month period with 2.4g/day of druggiven once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
243	EUCTR2009-017044-13-CZ (EUCTR)	05/08/2010	28/05/2010	A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic
244	EUCTR2009-017044-13-FR (EUCTR)	27/07/2010	22/06/2010	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis	Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development Inc	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom
245	EUCTR2009-017044-13-HU (EUCTR)	21/07/2010	26/04/2010	A Study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
246	EUCTR2009-017044-13-GB (EUCTR)	30/06/2010	17/03/2010	A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis	A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM	Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development LLC	NULL	Not Recruiting			Female: yes Male: yes	1000	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany
247	NCT01124149 (ClinicalTrials.gov)	June 29, 2010	13/5/2010	Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis	A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis	Ulcerative Colitis	Drug: MMX mesalamine/ mesalazine	Shire	NULL	Completed	18 Years	N/A	All	759	Phase 4	United States;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;India;Ireland;Poland;Romania;South Africa;Spain;United Kingdom;Brazil;Czech Republic
248	EUCTR2009-017044-13-ES (EUCTR)	25/06/2010	19/04/2010	Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis	Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis	Colitis UlcerosaUlcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine	Shire Development Inc.	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 4	France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom
249	NCT01149707 (ClinicalTrials.gov)	June 1, 2010	22/6/2010	Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis	A 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis	Left-Sided Ulcerative Colitis;Proctosigmoiditis	Drug: PUR 0110 Rectal Enema 250 mg;Drug: PUR 0110 Rectal Enema 500 mg;Drug: PUR 0110 Rectal Enema 1000 mg;Drug: Placebo Enema	PurGenesis Technologies Inc.	NULL	Completed	18 Years	75 Years	All	34	Phase 2	Germany
250	EUCTR2009-013890-16-PT (EUCTR)	28/05/2010	21/12/2009	Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica	Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica	This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy.Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients. MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856	Trade Name: Remicade Product Name: Remicade	GEDII - Grupo de Estudo da Doença inflamatória Intestinal	NULL	Not Recruiting			Female: yes Male: yes	20		Portugal
251	EUCTR2009-017839-18-DE (EUCTR)	14/05/2010	16/02/2010	A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS	A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS	Active mild-to-moderate distal ulcerative colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Product Name: PUR 0110 Product Code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex)	PurGenesis Techonologies Inc.	NULL	Not Recruiting			Female: yes Male: yes	56		Germany
252	NCT04753775 (ClinicalTrials.gov)	March 10, 2010	9/2/2021	RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.	RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.	Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)	Drug: Aloe vera gel	Ospedale Sandro Pertini, Roma	NULL	Completed	18 Years	N/A	All	44	N/A	NULL
253	NCT01020708 (ClinicalTrials.gov)	November 2009	20/11/2009	Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis	A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis	Ulcerative Colitis	Drug: mesalamine;Drug: ALTH12-1:4;Drug: ALTH12-2:4	Altheus Therapeutics, Inc.	NULL	Completed	18 Years	64 Years	Both	9	Phase 1	United States
254	EUCTR2007-003815-30-PT (EUCTR)	31/07/2009	05/03/2009	An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis	An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis	Mild or Moderately Active Steroid Dependent Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders	Trade Name: Dacortin Product Name: prednisone INN or Proposed INN: Prednisone INN or Proposed INN: Prednisone Trade Name: Dacortin Product Name: prednisone Product Code: H02AB INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE	GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)	NULL	Not Recruiting			Female: yes Male: yes			Portugal;Spain
255	NCT01149694 (ClinicalTrials.gov)	June 2009	22/6/2010	A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers	A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers	Ulcerative Colitis	Drug: PUR 0110 Rectal Enema or Placebo Enema	PurGenesis Technologies Inc.	NULL	Completed	18 Years	55 Years	Male	24	Phase 1	Germany
256	EUCTR2008-002784-14-ES (EUCTR)	02/04/2009	18/11/2008	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC)	A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s DiseaseEstudio abierto, de fase 3 para determinar la eficacia y la seguridad a largo plazo de MLN0002 en los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC)	Ulcerative Colitis and Crohn?s DiseaseColitis ulcerosa (CU) y enfermedad de Crohn (EC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1508	Phase 3	Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden
257	EUCTR2008-002782-32-ES (EUCTR)	02/03/2009	23/10/2008	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave	Moderate to Severe Ulcerative ColitisColitis ulcerosa moderada o grave MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB	Millennium Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	826	Phase 3	Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland
258	JPRN-UMIN000008967	2009/01/01	24/09/2012	Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis	Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis - Efficacy of Polaprezinc enema in UC	Ulcerative Colitis	Polaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week Placebo group: 100 mL tap water enema daily for one week	The Jikei University School of MedicineDivision of Gastroenterology and Hepatology	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	30	Not applicable	Japan
259	EUCTR2008-004564-40-ES (EUCTR)	15/12/2008	17/10/2008	ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP 690,550 EN SUJETOS CON COLITIS ULCEROSA DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP 690,550 EN SUJETOS CON COLITIS ULCEROSA DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	CP 690,550 es un fármaco en desarrollo para el tratamiento de los pacientes con colitis ulcerosa de moderada a grave.CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Code: CP-690,550 Product Code: CP-690,550 Product Code: CP-690,550	Pfizer S.A	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden
260	EUCTR2008-004610-27-ES (EUCTR)	25/11/2008	26/09/2008	Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis	Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Dersalazina sodica INN or Proposed INN: dersalazine sodium Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE	Palau Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Hungary;Slovakia;Belgium;Spain
261	EUCTR2008-000967-40-NL (EUCTR)	03/11/2008	30/05/2008	A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis	A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis	Moderately Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011	ActoGeniX NV.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Netherlands;Belgium;Sweden
262	NCT00737789 (ClinicalTrials.gov)	November 2008	19/8/2008	Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.	Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.	Ulcerative Colitis	Drug: Mesalazine slow-release granules;Drug: Mesalazine liquid enema	Ferring Pharmaceuticals	NULL	Completed	18 Years	N/A	Both	206	Phase 3	Belgium;France;Netherlands;United Kingdom
263	EUCTR2006-004776-12-IT (EUCTR)	15/10/2008	20/03/2009	Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02	Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02	Patients with mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide Trade Name: ENTOCORT CR INN or Proposed INN: Budesonide Product Name: Budesonide MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide	COSMO TECHNOLOGIES LTD	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
264	EUCTR2006-004776-12-SK (EUCTR)	18/09/2008	16/07/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden
265	ChiCTR-TRC-08000145	2008-09-01	2008-08-25	The study of the treatment and rehabilitation of ulcerative colitis	The study of the treatment and rehabilitation of ulcerative colitis	Ulcerative Colitis	1:5-ASA and low residue diet;2:5-ASA and EN;3:5-ASA and low residue diet and microecology prepar;4:5-ASA and low residue diet ang Gln;5:5-ASA and EN and Gln and microecology preparation;	Friendship Hospital of Capital Medical University	NULL	Completed	18	70	Both	1:60;2:60;3:60;4:60;5:60;	I (Phase 1 study)	China
266	EUCTR2008-000967-40-SE (EUCTR)	29/08/2008	04/06/2008	A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis	A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis	Moderately Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011	ActoGeniX NV.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Netherlands;Belgium;Sweden
267	EUCTR2006-004776-12-EE (EUCTR)	04/08/2008	11/06/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;France;Estonia;Italy;Latvia;Lithuania;Sweden
268	EUCTR2007-005166-12-DE (EUCTR)	29/07/2008	15/01/2008	A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine	A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine	active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract)	Hutchison MediPharma Enterprises Limited	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Germany
269	EUCTR2006-004776-12-GB (EUCTR)	23/07/2008	25/04/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492	Phase 3	France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden
270	EUCTR2006-004776-12-FR (EUCTR)	07/07/2008	09/05/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
271	EUCTR2006-004776-12-BE (EUCTR)	01/07/2008	18/06/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
272	EUCTR2006-004776-12-LT (EUCTR)	17/06/2008	22/04/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Sweden;Lithuania
273	EUCTR2008-000967-40-BE (EUCTR)	13/06/2008	05/08/2008	A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis	A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis	Moderately Active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Enema Product Code: AG011 Product Name: AG011 - Capsules Product Code: AG011	ActoGeniX N.V	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Netherlands;Belgium;Sweden
274	EUCTR2006-004776-12-SE (EUCTR)	02/06/2008	10/04/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
275	NCT00679432 (ClinicalTrials.gov)	June 2008	14/5/2008	(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis	Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.	Ulcerative Colitis	Procedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mg	Bausch Health Americas, Inc.	NULL	Completed	18 Years	75 Years	All	510	Phase 3	United States;Canada;India;Mexico
276	NCT00679380 (ClinicalTrials.gov)	June 2008	14/5/2008	(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis	Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC	Ulcerative Colitis	Procedure: Blood sampling, endoscopy;Drug: Budesonide MMX® 6 mg;Drug: Budesonide MMX® 9 mg;Drug: Entocort EC® 3 mg;Drug: Placebo	Bausch Health Americas, Inc.	Cosmo Technologies Ltd	Completed	18 Years	75 Years	All	514	Phase 3	Australia;Belgium;Estonia;France;Israel;Italy;Latvia;Lithuania;Poland;Romania;Russian Federation;Slovakia;Sweden;Ukraine;United Kingdom
277	EUCTR2006-004776-12-LV (EUCTR)	29/05/2008	29/04/2008	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC	Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02	COSMO Technologies Ltd	NULL	Not Recruiting			Female: yes Male: yes	492		United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
278	EUCTR2006-005299-42-BE (EUCTR)	20/05/2008	07/03/2008	A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF	A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF	- Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Finland;Belgium;France;Spain
279	EUCTR2006-005299-42-ES (EUCTR)	19/05/2008	03/03/2008	Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF	Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF	Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis)	Trade Name: Sandimmum Product Name: ciclosporina Trade Name: Remicade Product Name: infliximab	GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Finland;Belgium;France;Spain
280	EUCTR2007-004732-23-PL (EUCTR)	05/05/2008	12/05/2008	A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)	A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)	Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative	Product Name: Mesalamine INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE	EMET Pharmaceuticals, LLC	NULL	Not Recruiting			Female: yes Male: yes	435		Estonia;Latvia;Poland
281	EUCTR2007-007702-30-IT (EUCTR)	03/04/2008	08/07/2008	Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND	Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND	Ulcerative colitis MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB	COSMO TECHNOLOGIES LTD	NULL	Not Recruiting			Female: no Male: yes			Italy
282	EUCTR2007-004732-23-LV (EUCTR)	27/02/2008	28/02/2008	A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis	A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis	Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE	EMET Pharmaceuticals LLC	NULL	Not Recruiting			Female: yes Male: yes	435		Estonia;Latvia;Poland
283	NCT01045018 (ClinicalTrials.gov)	January 2008	17/12/2009	A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis	BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis	Mild to Moderate Ulcerative Colitis	Drug: Placebo;Drug: Mesalamine	EMET Pharmaceuticals, LLC	Eagle Pharmaceuticals, Inc.	Completed	18 Years	N/A	Both		Phase 3	NULL
284	EUCTR2006-005377-22-ES (EUCTR)	12/12/2007	29/10/2007	Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa	Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa	Tratamiento de colitis ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis	Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes	360	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany
285	EUCTR2006-004230-32-PL (EUCTR)	07/12/2007	05/09/2007	EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study	EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study	Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Clipper INN or Proposed INN: Beclomethasone diproprionate Trade Name: Deltacortene INN or Proposed INN: Prednisone Trade Name: Deltacortene INN or Proposed INN: Prednisone	Chiesi Farmaceutici SpA	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Belgium;Spain;Poland;Italy
286	EUCTR2007-003815-30-ES (EUCTR)	27/11/2007	24/10/2007	Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada.	Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada.	Colitis ulcerosa corticodependiente leve o moderada MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: DACORTIN Product Name: PREDNISONE INN or Proposed INN: PREDNISONE Other descriptive name: N/A	GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)	NULL	Not Recruiting			Female: yes Male: yes			Portugal;Spain
287	EUCTR2007-004732-23-EE (EUCTR)	22/10/2007	23/10/2007	A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis	A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis	Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative	Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE	EMET Pharmaceuticals LLC	NULL	Not Recruiting			Female: yes Male: yes	435		Estonia;Latvia;Poland
288	EUCTR2006-002670-22-ES (EUCTR)	20/09/2007	26/07/2007	Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte).	Comparación de la eficacia y la seguridad del infliximab, en monoterapia o en combinación con azatioprina, y la azatioprina en monoterapia en la colitis ulcerosa activa de moderada a grave (1.ª parte). Comparación del tratamiento de mantenimiento y el tratamiento intermitente con infliximab en la conservación de la remisión: seguimiento de la eficacia y la seguridad (2.ª parte).	Colitis Ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 INN or Proposed INN: azathioprine	Schering-Plough Research Institute, a division of Schering Corporation	NULL	Not Recruiting			Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Germany;Italy;United Kingdom
289	EUCTR2006-004230-32-ES (EUCTR)	22/08/2007	26/09/2007	EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA	EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA	Colitis ulcerosa activa, extendiéndose en sentido proximal más allá del recto. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Clipper INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE	Chiesi Farmaceutici SpA	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 3	Belgium;Poland;Spain;Italy
290	NCT02093767 (ClinicalTrials.gov)	August 2007	19/3/2014	Oligofructose-enriched Inulin for the Treatment of Mild to Moderate Active Ulcerative Colitis	Open-Label Trial of a Prebiotic Preparation Containing Inulin and Oligofructose (Synergy-1) for the Treatment of Mild to Moderate Acute Ulcerative Colitis	Ulcerative Colitis	Dietary Supplement: Synergy1	University of Alberta	Canadian Institutes of Health Research (CIHR);Crohn's and Colitis Canada;Beneo GmbH	Completed	18 Years	65 Years	All	24	N/A	Canada
291	JPRN-JapicCTI-070399	22/6/2007	21/05/2007	An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis	An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis	Active ulcerative colitis	Intervention name : Rebamipide INN of the intervention : Rebamipide Dosage And administration of the intervention : Intracolonial (enema) Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Intracolonial (enema)	Otsuka Pharmaceutical Co., Ltd.	NULL	complete	16		BOTH	120	Phase 2	Japan
292	EUCTR2006-005299-42-FR (EUCTR)	16/05/2007	06/03/2007	A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF	A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF	- Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC	Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN	GETAID	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Finland;Belgium;France;Spain
293	EUCTR2006-002782-40-ES (EUCTR)	23/03/2007	05/02/2007	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.	A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.	Moderately to severely active ulcerative colitis.Colitis Ulcerosa Activa de Intensidad Moderada a Severa MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis	Trade Name: Humira INN or Proposed INN: Adalimumab	Abbott GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	500		Portugal;France;Czech Republic;Hungary;Belgium;Spain;Austria;Denmark;Germany
294	EUCTR2006-004162-13-DE (EUCTR)	27/02/2007	06/10/2006	Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients	Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients	Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano. MedDRA version: 8.1;Level: LLT;Classification code 10021972;Term: Inflammatory bowel disease	Trade Name: Salofalk 4g/60ml Klysma INN or Proposed INN: MESALAZINE	Charité Universitätsmedizin, Campus Charité Mitte	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Germany
295	EUCTR2006-002036-25-GB (EUCTR)	09/11/2006	15/02/2012	Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC	Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC	Ulcerative Colitis	Product Name: Epidermal growth factor enema Product Code: EGF enema INN or Proposed INN: Epidermal growth factor Trade Name: Pentasa enema Product Name: Pentasa INN or Proposed INN: mesalazine enema	University Hospitals of Leicester NHS Trust	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 3	United Kingdom
296	ChiCTR-TRC-08000048	2006-10-01	2008-01-17	A multicenter, double-blind, randomized controlled trial: Traditional Chinese Medicine treatment for ulcerative colitis	Intervention and efficacy evaluation study of Traditional Chinese Medicine for ulcerative colitis	Ulcerative colitis	Controlled group:Take mesalazine 1g Qid in active stage. Sustain the treatment for another week after the symptoms relieve. Then take 0.5g Tid and adjust the dosage according to the condition. The treatment lasts for 6 months.;Experimental group:Take the intestine-clearing and dissipating dampness formula 2 times a day in the 1st stage. Enema is given once a day for 12 days. Take health-supporting and intestine-clearing formula for spleen and stomach deficiency 2 times a day. The treatment lasts for 6 months;	The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine	NULL	Completed	18	65	Both	Controlled group:112;Experimental group:112;	I (Phase 1 study)	China
297	EUCTR2005-003482-17-ES (EUCTR)	26/05/2006	15/03/2006	A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos.	A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos.	Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0;Level: LLT;Classification code 10045265	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	United Kingdom;Ireland;Spain;Italy;Greece
298	EUCTR2005-003481-42-ES (EUCTR)	26/05/2006	15/03/2006	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab.	A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab.	Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsos MedDRA version: 8.0;Level: LLT;Classification code 10045265	Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody	PDL BioPharma, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80		Hungary;Germany;Czech Republic;Slovakia;Ireland;Spain;Italy;Greece
299	NCT00326209 (ClinicalTrials.gov)	December 22, 2005	12/5/2006	Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission	A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation	Ulcerative Colitis	Drug: Encapsulated Mesalamine Granules (eMG)	Bausch Health Americas, Inc.	NULL	Completed	18 Years	N/A	All	393	Phase 3	United States
300	NCT00269438 (ClinicalTrials.gov)	December 2005	22/12/2005	New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis	Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy	Ulcerative Colitis	Drug: 5 ASA, enemas, suppositories, corticosteroids	Bausch Health Americas, Inc.	NULL	Completed	18 Years	80 Years	All	225	Phase 3	United States
301	EUCTR2004-000734-36-CZ (EUCTR)	13/07/2005	08/10/2004	A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.	A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.	Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study	Product Name: Mesalazine Product Code: SPD476 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA)	Shire Pharmaceutical Development Inc.	NULL	Not Recruiting			Female: yes Male: yes	125	Phase 3	Czech Republic
302	EUCTR2004-001677-26-ES (EUCTR)	14/01/2005	01/06/2005	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE	Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE	Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0;Level: LLT;Classification code 10045365	Product Name: Nolpitantium besylate Product Code: SR140333B INN or Proposed INN: Nolpitantium besylate	Sanofi-Synthelabo Recherche	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Estonia;Czech Republic;Hungary;Spain;Italy;Sweden
303	EUCTR2004-000733-12-CZ (EUCTR)	14/07/2004	01/07/2004	A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.	A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.	Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.	Product Name: Mesalazine Product Code: SPD476 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA)	Shire Pharmaceutical Development Inc	NULL	Not Recruiting			Female: yes Male: yes	255	Phase 3	Czech Republic
304	NCT00063830 (ClinicalTrials.gov)	April 3, 2003	7/7/2003	ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis.	ISIS 2302-CS27, Phase 2, Double-Blinded, Controlled Study of Four Dosing Regimens of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis	Ulcerative Colitis	Drug: Alicaforsen	Ionis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All		Phase 2	United States
305	NCT00063414 (ClinicalTrials.gov)	November 20, 2002	25/6/2003	ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis	ISIS 2302-CS22, Phase II, Double-Blinded, Active-Controlled Study of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis (Left-Sided Colitis or Pancolitis With Left Sided Disease Flare)	Ulcerative Colitis	Drug: Alicaforsen	Ionis Pharmaceuticals, Inc.	NULL	Completed	18 Years	N/A	All		Phase 2	United States
306	NCT00061282 (ClinicalTrials.gov)	September 30, 2002	23/5/2003	Clotrimazole Enemas for Pouchitis in Children and Adults	Clotrimazole Enemas for Pouchitis in Children and Adults	Ulcerative Colitis;Pouchitis;Ileitis;Inflammatory Bowel Disease	Drug: Clotrimazole	Web	NULL	Terminated	2 Years	N/A	All	11	Phase 1/Phase 2	United States
307	EUCTR2020-004300-34-BE (EUCTR)		26/01/2022	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	NA			Female: yes Male: yes	120	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of
308	EUCTR2017-002231-41-FR (EUCTR)		15/12/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
309	EUCTR2021-000630-34-PL (EUCTR)		05/10/2022	A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease	A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease	Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	NA			Female: yes Male: yes	93	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of
310	EUCTR2021-000630-34-CZ (EUCTR)		27/10/2022	A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease	A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease	Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	NA			Female: yes Male: yes	93	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Australia;China;Japan;Korea, Republic of
311	EUCTR2020-004300-34-CZ (EUCTR)		28/04/2021	A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy	Moderately to severely active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002	Takeda Development Center Americas, Inc.	NULL	NA			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
312	EUCTR2007-005702-49-PL (EUCTR)		17/06/2009	A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II	A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II	Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents MedDRA version: 11.0;Level: LLT;Classification code 10045365;Term: entered code. Term in E.1.1>	Trade Name: Asacol Product Name: Asacol Product Code: NA INN or Proposed INN: MESALAZINE	Procter & Gamble Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Poland

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